Research Publications

Hepatocyte spheroids as a viable in vitro model for recapitulation of complex in vivo metabolism pathways of loratadine in humans.

Chacko SA, Ly VT, Christopher LJ, Gan J.

Xenobiotica. 2020 Jun;50(6):621-629. doi: 10.1080/00498254.2019.1675100. Epub 2019 Oct 10.

PMID: 31566996

 

Corrigendum to "A systematic strategy for estimating hERG block potency and its implications in a new cardiac safety paradigm" [Toxicology and Applied Pharmacology volume 394C (2020) 114961].

Ridder BJ, Leishman DJ, Bridgland-Taylor M, Samieegohar M, Han X, Wu WW, Randolph A, Tran P, Sheng J, Danker T, Lindqvist A, Konrad D, Hebeisen S, Polonchuk L, Gissinger E, Renganathan M, Koci B, Wei H, Fan J, Levesque P, Kwagh J, Imredy J, Zhai J, Rogers M, Humphries E, Kirby R, Stoelzle-Feix S, Brinkwirth N, Rotordam MG, Becker N, Friis S, Rapedius M, Goetze TA, Strassmaier T, Okeyo G, Kramer J, Kuryshev Y, Wu C, Himmel H, Mirams GR, Strauss DG, Bardenet R, Li Z.

Toxicol Appl Pharmacol. 2020 May 15;395:114983. doi: 10.1016/j.taap.2020.114983. Epub 2020 Apr 2. No abstract available.

PMID: 32247767

 

Bridging size and charge variants of a therapeutic monoclonal antibody by two-dimensional liquid chromatography.

Chen Z, Zeng M, Park SJ, Balakrishnan G, Zhou K, Pan D, Das TK.

J Pharm Biomed Anal. 2020 May 10;183:113178. doi: 10.1016/j.jpba.2020.113178. Epub 2020 Feb 14.

PMID: 32086124

 

Response to "Letter to the Editor concerning: 'A systematic review of network meta-analyses among patients with nonvalvular atrial fibrillation: A comparison of efficacy and safety following treatment with direct oral anticoagulants'".

Cohen AT, Hill NR, Luo X, Masseria C, Abariga SA, Ashaye AO.

Int J Cardiol. 2020 May 1;306:101. doi: 10.1016/j.ijcard.2019.11.141. Epub 2019 Nov 28. No abstract available.

PMID: 31898985

 

A systematic strategy for estimating hERG block potency and its implications in a new cardiac safety paradigm.

Ridder BJ, Leishman DJ, Bridgland-Taylor M, Samieegohar M, Han X, Wu WW, Randolph A, Tran P, Sheng J, Danker T, Lindqvist A, Konrad D, Hebeisen S, Polonchuk L, Gissinger E, Renganathan M, Koci B, Wei H, Fan J, Levesque P, Kwagh J, Imredy J, Zhai J, Rogers M, Humphries E, Kirby R, Stoelzle-Feix S, Brinkwirth N, Rotordam MG, Becker N, Friis S, Rapedius M, Goetze TA, Strassmaier T, Okeyo G, Kramer J, Kuryshev Y, Wu C, Himmel H, Mirams GR, Strauss DG, Bardenet R, Li Z.

Toxicol Appl Pharmacol. 2020 May 1;394:114961. doi: 10.1016/j.taap.2020.114961. Epub 2020 Mar 21. Erratum in: Toxicol Appl Pharmacol. 2020 Apr 2;:114983.

PMID: 32209365

 

Urelumab alone or in combination with rituximab in patients with relapsed or refractory B-cell lymphoma.

Timmerman J, Herbaux C, Ribrag V, Zelenetz AD, Houot R, Neelapu SS, Logan T, Lossos IS, Urba W, Salles G, Ramchandren R, Jacobson C, Godwin J, Carpio C, Lathers D, Liu Y, Neely J, Suryawanshi S, Koguchi Y, Levy R.

Am J Hematol. 2020 May;95(5):510-520. doi: 10.1002/ajh.25757. Epub 2020 Feb 29.

PMID: 32052473

 

Immunosuppression and the risk of readmission and mortality in patients with rheumatoid arthritis undergoing hip fracture, abdominopelvic and cardiac surgery.

George MD, Baker JF, Winthrop KL, Goldstein SD, Alemao E, Chen L, Wu Q, Xie F, Curtis JR.

Ann Rheum Dis. 2020 May;79(5):573-580. doi: 10.1136/annrheumdis-2019-216802. Epub 2020 Mar 24.

PMID: 32209540

 

Disruptive innovation in rheumatology: new networks of global public-private partnerships are needed to take advantage of scientific progress.

Huizinga TW, Holers VM, Anolik J, Brenner MB, Buckley CD, Bykerk V, Connolly SE, Deane KD, Guo J, Hodge M, Hoffmann S, Nestle F, Pitzalis C, Raychaudhuri S, Yamamoto K, Li Z, Klareskog L.

Ann Rheum Dis. 2020 May;79(5):553-555. doi: 10.1136/annrheumdis-2019-216846. Epub 2020 Mar 5. Review. No abstract available.

PMID: 32139419

 

Physiologically-Based Pharmacokinetic Models for Evaluating Membrane Transporter Mediated Drug-Drug Interactions: Current Capabilities, Case Studies, Future Opportunities, and Recommendations.

Taskar KS, Pilla Reddy V, Burt H, Posada MM, Varma M, Zheng M, Ullah M, Emami Riedmaier A, Umehara KI, Snoeys J, Nakakariya M, Chu X, Beneton M, Chen Y, Huth F, Narayanan R, Mukherjee D, Dixit V, Sugiyama Y, Neuhoff S.

Clin Pharmacol Ther. 2020 May;107(5):1082-1115. doi: 10.1002/cpt.1693. Epub 2019 Dec 31. Review.

PMID: 31628859

 

Patient-reported outcome measures in studies of myelodysplastic syndromes and acute myeloid leukemia: Literature review and landscape analysis.

Stauder R, Lambert J, Desruol-Allardin S, Savre I, Gaugler L, Stojkov I, Siebert U, Chevrou-Séverac H.

Eur J Haematol. 2020 May;104(5):476-487. doi: 10.1111/ejh.13389. Epub 2020 Mar 3.

PMID: 31985078

 

Characterization of BAY 1905254, an immune checkpoint inhibitor targeting the immunoglobulin-like domain containing receptor 2 (ILDR2).

Huetter J, Gritzan U, Gutcher I, Doecke WD, Luetke-Eversloh MV, Golfier S, Roider HG, Frisk AL, Hunter J, Pow A, Drake A, Levine Z, Levy O, Azulay M, Barbiro I, Cojocaru G, Vaknin I, Kreft B, Roese L.

Cancer Immunol Res. 2020 Apr 20. pii: canimm.0321.2019. doi: 10.1158/2326-6066.CIR-19-0321. [Epub ahead of print]

PMID: 32312711

 

Comparative efficacy and safety of current therapies for early rheumatoid arthritis: a systematic literature review and network meta-analysis.

Paul D, Fazeli MS, Mintzer L, Duarte L, Gupta K, Ferri L.

Clin Exp Rheumatol. 2020 Apr 17. [Epub ahead of print] Review.

PMID: 32301430

 

Is aspirin a substrate of MDR1/P-glycoprotein?

Singh R, Naik T, Nigam A, Chatterjee S, Rajanna P, Shen H, Iyer R.

Xenobiotica. 2020 Apr 17:1-26. doi: 10.1080/00498254.2020.1757785. [Epub ahead of print]

PMID: 32302241

 

Pomalidomide-bortezomib-dexamethasone in relapsed or refractory multiple myeloma: Japanese subset analysis of OPTIMISMM.

Sunami K, Matsue K, Suzuki K, Takezako N, Shinagawa A, Sakurai S, Tamakoshi H, Biyukov T, Peluso T, Richardson P.

Cancer Sci. 2020 Apr 16. doi: 10.1111/cas.14415. [Epub ahead of print]

PMID: 32297407

 

Minimization of artifact protein aggregation using tetradecyl sulfate and hexadecyl sulfate in capillary gel electrophoresis under reducing conditions.

Guan Q, Atsma J, Tulsan R, Voronov S, Ding J, Beckman J, Li ZJ.

Electrophoresis. 2020 Apr 16. doi: 10.1002/elps.201900435. [Epub ahead of print]

PMID:32297333

 

Characterization of a novel hydroxypropyl methylcellulose (HPMC) direct compression grade excipient for pharmaceutical tablets.

Allenspach C, Timmins P, Sharif S, Minko T.

Int J Pharm. 2020 Apr 16:119343. doi: 10.1016/j.ijpharm.2020.119343. [Epub ahead of print]

PMID: 32305364

 

Modified Goldilocks Design with strict type I error control in confirmatory clinical trials.

Zhan T, Zhang H, Hartford A, Mukhopadhyay S.

J Biopharm Stat. 2020 Apr 16:1-13. doi: 10.1080/10543406.2020.1744620. [Epub ahead of print]

PMID: 32297825

 

High-Throughput Platform to Identify Antibody Conjugation Sites from Antibody-Drug Conjugate Libraries.

Yamazoe S, Hogan JM, West SM, Deng XA, Kotapati S, Shao X, Holder P, Lamba V, Huber M, Qiang C, Gangwar S, Rao C, Dollinger G, Rajpal A, Strop P.

Bioconjug Chem. 2020 Apr 15;31(4):1199-1208. doi: 10.1021/acs.bioconjchem.0c00146. Epub 2020 Mar 27.

PMID: 32178516

 

Evaluation of correlation between bioanalytical methods.

Gleason CR, Ji QC, Wickremsinhe ER.

Bioanalysis. 2020 Apr 14. doi: 10.4155/bio-2020-0019. [Epub ahead of print]

PMID: 32285680

 

The Connect CLL Registry: final analysis of 1494 patients with chronic lymphocytic leukemia across 199 US sites.

Mato A, Nabhan C, Lamanna N, Kay NE, Grinblatt DL, Flowers CR, Farber CM, Davids MS, Swern AS, Sullivan K, Flick ED, Gressett Ussery SM, Gharibo M, Kiselev P, Sharman JP.

Blood Adv. 2020 Apr 14;4(7):1407-1418. doi: 10.1182/bloodadvances.2019001145.

PMID: 32271900

The Unfolded Protein Response Mediator PERK Governs Myeloid Cell-Driven Immunosuppression in Tumors through Inhibition of STING Signaling.

Mohamed E, Sierra RA, Trillo-Tinoco J, Cao Y, Innamarato P, Payne KK, de Mingo Pulido A, Mandula J, Zhang S, Thevenot P, Biswas S, Abdalla SK, Costich TL, Hänggi K, Anadon CM, Flores ER, Haura EB, Mehrotra S, Pilon-Thomas S, Ruffell B, Munn DH, Cubillos-Ruiz JR, Conejo-Garcia JR, Rodriguez PC.

Immunity. 2020 Apr 14;52(4):668-682.e7. doi: 10.1016/j.immuni.2020.03.004.

PMID: 32294407

 

Characteristics and Outcomes of Patients Treated With Apremilast in the Real World: Results From the APPRECIATE Study.

Augustin M, Kleyn CE, Conrad C, Sator PG, Ståhle M, Eyerich K, Radtke MA, Bundy C, Mellars L, Greggio C, Cordey M, Koscielny V, Griffiths CEM.

J Eur Acad Dermatol Venereol. 2020 Apr 11. doi: 10.1111/jdv.16431. [Epub ahead of print]

PMID: 32279378

 

Macrofilaricides: An Unmet Medical Need for Filarial Diseases.

Hawryluk NA.

ACS Infect Dis. 2020 Apr 10;6(4):662-671. doi: 10.1021/acsinfecdis.9b00469. Epub 2020 Mar 5.

PMID: 32091199

 

Nickel/Photoredox-Catalyzed Methylation of (Hetero)aryl Chlorides Using Trimethyl Orthoformate as a Methyl Radical Source.

Kariofillis SK, Shields BJ, Tekle-Smith MA, Zacuto MJ, Doyle AG.

J Am Chem Soc. 2020 Apr 10. doi: 10.1021/jacs.0c02805. [Epub ahead of print]

PMID: 32275411

 

The economic burden to payers of patients with diffuse large B-cell lymphoma during the treatment period by line of therapy.

Tkacz J, Garcia J, Gitlin M, McMorrow D, Snyder S, Bonafede M, Chung KC, Maziarz RT.

Leuk Lymphoma. 2020 Apr 9:1-9. doi: 10.1080/10428194.2020.1734592. [Epub ahead of print]

PMID: 32270727

 

Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma.

Weisel K, Dimopoulos M, Moreau P, Yagci M, Larocca A, Kanate AS, Vural F, Cascavilla N, Basu S, Johnson P, Byeff P, Hus M, Rodríguez-Otero P, Muelduer E, Anttila P, Hayden PJ, Krauth MT, Lucio P, Ben-Yehuda D, Mendeleeva L, Guo S, Yu X, Grote L, Biyukov T, Dhanasiri S, Richardson P.

Leuk Lymphoma. 2020 Apr 9:1-10. doi: 10.1080/10428194.2020.1747066. [Epub ahead of print]

PMID: 32268815

 

An Improved P_III/P_V═O-Catalyzed Reductive C-N Coupling of Nitroaromatics and Boronic Acids by Mechanistic Differentiation of Rate- and Product-Determining Steps.

Li G, Nykaza TV, Cooper JC, Ramirez A, Luzung MR, Radosevich AT.

J Am Chem Soc. 2020 Apr 8;142(14):6786-6799. doi: 10.1021/jacs.0c01666. Epub 2020 Mar 25.

PMID: 32178514

 

Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study.

Cortes JE, Jiang Q, Wang J, Weng J, Zhu H, Liu X, Hochhaus A, Kim DW, Radich J, Savona M, Martin-Regueira P, Sy O, Gurnani R, Saglio G.

Leukemia. 2020 Apr 7. doi: 10.1038/s41375-020-0805-1. [Epub ahead of print]

PMID: 32265500

 

CXCR1 and CXCR2 Chemokine Receptor Agonists Produced by Tumors Induce Neutrophil Extracellular Traps that Interfere with Immune Cytotoxicity.

Teijeira Á, Garasa S, Gato M, Alfaro C, Migueliz I, Cirella A, de Andrea C, Ochoa MC, Otano I, Etxeberria I, Andueza MP, Nieto CP, Resano L, Azpilikueta A, Allegretti M, de Pizzol M, Ponz-Sarvisé M, Rouzaut A, Sanmamed MF, Schalper K, Carleton M, Mellado M, Rodriguez-Ruiz ME, Berraondo P, Perez-Gracia JL, Melero I.

Immunity. 2020 Apr 6. pii: S1074-7613(20)30089-3. doi: 10.1016/j.immuni.2020.03.001. [Epub ahead of print]

PMID: 32289253

 

Congruent Release of Drug and Polymer from Amorphous Solid Dispersions: Insights into the Role of Drug-Polymer Hydrogen Bonding, Surface Crystallization, and Glass Transition.

Saboo S, Kestur US, Flaherty DP, Taylor LS.

Mol Pharm. 2020 Apr 6;17(4):1261-1275. doi: 10.1021/acs.molpharmaceut.9b01272. Epub 2020 Mar 17.

PMID: 32134677

 

Investigation of Within-Tablet Dynamics for Extended Release of a Poorly Soluble Basic Drug from Hydrophilic Matrix Tablets Using ATR-FTIR Imaging.

Zahoor FD, Mader KT, Timmins P, Brown J, Sammon C.

Mol Pharm. 2020 Apr 6;17(4):1090-1099. doi: 10.1021/acs.molpharmaceut.9b01063. Epub 2020 Mar 2.

PMID: 32069060

 

Effects of repeated oral doses of ketoconazole on a sequential ascending single oral dose of fedratinib in healthy subjects.

Ogasawara K, Xu C, Kanamaluru V, Palmisano M, Krishna G.

Cancer Chemother Pharmacol. 2020 Apr 4. doi: 10.1007/s00280-020-04067-3. [Epub ahead of print]

PMID: 32248324

 

Disruption of Glycogen Utilization Markedly Improves the Efficacy of Carboplatin against Preclinical Models of Clear Cell Ovarian Carcinoma.

Khan T, He Y, Kryza T, Harrington BS, Gunter JH, Sullivan MA, Cuda T, Rogers R, Davies CM, Broomfield A, Gough M, Wu AC, McGann T, Weroha SJ, Haluska P, Forbes JM, Armes JE, Barry SC, Coward JI, Jagasia N, Chetty N, Snell CE, Lourie R, Perrin LC, Hooper JD.

Cancers (Basel). 2020 Apr 3;12(4). pii: E869. doi: 10.3390/cancers12040869.

PMID: 32260077

 

Factors associated with non-prescription of oral anticoagulant treatment in non-valvular atrial fibrillation patients with dementia: a CPRD-HES study.

Besford M, Graham S, Sammon C, Mehmud F, Allan V, Alikhan R, Ramagopalan S.

Age Ageing. 2020 Apr 2. pii: afaa045. doi: 10.1093/ageing/afaa045. [Epub ahead of print]

PMID: 32242616

 

Reduced Apolipoprotein M and Adverse Outcomes Across the Spectrum of Human Heart Failure.

Chirinos JA, Zhao L, Jia Y, Frej C, Adamo L, Mann D, Shewale SV, Millar JS, Rader DJ, French B, Brandimarto J, Margulies KB, Parks JS, Wang Z, Sieffert DA, Fang J, Sweitzer N, Christoffersen C, Dahlbäck B, Car BD, Gordon DA, Cappola TP, Javaheri A.

Circulation. 2020 Apr 2. doi: 10.1161/CIRCULATIONAHA.119.045323. [Epub ahead of print]

PMID: 32237898

 

Discovery and SAR of aryl hydroxy pyrimidinones as potent small molecule agonists of the GPCR APJ.

Myers MC, Bilder DM, Cavallaro CL, Chao HJ, Su S, Burford NT, Nayeem A, Wang T, Yan M, Langish RA, Dabros M, Li YX, Rose AV, Behnia K, Onorato JM, Gargalovic PS, Wexler RR, Lawrence RM.

Bioorg Med Chem Lett. 2020 Apr 1;30(7):126955. doi: 10.1016/j.bmcl.2020.126955. Epub 2020 Jan 22.

PMID: 32035698

Circulating and tissue matricellular RNA and protein expression in calcific aortic valve disease.

Kossar AP, Anselmo W, Grau JB, Liu Y, Small A, Carter SL, Salvador L, Zhao L, Cvijic ME, Li Z, Yarde M, Rioux N, Rader DJ, Levy RJ, Ferrari G.

Physiol Genomics. 2020 Apr 1;52(4):191-199. doi: 10.1152/physiolgenomics.00104.2019. Epub 2020 Feb 24.

PMID: 32089075

 

Comparative safety of biologic versus conventional synthetic DMARDs in rheumatoid arthritis with COPD: a real-world population study.

Hudson M, Dell'Aniello S, Shen S, Simon TA, Ernst P, Suissa S.

Rheumatology (Oxford). 2020 Apr 1;59(4):820-827. doi: 10.1093/rheumatology/kez359.

PMID: 31504972

Economic Evaluation of Chimeric Antigen Receptor T-Cell Therapy by Site of Care Among Patients With Relapsed or Refractory Large B-Cell Lymphoma.

Lyman GH, Nguyen A, Snyder S, Gitlin M, Chung KC.

JAMA Netw Open. 2020 Apr 1;3(4):e202072. doi: 10.1001/jamanetworkopen.2020.2072.

PMID: 32250433

 

Lenalidomide maintenance for diffuse large B-cell lymphoma patients responding to R-CHOP: quality of life, dosing, and safety results from the randomised controlled REMARC study.

Thieblemont C, Howlett S, Casasnovas RO, Mounier N, Perrot A, Morschhauser F, Fruchart C, Daguindau N, van Eygen K, Obéric L, Bouabdallah R, Pica GM, Nicolas-Virezelier E, Abraham J, Fitoussi O, Snauwaert S, Eisenmann JC, Lionne-Huyghe P, Bron D, Tricot S, Deeren D, Gonzalez H, Costello R, Le Du K, da Silva MG, Grosicki S, Trotman J, Catalano J, Caballero D, Greil R, Cohen AM, Gaulard P, Roulin L, Takeshita K, Casadebaig ML, Tilly H, Coiffier B.

Br J Haematol. 2020 Apr;189(1):84-96. doi: 10.1111/bjh.16300. Epub 2019 Nov 8.

PMID: 31702836

 

A Machine-Learning Approach to Identify a Prognostic Cytokine Signature That Is Associated With Nivolumab Clearance in Patients With Advanced Melanoma.

Wang R, Shao X, Zheng J, Saci A, Qian X, Pak I, Roy A, Bello A, Rizzo JI, Hosein F, Moss RA, Wind-Rotolo M, Feng Y.

Clin Pharmacol Ther. 2020 Apr;107(4):978-987. doi: 10.1002/cpt.1724. Epub 2019 Dec 19.

PMID: 31721173

 

Investigating Overlap in Signals from EVDAS, FAERS, and VigiBase_®.

Vogel U, van Stekelenborg J, Dreyfus B, Garg A, Habib M, Hosain R, Wisniewski A.

Drug Saf. 2020 Apr;43(4):351-362. doi: 10.1007/s40264-019-00899-y.

PMID: 32020559

 

STK11 and KEAP1 mutations as prognostic biomarkers in an observational real-world lung adenocarcinoma cohort.

Papillon-Cavanagh S, Doshi P, Dobrin R, Szustakowski J, Walsh AM.

ESMO Open. 2020 Apr;5(2). pii: e000706. doi: 10.1136/esmoopen-2020-000706.

PMID: 32312757

 

Efficacy of Nivolumab plus Ipilimumab According to Number of IMDC Risk Factors in CheckMate 214.

Escudier B, Motzer RJ, Tannir NM, Porta C, Tomita Y, Maurer MA, McHenry MB, Rini BI.

Eur Urol. 2020 Apr;77(4):449-453. doi: 10.1016/j.eururo.2019.10.025. Epub 2019 Nov 13.

PMID: 31732098

 

The safety and pharmacokinetics of a novel, selective S1P1R modulator in healthy participants.

Singhal S, Girgis IG, Xie J, Dutta S, Shevell DE, Throup J.

Expert Opin Investig Drugs. 2020 Apr;29(4):411-422. doi: 10.1080/13543784.2020.1742322.

PMID: 32306792

 

Quality of life with second or third line nab-paclitaxel-based regimens in advanced non-small-cell lung cancer.

Ponce Aix S, Talbot D, Govindan R, Dols MC, Postmus PE, Lewanski C, Bennouna J, Fischer JR, Juan-Vidal O, Stewart DJ, Ardizzoni A, Bhore R, Wolfsteiner M, Reck M, Ong TJ, Morgensztern D.

Future Oncol. 2020 Apr;16(12):749-762. doi: 10.2217/fon-2019-0796. Epub 2020 Mar 31.

PMID: 32228198

 

Microhomology-mediated end joining drives complex rearrangements and overexpression of MYC and PVT1 in multiple myeloma.

Mikulasova A, Ashby C, Tytarenko RG, Qu P, Rosenthal A, Dent JA, Ryan KR, Bauer MA, Wardell CP, Hoering A, Mavrommatis K, Trotter M, Deshpande S, Yaccoby S, Tian E, Keats J, Auclair D, Jackson GH, Davies FE, Thakurta A, Morgan GJ, Walker BA.

Haematologica. 2020 Apr;105(4):1055-1066. doi: 10.3324/haematol.2019.217927. Epub 2019 Jun 20.

PMID: 31221783

Cost-effectiveness of targeted screening for the identification of patients with atrial fibrillation: evaluation of a machine learning risk prediction algorithm.

Hill NR, Sandler B, Mokgokong R, Lister S, Ward T, Boyce R, Farooqui U, Gordon J.

J Med Econ. 2020 Apr;23(4):386-393. doi: 10.1080/13696998.2019.1706543. Epub 2020 Jan 10.

PMID: 31855091

 

Enasidenib in patients with mutant IDH2 myelodysplastic syndromes: a phase 1 subgroup analysis of the multicentre, AG221-C-001 trial.

Stein EM, Fathi AT, DiNardo CD, Pollyea DA, Roboz GJ, Collins R, Sekeres MA, Stone RM, Attar EC, Frattini MG, Tosolini A, Xu Q, See WL, MacBeth KJ, de Botton S, Tallman MS, Kantarjian HM.

Lancet Haematol. 2020 Apr;7(4):e309-e319. doi: 10.1016/S2352-3026(19)30284-4. Epub 2020 Mar 5.

PMID: 32145771

 

Iberdomide (CC-220) is a potent cereblon E3 ligase modulator with antitumor and immunostimulatory activities in lenalidomide- and pomalidomide-resistant multiple myeloma cells with dysregulated CRBN.

Bjorklund CC, Kang J, Amatangelo M, Polonskaia A, Katz M, Chiu H, Couto S, Wang M, Ren Y, Ortiz M, Towfic F, Flynt JE, Pierceall W, Thakurta A.

Leukemia. 2020 Apr;34(4):1197-1201. doi: 10.1038/s41375-019-0620-8. Epub 2019 Nov 12. No abstract available.

PMID: 31719682

 

Collagen biology and non-invasive biomarkers of liver fibrosis.

Karsdal MA, Daniels SJ, Holm Nielsen S, Bager C, Rasmussen DGK, Loomba R, Surabattula R, Villesen IF, Luo Y, Shevell D, Gudmann NS, Nielsen MJ, George J, Christian R, Leeming DJ, Schuppan D.

Liver Int. 2020 Apr;40(4):736-750. doi: 10.1111/liv.14390. Epub 2020 Feb 19. Review.

PMID: 31997561

 

Reverse TCR repertoire evolution toward dominant low-affinity clones during chronic CMV infection.

Schober K, Voit F, Grassmann S, Müller TR, Eggert J, Jarosch S, Weißbrich B, Hoffmann P, Borkner L, Nio E, Fanchi L, Clouser CR, Radhakrishnan A, Mihatsch L, Lückemeier P, Leube J, Dössinger G, Klein L, Neuenhahn M, Oduro JD, Cicin-Sain L, Buchholz VR, Busch DH.

Nat Immunol. 2020 Apr;21(4):434-441. doi: 10.1038/s41590-020-0628-2. Epub 2020 Mar 16.

PMID: 32205883

 

Crystal structure of the SALL4-pomalidomide-cereblon-DDB1 complex.

Matyskiela ME, Clayton T, Zheng X, Mayne C, Tran E, Carpenter A, Pagarigan B, McDonald J, Rolfe M, Hamann LG, Lu G, Chamberlain PP.

Nat Struct Mol Biol. 2020 Apr;27(4):319-322. doi: 10.1038/s41594-020-0405-9. Epub 2020 Apr 6.

PMID: 32251415

 

Pharmacokinetics and Clinical Pharmacology of Monoclonal Antibodies in Pediatric Patients.

Temrikar ZH, Suryawanshi S, Meibohm B.

Paediatr Drugs. 2020 Apr;22(2):199-216. doi: 10.1007/s40272-020-00382-7. Review.

PMID: 32052309

 

A Case Study Examining the Usefulness of Cure Modelling for the Prediction of Survival Based on Data Maturity.

Grant TS, Burns D, Kiff C, Lee D.

Pharmacoeconomics. 2020 Apr;38(4):385-395. doi: 10.1007/s40273-019-00867-5.

PMID: 31848900

 

Fast understanding of phases and phase separation in liquid crystal drug delivery systems using deuterium solid-state NMR.

Abraham A, Chan E, Park H.

Solid State Nucl Magn Reson. 2020 Apr;106:101642. doi: 10.1016/j.ssnmr.2020.101642. Epub 2020 Jan 11.

PMID: 32035327

 

Abatacept retention and clinical outcomes in Austrian patients with rheumatoid arthritis: real-world data from the 2-year ACTION study.

Peichl P, Alten R, Galeazzi M, Lorenz HM, Nüßlein H, Navarro F, Elbez Y, Chartier M, Hackl R, Rauch C, Connolly SE.

Wien Med Wochenschr. 2020 Apr;170(5-6):132-140. doi: 10.1007/s10354-019-00710-8. Epub 2019 Oct 25.

PMID: 31654156

 

Risk Assessment Approach to Microbiological Controls of Cell Therapies.

Cundell T, Drummond S, Ford I, Reber D, Singer D; members of the Pharmaceutical Microbiology Expert Discussion Group.

PDA J Pharm Sci Technol. 2020 Mar-Apr;74(2):229-248. doi: 10.5731/pdajpst.2019.010546. Epub 2020 Jan 15.

PMID: 31941793

 

A 15-gene immune, stromal and proliferation gene signature that significantly associates with poor survival in patients with pancreatic ductal adenocarcinoma.

Kandimalla R, Tomihara H, Banwait JK, Yamamura K, Singh G, Baba H, Goel A.

Clin Cancer Res. 2020 Mar 31. pii: clincanres.4044.2019. doi: 10.1158/1078-0432.CCR-19-4044. [Epub ahead of print]

PMID: 32234757

 

Phase I study of CC-90010, a reversible, oral BET inhibitor in patients with advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma.

Moreno V, Sepulveda JM, Vieito M, Hernández-Guerrero T, Doger B, Saavedra O, Ferrero O, Sarmiento R, Arias M, De Alvaro J, Di Martino J, Zuraek M, Sanchez-Pérez T, Aronchik I, Filvaroff EH, Lamba M, Hanna B, Nikolova Z, Brana I.

Ann Oncol. 2020 Mar 30. pii: S0923-7534(20)36381-X. doi: 10.1016/j.annonc.2020.03.294. [Epub ahead of print]

PMID: 32240793

The Risk / Benefit Tradeoff of Antithrombotic Therapy in Patients with Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights from AUGUSTUS.

Alexander JH, Wojdyla D, Vora AN, Thomas L, Granger CB, Goodman SG, Aronson R, Windecker S, Mehran R, Lopes RD.

Circulation. 2020 Mar 29. doi: 10.1161/CIRCULATIONAHA.120.046534. [Epub ahead of print]

PMID: 32223444

 

Impact of Expansion of PGY1 Pharmacy Residency Program From 2 to 4 Residents.

Brophy A, Bente J, Sobolewski K, DeStefano D, Costello J.

J Pharm Pract. 2020 Mar 27:897190020912934. doi: 10.1177/0897190020912934. [Epub ahead of print]

PMID: 32216571

 

Cross-site and cross-platform variability of automated patch clamp assessments of drug effects on human cardiac currents in recombinant cells.

Kramer J, Himmel HM, Lindqvist A, Stoelzle-Feix S, Chaudhary KW, Li D, Bohme GA, Bridgland-Taylor M, Hebeisen S, Fan J, Renganathan M, Imredy J, Humphries ESA, Brinkwirth N, Strassmaier T, Ohtsuki A, Danker T, Vanoye C, Polonchuk L, Fermini B, Pierson JB, Gintant G.

Sci Rep. 2020 Mar 27;10(1):5627. doi: 10.1038/s41598-020-62344-w.

PMID: 32221320

 

Leveraging gene expression subgroups to classify DLBCL patients and select for clinical benefit from a novel agent.

Risueño A, Hagner PR, Towfic F, Fontanillo C, Djebbari A, Parker JS, Drew CP, Nowakowski GS, Maurer MJ, Cerhan JR, Wei X, Ren Y, Lee CW, Couto S, Wang M, Pourdehnad M, Gandhi AK, Trotter MWB.

Blood. 2020 Mar 26;135(13):1008-1018. doi: 10.1182/blood.2019002414.

PMID: 31977005

 

Avadomide monotherapy in relapsed/refractory DLBCL: safety, efficacy, and a predictive gene classifier.

Carpio C, Bouabdallah R, Ysebaert L, Sancho JM, Salles G, Cordoba R, Pinto A, Gharibo M, Rasco D, Panizo C, Lopez-Martin JA, Santoro A, Salar A, Damian S, Martin A, Verhoef G, Van den Neste E, Wang M, Couto S, Carrancio S, Weng A, Wang X, Schmitz F, Wei X, Hege K, Trotter MWB, Risueño A, Buchholz TJ, Hagner PR, Gandhi AK, Pourdehnad M, Ribrag V.

Blood. 2020 Mar 26;135(13):996-1007. doi: 10.1182/blood.2019002395.

PMID: 31977002

 

Prevalence of chronic kidney disease in the community using data from OxRen: a UK population-based cohort study.

Hirst JA, Hill N, O'Callaghan CA, Lasserson D, McManus RJ, Ogburn E, Mena JMO, Shine B, Taylor CJ, Vazquez-Montes MD, Yang Y, Hobbs FR.

Br J Gen Pract. 2020 Mar 26;70(693):e285-e293. doi: 10.3399/bjgp20X708245. Print 2020 Apr.

PMID: 32041766

 

A Phase 3 Trial of Luspatercept in Patients with Transfusion-Dependent β-Thalassemia.

Cappellini MD, Viprakasit V, Taher AT, Georgiev P, Kuo KHM, Coates T, Voskaridou E, Liew HK, Pazgal-Kobrowski I, Forni GL, Perrotta S, Khelif A, Lal A, Kattamis A, Vlachaki E, Origa R, Aydinok Y, Bejaoui M, Ho PJ, Chew LP, Bee PC, Lim SM, Lu MY, Tantiworawit A, Ganeva P, Gercheva L, Shah F, Neufeld EJ, Thompson A, Laadem A, Shetty JK, Zou J, Zhang J, Miteva D, Zinger T, Linde PG, Sherman ML, Hermine O, Porter J, Piga A; BELIEVE Investigators.

N Engl J Med. 2020 Mar 26;382(13):1219-1231. doi: 10.1056/NEJMoa1910182.

PMID: 32212518

 

Correction to: Evaluation of the bioequivalence and food effect on the bioavailability of CC-486 (oral azacitidine) tablets in adult patients with cancer.

Babiker HM, Milhem M, Aisner J, Edenfield W, Shepard D, Savona M, Iyer S, Abdelrahim M, Beach CL, Skikne B, Laille E, Tsai KT, Ho T.

Cancer Chemother Pharmacol. 2020 Mar 25. doi: 10.1007/s00280-020-04056-6. [Epub ahead of print]

PMID: 32215699

 

Enantiodivergent Formation of C-P Bonds: Synthesis of P-Chiral Phosphines and Methylphosphonate Oligonucleotides.

Xu D, Rivas-Bascón N, Padial NM, Knouse KW, Zheng B, Vantourout JC, Schmidt MA, Eastgate MD, Baran PS.

J Am Chem Soc. 2020 Mar 25;142(12):5785-5792. doi: 10.1021/jacs.9b13898. Epub 2020 Mar 16.

PMID: 32109356

 

 Quantifying Target Occupancy of Small Molecules Within Living Cells.

Robers MB, Friedman-Ohana R, Huber K, Kilpatrick L, Vasta JD, Berger BT, Chaudhry C, Hill S, Müller S, Knapp S, Wood KV.

Annu Rev Biochem. 2020 Mar 24. doi: 10.1146/annurev-biochem-011420-092302. [Epub ahead of print]

PMID: 32208767

 

Triggers of Inflammatory Heart Disease.

Lasrado N, Yalaka B, Reddy J.

Front Cell Dev Biol. 2020 Mar 24;8:192. doi: 10.3389/fcell.2020.00192. eCollection 2020. Review.

PMID: 32266270

 

Multiple Plasma Biomarkers for Risk Stratification in Patients With Heart Failure and Preserved Ejection Fraction.

Chirinos JA, Orlenko A, Zhao L, Basso MD, Cvijic ME, Li Z, Spires TE, Yarde M, Wang Z, Seiffert DA, Prenner S, Zamani P, Bhattacharya P, Kumar A, Margulies KB, Car BD, Gordon DA, Moore JH, Cappola TP.

J Am Coll Cardiol. 2020 Mar 24;75(11):1281-1295. doi: 10.1016/j.jacc.2019.12.069.

PMID: 32192654

 

Multiplexed ion beam imaging (MIBI) for characterization of the tumor microenvironment across tumor types.

Ptacek J, Locke D, Finck R, Cvijic ME, Li Z, Tarolli JG, Aksoy M, Sigal Y, Zhang Y, Newgren M, Finn J.

Lab Invest. 2020 Mar 23. doi: 10.1038/s41374-020-0417-4. [Epub ahead of print]

PMID: 32203152

 

Safety, pharmacokinetics and pharmacodynamics of branebrutinib (BMS-986195), a covalent, irreversible inhibitor of Bruton's tyrosine kinase: Randomised phase I, placebo-controlled trial in healthy participants.

Catlett IM, Nowak M, Kundu S, Zheng N, Liu A, He B, Girgis IG, Grasela DM.

Br J Clin Pharmacol. 2020 Mar 21. doi: 10.1111/bcp.14290. [Epub ahead of print]

PMID: 32198939

 

Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics.

Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B.

Clin Cancer Res. 2020 Mar 20. doi: 10.1158/1078-0432.CCR-19-2942. [Epub ahead of print]

PMID: 32198149

 

Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis.

Dellon ES, Collins MH, Rothenberg ME, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer A, Straumann A, Safroneeva E, Rodriguez C, Minton N, Hua SY, Hirano I.

Clin Gastroenterol Hepatol. 2020 Mar 20. pii: S1542-3565(20)30348-7. doi: 10.1016/j.cgh.2020.03.036. [Epub ahead of print]

PMID: 32205221

 

Discovery of CRBN E3 Ligase Modulator CC-92480 for the Treatment of Relapsed and Refractory Multiple Myeloma.

Hansen JD, Correa M, Nagy MA, Alexander M, Plantevin V, Grant V, Whitefield B, Huang D, Kercher T, Harris R, Narla RK, Leisten J, Tang Y, Moghaddam M, Ebinger K, Piccotti J, Havens CG, Cathers B, Carmichael J, Daniel T, Vessey R, Hamann LG, Leftheris K, Mendy D, Baculi F, LeBrun LA, Khambatta G, Lopez-Girona A.

J Med Chem. 2020 Mar 19. doi: 10.1021/acs.jmedchem.9b01928. [Epub ahead of print]

PMID: 32130004

 

Accelerating the development of innovative cellular therapy products for the treatment of cancer.

Stewart MD, Keane A, Butterfield LH, Levine BL, Thompson B, Xu Y, Ramsborg C, Lee A, Kalos M, Koerner C, Moore T, Markovic I, Lasiter L, Ibrahim R, Bluestone J, Sigal E, Allen J.

Cytotherapy. 2020 Mar 18. pii: S1465-3249(20)30034-7. doi: 10.1016/j.jcyt.2020.01.014. [Epub ahead of print]

PMID: 32199724

 

Iridium(I)-Catalyzed α-C(sp₃)-H Alkylation of Saturated Azacycles.

Verma P, Richter JM, Chekshin N, Qiao JX, Yu JQ.

J Am Chem Soc. 2020 Mar 18;142(11):5117-5125. doi: 10.1021/jacs.9b12320. Epub 2020 Mar 9.

PMID: 32098471

 

Propensity score matching and inverse probability of treatment weighting to address confounding by indication in comparative effectiveness research of oral anticoagulants.

Allan V, Ramagopalan SV, Mardekian J, Jenkins A, Li X, Pan X, Luo X.

J Comp Eff Res. 2020 Mar 18. doi: 10.2217/cer-2020-0013. [Epub ahead of print]

PMID: 32186922

 

Relationship between remission, disease activity and patient-reported outcome measures in patients with recent-onset systemic lupus erythematosus.

Heijke R, Björk M, Frodlund M, McDonald L, Alemao E, Sjöwall C.

Lupus. 2020 Mar 18:961203320912338. doi: 10.1177/0961203320912338. [Epub ahead of print] No abstract available.

PMID: 32188304

 

Human papillomavirus type 16 infection activates the host serine arginine protein kinase 1 (SRPK1) - splicing factor axis.

Mole S, Faizo AAA, Hernandez-Lopez H, Griffiths M, Stevenson A, Roberts S, Graham SV.

J Gen Virol. 2020 Mar 17. doi: 10.1099/jgv.0.001402. [Epub ahead of print]

PMID: 32182205

 

Metabolic and Pharmaceutical Aspects of Fluorinated Compounds.

Johnson BM, Shu YZ, Zhuo X, Meanwell NA.

J Med Chem. 2020 Mar 17. doi: 10.1021/acs.jmedchem.9b01877. [Epub ahead of print]

PMID: 32182061

 

Rational Development of Remote C-H Functionalization of Biphenyl: Experimental and Computational Studies.

Fan Z, Bay KL, Chen X, Zhuang Z, Park HS, Yeung KS, Houk KN, Yu JQ.

Angew Chem Int Ed Engl. 2020 Mar 16;59(12):4770-4777. doi: 10.1002/anie.201915624. Epub 2020 Feb 12.

PMID: 31943648

 

Late-stage oxidative C(sp₃)-H methylation.

Feng K, Quevedo RE, Kohrt JT, Oderinde MS, Reilly U, White MC.

Nature. 2020 Mar 16. doi: 10.1038/s41586-020-2137-8. [Epub ahead of print]

PMID: 32179876

 

Role of wetting agents and disintegrants in development of danazol nanocrystalline tablets.

Meruva S, Thool P, Gong Y, Karki S, Bowen W, Kumar S.

Int J Pharm. 2020 Mar 15;577:119026. doi: 10.1016/j.ijpharm.2020.119026. Epub 2020 Jan 12.

PMID: 31940456

 

International prognostic indices in diffuse large B-cell lymphoma (DLBCL): a comparison of IPI, R-IPI and NCCN-IPI.

Ruppert AS, Dixon JG, Salles GA, Wall A, Cunningham D, Poeschel V, Haioun C, Tilly H, Ghesquieres H, Ziepert M, Flament J, Flowers C, Shi Q, Schmitz N.

Blood. 2020 Mar 13. pii: blood.2019002729. doi: 10.1182/blood.2019002729. [Epub ahead of print]

PMID: 32232482

 

Population Pharmacokinetics and Exposure Response Analysis of Pomalidomide in Subjects With Relapsed or Refractory Multiple Myeloma From the Novel Combination Treatment of Pomalidomide, Bortezomib, and Low-Dose Dexamethasone.

Li Y, Kassir N, Wang X, Palmisano M, Zhou S.

J Clin Pharmacol. 2020 Mar 13. doi: 10.1002/jcph.1602. [Epub ahead of print]

PMID: 32168381

 

Apixaban versus Warfarin in Patients with Atrial Fibrillation and Advanced Chronic Kidney Disease.

Stanifer JW, Pokorney SD, Chertow GM, Hohnloser SH, Wojdyla DM, Garonzik S, Byon W, Hijazi Z, Lopes RD, Alexander JH, Wallentin L, Granger CB.

Circulation. 2020 Mar 12. doi: 10.1161/CIRCULATIONAHA.119.044059. [Epub ahead of print]

PMID: 32160801

 

Assessment of Glucose Control Metrics by Discriminant Ratio.

Moscardó V, Herrero P, Reddy M, Hill N, Georgiou P, Oliver N.

Diabetes Technol Ther. 2020 Mar 12. doi: 10.1089/dia.2019.0415. [Epub ahead of print]

PMID: 32163723

 

New genetic predictors for abacavir tolerance in HLA-B*57:01 positive individuals.

Pavlos R, Deshpande P, Chopra A, Leary S, Strautins K, Nolan D, Thorborn D, Shaefer M, Rauch A, Dunn D, Montaner J, Rachlis A, Almeida CA, Choo L, James I, Redwood AJ, Li Y, Gaudieri S, Mallal SA, Phillips EJ.

Hum Immunol. 2020 Mar 12. pii: S0198-8859(19)31410-7. doi: 10.1016/j.humimm.2020.02.011. [Epub ahead of print]

PMID: 32173028

Discovery and Optimization of Novel Pyrazolopyrimidines as Potent and Orally Bioavailable Allosteric HIV-1 Integrase Inhibitors.

Li G, Meanwell NA, Krystal MR, Langley DR, Naidu BN, Sivaprakasam P, Lewis H, Kish K, Khan JA, Ng A, Trainor GL, Cianci C, Dicker IB, Walker MA, Lin Z, Protack T, Discotto L, Jenkins S, Gerritz SW, Pendri A.

J Med Chem. 2020 Mar 12;63(5):2620-2637. doi: 10.1021/acs.jmedchem.9b01681. Epub 2020 Feb 21.

PMID: 32081010

 

A roadmap to using historical controls in clinical trials - by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG).

Ghadessi M, Tang R, Zhou J, Liu R, Wang C, Toyoizumi K, Mei C, Zhang L, Deng CQ, Beckman RA.

Orphanet J Rare Dis. 2020 Mar 12;15(1):69. doi: 10.1186/s13023-020-1332-x. Review.

PMID: 32164754

 

Targeting the Wnt signaling pathway through R-spondin 3 identifies an anti-fibrosis treatment strategy for multiple organs.

Zhang M, Haughey M, Wang NY, Blease K, Kapoun AM, Couto S, Belka I, Hoey T, Groza M, Hartke J, Bennett B, Cain J, Gurney A, Benish B, Castiglioni P, Drew C, Lachowicz J, Carayannopoulos L, Nathan SD, Distler J, Brenner DA, Hariharan K, Cho H, Xie W.

PLoS One. 2020 Mar 11;15(3):e0229445. doi: 10.1371/journal.pone.0229445. eCollection 2020.

PMID: 32160239

Pd_II -Catalyzed Enantioselective C(sp₃ )-H Arylation of Cyclobutyl Ketones Using a Chiral Transient Directing Group.

Xiao LJ, Hong K, Luo F, Hu L, Ewing WR, Yeung KS, Yu JQ.

Angew Chem Int Ed Engl. 2020 Mar 10. doi: 10.1002/anie.202000532. [Epub ahead of print]

PMID: 32155313

 

KLK6 expression in skin induces PAR1-mediated psoriasiform dermatitis and inflammatory joint disease.

Billi AC, Ludwig JE, Fritz Y, Rozic R, Swindell WR, Tsoi LC, Gruszka D, Abdollahi-Roodsaz S, Xing X, Diaconu D, Uppala R, Camhi MI, Klenotic PA, Sarkar MK, Husni ME, Scher JU, McDonald C, Kahlenberg JM, Midura RJ, Gudjonsson JE, Ward NL.

J Clin Invest. 2020 Mar 10. pii: 133159. doi: 10.1172/JCI133159. [Epub ahead of print]

PMID: 32155135

 

Proteomic Modulation in the Dorsal Spinal Cord Following Spinal Cord Stimulation Therapy in an In Vivo Neuropathic Pain Model.

Tilley DM, Lietz CB, Cedeno DL, Kelley CA, Li L, Vallejo R.

Neuromodulation. 2020 Mar 10. doi: 10.1111/ner.13103. [Epub ahead of print]

PMID: 32157770

 

Investigation on the Effect of Capillary Microsampling on Hematologic and Toxicokinetic Evaluation in Regulatory Safety Studies in Mice.

Wang B, Wang L, Batog A, Brodie T, Ramaiah L, Chadwick KD, Su T, Mangipudy R, Pilutla RC, Ji QC.

AAPS J. 2020 Mar 9;22(2):55. doi: 10.1208/s12248-020-00438-z.

PMID: 32152888

 

Approaches for the identification of chronic kidney disease in CPRD-HES-linked studies.

Ramagopalan S, Leahy TP, Stamp E, Sammon C.

J Comp Eff Res. 2020 Mar 9. doi: 10.2217/cer-2019-0190. [Epub ahead of print]

PMID: 32148084

 

Allele-Selective Knockdown of MYH7 Using Antisense Oligonucleotides.

Anderson BR, Jensen ML, Hagedorn PH, Little SC, Olson RE, Ammar R, Kienzle B, Thompson J, McDonald I, Mercer S, Vikesaa J, Nordbo B, Iben L, Cao Y, Natale J, Dalton-Kay G, Cacace A, Hansen BR, Hedtjärn M, Koch T, Bristow LJ.

Mol Ther Nucleic Acids. 2020 Mar 6;19:1290-1298. doi: 10.1016/j.omtn.2020.01.012. Epub 2020 Jan 21.

PMID: 32092825

Treatment Switch Patterns and Healthcare Costs in Biologic-Naive Patients with Psoriatic Arthritis.

Wu JJ, Pelletier C, Ung B, Tian M, Khilfeh I, Curtis JR.

Adv Ther. 2020 Mar 5. doi: 10.1007/s12325-020-01262-9. [Epub ahead of print]

PMID: 32141018

 

Targeting of inflammatory pathways with R2CHOP in high-risk DLBCL.

Hartert KT, Wenzl K, Krull JE, Manske M, Sarangi V, Asmann Y, Larson MC, Maurer MJ, Slager S, Macon WR, King RL, Feldman AL, Gandhi AK, Link BK, Habermann TM, Yang ZZ, Ansell SM, Cerhan JR, Witzig TE, Nowakowski GS, Novak AJ.

Leukemia. 2020 Mar 5. doi: 10.1038/s41375-020-0766-4. [Epub ahead of print]

PMID: 32139889

 

PIKES Analysis Reveals Response to Degraders and Key Regulatory Mechanisms of the CRL4 Network.

Reichermeier KM, Straube R, Reitsma JM, Sweredoski MJ, Rose CM, Moradian A, den Besten W, Hinkle T, Verschueren E, Petzold G, Thomä NH, Wertz IE, Deshaies RJ, Kirkpatrick DS.

Mol Cell. 2020 Mar 5;77(5):1092-1106.e9. doi: 10.1016/j.molcel.2019.12.013. Epub 2020 Jan 20.

PMID: 31973889

 

Fedratinib in patients with myelofibrosis previously treated with ruxolitinib: An updated analysis of the JAKARTA2 study using stringent criteria for ruxolitinib failure.

Harrison CN, Schaap N, Vannucchi AM, Kiladjian JJ, Jourdan E, Silver RT, Schouten HC, Passamonti F, Zweegman S, Talpaz M, Verstovsek S, Rose S, Shen J, Berry T, Brownstein C, Mesa RA.

Am J Hematol. 2020 Mar 4. doi: 10.1002/ajh.25777. [Epub ahead of print]

PMID: 32129512

 

Prevalence of Sjögren's syndrome associated with rheumatoid arthritis in the USA: an observational study from the Corrona registry.

Harrold LR, Shan Y, Rebello S, Kramer N, Connolly SE, Alemao E, Kelly S, Kremer JM, Rosenstein ED.

Clin Rheumatol. 2020 Mar 4. doi: 10.1007/s10067-020-05004-8. [Epub ahead of print]

PMID: 32130579

 

Inoculum size and traits of the infecting clinical strain define the protection level against Mycobacterium tuberculosis infection in a rabbit model.

Tsenova L, Fallows D, Kolloli A, Singh P, O'Brien P, Kushner N, Kaplan G, Subbian S.

Eur J Immunol. 2020 Mar 4. doi: 10.1002/eji.201948448. [Epub ahead of print]

PMID: 32130727

 

The path to a better biomarker: Application of a risk management framework for the implementation of PD-L1 and TILs as immuno-oncology biomarkers in breast cancer clinical trials and daily practice.

Gonzalez-Ericsson PI, Stovgaard ES, Sua LF, Reisenbichler E, Kos Z, Carter JM, Michiels S, Le Quesne J, Nielsen TO, Laenkholm AV, Fox SB, Adam J, Bartlett JM, Rimm DL, Quinn C, Peeters D, Dieci MV, Vincent-Salomon A, Cree I, Hida AI, Balko JM, Haynes HR, Frahm I, Acosta-Haab G, Balancin M, Bellolio E, Yang W, Kirtani P, Sugie T, Ehinger A, Castaneda CA, Kok M, McArthur H, Siziopikou K, Badve S, Fineberg S, Gown A, Viale G, Schnitt SJ, Pruneri G, Penault-Llorca F, Hewitt S, Thompson EA, Allison KH, Symmans WF, Bellizzi AM, Brogi E, Moore DA, Larsimont D, Dillon DA, Lazar A, Lien H, Goetz MP, Broeckx G, El Bairi K, Harbeck N, Cimino-Mathews A, Sotiriou C, Adams S, Liu SW, Loibl S, Chen IC, Lakhani SR, Juco JW, Denkert C, Blackley EF, Demaria S, Leon-Ferre R, Gluz O, Zardavas D, Emancipator K, Ely S, Loi S, Salgado R, Sanders M; International Immuno-Oncology Biomarker Working Group.

J Pathol. 2020 Mar 4. doi: 10.1002/path.5406. [Epub ahead of print] Review.

PMID: 32129476

 

Stent Thrombosis in Patients With Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial.

Lopes RD, Leonardi S, Wojdyla DM, Vora AN, Thomas L, Storey RF, Vinereanu D, Granger CB, Goodman SG, Aronson R, Windecker S, Thiele H, Valgimigli M, Mehran R, Alexander JH.

Circulation. 2020 Mar 3;141(9):781-783. doi: 10.1161/CIRCULATIONAHA.119.044584. Epub 2019 Nov 11. No abstract available.

PMID: 31707833

 

Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View.

Parab AA, Mehta P, Vattikola A, Denney CK, Cherry M, Maniar RM, Kjaer J.

Ther Innov Regul Sci. 2020 Mar 3. doi: 10.1007/s43441-020-00138-y. [Epub ahead of print]

PMID: 32128701

 

Scientific Regulatory Policy Committee Points to Consider*: Nuisance Factors, Block Effects, and Batch Effects in Nonclinical Safety Assessment Studies.

Schultze AE, Bennet B, Rae JC, Chiang AY, Frazier K, Katavolos P, McKinney L, Patrick DJ, Tripathi N.

Toxicol Pathol. 2020 Mar 3:192623320906385. doi: 10.1177/0192623320906385. [Epub ahead of print]

PMID: 32122253

 

A conserved intratumoral regulatory T cell signature identifies 4-1BB as a pan-cancer target.

Freeman ZT, Nirschl TR, Hovelson DH, Johnston RJ, Engelhardt JJ, Selby MJ, Kochel CM, Lan RY, Zhai J, Ghasemzadeh A, Gupta A, Skaist AM, Wheelan SJ, Jiang H, Pearson AT, Snyder LA, Korman AJ, Tomlins SA, Yegnasubramanian S, Drake CG.

J Clin Invest. 2020 Mar 2;130(3):1405-1416. doi: 10.1172/JCI128672.

PMID: 32015231

Regional variation in clinical characteristics and outcomes in patients with atrial fibrillation: Findings from the ARISTOTLE trial.

Bahit MC, Granger CB, Alexander JH, Mulder H, Wojdyla DM, Hanna M, Goto S, Xavier D, Verheugt FWA, Lanas F, Hijazi Z, Wallentin L, Lopes RD.

Int J Cardiol. 2020 Mar 1;302:53-58. doi: 10.1016/j.ijcard.2019.12.060. Epub 2019 Dec 30.

PMID: 31932116

Hybrid mode of hydrophobic interaction chromatography of monoclonal antibodies and related biomolecules: Influence of elution conditions on chromatographic performance using poly (alkyl aspartamide) silica columns.

Srikoti M, Bolgar MS, Kazakevich Y.

J Chromatogr B Analyt Technol Biomed Life Sci. 2020 Mar 1;1140:121984. doi: 10.1016/j.jchromb.2020.121984. Epub 2020 Jan 28.

PMID: 32014662

 

Mapping binding epitopes of monoclonal antibodies targeting major histocompatibility complex class I chain-related A (MICA) with hydrogen/deuterium exchange and electron-transfer dissociation mass spectrometry.

Huang RY, Kuhne M, Deshpande S, Rangan V, Srinivasan M, Wang Y, Chen G.

Anal Bioanal Chem. 2020 Mar;412(7):1693-1700. doi: 10.1007/s00216-020-02409-x. Epub 2020 Jan 29.

PMID: 31993727

 

Understanding mAb aggregation during low pH viral inactivation and subsequent neutralization.

Wälchli R, Ressurreição M, Vogg S, Feidl F, Angelo J, Xu X, Ghose S, Jian Li Z, Le Saoût X, Souquet J, Broly H, Morbidelli M.

Biotechnol Bioeng. 2020 Mar;117(3):687-700. doi: 10.1002/bit.27237. Epub 2019 Dec 11.

PMID: 31784982

 

Evaluation of the bioequivalence and food effect on the bioavailability of CC-486 (oral azacitidine) tablets in adult patients with cancer.

Babiker HM, Milhem M, Aisner J, Edenfield W, Shepard D, Savona M, Iyer S, Abdelrahim M, Beach CL, Skikne B, Laille E, Tsai KT, Ho T.

Cancer Chemother Pharmacol. 2020 Mar;85(3):621-626. doi: 10.1007/s00280-020-04037-9. Epub 2020 Feb 8. Erratum in: Cancer Chemother Pharmacol. 2020 Mar 25;:.

PMID: 32036412

 

Real-world Treatment Patterns and Clinical Outcomes Across Lines of Therapy in Patients With Advanced/Metastatic Gastric or Gastroesophageal Junction Cancer.

Le DT, Ott PA, Korytowsky B, Le H, Le TK, Zhang Y, Maglinte GA, Abraham P, Patel D, Shangguan T, Chau I.

Clin Colorectal Cancer. 2020 Mar;19(1):32-38.e3. doi: 10.1016/j.clcc.2019.09.001. Epub 2019 Sep 24.

PMID: 31813769

 

Evaluation of Therapeutics for Severely Debilitating or Life-Threatening Diseases or Conditions: Defining Scope to Enable Global Guidance Development.

Liu M, Fields FO, Prescott JS, Bello A, Bower N, Darakjy S, Hartke J, Kadambi V, Lapadula D, Stoch A, Derzi M.

Clin Pharmacol Ther. 2020 Mar;107(3):514-520. doi: 10.1002/cpt.1673. Epub 2019 Nov 22. Review.

PMID: 31608984

 

Immunogenicity in Clinical Practice and Drug Development: When is it Significant?

Shakhnovich V, Meibohm B, Rosenberg A, Kierzek AM, Hasenkamp R, Funk RS, Thalhauser CJ, van der Graaf PH, Wang YC, Hamuro L.

Clin Transl Sci. 2020 Mar;13(2):219-223. doi: 10.1111/cts.12717. Epub 2019 Nov 25. No abstract available.

PMID: 31762152

 

Kinetic modeling of Chinese hamster ovary cell culture: factors and principles.

Tang P, Xu J, Louey A, Tan Z, Yongky A, Liang S, Li ZJ, Weng Y, Liu S.

Crit Rev Biotechnol. 2020 Mar;40(2):265-281. doi: 10.1080/07388551.2019.1711015. Epub 2020 Jan 12.

PMID: 31928250

 

Induction of Human Intestinal and Hepatic Organic Anion Transporting Polypeptides: Where Is the Evidence for Its Relevance in Drug-Drug Interactions?

Rodrigues AD, Lai Y, Shen H, Varma MVS, Rowland A, Oswald S.

Drug Metab Dispos. 2020 Mar;48(3):205-216. doi: 10.1124/dmd.119.089615. Epub 2019 Dec 26.

PMID: 31879282

 

CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations.

Felip E, Ardizzoni A, Ciuleanu T, Cobo M, Laktionov K, Szilasi M, Califano R, Carcereny E, Griffiths R, Paz-Ares L, Duchnowska R, Garcia MA, Isla D, Jassem J, Appel W, Milanowski J, Van Meerbeeck JP, Wolf J, Li A, Acevedo A, Popat S.

Eur J Cancer. 2020 Mar;127:160-172. doi: 10.1016/j.ejca.2019.11.019. Epub 2020 Feb 3.

PMID: 32028209

 

Analysis of Japanese patients from the AUGMENT phase III study of lenalidomide + rituximab (R₂) vs. rituximab + placebo in relapsed/refractory indolent non-Hodgkin lymphoma.

Izutsu K, Minami Y, Fukuhara N, Terui Y, Jo T, Yamamoto G, Ishikawa T, Kobayashi T, Kiguchi T, Nagai H, Ohtsu T, Kalambakas S, Fustier P, Midorikawa S, Tobinai K.

Int J Hematol. 2020 Mar;111(3):409-416. doi: 10.1007/s12185-019-02802-y. Epub 2019 Dec 19.

PMID: 31858429

 

A Bayesian zero-inflated binomial regression and its application in dose-finding study.

Wanitjirattikal P, Shi C.

J Biopharm Stat. 2020 Mar;30(2):322-333. doi: 10.1080/10543406.2019.1684313. Epub 2019 Nov 6.

PMID: 31693441

 

Comparative safety and efficacy of ozanimod versus fingolimod for relapsing multiple sclerosis.

Swallow E, Patterson-Lomba O, Yin L, Mehta R, Pelletier C, Kao D, Sheffield JK, Stonehouse T, Signorovitch J.

J Comp Eff Res. 2020 Mar;9(4):275-285. doi: 10.2217/cer-2019-0169. Epub 2020 Jan 17.

PMID: 31948278

 

Treatment Patterns and Economic Burden by Lines of Therapy Among Patients with Advanced Hepatocellular Carcinoma Treated with Systemic Cancer Therapy.

Bonafede MM, Korytowsky B, Singh P, Cai Q, Cappell K, Jariwala-Parikh K, Sill B, Parikh ND.

J Gastrointest Cancer. 2020 Mar;51(1):217-226. doi: 10.1007/s12029-019-00230-z.

PMID: 31011982

 

Multiplex immunofluorescence staining and image analysis assay for diffuse large B cell lymphoma.

Lee CW, Ren YJ, Marella M, Wang M, Hartke J, Couto SS.

J Immunol Methods. 2020 Mar;478:112714. doi: 10.1016/j.jim.2019.112714. Epub 2019 Nov 26.

PMID: 31783023

 

Defining tumor resistance to PD-1 pathway blockade: recommendations from the first meeting of the SITC Immunotherapy Resistance Taskforce.

Kluger HM, Tawbi HA, Ascierto ML, Bowden M, Callahan MK, Cha E, Chen HX, Drake CG, Feltquate DM, Ferris RL, Gulley JL, Gupta S, Humphrey RW, LaVallee TM, Le DT, Hubbard-Lucey VM, Papadimitrakopoulou VA, Postow MA, Rubin EH, Sharon E, Taube JM, Topalian SL, Zappasodi R, Sznol M, Sullivan RJ.

J Immunother Cancer. 2020 Mar;8(1). pii: e000398. doi: 10.1136/jitc-2019-000398.

PMID: 32238470

 

Establishing guidelines to harmonize tumor mutational burden (TMB): in silico assessment of variation in TMB quantification across diagnostic platforms: phase I of the Friends of Cancer Research TMB Harmonization Project.

Merino DM, McShane LM, Fabrizio D, Funari V, Chen SJ, White JR, Wenz P, Baden J, Barrett JC, Chaudhary R, Chen L, Chen WS, Cheng JH, Cyanam D, Dickey JS, Gupta V, Hellmann M, Helman E, Li Y, Maas J, Papin A, Patidar R, Quinn KJ, Rizvi N, Tae H, Ward C, Xie M, Zehir A, Zhao C, Dietel M, Stenzinger A, Stewart M, Allen J; TMB Harmonization Consortium.

J Immunother Cancer. 2020 Mar;8(1). pii: e000147. doi: 10.1136/jitc-2019-000147.

PMID: 32217756

 

Ceritinib plus Nivolumab in Patients with Advanced ALK-Rearranged Non-Small Cell Lung Cancer: Results of an Open-Label, Multicenter, Phase 1B Study.

Felip E, de Braud FG, Maur M, Loong HH, Shaw AT, Vansteenkiste JF, John T, Liu G, Lolkema MP, Selvaggi G, Giannone V, Cazorla P, Baum J, Balbin OA, Wang LV, Lau YY, Scott JW, Tan DS.

J Thorac Oncol. 2020 Mar;15(3):392-403. doi: 10.1016/j.jtho.2019.10.006. Epub 2019 Oct 18.

PMID: 31634667

 

Nivolumab Monotherapy and Nivolumab Plus Ipilimumab in Recurrent Small Cell Lung Cancer: Results From the CheckMate 032 Randomized Cohort.

Ready NE, Ott PA, Hellmann MD, Zugazagoitia J, Hann CL, de Braud F, Antonia SJ, Ascierto PA, Moreno V, Atmaca A, Salvagni S, Taylor M, Amin A, Camidge DR, Horn L, Calvo E, Li A, Lin WH, Callahan MK, Spigel DR.

J Thorac Oncol. 2020 Mar;15(3):426-435. doi: 10.1016/j.jtho.2019.10.004. Epub 2019 Oct 17.

PMID: 31629915

 

Clinical Phenogroups in Heart Failure With Preserved Ejection Fraction: Detailed Phenotypes, Prognosis, and Response to Spironolactone.

Cohen JB, Schrauben SJ, Zhao L, Basso MD, Cvijic ME, Li Z, Yarde M, Wang Z, Bhattacharya PT, Chirinos DA, Prenner S, Zamani P, Seiffert DA, Car BD, Gordon DA, Margulies K, Cappola T, Chirinos JA.

JACC Heart Fail. 2020 Mar;8(3):172-184. doi: 10.1016/j.jchf.2019.09.009. Epub 2020 Jan 8.

PMID: 31926856

 

Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study.

Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, López-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P.

Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14.

PMID: 31953079

 

Relative efficacy of treatment options in transplant-ineligible newly diagnosed multiple myeloma: results from a systematic literature review and network meta-analysis.

Ramasamy K, Dhanasiri S, Thom H, Buchanan V, Robinson S, D'Souza VK, Weisel K.

Leuk Lymphoma. 2020 Mar;61(3):668-679. doi: 10.1080/10428194.2019.1683736. Epub 2019 Nov 11.

PMID: 31709875

 

Dasatinib discontinuation in patients with chronic-phase chronic myeloid leukemia and stable deep molecular response: the DASFREE study.

Shah NP, García-Gutiérrez V, Jiménez-Velasco A, Larson S, Saussele S, Rea D, Mahon FX, Levy MY, Gómez-Casares MT, Pane F, Nicolini FE, Mauro MJ, Sy O, Martin-Regueira P, Lipton JH.

Leuk Lymphoma. 2020 Mar;61(3):650-659. doi: 10.1080/10428194.2019.1675879. Epub 2019 Oct 24.

PMID: 31647335

 

ILC2s amplify PD-1 blockade by activating tissue-specific cancer immunity.

Moral JA, Leung J, Rojas LA, Ruan J, Zhao J, Sethna Z, Ramnarain A, Gasmi B, Gururajan M, Redmond D, Askan G, Bhanot U, Elyada E, Park Y, Tuveson DA, Gönen M, Leach SD, Wolchok JD, DeMatteo RP, Merghoub T, Balachandran VP.

Nature. 2020 Mar;579(7797):130-135. doi: 10.1038/s41586-020-2015-4. Epub 2020 Feb 19.

PMID: 32076273

 

Does recall period matter? Comparing PROMIS_® physical function with no recall, 24-hr recall, and 7-day recall.

Condon DM, Chapman R, Shaunfield S, Kallen MA, Beaumont JL, Eek D, Mitra D, Benjamin KL, McQuarrie K, Liu J, Shaw JW, Martin Nguyen A, Keating K, Cella D.

Qual Life Res. 2020 Mar;29(3):745-753. doi: 10.1007/s11136-019-02344-0. Epub 2019 Nov 7.

PMID: 31701432

 

SEND harmonization & cross-study analysis: A proposal to better harvest the value from SEND data.

Carfagna MA, Bjerregaard TG, Fukushima T, Houser W, Sloan C, Snyder K, Anderson J, Page T.

Regul Toxicol Pharmacol. 2020 Mar;111:104542. doi: 10.1016/j.yrtph.2019.104542. Epub 2019 Nov 20.

PMID: 31756353

 

Spebrutinib (CC-292) Affects Markers of B Cell Activation, Chemotaxis, and Osteoclasts in Patients with Rheumatoid Arthritis: Results from a Mechanistic Study.

Schafer PH, Kivitz AJ, Ma J, Korish S, Sutherland D, Li L, Azaryan A, Kosek J, Adams M, Capone L, Hur EM, Hough DR, Ringheim GE.

Rheumatol Ther. 2020 Mar;7(1):101-119. doi: 10.1007/s40744-019-00182-7. Epub 2019 Nov 13.

PMID: 31721017

 

Evaluating REMS Burden: A Comparative Time Analysis of 3 Channels for REMS Stakeholders to Perform Mandatory REMS Tasks.

Chapman J, Freeman J, Hechavarria J, Dodeja P, Sheehan P.

Ther Innov Regul Sci. 2020 Mar;54(2):318-323. doi: 10.1007/s43441-019-00060-y. Epub 2020 Jan 6.

PMID: 32072583

New Technologies to Image Tumors.

McNamara G, Lucas J, Beeler JF, Basavanhally A, Lee G, Hedvat CV, Baxi VA, Locke D, Borowsky A, Levenson R.

Cancer Treat Res. 2020 Mar;180:51-94. doi: 10.1007/978-3-030-38862-1_2.

PMID: 32215866

 

Discovery of New Immune Checkpoints: Family Grows Up.

Kong X.

Adv Exp Med Biol. 2020 Mar;1248:61-82. doi: 01007/978-981-15-3266-5_4. Review.

PMID: 32185707

 

Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation.

Prior H, Baldrick P, Beken S, Booler H, Bower N, Brooker P, Brown P, Burlinson B, Burns-Naas LA, Casey W, Chapman M, Clarke D, de Haan L, Doehr O, Downes N, Flaherty M, Gellatly N, Moesgaard SG, Harris J, Holbrook M, Hui J, Jones D, Jones K, Kedar H, Mahl A, Manninen A, McGuire A, Mortimer-Cassen E, Peraza M, Pugsley MK, Richard J, Roberts R, Roosen W, Rothfuss A, Schoenmakers A, Sewell F, Weaver R, Weir L, Wolfreys A, Kimber I.

Regul Toxicol Pharmacol. 2020 Feb 29;113:104624. doi: 10.1016/j.yrtph.2020.104624. [Epub ahead of print]

PMID: 32126256

 

Armoring the Interface with Surfactants to Prevent the Adsorption of Monoclonal Antibodies.

Kanthe AD, Krause M, Zheng S, Ilott A, Li J, Bu W, Bera MK, Lin B, Maldarelli C, Tu RS.

ACS Appl Mater Interfaces. 2020 Feb 26;12(8):9977-9988. doi: 10.1021/acsami.9b21979. Epub 2020 Feb 17.

PMID: 32013386

 

Health-related quality of life results from the IFM 2009 trial: treatment with lenalidomide, bortezomib, and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma.

Roussel M, Hebraud B, Hulin C, Perrot A, Caillot D, Stoppa AM, Macro M, Escoffre M, Arnulf B, Belhadj K, Karlin L, Garderet L, Facon T, Guo S, Weng J, Dhanasiri S, Leleu X, Moreau P, Attal M.

Leuk Lymphoma. 2020 Feb 22:1-11. doi: 10.1080/10428194.2020.1719091. [Epub ahead of print]

PMID: 32090636

 

Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2-5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept.

Brunner HI, Tzaribachev N, Cornejo GV, Joos R, Gervais E, Cimaz R, Calvo Penadés I, Cuttica R, Lutz T, Quartier P, Gandhi Y, Nys M, Wong R, Martini A, Lovell DJ, Ruperto N; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation.

Pediatr Rheumatol Online J. 2020 Feb 22;18(1):19. doi: 10.1186/s12969-020-0410-x.

PMID: 32087715

 

Approaches for machine learning intermolecular interaction energies and application to energy components from symmetry adapted perturbation theory.

Metcalf DP, Koutsoukas A, Spronk SA, Claus BL, Loughney DA, Johnson SR, Cheney DL, Sherrill CD.

J Chem Phys. 2020 Feb 21;152(7):074103. doi: 10.1063/1.5142636.

PMID: 32087645

 

Differential RNA splicing as a potentially important driver mechanism in multiple myeloma.

Bauer MA, Ashby C, Wardell C, Boyle EM, Ortiz M, Flynt E, Thakurta A, Morgan G, Walker BA.

Haematologica. 2020 Feb 20. pii: haematol.2019.235424. doi: 10.3324/haematol.2019.235424. [Epub ahead of print]

PMID: 32079689

 

Effect of restricted dissolved oxygen on expression of Clostridium difficile toxin A subunit from E. coli.

Sharma AK, Phue J, Khatipov E, Dalal N, Anderson ED, Shiloach J.

Sci Rep. 2020 Feb 20;10(1):3059. doi: 10.1038/s41598-020-59978-1.

PMID: 32080292

 

A budget impact analysis for making treatment decisions based on anti-cyclic citrullinated peptide (anti-CCP) testing in rheumatoid arthritis.

Park SH, Han X, Lobo F, Kratochvil D, Patel D.

J Med Econ. 2020 Feb 19:1. doi: 10.1080/13696998.2020.1732991. [Epub ahead of print]

PMID: 32075453

 

Modeling and Simulation of the Pharmacokinetics and Target Engagement of an Antagonist Monoclonal Antibody to Interferon-γ-Induced Protein 10, BMS-986184, in Healthy Participants to Guide Therapeutic Dosing.

Cai W, Leil TA, Gibiansky L, Krishna M, Zhang H, Gu H, Sun H, Throup J, Banerjee S, Girgis I.

Clin Pharmacol Drug Dev. 2020 Feb 18. doi: 10.1002/cpdd.784. [Epub ahead of print]

PMID: 32068354

 

Thalidomide Inhibits Human iPSC Mesendoderm Differentiation by Modulating CRBN-dependent Degradation of SALL4.

Belair DG, Lu G, Waller LE, Gustin JA, Collins ND, Kolaja KL.

Sci Rep. 2020 Feb 18;10(1):2864. doi: 10.1038/s41598-020-59542-x.

PMID: 32071327

 

Estimated susceptibility of Canadian meningococcal B isolates to a meningococcal serogroup B vaccine (MenB-FHbp).

Bettinger JA, Liberator P, Halperin SA, Vaudry W, Sadarangani M, Hao L, Lambert N, Jansen KU, Anderson AS, Tsang R; members of the Canadian Immunization Monitoring Program, Active (IMPACT).

Vaccine. 2020 Feb 18;38(8):2026-2033. doi: 10.1016/j.vaccine.2019.12.051. Epub 2020 Jan 23.

PMID: 31983586

 

Ni(COD)(DQ): An Air-Stable 18-Electron Nickel(0)-Olefin Precatalyst.

Tran VT, Li ZQ, Apolinar O, Derosa J, Joannou MV, Wisniewski SR, Eastgate MD, Engle KM.

Angew Chem Int Ed Engl. 2020 Feb 17. doi: 10.1002/anie.202000124. [Epub ahead of print]

PMID: 32065839

 

Achievement of red blood cell transfusion independence in red blood cell transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes correlates with serum erythropoietin levels.

Santini V, Almeida A, Giagounidis A, Skikne B, Beach CL, Weaver J, Tu N, Fenaux P.

Leuk Lymphoma. 2020 Feb 17:1-9. doi: 10.1080/10428194.2020.1719088. [Epub ahead of print]

PMID: 32064987

 

Effect of Serum Albumin Levels in Patients With Heart Failure With Preserved Ejection Fraction (from the TOPCAT Trial).

Prenner SB, Kumar A, Zhao L, Cvijic ME, Basso M, Spires T, Li Z, Yarde M, Bhattacharya P, Zamani P, Mazurek J, Wang Z, Seiffert D, Gordon DA, Chirinos JA.

Am J Cardiol. 2020 Feb 15;125(4):575-582. doi: 10.1016/j.amjcard.2019.11.006. Epub 2019 Nov 19.

PMID: 31843232

 

Orally bioavailable amine-linked macrocyclic inhibitors of factor XIa.

Fang T, Corte JR, Gilligan PJ, Jeon Y, Osuna H, Rossi KA, Myers JE Jr, Sheriff S, Lou Z, Zheng JJ, Harper TW, Bozarth JM, Wu Y, Luettgen JM, Seiffert DA, Wexler RR, Lam PYS.

Bioorg Med Chem Lett. 2020 Feb 15;30(4):126949. doi: 10.1016/j.bmcl.2020.126949. Epub 2020 Jan 7.

PMID: 31932224

 

Intermittent dosing of the transforming growth factor beta receptor 1 inhibitor, BMS-986260, mitigates class-based cardiovascular toxicity in dogs but not rats.

Rak GD, White MR, Augustine-Rauch K, Newsome C, Graziano MJ, Schulze GE.

J Appl Toxicol. 2020 Feb 15. doi: 10.1002/jat.3954. [Epub ahead of print]

PMID: 32061184

 

Nonindependence of patient data in the clinical practice research datalink: a case study in atrial fibrillation patients.

Sammon CJ, Leahy TP, Ramagopalan S.

J Comp Eff Res. 2020 Feb 14. doi: 10.2217/cer-2019-0191. [Epub ahead of print]

PMID: 32056446

 

Quantification of PD-L1 expression with [₁₈F]BMS-986192 PET/CT in patients with advanced stage non-small-cell lung cancer.

Huisman M, Niemeijer AL, Windhorst B, Schuit R, Leung D, Hayes W, Poot A, Bahce I, Radonic T, Oprea-Lager D, Hoekstra O, Thunnissen E, Hendrikse H, Smit E, De Langen J, Boellaard R.

J Nucl Med. 2020 Feb 14. pii: jnumed.119.240895. doi: 10.2967/jnumed.119.240895. [Epub ahead of print]

PMID: 32060213

 

Multiple Myeloma DREAM Challenge reveals epigenetic regulator PHF19 as marker of aggressive disease.

Mason MJ, Schinke C, Eng CLP, Towfic F, Gruber F, Dervan A, White BS, Pratapa A, Guan Y, Chen H, Cui Y, Li B, Yu T, Chaibub Neto E, Mavrommatis K, Ortiz M, Lyzogubov V, Bisht K, Dai HY, Schmitz F, Flynt E, Dan Rozelle, Danziger SA, Ratushny A; Multiple Myeloma DREAM Consortium, Dalton WS, Goldschmidt H, Avet-Loiseau H, Samur M, Hayete B, Sonneveld P, Shain KH, Munshi N, Auclair D, Hose D, Morgan G, Trotter M, Bassett D, Goke J, Walker BA, Thakurta A, Guinney J.

Leukemia. 2020 Feb 14. doi: 10.1038/s41375-020-0742-z. [Epub ahead of print]

PMID: 32060406

 

Herpes Zoster, Hepatitis C, and Tuberculosis Risk with Apremilast Compared to Biologics, DMARDs and Corticosteroids to Treat Psoriasis and Psoriatic Arthritis.

Hagberg KW, Persson R, Vasilakis-Scaramozza C, Niemcryk S, Peng M, Paris M, Lindholm A, Jick S.

Clin Epidemiol. 2020 Feb 12;12:153-161. doi: 10.2147/CLEP.S239511. eCollection 2020.

PMID: 32104099

 

Synthesis of Cyclobutane-Fused Tetracyclic Scaffolds via Visible-Light Photocatalysis for Building Molecular Complexity.

Oderinde MS, Mao E, Ramirez A, Pawluczyk J, Jorge C, Cornelius LAM, Kempson J, Vetrichelvan M, Pitchai M, Gupta A, Gupta AK, Meanwell NA, Mathur A, Dhar TGM.

J Am Chem Soc. 2020 Feb 12;142(6):3094-3103. doi: 10.1021/jacs.9b12129. Epub 2020 Jan 22.

PMID: 31927959

 

Glutathione and Reactive Oxygen Species Dual-Responsive Block Copolymer Prodrugs for Boosting Tumor Site-Specific Drug Release and Enhanced Antitumor Efficacy.

Yin W, Ke W, Lu N, Wang Y, Japir AAMM, Mohammed F, Wang Y, Pan Y, Ge Z.

Biomacromolecules. 2020 Feb 10;21(2):921-929. doi: 10.1021/acs.biomac.9b01578. Epub 2020 Jan 30.

PMID: 31961134

 

Gastrointestinal bleeding and the risk of colorectal cancer in anticoagulated patients with atrial fibrillation.

Rasmussen PV, Dalgaard F, Gislason GH, Brandes A, Johnsen SP, Grove EL, Torp-Pedersen C, Dybro L, Harboe L, Münster AB, Pedersen L, Blanche P, Pallisgaard JL, Hansen ML.

Eur Heart J. 2020 Feb 7. pii: ehz964. doi: 10.1093/eurheartj/ehz964. [Epub ahead of print]

PMID: 32030399

 

Recommended Practices for Macerating Human Thyroid Cartilage.

LaGoy A, Evangelou EA, Somogyi T, DiGangi EA.

J Forensic Sci. 2020 Feb 7. doi: 10.1111/1556-4029.14289. [Epub ahead of print]

PMID: 32031684

 

A pharmaceutical industry perspective on microphysiological kidney systems for evaluation of safety for new therapies.

Phillips JA, Grandhi TSP, Davis M, Gautier JC, Hariparsad N, Keller D, Sura R, Van Vleet TR.

Lab Chip. 2020 Feb 7;20(3):468-476. doi: 10.1039/c9lc00925f. Epub 2020 Jan 28.

PMID: 31989145

 

Microphysiological systems for ADME-related applications: current status and recommendations for system development and characterization.

Fowler S, Chen WLK, Duignan DB, Gupta A, Hariparsad N, Kenny JR, Lai WG, Liras J, Phillips JA, Gan J.

Lab Chip. 2020 Feb 7;20(3):446-467. doi: 10.1039/c9lc00857h. Epub 2020 Jan 14.

PMID: 31932816

 

Integrative network modeling reveals mechanisms underlying T cell exhaustion.

Bolouri H, Young M, Beilke J, Johnson R, Fox B, Huang L, Santini CC, Hill CM, Vries AVV, Shannon PT, Dervan A, Sivakumar P, Trotter M, Bassett D, Ratushny A.

Sci Rep. 2020 Feb 5;10(1):1915. doi: 10.1038/s41598-020-58600-8.

PMID: 32024856

 

Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study.

Van Voorhees AS, Stein Gold L, Lebwohl M, Strober B, Lynde C, Tyring S, Cauthen A, Sofen H, Zhang Z, Paris M, Wang Y.

J Am Acad Dermatol. 2020 Feb 4. pii: S0190-9622(20)30158-4. doi: 10.1016/j.jaad.2020.01.072. [Epub ahead of print]

PMID: 32032692

 

Infections in patients diagnosed with multiple sclerosis: A multi-database study.

Persson R, Lee S, Ulcickas Yood M, Wagner Usn Mc CM, Minton N, Niemcryk S, Lindholm A, Evans AM, Jick SS.

Mult Scler Relat Disord. 2020 Feb 4;41:101982. doi: 10.1016/j.msard.2020.101982. [Epub ahead of print]

PMID: 32070858

 

Feeding tricarboxylic acid cycle intermediates improves lactate consumption and antibody production in Chinese hamster ovary cell cultures.

Zhang X, Jiang R, Lin H, Xu S.

Biotechnol Prog. 2020 Feb 3:e2975. doi: 10.1002/btpr.2975. [Epub ahead of print]

PMID: 32012447

 

Near Infrared-Triggered Liposome Cages for Rapid, Localized Small Molecule Delivery.

Shin JE, Ogunyankin MO, Zasadzinski JA.

Sci Rep. 2020 Feb 3;10(1):1706. doi: 10.1038/s41598-020-58764-3.

PMID: 32015363

An amide-based sulfenamide prodrug of gamma secretase inhibitor BMS-708163 delivers parent drug from an oral conventional solid dosage form in male beagle dog.

Guarino VR, Olson RE, Everlof JG, Wang N, McDonald I, Haskell R, Clarke W, Lentz KA.

Bioorg Med Chem Lett. 2020 Feb 1;30(3):126856. doi: 10.1016/j.bmcl.2019.126856. Epub 2019 Dec 16.

PMID: 31870650

 

Heterocycle amide isosteres: An approach to overcoming resistance for HIV-1 integrase strand transfer inhibitors.

Peese KM, Naidu BN, Patel M, Li C, Langley DR, Terry B, Protack T, Gali V, Lin Z, Samanta HK, Zheng M, Jenkins S, Dicker IB, Krystal MR, Meanwell NA, Walker MA.

Bioorg Med Chem Lett. 2020 Feb 1;30(3):126784. doi: 10.1016/j.bmcl.2019.126784. Epub 2019 Nov 9.

PMID: 31761656

Protein Biomarker Quantification by Immunoaffinity Liquid Chromatography-Tandem Mass Spectrometry: Current State and Future Vision.

Neubert H, Shuford CM, Olah TV, Garofolo F, Schultz GA, Jones BR, Amaravadi L, Laterza OF, Xu K, Ackermann BL.

Clin Chem. 2020 Feb 1;66(2):282-301. doi: 10.1093/clinchem/hvz022.

PMID: 32040572

 

Educational Impact on Apixaban Adherence in Atrial Fibrillation (the AEGEAN STUDY): A Randomized Clinical Trial.

Montalescot G, Brotons C, Cosyns B, Crijns HJ, D'Angelo A, Drouet L, Eberli F, Lane DA, Besse B, Chan A, Vicaut E, Darius H; AEGEAN Study Investigators.

Am J Cardiovasc Drugs. 2020 Feb;20(1):61-71. doi: 10.1007/s40256-019-00356-2.

PMID: 31243691

Model-based evaluation of the efficacy and safety of nivolumab once every 4 weeks across multiple tumor types.

Zhao X, Shen J, Ivaturi V, Gopalakrishnan M, Feng Y, Schmidt BJ, Statkevich P, Goodman V, Gobburu J, Bello A, Roy A, Agrawal S.

Ann Oncol. 2020 Feb;31(2):302-309. doi: 10.1016/j.annonc.2019.10.015. Epub 2019 Dec 9.

PMID: 31959348

 

Association of Seropositivity and Mortality in Rheumatoid Arthritis and the Impact of Treatment With Disease-Modifying Antirheumatic Drugs: Results From a Real-World Study.

Alemao E, Bao Y, Weinblatt ME, Shadick N.

Arthritis Care Res (Hoboken). 2020 Feb;72(2):176-183. doi: 10.1002/acr.24071. Epub 2020 Jan 13.

PMID: 31529682

Pomalidomide plus low-dose dexamethasone in relapsed refractory multiple myeloma after lenalidomide treatment failure.

Siegel DS, Schiller GJ, Song KW, Agajanian R, Stockerl-Goldstein K, Kaya H, Sebag M, Samaras C, Malek E, Talamo G, Seet CS, Mouro J, Pierceall WE, Zafar F, Chung W, Srinivasan S, Agarwal A, Bahlis NJ.

Br J Haematol. 2020 Feb;188(4):501-510. doi: 10.1111/bjh.16213. Epub 2019 Oct 6.

PMID: 31588567

 

Benefit-risk assessment of nivolumab 240 mg flat dose relative to 3 mg/kg Q2W regimen in Japanese patients with advanced cancers.

Bei D, Osawa M, Uemura S, Ohno T, Gobburu J, Roy A, Hasegawa M.

Cancer Sci. 2020 Feb;111(2):528-535. doi: 10.1111/cas.14252. Epub 2020 Jan 21.

PMID: 31773815

 

Phase 1 Study of Erlotinib and Metformin in Metastatic Triple-Negative Breast Cancer.

Fenn K, Maurer M, Lee SM, Crew KD, Trivedi MS, Accordino MK, Hershman DL, Kalinsky K.

Clin Breast Cancer. 2020 Feb;20(1):80-86. doi: 10.1016/j.clbc.2019.08.004. Epub 2019 Aug 29.

PMID: 31570268

 

Outcomes of Long-term Treatment of Chronic HBV Infection With Entecavir or Other Agents From a Randomized Trial in 24 Countries.

Hou JL, Zhao W, Lee C, Hann HW, Peng CY, Tanwandee T, Morozov V, Klinker H, Sollano JD, Streinu-Cercel A, Cheinquer H, Xie Q, Wang YM, Wei L, Jia JD, Gong G, Han KH, Cao W, Cheng M, Tang X, Tan D, Ren H, Duan Z, Tang H, Gao Z, Chen S, Lin S, Sheng J, Chen C, Shang J, Han T, Ji Y, Niu J, Sun J, Chen Y, Cooney EL, Lim SG.

Clin Gastroenterol Hepatol. 2020 Feb;18(2):457-467.e21. doi: 10.1016/j.cgh.2019.07.010. Epub 2019 Jul 12.

PMID: 31306800

 

Population Pharmacokinetics of an Anti-PD-L1 Antibody, Durvalumab in Patients with Hematologic Malignancies.

Ogasawara K, Newhall K, Maxwell SE, Dell'Aringa J, Komashko V, Kilavuz N, Delarue R, Czuczman M, Sternas L, Rose S, Beach CL, Novick S, Zhou S, Palmisano M, Li Y.

Clin Pharmacokinet. 2020 Feb;59(2):217-227. doi: 10.1007/s40262-019-00804-x.

PMID: 31332669

 

Next-Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development.

Roth SE, Avigan MI, Bourdet D, Brott D, Church R, Dash A, Keller D, Sherratt P, Watkins PB, Westcott-Baker L, Lentini S, Merz M, Ramaiah L, Ramaiah SK, Stanley AM, Marcinak J.

Clin Pharmacol Ther. 2020 Feb;107(2):333-346. doi: 10.1002/cpt.1571. Epub 2019 Sep 14. Review.

PMID: 31314926

 

Adverse events associated with weight-based, high-dose montelukast exposures in children.

Arnold DH, Bowman N, Reiss TF, Hartert TV, Akers WS, Seger DL.

Clin Toxicol (Phila). 2020 Feb;58(2):145-146. doi: 10.1080/15563650.2019.1609686. Epub 2019 May 6. No abstract available. Erratum in: Clin Toxicol (Phila). 2020 Feb;58(2):e1.

PMID: 31056949

 

Association among anti-citrullinated protein antibody status, erosive disease and healthcare resource utilization in patients with rheumatoid arthritis.

Harrold LR, Shan Y, Connolly SE, Alemao E, Rebello S, Guo L, Kremer JM.

Curr Med Res Opin. 2020 Feb;36(2):337-342. doi: 10.1080/03007995.2019.1680354. Epub 2019 Oct 24.

PMID: 31612736

 

Validation of obesity coding among newly treated nonvalvular atrial fibrillation patients using an integrated electronic medical record and claims database.

Jain R, Watzker A, Luo X, Kang AL, Baker CL, Rosenblatt L, Mardekian J, Menzin J.

Curr Med Res Opin. 2020 Feb;36(2):189-197. doi: 10.1080/03007995.2019.1666448. Epub 2019 Sep 28.

PMID: 31564172

 

Economic and Clinical Burden of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes in the U.S.

Younossi ZM, Tampi RP, Racila A, Qiu Y, Burns L, Younossi I, Nader F.

Diabetes Care. 2020 Feb;43(2):283-289. doi: 10.2337/dc19-1113. Epub 2019 Oct 28.

PMID: 31658974

 

Implementing robotic surgery for uterine cancer in the United States: Better outcomes without increased costs.

Casarin J, Song C, Multinu F, Cappuccio S, Liu E, Butler KA, Glaser GE, Cliby WA, Langstraat CL, Ghezzi F, Fu AZ, Mariani A.

Gynecol Oncol. 2020 Feb;156(2):451-458. doi: 10.1016/j.ygyno.2019.11.016. Epub 2019 Nov 25.

PMID: 31780236

 

Comparison of inpatient admission rates of patients treated with apixaban vs. warfarin for venous thromboembolism in the emergency department.

Deitelzweig S, Hlavacek P, Mardekian J, Rosenblatt L, Russ C, Tuell K, Lingohr-Smith M, Lin J, Guo JD.

Hosp Pract (1995). 2020 Feb;48(1):41-48. doi: 10.1080/21548331.2020.1718925. Epub 2020 Feb 6.

PMID: 31976776

 

Pharmacokinetics and safety of apremilast in pediatric patients with moderate to severe plaque psoriasis: Results from a phase 2 open-label study.

Paller AS, Hong Y, Becker EM, de Lucas R, Paris M, Zhang W, Zhang Z, Barcellona C, Maes P, Fiorillo L.

J Am Acad Dermatol. 2020 Feb;82(2):389-397. doi: 10.1016/j.jaad.2019.08.019. Epub 2019 Aug 10.

PMID: 31408686

 

Key factors associated with uncontrolled asthma - the Asthma Control in Latin America Study.

Neffen H, Chahuàn M, Hernández DD, Vallejo-Perez E, Bolivar F, Sánchez MH, Galleguillos F, Castaños C, S Silva R, Giugno E, Pavie J, Contreras R, Lamarao F, Moraes Dos Santos F, Rodriguez C, Tobler J, Viana K, Vieira C, Soares C.

J Asthma. 2020 Feb;57(2):113-122. doi: 10.1080/02770903.2018.1553050. Epub 2019 Mar 27.

PMID: 30915868

 

Safety and effectiveness of reduced-dose apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A sub-analysis of the STANDARD study.

Inoue H, Umeyama M, Yamada T, Hashimoto H, Komoto A, Yasaka M.

J Cardiol. 2020 Feb;75(2):208-215. doi: 10.1016/j.jjcc.2019.07.007. Epub 2019 Aug 15.

PMID: 31421933

 

Current treatment patterns and medical costs for multiple myeloma in Japan: a cross-sectional analysis of a health insurance claims database.

Uno S, Goto R, Suzuki K, Iwasaki K, Takeshima T, Ohtsu T.

J Med Econ. 2020 Feb;23(2):166-173. doi: 10.1080/13696998.2019.1686870. Epub 2019 Nov 18.

PMID: 31682533

 

Real-world treatment patterns, cost of care and effectiveness of therapies for patients with squamous cell carcinoma of head and neck pre and post approval of immuno-oncology agents.

Abraham P, Kish JK, Korytowsky B, Radtchenko J, Singh P, Shaw J, Feinberg B.

J Med Econ. 2020 Feb;23(2):125-131. doi: 10.1080/13696998.2019.1676760. Epub 2019 Oct 18.

PMID: 31581922

 

Tunable Two-Compartment On-Demand Sustained Drug Release Based on Lipid Gels.

Wang X, Huang L, Zhang Y, Meng F, Donoso M, Haskell R, Luo L.

J Pharm Sci. 2020 Feb;109(2):1059-1067. doi: 10.1016/j.xphs.2019.10.021. Epub 2019 Oct 17.

PMID:31629734

 

Effect of Moisture Sorption on Free Volume and Relaxation of Spray Dried Dispersions: Relation to Drug Recrystallization.

Li J, Hubert M, Pinnamaneni S, Tao L, Zhao J, Sharif S, Ramakrishnan RK, Nazarenko S.

J Pharm Sci. 2020 Feb;109(2):1050-1058. doi: 10.1016/j.xphs.2019.10.018. Epub 2019 Oct 14.

PMID: 31622601

 

Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: a double-blind, randomised, placebo-controlled, phase 2 trial.

Maher TM, Corte TJ, Fischer A, Kreuter M, Lederer DJ, Molina-Molina M, Axmann J, Kirchgaessler KU, Samara K, Gilberg F, Cottin V.

Lancet Respir Med. 2020 Feb;8(2):147-157. doi: 10.1016/S2213-2600(19)30341-8. Epub 2019 Sep 29.

PMID: 31578169

Immunotherapy rechallenge after nivolumab treatment in advanced non-small cell lung cancer in the real-world setting: A national data base analysis.

Giaj Levra M, Cotté FE, Corre R, Calvet C, Gaudin AF, Penrod JR, Grumberg V, Jouaneton B, Jolivel R, Assié JB, Chouaïd C.

Lung Cancer. 2020 Feb;140:99-106. doi: 10.1016/j.lungcan.2019.12.017. Epub 2019 Dec 31.

PMID: 31911324

 

Real-world effectiveness and safety of nivolumab in patients with non-small cell lung cancer: A multicenter retrospective observational study in Japan.

Morita R, Okishio K, Shimizu J, Saito H, Sakai H, Kim YH, Hataji O, Yomota M, Nishio M, Aoe K, Kanai O, Kumagai T, Kibata K, Tsukamoto H, Oizumi S, Fujimoto D, Tanaka H, Mizuno K, Masuda T, Kozuki T, Haku T, Suzuki H, Okamoto I, Hoshiyama H, Ueda J, Ohe Y.

Lung Cancer. 2020 Feb;140:8-18. doi: 10.1016/j.lungcan.2019.11.014. Epub 2019 Nov 20.

PMID: 31838169

 

Absolute lymphocyte count as a prognostic biomarker for overall survival in patients with advanced melanoma treated with ipilimumab.

Postow MA, Chasalow SD, Kuk D, Panageas KS, Cheng ML, Yuan J, Wolchok JD.

Melanoma Res. 2020 Feb;30(1):71-75. doi: 10.1097/CMR.0000000000000633.

PMID: 31425479

 

A High-Throughput BRET Cellular Target Engagement Assay Links Biochemical to Cellular Activity for Bruton's Tyrosine Kinase.

Ong LL, Vasta JD, Monereau L, Locke G, Ribeiro H, Pattoli MA, Skala S, Burke JR, Watterson SH, Tino JA, Meisenheimer PL, Arey B, Lippy J, Zhang L, Robers MB, Tebben A, Chaudhry C.

SLAS Discov. 2020 Feb;25(2):176-185. doi: 10.1177/2472555219884881. Epub 2019 Nov 9.

PMID: 31709883

 

Role of Indoleamine-2,3-Dioxygenase Inhibitors in Salvage Therapy for Non-Muscle Invasive Bladder Cancer.

Chu CE, Porten SP, Grossfeld GD, Meng MV.

Urol Clin North Am. 2020 Feb;47(1):111-118. doi: 10.1016/j.ucl.2019.09.013. Review.

PMID: 31757294

 

From single-arm studies to externally controlled studies. Methodological considerations and guidelines.

Cucherat M, Laporte S, Delaitre O, Behier JM; participants of Giens XXXV Round Table Clinical Research, d'Andon A, Binlich F, Bureau S, Cornu C, Fouret C, Hoog Labouret N, Laviolle B, Miadi-Fargier H, Paoletti X, Roustit M, Simon T, Varoqueaux N, Vicaut E, Westerloppe J.

Therapie. 2020 Jan - Feb;75(1):21-27. doi: 10.1016/j.therap.2019.11.007. Epub 2019 Dec 16.

PMID: 32063399

 

Acceptability and content validity of patient-reported measures considered from the rheumatoid arthritis patient's perspective.

Shaw Y, Zhang C, Bradley M, Simon TA, Schumacher R, McDonald D, Michaud K.

Arthritis Care Res (Hoboken). 2020 Jan 31. doi: 10.1002/acr.24156. [Epub ahead of print]

PMID: 32004411

 

Efficacy and safety of dapagliflozin plus saxagliptin versus insulin glargine over 52 weeks as add-on to metformin with or without sulphonylurea in patients with type 2 diabetes: A randomized, parallel-design, open-label, Phase 3 trial.

Vilsbøll T, Ekholm E, Johnsson E, Garcia-Sanchez R, Dronamraju N, Jabbour SA, Lind M.

Diabetes Obes Metab. 2020 Jan 31. doi: 10.1111/dom.13981. [Epub ahead of print]

PMID: 32003150

 

Variable global distribution of cell-of-origin from the ROBUST phase III study in diffuse large B-cell lymphoma.

Nowakowski GS, Chiappella A, Witzig TE, Scott DW, Spina M, Gascoyne RD, Zhang L, Russo J, Kang J, Zhang J, Xu Y, Vitolo U.

Haematologica. 2020 Jan 31;105(2):e72-e75. doi: 10.3324/haematol.2019.220475. Print 2020. No abstract available.

PMID: 31221781

 

Cell-Based In Vitro Assay Automation: Balancing Technology and Data Reproducibility/Predictability.

Thomas-Fowlkes B, Cifelli S, Souza S, Visconti R, Struck A, Weinglass A, Wildey MJ.

SLAS Technol. 2020 Jan 31:2472630320902095. doi: 10.1177/2472630320902095. [Epub ahead of print]

PMID: 32003291

 

Stability behaviour of antiretroviral drugs and their combinations. 11: Characterization of interaction products of zidovudine and efavirenz, and evaluation of their anti HIV-1 activity, and physiochemical and ADMET properties.

Kurmi M, Sahu A, Balhara A, Singh IP, Kulkarni S, Singh NK, Garg P, Singh S.

J Pharm Biomed Anal. 2020 Jan 30;178:112911. doi: 10.1016/j.jpba.2019.112911. Epub 2019 Oct 6.

PMID: 31627078

 

Safety, tolerability and immunogenicity of V934/V935 hTERT vaccination in cancer patients with selected solid tumors: a phase I study.

Aurisicchio L, Fridman A, Mauro D, Sheloditna R, Chiappori A, Bagchi A, Ciliberto G.

J Transl Med. 2020 Jan 30;18(1):39. doi: 10.1186/s12967-020-02228-9.

PMID: 32000810

 

Author Correction: Blood-brain barrier permeable nano immunoconjugates induce local immune responses for glioma therapy.

Galstyan A, Markman JL, Shatalova ES, Chiechi A, Korman AJ, Patil R, Klymyshyn D, Tourtellotte WG, Israel LL, Braubach O, Ljubimov VA, Mashouf LA, Ramesh A, Grodzinski ZB, Penichet ML, Black KL, Holler E, Sun T, Ding H, Ljubimov AV, Ljubimova JY.

Nat Commun. 2020 Jan 30;11(1):701. doi: 10.1038/s41467-020-14427-5.

PMID: 32001685

 

Considerations for Soluble Protein Biomarker Blood Sample Matrix Selection.

Mathews JA, Ni YG, Wang C, Peterson JE, Ray C, Zhao X, Duan D, Hamon S, Allinson J, Hokom M, Wegner G.

AAPS J. 2020 Jan 29;22(2):38. doi: 10.1208/s12248-020-0412-0.

PMID: 31997095

 

Cost-effectiveness analysis of nivolumab for the treatment of squamous cell carcinoma of the head and neck in the United States.

Haddad R, Cohen EEW, Venkatachalam M, Young K, Singh P, Shaw JW, Korytowsky B, Abraham P, Harrington KJ.

J Med Econ. 2020 Jan 29:1-6. doi: 10.1080/13696998.2020.1715414. [Epub ahead of print]

PMID: 31928375

 

Immunogenicity Risk Assessment for PEGylated Therapeutics.

Mora JR, White JT, DeWall SL.

AAPS J. 2020 Jan 28;22(2):35. doi: 10.1208/s12248-020-0420-0.

PMID: 31993858

 

Discovery of BMS-986260, a Potent, Selective, and Orally Bioavailable TGFβR1 Inhibitor as an Immuno-oncology Agent.

Velaparthi U, Darne CP, Warrier J, Liu P, Rahaman H, Augustine-Rauch K, Parrish K, Yang Z, Swanson J, Brown J, Dhar G, Anandam A, Holenarsipur VK, Palanisamy K, Wautlet BS, Fereshteh MP, Lippy J, Tebben AJ, Sheriff S, Ruzanov M, Yan C, Gupta A, Gupta AK, Vetrichelvan M, Mathur A, Gelman M, Singh R, Kinsella T, Murtaza A, Fargnoli J, Vite G, Borzilleri RM.

ACS Med Chem Lett. 2020 Jan 28;11(2):172-178. doi: 10.1021/acsmedchemlett.9b00552. eCollection 2020 Feb 13.

PMID: 32071685

 

Bleeding and recurrent VTE with apixaban vs warfarin as outpatient treatment: time-course and subgroup analyses.

Weycker D, Wygant GD, Guo JD, Lee T, Luo X, Rosenblatt L, Mardekian J, Atwood M, Hanau A, Cohen AT.

Blood Adv. 2020 Jan 28;4(2):432-439. doi: 10.1182/bloodadvances.2019001081.

PMID: 31990332

BRAF and DIS3 Mutations Associate with Adverse Outcome in a Long-term Follow-up of Patients with Multiple Myeloma.

Boyle EM, Ashby C, Tytarenko RG, Deshpande S, Wang H, Wang Y, Rosenthal A, Sawyer J, Tian E, Flynt E, Hoering A, Johnson SK, Rutherford MW, Wardell CP, Bauer MA, Dumontet C, Facon T, Thanendrarajan S, Schinke CD, Zangari M, van Rhee F, Barlogie B, Cairns D, Jackson G, Thakurta A, Davies FE, Morgan GJ, Walker BA.

Clin Cancer Res. 2020 Jan 27. doi: 10.1158/1078-0432.CCR-19-1507. [Epub ahead of print]

PMID: 31988198

 

Decoding the small size challenges of mini-tablets for enhanced dose flexibility and micro-dosing.

Mitra B, Thool P, Meruva S, Aycinena JA, Li J, Patel J, Patel K, Agarwal A, Karki S, Bowen W.

Int J Pharm. 2020 Jan 25;574:118905. doi: 10.1016/j.ijpharm.2019.118905. Epub 2019 Dec 3.

PMID: 31809860

 

Prognosis, Biology, and Targeting of TP53 Dysregulation in Multiple Myeloma.

Flynt E, Bisht K, Sridharan V, Ortiz M, Towfic F, Thakurta A.

Cells. 2020 Jan 24;9(2). pii: E287. doi: 10.3390/cells9020287. Review.

PMID: 31991614

 

Potent, Orally Bioavailable, and Efficacious Macrocyclic Inhibitors of Factor XIa. Discovery of Pyridine-Based Macrocycles Possessing Phenylazole Carboxamide P1 Groups.

Corte JR, Pinto DJP, Fang T, Osuna H, Yang W, Wang Y, Lai A, Clark CG, Sun JH, Rampulla R, Mathur A, Kaspady M, Neithnadka PR, Li YC, Rossi KA, Myers JE Jr, Sheriff S, Lou Z, Harper TW, Huang C, Zheng JJ, Bozarth JM, Wu Y, Wong PC, Crain EJ, Seiffert DA, Luettgen JM, Lam PYS, Wexler RR, Ewing WR.

J Med Chem. 2020 Jan 23;63(2):784-803. doi: 10.1021/acs.jmedchem.9b01768. Epub 2020 Jan 2.

PMID: 31833761

 

A novel approach enables imaged capillary isoelectric focusing analysis of PEGylated proteins.

Zhang X, Chemmalil L, Ding J, Li Z.

Electrophoresis. 2020 Jan 22. doi: 10.1002/elps.201900406. [Epub ahead of print]

PMID: 31967659

 

Treatment Considerations for Patients with Unresectable Metastatic Melanoma Who Develop Pembrolizumab-Induced Guillain-Barré Toxicity: A Case Report.

Muralikrishnan S, Ronan LK, Coker S, Rauschkolb PK, Shirai K.

Case Rep Oncol. 2020 Jan 21;13(1):43-48. doi: 10.1159/000504930. eCollection 2020 Jan-Apr.

PMID: 32110218

 

Cardiovascular Toxicity Induced by Kinase Inhibitors: Mechanisms and Preclinical Approaches.

Lamore SD, Kohnken RA, Peters MF, Kolaja KL.

Chem Res Toxicol. 2020 Jan 21;33(1):125-136. doi: 10.1021/acs.chemrestox.9b00387. Epub 2020 Jan 10.

PMID: 31840498

 

Use of Zebrafish in Drug Discovery Toxicology.

Cassar S, Adatto I, Freeman JL, Gamse JT, Iturria I, Lawrence C, Muriana A, Peterson RT, Van Cruchten S, Zon LI.

Chem Res Toxicol. 2020 Jan 21;33(1):95-118. doi: 10.1021/acs.chemrestox.9b00335. Epub 2019 Nov 16.

PMID: 31625720

 

Liver microphysiological systems development guidelines for safety risk assessment in the pharmaceutical industry.

Baudy AR, Otieno MA, Hewitt P, Gan J, Roth A, Keller D, Sura R, Van Vleet TR, Proctor WR.

Lab Chip. 2020 Jan 21;20(2):215-225. doi: 10.1039/c9lc00768g. Epub 2019 Dec 4.

PMID: 31799979

 

Inpatient and outpatient treatment patterns of cancer-associated thrombosis in the United States.

Guo JD, Hlavacek P, Poretta T, Wygant G, Lane D, Gorritz M, Wang X, Chen CC, Wade RL, Pan X, Rajpura J, Stwalley B, Rosenblatt L.

J Thromb Thrombolysis. 2020 Jan 18. doi: 10.1007/s11239-019-02032-3. [Epub ahead of print]

PMID: 31955338

 

Large-scale Analyses of Disease Biomarkers and Apremilast Pharmacodynamic Effects.

Medvedeva IV, Stokes ME, Eisinger D, LaBrie ST, Ai J, Trotter MWB, Schafer P, Yang R.

Sci Rep. 2020 Jan 17;10(1):605. doi: 10.1038/s41598-020-57542-5.

PMID: 31953524

 

The value of immunotherapy for survivors of stage IV non-small cell lung cancer: patient perspectives on quality of life.

Park R, Shaw JW, Korn A, McAuliffe J.

J Cancer Surviv. 2020 Jan 16. doi: 10.1007/s11764-020-00853-3. [Epub ahead of print]

PMID: 31950409

 

Can real-world data really replace randomised clinical trials?

Ramagopalan SV, Simpson A, Sammon C.

BMC Med. 2020 Jan 15;18(1):13. doi: 10.1186/s12916-019-1481-8. No abstract available.

PMID: 31937304

 

A Phase Ib/II Trial of the First-in-Class Anti-CXCR4 Antibody Ulocuplumab in Combination with Lenalidomide or Bortezomib Plus Dexamethasone in Relapsed Multiple Myeloma.

Ghobrial IM, Liu CJ, Redd RA, Perez RP, Baz R, Zavidij O, Sklavenitis-Pistofidis R, Richardson PG, Anderson KC, Laubach J, Henrick P, Savell A, Reyes K, Hornburg K, Chuma S, Sabbatini P, Robbins MD, Becker PS.

Clin Cancer Res. 2020 Jan 15;26(2):344-353. doi: 10.1158/1078-0432.CCR-19-0647. Epub 2019 Oct 31.

PMID: 31672767

 

Costs and Cost Drivers Associated with Non-Small-Cell Lung Cancer Patients Who Received Two or More Lines of Therapy in Europe.

Verleger K, Penrod JR, Manley Daumont M, Solem C, Luo L, Macahilig C, Hertel N.

Clinicoecon Outcomes Res. 2020 Jan 15;12:23-33. doi: 10.2147/CEOR.S223760. eCollection 2020.

PMID: 32021337

 

Applications of fluorine-containing amino acids for drug design.

Mei H, Han J, Klika KD, Izawa K, Sato T, Meanwell NA, Soloshonok VA.

Eur J Med Chem. 2020 Jan 15;186:111826. doi: 10.1016/j.ejmech.2019.111826. Epub 2019 Nov 4. Review.

PMID: 31740056

 

Nickel-Catalyzed 1,2-Diarylation of Alkenyl Carboxylates: A Gateway to 1,2,3-Trifunctionalized Building Blocks.

Derosa J, Kang T, Tran VT, Wisniewski SR, Karunananda MK, Jankins TC, Xu KL, Engle KM.

Angew Chem Int Ed Engl. 2020 Jan 13;59(3):1201-1205. doi: 10.1002/anie.201913062. Epub 2019 Dec 12.

PMID: 31693286

 

Effective temperature shift strategy development and scale confirmation for simultaneous optimization of protein productivity and quality in Chinese hamster ovary cells.

McHugh KP, Xu J, Aron KL, Borys MC, Li ZJ.

Biotechnol Prog. 2020 Jan 12:e2959. doi: 10.1002/btpr.2959. [Epub ahead of print]

PMID: 31930722

A window-of-opportunity trial of the CXCR1/2 inhibitor reparixin in operable HER-2-negative breast cancer.

Goldstein LJ, Perez RP, Yardley D, Han LK, Reuben JM, Gao H, McCanna S, Butler B, Ruffini PA, Liu Y, Rosato RR, Chang JC.

Breast Cancer Res. 2020 Jan 10;22(1):4. doi: 10.1186/s13058-019-1243-8.

PMID: 31924241

 

High-Dose Ipilimumab and High-Dose Interleukin-2 for Patients With Advanced Melanoma.

Silk AW, Kaufman HL, Curti B, Mehnert JM, Margolin K, McDermott D, Clark J, Newman J, Bommareddy PK, Denzin L, Najmi S, Haider A, Shih W, Kane MP, Zloza A.

Front Oncol. 2020 Jan 10;9:1483. doi: 10.3389/fonc.2019.01483. eCollection 2019.

PMID: 31998643

 

Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes.

Fenaux P, Platzbecker U, Mufti GJ, Garcia-Manero G, Buckstein R, Santini V, Díez-Campelo M, Finelli C, Cazzola M, Ilhan O, Sekeres MA, Falantes JF, Arrizabalaga B, Salvi F, Giai V, Vyas P, Bowen D, Selleslag D, DeZern AE, Jurcic JG, Germing U, Götze KS, Quesnel B, Beyne-Rauzy O, Cluzeau T, Voso MT, Mazure D, Vellenga E, Greenberg PL, Hellström-Lindberg E, Zeidan AM, Adès L, Verma A, Savona MR, Laadem A, Benzohra A, Zhang J, Rampersad A, Dunshee DR, Linde PG, Sherman ML, Komrokji RS, List AF.

N Engl J Med. 2020 Jan 9;382(2):140-151. doi: 10.1056/NEJMoa1908892.

PMID: 31914241

 

Effects of Apremilast, an Oral Inhibitor of Phosphodiesterase 4, in a Randomized Trial of Patients With Active Ulcerative Colitis.

Danese S, Neurath MF, Kopoń A, Zakko SF, Simmons TC, Fogel R, Siegel CA, Panaccione R, Zhan X, Usiskin K, Chitkara D.

Clin Gastroenterol Hepatol. 2020 Jan 8. pii: S1542-3565(20)30005-7. doi: 10.1016/j.cgh.2019.12.032. [Epub ahead of print]

PMID: 31926340

 

Treatment to Target in Psoriatic Arthritis with Apremilast: Probability of Achieving Targets and Comprehensive Control of Disease Manifestations.

Mease PJ, Gladman DD, Ogdie A, Coates LC, Behrens F, Kavanaugh A, Mcinnes I, Queiro R, Guerette B, Brunori M, Teng L, Smolen JS.

Arthritis Care Res (Hoboken). 2020 Jan 7. doi: 10.1002/acr.24134. [Epub ahead of print]

PMID: 31909868

 

Application of in-sample calibration curve methodology for regulated bioanalysis: Critical considerations in method development, validation and sample analysis.

Yuan L, Gu H, Zeng J, Pillutla RC, Ji QC.

J Pharm Biomed Anal. 2020 Jan 5;177:112844. doi: 10.1016/j.jpba.2019.112844. Epub 2019 Aug 29.

PMID: 31491659

 

The Evolving Druggability and Developability Space: Chemically Modified New Modalities and Emerging Small Molecules.

Yang W, Gadgil P, Krishnamurthy VR, Landis M, Mallick P, Patel D, Patel PJ, Reid DL, Sanchez-Felix M.

AAPS J. 2020 Jan 3;22(2):21. doi: 10.1208/s12248-019-0402-2.

PMID: 31900602

 

Application and Impact of Human Dose Projection from Discovery to Early Drug Development.

Patel D, Yang W, Lipert M, Wu T.

AAPS PharmSciTech. 2020 Jan 2;21(2):44. doi: 10.1208/s12249-019-1598-2. Review.

PMID: 31897807

Design, synthesis and biological evaluation of phenol-linked uncialamycin antibody-drug conjugates.

Poudel YB, Rao C, Kotapati S, Deshpande M, Thevanayagam L, Pan C, Cardarelli J, Chowdari N, Kaspady M, Samikannu R, Kuppusamy P, Saravanakumar P, Arunachalam PN, Deshpande S, Rangan V, Rampulla R, Mathur A, Vite GD, Gangwar S.

Bioorg Med Chem Lett. 2020 Jan 1;30(1):126782. doi: 10.1016/j.bmcl.2019.126782. Epub 2019 Nov 9.

PMID: 31767265

 

Estimates of Responsiveness, Minimally Important Differences, and Patient Acceptable Symptom State in Five Patient-Reported Outcomes Measurement Information System Short Forms in Systemic Lupus Erythematosus.

Katz P, Pedro S, Alemao E, Yazdany J, Dall'Era M, Trupin L, Rush S, Michaud K.

ACR Open Rheumatol. 2020 Jan;2(1):53-60. doi: 10.1002/acr2.11100. Epub 2019 Dec 4.

PMID: 31943975

 

Consensus guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury occurring during clinical trials in adults with chronic cholestatic liver disease.

Palmer M, Regev A, Lindor K, Avigan MI, Dimick-Santos L, Treem W, Marcinak JF, Lewis JH, Anania FA, Seekins D, Shneider BL, Chalasani N.

Aliment Pharmacol Ther. 2020 Jan;51(1):90-109. doi: 10.1111/apt.15579. Epub 2019 Nov 25. Review.

PMID: 31762074

 

Myeloid Cells Orchestrate Systemic Immunosuppression, Impairing the Efficacy of Immunotherapy against HPV₊ Cancers.

Galliverti G, Wullschleger S, Tichet M, Murugan D, Zangger N, Horton W, Korman AJ, Coussens LM, Swartz MA, Hanahan D.

Cancer Immunol Res. 2020 Jan;8(1):131-145. doi: 10.1158/2326-6066.CIR-19-0315. Epub 2019 Nov 26.

PMID: 31771984

 

Connect MM Registry as a national reference for United States multiple myeloma patients.

Ailawadhi S, Jagannath S, Narang M, Rifkin RM, Terebelo HR, Toomey K, Durie BGM, Hardin JW, Gasparetto CJ, Wagner L, Omel JL, Kumar V, Yue L, Kitali A, Agarwal A, Abonour R; Connect MM Registry Investigators.

Cancer Med. 2020 Jan;9(1):35-42. doi: 10.1002/cam4.2656. Epub 2019 Nov 7.

PMID: 31701679

 

Population Pharmacokinetics of Ipilimumab in Combination With Nivolumab in Patients With Advanced Solid Tumors.

Sanghavi K, Zhang J, Zhao X, Feng Y, Statkevich P, Sheng J, Roy A, Vezina HE.

CPT Pharmacometrics Syst Pharmacol. 2020 Jan;9(1):29-39. doi: 10.1002/psp4.12477. Epub 2019 Dec 1.

PMID: 31709718

 

Treatment patterns and healthcare costs among biologic-naive patients initiating apremilast or biologics for the treatment of psoriatic arthritis: results from a US claims analysis.

Wu JJ, Pelletier C, Ung B, Tian M.

Curr Med Res Opin. 2020 Jan;36(1):169-176. doi: 10.1080/03007995.2019.1668204. Epub 2019 Sep 28.

PMID: 31517542

 

Application of Augmented Intelligence for Pharmacovigilance Case Seriousness Determination.

Routray R, Tetarenko N, Abu-Assal C, Mockute R, Assuncao B, Chen H, Bao S, Danysz K, Desai S, Cicirello S, Willis V, Alford SH, Krishnamurthy V, Mingle E.

Drug Saf. 2020 Jan;43(1):57-66. doi: 10.1007/s40264-019-00869-4.

PMID: 31605285

 

Application of the adverse outcome pathway framework to genotoxic modes of action.

Sasaki JC, Allemang A, Bryce SM, Custer L, Dearfield KL, Dietz Y, Elhajouji A, Escobar PA, Fornace AJ Jr, Froetschl R, Galloway S, Hemmann U, Hendriks G, Li HH, Luijten M, Ouedraogo G, Peel L, Pfuhler S, Roberts DJ, Thybaud V, van Benthem J, Yauk CL, Schuler M.

Environ Mol Mutagen. 2020 Jan;61(1):114-134. doi: 10.1002/em.22339. Epub 2019 Oct 31.

PMID: 31603995

 

 Potential of machine learning methods to identify patients with nonvalvular atrial fibrillation.

Suzuki R, Katada J, Ramagopalan S, McDonald L.

Future Cardiol. 2020 Jan;16(1):43-52. doi: 10.2217/fca-2019-0056. Epub 2019 Dec 3.

PMID: 31793345

 

ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer.

Sonpavde G, Necchi A, Gupta S, Steinberg GD, Gschwend JE, Van Der Heijden MS, Garzon N, Ibrahim M, Raybold B, Liaw D, Rutstein M, Galsky MD.

Future Oncol. 2020 Jan;16(2):4359-4368. doi: 10.2217/fon-2019-0611. Epub 2019 Dec 11.

PMID: 31823654

 

Consistency of recording of chemotherapy cycles in the National Cancer Registration and Analysis Service Systemic Anti-Cancer Therapy database and the Hospital Episode Statistics Admitted Patient Care database.

McDonald L, Sammon C, Carroll R, Harish A, C AS, Tyas D, Ramagopalan SV.

Future Oncol. 2020 Jan;16(3):4455-4460. doi: 10.2217/fon-2019-0669. Epub 2019 Dec 10.

PMID: 31820657

 

Correction to: Developing real-world comparators for clinical trials in chemotherapy-refractory patients with gastric cancer or gastroesophageal junction cancer.

Chau I, Le DT, Ott PA, Korytowsky B, Le H, Le TK, Zhang Y, Sanchez T, Maglinte GA, Laurie M, Abraham P, Patel D, Shangguan T.

Gastric Cancer. 2020 Jan;23(1):142. doi: 10.1007/s10120-019-01021-y.

PMID: 31679092

 

Developing real-world comparators for clinical trials in chemotherapy-refractory patients with gastric cancer or gastroesophageal junction cancer.

Chau I, Le DT, Ott PA, Korytowsky B, Le H, Le TK, Zhang Y, Sanchez T, Maglinte GA, Laurie M, Abraham P, Patel D, Shangguan T.

Gastric Cancer. 2020 Jan;23(1):133-141. doi: 10.1007/s10120-019-01008-9. Epub 2019 Sep 23. Erratum in: Gastric Cancer. 2019 Nov 3;:.

PMID: 31549264

 

Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma.

Ambavane A, Yang S, Atkins MB, Rao S, Shah A, Regan MM, McDermott DF, Michaelson MD.

Immunotherapy. 2020 Jan;12(1):37-51. doi: 10.2217/imt-2019-0199. Epub 2020 Jan 29.

PMID: 31992108

 

Left atrial ejection fraction and outcomes in heart failure with preserved ejection fraction.

Kanagala P, Arnold JR, Cheng ASH, Singh A, Khan JN, Gulsin GS, Yang J, Zhao L, Gupta P, Squire IB, Ng LL, McCann GP.

Int J Cardiovasc Imaging. 2020 Jan;36(1):101-110. doi: 10.1007/s10554-019-01684-9. Epub 2019 Aug 10.

PMID: 31401742

 

Elotuzumab plus lenalidomide and dexamethasone for newly diagnosed multiple myeloma: a randomized, open-label, phase 2 study in Japan.

Kubo K, Hori M, Ohta K, Handa H, Hatake K, Matsumoto M, Hagiwara S, Ohashi K, Nakaseko C, Suzuki K, Ito S, Kinoshita G, Shelat SG, Miyoshi M, Takezako N.

Int J Hematol. 2020 Jan;111(1):65-74. doi: 10.1007/s12185-019-02757-0. Epub 2019 Nov 7.

PMID: 31701481

 

Incidence of seroconversion and sero-reversion in patients with multiple sclerosis (MS) who had been treated with natalizumab: A systematic review and meta-analysis.

Azimi A, Hanaei S, Sahraian MA, Mohammadifar M, Ramagopalan SV, Ghajarzadeh M.

J Clin Neurosci. 2020 Jan;71:129-134. doi: 10.1016/j.jocn.2019.08.103. Epub 2019 Sep 23.

PMID: 31558363

 

Population Pharmacokinetic Model to Assess the Impact of Disease State on Thalidomide Pharmacokinetics.

Gaudy A, Hwang R, Palmisano M, Chen N.

J Clin Pharmacol. 2020 Jan;60(1):67-74. doi: 10.1002/jcph.1506. Epub 2019 Aug 7.

PMID: 31392755

 

Comparative effectiveness of nivolumab versus clinical practice for advanced gastric or gastroesophageal junction cancer.

Chau I, Ayers D, Goring S, Cope S, Korytowsky B, Abraham P.

J Comp Eff Res. 2020 Jan;9(2):103-114. doi: 10.2217/cer-2019-0145. Epub 2019 Dec 24.

PMID: 31872771

 

Therapeutic inertia in the management of moderate-to-severe plaque psoriasis.

Halioua B, Corgibet F, Maghia R, Hello S, Caillet G, Nicolas C, Riboulet JL, Mahé E.

J Eur Acad Dermatol Venereol. 2020 Jan;34(1):e30-e32. doi: 10.1111/jdv.15882. Epub 2019 Sep 2. No abstract available.

PMID: 31419345

 

Unique Impacts of Methionine Oxidation, Tryptophan Oxidation, and Asparagine Deamidation on Antibody Stability and Aggregation.

Alam ME, Slaney TR, Wu L, Das TK, Kar S, Barnett GV, Leone A, Tessier PM.

J Pharm Sci. 2020 Jan;109(1):656-669. doi: 10.1016/j.xphs.2019.10.051. Epub 2019 Oct 31.

PMID: 31678251

 

A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products.

Hubert M, Yang DT, Kwok SC, Rios A, Das TK, Patel A, Wuchner K, Antochshuk V, Junge F, Bou-Assaf GM, Cao S, Saggu M, Montrond L, Afonina N, Kolhe P, Loladze V, Narhi L.

J Pharm Sci. 2020 Jan;109(1):830-844. doi: 10.1016/j.xphs.2019.10.025. Epub 2019 Oct 21.

PMID: 31647951

 

Stress Factors in mAb Drug Substance Production Processes: Critical Assessment of Impact on Product Quality and Control Strategy.

Das TK, Narhi LO, Sreedhara A, Menzen T, Grapentin C, Chou DK, Antochshuk V, Filipe V.

J Pharm Sci. 2020 Jan;109(1):116-133. doi: 10.1016/j.xphs.2019.09.023. Epub 2019 Oct 5. Review.

PMID: 31593689

 

An Industry Perspective on Forced Degradation Studies of Biopharmaceuticals: Survey Outcome and Recommendations.

Halley J, Chou YR, Cicchino C, Huang M, Sharma V, Tan NC, Thakkar S, Zhou LL, Al-Azzam W, Cornen S, Gauden M, Gu Z, Kar S, Lazar AC, Mehndiratta P, Smith J, Sosic Z, Weisbach P, Stokes ESE.

J Pharm Sci. 2020 Jan;109(1):6-21. doi: 10.1016/j.xphs.2019.09.018. Epub 2019 Sep 26.

PMID: 31563512

 

Structure-Function Assessment and High-Throughput Quantification of Site-Specific Aspartate Isomerization in Monoclonal Antibody Using a Novel Analytical Tool Kit.

Zhou K, Cao X, Bautista J, Chen Z, Hershey N, Ludwig R, Tao L, Zeng M, Das TK.

J Pharm Sci. 2020 Jan;109(1):422-428. doi: 10.1016/j.xphs.2019.08.018. Epub 2019 Aug 27.

PMID: 31469998

 

A simplified frailty scale predicts outcomes in transplant-ineligible patients with newly diagnosed multiple myeloma treated in the FIRST (MM-020) trial.

Facon T, Dimopoulos MA, Meuleman N, Belch A, Mohty M, Chen WM, Kim K, Zamagni E, Rodriguez-Otero P, Renwick W, Rose C, Tempescul A, Boyle E, Manier S, Attal M, Moreau P, Macro M, Leleu X, Lorraine Chretien M, Ludwig H, Guo S, Sturniolo M, Tinel A, Silvia Monzini M, Costa B, Houck V, Hulin C, Yves Mary J.

Leukemia. 2020 Jan;34(1):224-233. doi: 10.1038/s41375-019-0539-0. Epub 2019 Aug 19.

PMID: 31427722

 

Soluble SLAMF7 promotes the growth of myeloma cells via homophilic interaction with surface SLAMF7.

Kikuchi J, Hori M, Iha H, Toyama-Sorimachi N, Hagiwara S, Kuroda Y, Koyama D, Izumi T, Yasui H, Suzuki A, Furukawa Y.

Leukemia. 2020 Jan;34(1):180-195. doi: 10.1038/s41375-019-0525-6. Epub 2019 Jul 29.

PMID: 31358854

 

Incident cardiovascular disease in patients diagnosed with multiple sclerosis: A multi-database study.

Persson R, Lee S, Yood MU, Wagner M, Minton N, Niemcryk S, Lindholm A, Evans A, Jick S.

Mult Scler Relat Disord. 2020 Jan;37:101423. doi: 10.1016/j.msard.2019.101423. Epub 2019 Oct 1.

PMID: 32172996

 

Analysis of historical negative control group data from the rat in vivo micronucleus assay.

Lovell DP, Fellows M, Saul J, Whitwell J, Custer L, Dertinger S, Escobar P, Fiedler R, Hemmann U, Kenny J, Smith R, van der Leede BM, Zeller A.

Mutat Res. 2020 Jan;849:503086. doi: 10.1016/j.mrgentox.2019.503086. Epub 2019 Oct 12.

PMID: 32087845

 

Evaluating Partitioned Survival and Markov Decision-Analytic Modeling Approaches for Use in Cost-Effectiveness Analysis: Estimating and Comparing Survival Outcomes.

Smare C, Lakhdari K, Doan J, Posnett J, Johal S.

Pharmacoeconomics. 2020 Jan;38(1):97-108. doi: 10.1007/s40273-019-00845-x.

PMID: 31741315

A Systematic Review of Network Meta-Analyses and Real-World Evidence Comparing Apixaban and Rivaroxaban in Nonvalvular Atrial Fibrillation.

Hill NR, Sandler B, Bergrath E, Milenković D, Ashaye AO, Farooqui U, Cohen AT.

Clin Appl Thromb Hemost. 2020 Jan-Dec;26:1076029619898764. doi: 10.1177/1076029619898764.

PMID: 31918558

 

Design and characterization of mouse IgG1 and IgG2a bispecific antibodies for use in syngeneic models.

Wang F, Tsai JC, Davis JH, Chau B, Dong J, West SM, Hogan JM, Wheeler ML, Bee C, Morishige W, Cayton T, David-Brown D, Zhang C, Kozhich A, Sproul T, Dollinger G, Rajpal A, Strop P.

MAbs. 2020 Jan-Dec;12(1):1685350. doi: 10.1080/19420862.2019.1685350.

PMID: 31856660

Single-Dose Pharmacokinetics, Safety, and Tolerability of Avadomide (CC-122) in Subjects With Mild, Moderate, or Severe Renal Impairment.

Li Y, MacGorman K, Liu L, Chen J, Hoffmann M, Palmisano M, Zhou S.

Clin Pharmacol Drug Dev. 2019 Dec 31. doi: 10.1002/cpdd.760. [Epub ahead of print]

PMID: 31891240

 

Recent advances and optimal management of human epidermal growth factor receptor-2-positive early-stage breast cancer.

Batoo S, Bayraktar S, Al-Hattab E, Basu S, Okuno S, Glück S.

J Carcinog. 2019 Dec 31;18:5. doi: 10.4103/jcar.JCar_14_19. eCollection 2019. Review.

PMID: 31949426

 

Solid state nuclear magnetic resonance studies of hydroxypropylmethylcellulose acetyl succinate polymer, a useful carrier in pharmaceutical solid dispersions.

Pugliese A, Hawarden LE, Abraham A, Tobyn M, Blanc F.

Magn Reson Chem. 2019 Dec 27. doi: 10.1002/mrc.4984. [Epub ahead of print]

PMID: 31880823

 

Trajectories of health-related quality of life among renal transplant patients associated with graft failure and symptom distress: Analysis of the BENEFIT and BENEFIT-EXT trials.

Purnajo I, Beaumont JL, Polinsky M, Alemao E, Everly MJ.

Am J Transplant. 2019 Dec 24. doi: 10.1111/ajt.15757. [Epub ahead of print]

PMID: 31874117

 

Pegbelfermin (BMS-986036), a PEGylated fibroblast growth factor 21 analogue, in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 2a trial.

Sanyal A, Charles ED, Neuschwander-Tetri BA, Loomba R, Harrison SA, Abdelmalek MF, Lawitz EJ, Halegoua-DeMarzio D, Kundu S, Noviello S, Luo Y, Christian R.

Lancet. 2019 Dec 22;392(10165):2705-2717. doi: 10.1016/S0140-6736(18)31785-9. Epub 2018 Dec 13.

PMID: 30554783

 

Covariate adjustment for randomized controlled trials revisited.

Wang J.

Pharm Stat. 2019 Dec 21. doi: 10.1002/pst.1988. [Epub ahead of print]

PMID: 31863636

 

Inflammatory bowel disease - one entity with many molecular faces.

Szymańska S, Matuszczyk M, Osuch M, Meglicka M, Szymanska E, Bierła J, Kierkuś J.

Prz Gastroenterol. 2019 Dec 20;14(4):228-232. doi: 10.5114/pg.2019.90249. Epub 2019 Dec 20. Review.

PMID: 31988668

 

Cancer diagnosis and care among rural-to-urban migrants in China.

Myerson R, Lu T, Yuan Y, Liu GG.

BMJ Glob Health. 2019 Dec 18;4(6):e001923. doi: 10.1136/bmjgh-2019-001923. eCollection 2019.

PMID: 31908866

An Integrated Approach for Determining a Protein-Protein Binding Interface in Solution and an Evaluation of Hydrogen-Deuterium Exchange Kinetics for Adjudicating Candidate Docking Models.

Zhang MM, Beno BR, Huang RY, Adhikari J, Deyanova EG, Li J, Chen G, Gross ML.

Anal Chem. 2019 Dec 17;91(24):15709-15717. doi: 10.1021/acs.analchem.9b03879. Epub 2019 Nov 22.

PMID: 31710208

 

Cost-Effectiveness of Extended and One-Time Screening Versus No Screening for Non-Valvular Atrial Fibrillation in the USA.

Oguz M, Lanitis T, Li X, Wygant G, Singer DE, Friend K, Hlavacek P, Nikolaou A, Mattke S.

Appl Health Econ Health Policy. 2019 Dec 17. doi: 10.1007/s40258-019-00542-y. [Epub ahead of print]

PMID: 31849021

 

Nonhomologous end-joining repair is likely involved in the repair of double-stranded DNA breaks induced by riluzole in melanoma cells.

Cerchio R Jr, Marinaro C, Foo TK, Xia B, Chen S.

Melanoma Res. 2019 Dec 17. doi: 10.1097/CMR.0000000000000652. [Epub ahead of print]

PMID:31855905

 

Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study.

Sands BE, Feagan BG, Sandborn WJ, Schreiber S, Peyrin-Biroulet L, Colombel JF, Rossiter G, Usiskin K, Ather S, Zhan X, DʼHaens G.

Am J Gastroenterol. 2019 Dec 16. doi: 10.14309/ajg.0000000000000493. [Epub ahead of print]

PMID: 31850931

 

Practical applications of bio-fluorescent particle counting in Environmental Monitoring investigations.

Prasad A, Villari P, Henry R', Weber J, Hauschild J, Yan L, Horsch J, Shereefa S, Rau JE, Milling A, Bolden JS, Plourde L, Claassen M, IJzerman-Boon P, Forng RY, Portmann R, Urwyler S, Dassu D.

PDA J Pharm Sci Technol. 2019 Dec 16. pii: pdajpst.2019.009969. doi: 10.5731/pdajpst.2019.009969. [Epub ahead of print]

PMID: 31843986

 

Triple Therapy with MerTK and PD1 Inhibition Plus Radiotherapy Promotes Abscopal Antitumor Immune Responses.

Caetano MS, Younes AI, Barsoumian HB, Quigley M, Menon H, Gao C, Spires T, Reilly TP, Cadena AP, Cushman TR, Schoenhals JE, Li A, Nguyen QN, Cortez MA, Welsh JW.

Clin Cancer Res. 2019 Dec 15;25(24):7576-7584. doi: 10.1158/1078-0432.CCR-19-0795. Epub 2019 Sep 20.

PMID: 31540976

 

Colocalization of GWAS and eQTL signals at loci with multiple signals identifies additional candidate genes for body fat distribution.

Wu Y, Broadaway KA, Raulerson CK, Scott LJ, Pan C, Ko A, He A, Tilford C, Fuchsberger C, Locke AE, Stringham HM, Jackson AU, Narisu N, Kuusisto J, Pajukanta P, Collins FS, Boehnke M, Laakso M, Lusis AJ, Civelek M, Mohlke KL.

Hum Mol Genet. 2019 Dec 15;28(24):4161-4172. doi: 10.1093/hmg/ddz263.

PMID: 31691812

 

Adverse vacuolation in multiple tissues in cynomolgus monkeys following repeat-dose administration of a PEGylated protein.

Fletcher AM, Tellier P, Douville J, Mansell P, Graziano MJ, Mangipudy RS, Brodie TA, Achanzar WE.

Toxicol Lett. 2019 Dec 15;317:120-129. doi: 10.1016/j.toxlet.2019.09.023. Epub 2019 Sep 30.

PMID: 31580884

 

First-In-Human Phase I Study Of A Dual mTOR Kinase And DNA-PK Inhibitor (CC-115) In Advanced Malignancy.

Munster P, Mita M, Mahipal A, Nemunaitis J, Massard C, Mikkelsen T, Cruz C, Paz-Ares L, Hidalgo M, Rathkopf D, Blumenschein G Jr, Smith DC, Eichhorst B, Cloughesy T, Filvaroff EH, Li S, Raymon H, de Haan H, Hege K, Bendell JC.

Cancer Manag Res. 2019 Dec 13;11:10463-10476. doi: 10.2147/CMAR.S208720. eCollection 2019.

PMID: 31853198

 

First-Line Doublet Chemotherapy for Metastatic Triple-Negative Breast Cancer: Circulating Tumor Cell Analysis of the tnAcity Trial.

Liu MC, Janni W, Georgoulias V, Yardley DA, Harbeck N, Wei X, McGovern D, Beck R.

Cancer Manag Res. 2019 Dec 12;11:10427-10433. doi: 10.2147/CMAR.S208712. eCollection 2019.

PMID: 31849532

Development of a prognostic composite cytokine signature based on the correlation with nivolumab clearance: translational PK/PD analysis in patients with renal cell carcinoma.

Wang R, Zheng J, Shao X, Ishii Y, Roy A, Bello A, Lee R, Zhang J, Wind-Rotolo M, Feng Y.

J Immunother Cancer. 2019 Dec 11;7(1):348. doi: 10.1186/s40425-019-0819-2.

PMID: 31829287

 

An analysis of orphan medicine expenditure in Europe: is it sustainable?

Mestre-Ferrandiz J, Palaska C, Kelly T, Hutchings A, Parnaby A.

Orphanet J Rare Dis. 2019 Dec 11;14(1):287. doi: 10.1186/s13023-019-1246-7.

PMID: 31829218

 

Visualizing the Selectivity and Dynamics of Interferon Signaling In Vivo.

Stifter SA, Bhattacharyya N, Sawyer AJ, Cootes TA, Stambas J, Doyle SE, Feigenbaum L, Paul WE, Britton WJ, Sher A, Feng CG.

Cell Rep. 2019 Dec 10;29(11):3539-3550.e4. doi: 10.1016/j.celrep.2019.11.021.

PMID: 31825834

 

Treatment-Free Survival: A Novel Outcome Measure of the Effects of Immune Checkpoint Inhibition-A Pooled Analysis of Patients With Advanced Melanoma.

Regan MM, Werner L, Rao S, Gupte-Singh K, Hodi FS, Kirkwood JM, Kluger HM, Larkin J, Postow MA, Ritchings C, Sznol M, Tarhini AA, Wolchok JD, Atkins MB, McDermott DF.

J Clin Oncol. 2019 Dec 10;37(35):3350-3358. doi: 10.1200/JCO.19.00345. Epub 2019 Sep 9.

PMID: 31498030

 

Disease activity measures at baseline predict structural damage progression: data from the randomized, controlled AMPLE and AVERT trials.

Keystone EC, Ahmad HA, Yazici Y, Bergman MJ.

Rheumatology (Oxford). 2019 Dec 9. pii: kez455. doi: 10.1093/rheumatology/kez455. [Epub ahead of print]

PMID: 31819995

 

Prospective Study Evaluating Changes in Bone Quality in Premenopausal Women With Breast Cancer Undergoing Adjuvant Chemotherapy.

Hopson MB, Onishi M, Awad D, Buono D, Maurer M, Crew KD, Shane E, Hershman DL, Kalinsky K.

Clin Breast Cancer. 2019 Dec 5. pii: S1526-8209(19)30759-1. doi: 10.1016/j.clbc.2019.12.001. [Epub ahead of print]

PMID: 31926840

Prospective Study Evaluating Changes in Bone Quality in Premenopausal Women With Breast Cancer Undergoing Adjuvant Chemotherapy.

Hopson MB, Onishi M, Awad D, Buono D, Maurer M, Crew KD, Shane E, Hershman DL, Kalinsky K.

Clin Breast Cancer. 2019 Dec 5. pii: S1526-8209(19)30759-1. doi: 10.1016/j.clbc.2019.12.001. [Epub ahead of print]

PMID: 31926840

 

Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.

Windecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrøm T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabaté M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, Alexander JH; AUGUSTUS Investigators.

Circulation. 2019 Dec 3;140(23):1921-1932. doi: 10.1161/CIRCULATIONAHA.119.043308. Epub 2019 Sep 26.

PMID: 31557056

 

Hospitalization Among Patients With Atrial Fibrillation and a Recent Acute Coronary Syndrome or Percutaneous Coronary Intervention Treated With Apixaban or Aspirin: Insights From the AUGUSTUS Trial.

Vora AN, Alexander JH, Wojdyla DM, Aronson R, Granger CB, Darius H, Windecker S, Mehran R, Averkov O, Budaj A, Kong DF, Kobalava Z, Mehta RH, Mirza Z, Guimaraes PO, Parkhomenko A, Quadros A, Thiele H, Goodman SG, Lopes RD.

Circulation. 2019 Dec 3;140(23):1960-1963. doi: 10.1161/CIRCULATIONAHA.119.043754. Epub 2019 Sep 25. No abstract available.

PMID: 31553201

 

Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.

Windecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrøm T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabaté M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, Alexander JH; AUGUSTUS Investigators.

Circulation. 2019 Dec 3;140(23):1921-1932. doi: 10.1161/CIRCULATIONAHA.119.043308. Epub 2019 Sep 26.

PMID: 31557056

 

Hospitalization Among Patients With Atrial Fibrillation and a Recent Acute Coronary Syndrome or Percutaneous Coronary Intervention Treated With Apixaban or Aspirin: Insights From the AUGUSTUS Trial.

Vora AN, Alexander JH, Wojdyla DM, Aronson R, Granger CB, Darius H, Windecker S, Mehran R, Averkov O, Budaj A, Kong DF, Kobalava Z, Mehta RH, Mirza Z, Guimaraes PO, Parkhomenko A, Quadros A, Thiele H, Goodman SG, Lopes RD.

Circulation. 2019 Dec 3;140(23):1960-1963. doi: 10.1161/CIRCULATIONAHA.119.043754. Epub 2019 Sep 25. No abstract available.

PMID: 31553201

 

Galectin-1-driven T cell exclusion in the tumor endothelium promotes immunotherapy resistance.

Nambiar DK, Aguilera T, Cao H, Kwok S, Kong C, Bloomstein J, Wang Z, Rangan VS, Jiang D, von Eyben R, Liang R, Agarwal S, Colevas AD, Korman A, Allen CT, Uppaluri R, Koong AC, Giaccia A, Le QT.

J Clin Invest. 2019 Dec 2;129(12):5553-5567. doi: 10.1172/JCI129025.

PMID: 31710313

Galectin-1-driven T cell exclusion in the tumor endothelium promotes immunotherapy resistance.

Nambiar DK, Aguilera T, Cao H, Kwok S, Kong C, Bloomstein J, Wang Z, Rangan VS, Jiang D, von Eyben R, Liang R, Agarwal S, Colevas AD, Korman A, Allen CT, Uppaluri R, Koong AC, Giaccia A, Le QT.

J Clin Invest. 2019 Dec 2;129(12):5553-5567. doi: 10.1172/JCI129025.

PMID: 31710313

 

The potential role of YAP in Axl-mediated resistance to EGFR tyrosine kinase inhibitors.

Saab S, Chang OS, Nagaoka K, Hung MC, Yamaguchi H.

Am J Cancer Res. 2019 Dec 1;9(12):2719-2729. eCollection 2019.

PMID: 31911857

The potential role of YAP in Axl-mediated resistance to EGFR tyrosine kinase inhibitors.

Saab S, Chang OS, Nagaoka K, Hung MC, Yamaguchi H.

Am J Cancer Res. 2019 Dec 1;9(12):2719-2729. eCollection 2019.

PMID: 31911857

A generic method for intact and subunit level characterization of mAb charge variants by native mass spectrometry.

Leblanc Y, Faid V, Lauber MA, Wang Q, Bihoreau N, Chevreux G.

J Chromatogr B Analyt Technol Biomed Life Sci. 2019 Dec 1;1133:121814. doi: 10.1016/j.jchromb.2019.121814. Epub 2019 Oct 16.

PMID: 31731217

 

The Effects of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Volunteers: A Single-Sequence Crossover Study.

Garonzik S, Byon W, Myers E, Li X, Marchisin D, Murthy B.

Am J Cardiovasc Drugs. 2019 Dec;19(6):561-567. doi: 10.1007/s40256-019-00348-2.

PMID: 31030414

 

Toward Accelerated Authorization and Access to New Medicines for Juvenile Idiopathic Arthritis.

Schanberg LE, Ramanan AV, De Benedetti F, Beukelman T, Eakin GS, Del Gaizo V, Ringold S, Vesely R, Schrandt S, Jaki T, Bili A, Chung JB, De Bono S, Douglass W, Enejosa JV, Kanik KS, Knobe K, Kunder R, Leite-Schnell JC, Suehiro RM, Wong RL, Mieszkalski KL, Marrow LC, Siebenaler K, Fraulo E, Kimura Y.

Arthritis Rheumatol. 2019 Dec;71(12):1976-1984. doi: 10.1002/art.41043. Epub 2019 Nov 1.

PMID: 31313532

 

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).

Booth B, Stevenson L, Pillutla R, Buonarati M, Beaver C, Fraier D, Garofolo F, Haidar S, Islam R, James C, Kadavil J, Kavetska O, Li F, Satterwhite C, Savoie N, Subramaniam S, Tampal N, Thway T, Woolf E, Blaye OL, Andisik M, Briscoe C, Cape S, Dasgupta A, Fischer S, Haidar S, Hayes R, Kamerud J, Lima Santos GM, Nehls C, Soo C, Vinter S, Whale E, Xu K, Cho SJ, Edmison A, Kassim S, Rocha TC, Welink J, Amur S, Bandukwala A, Cherry E, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Pedras-Vasconcelos J, Saito Y, Saunders TS, Skibeli V, Verthelyi D, Wang YM, Yan H.

Bioanalysis. 2019 Dec;11(23):2099-2132. doi: 10.4155/bio-2019-0270. Epub 2019 Dec 9.

PMID: 31833782

 

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).

Piccoli S, Mehta D, Vitaliti A, Allinson J, Amur S, Eck S, Green C, Hedrick M, Hopper S, Ji A, Joyce A, Litwin V, Maher K, Mathews J, Peng K, Safavi A, Wang YM, Zhang Y, Amaravadi L, Palackal N, Thankamony S, Beaver C, Bame E, Emrich T, Grimaldi C, Haulenbeek J, Joyce A, Kakkanaiah V, Lanham D, Maher K, Mayer A, Trampont PC, Vermet L, Dakappagari N, Fleener C, Garofolo F, Rogers C, Tangri S, Xu Y, Liang M, Rajadhyaksha M, Richards S, Schweighardt B, Purushothama S, Baltrukonis D, Brumm J, Cherry E, Delcarpini J, Gleason C, Kirshner S, Kubiak R, Pan L, Partridge M, Pedras-Vasconcelos J, Qu Q, Skibeli V, Saunders TS, Staack RF, Stubenrauch K, Torri A, Verthelyi D, Yan H, Gorovits B, Palmer R, Milton M, Long B, Corsaro B, Farrokhi V, Fiscella M, Henderson N, Jawa V, McNally J, Murphy R, Waldner H, Yang TY.

Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10.

PMID: 31820675

 

Exploratory biomarker assays: key assay parameters to evaluate in the face of evolving biomarker context-of-use.

Thankamony SP, Zhang Y.

Bioanalysis. 2019 Dec;11(23):2095-2097. doi: 10.4155/bio-2019-0223. Epub 2019 Nov 28. No abstract available.

PMID: 31777269

 

Development of a prognostic model for overall survival in multiple myeloma using the Connect_® MM Patient Registry.

Terebelo HR, Abonour R, Gasparetto CJ, Toomey K, Durie BGM, Hardin JW, Jagannath S, Wagner L, Narang M, Flick ED, Srinivasan S, Yue L, Kitali A, Agarwal A, Rifkin RM; CONNECT MM Registry Investigators.

Br J Haematol. 2019 Dec;187(5):602-614. doi: 10.1111/bjh.16139. Epub 2019 Aug 5.

PMID: 31382320

 

Myocardial Microvascular Dysfunction in Rheumatoid Arthritis_{Quantitation by 13N-Ammonia Positron Emission Tomography/Computed Tomography}.

Amigues I, Russo C, Giles JT, Tugcu A, Weinberg R, Bokhari S, Bathon JM.

Circ Cardiovasc Imaging. 2019 Dec;12(1):e007495. doi: 10.1161/CIRCIMAGING.117.007495.

PMID: 30636512

 

Population Pharmacokinetics of Nivolumab in Combination With Ipilimumab in Patients With Advanced Malignancies.

Zhang J, Sanghavi K, Shen J, Zhao X, Feng Y, Statkevich P, Sheng J, Roy A, Zhu L.

CPT Pharmacometrics Syst Pharmacol. 2019 Dec;8(12):962-970. doi: 10.1002/psp4.12476. Epub 2019 Dec 1.

PMID: 31710163

 

Antibodies to Modulate Surface Receptor Systems Are Often Bivalent and Must Compete in a Two-Dimensional Cell Contact Region.

Schmidt BJ, Bee C, Han M, Jing Y, Cheng Y, Tenney DJ, Leil TA.

CPT Pharmacometrics Syst Pharmacol. 2019 Dec;8(12):873-877. doi: 10.1002/psp4.12468. Epub 2019 Oct 23. No abstract available.

PMID: 31529681

 

The Effects of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Volunteers: A Single-Sequence Crossover Study.

Garonzik S, Byon W, Myers E, Li X, Marchisin D, Murthy B.

Am J Cardiovasc Drugs. 2019 Dec;19(6):561-567. doi: 10.1007/s40256-019-00348-2.

PMID: 31030414

 

Toward Accelerated Authorization and Access to New Medicines for Juvenile Idiopathic Arthritis.

Schanberg LE, Ramanan AV, De Benedetti F, Beukelman T, Eakin GS, Del Gaizo V, Ringold S, Vesely R, Schrandt S, Jaki T, Bili A, Chung JB, De Bono S, Douglass W, Enejosa JV, Kanik KS, Knobe K, Kunder R, Leite-Schnell JC, Suehiro RM, Wong RL, Mieszkalski KL, Marrow LC, Siebenaler K, Fraulo E, Kimura Y.

Arthritis Rheumatol. 2019 Dec;71(12):1976-1984. doi: 10.1002/art.41043. Epub 2019 Nov 1.

PMID: 31313532

 

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).

Booth B, Stevenson L, Pillutla R, Buonarati M, Beaver C, Fraier D, Garofolo F, Haidar S, Islam R, James C, Kadavil J, Kavetska O, Li F, Satterwhite C, Savoie N, Subramaniam S, Tampal N, Thway T, Woolf E, Blaye OL, Andisik M, Briscoe C, Cape S, Dasgupta A, Fischer S, Haidar S, Hayes R, Kamerud J, Lima Santos GM, Nehls C, Soo C, Vinter S, Whale E, Xu K, Cho SJ, Edmison A, Kassim S, Rocha TC, Welink J, Amur S, Bandukwala A, Cherry E, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Pedras-Vasconcelos J, Saito Y, Saunders TS, Skibeli V, Verthelyi D, Wang YM, Yan H.

Bioanalysis. 2019 Dec;11(23):2099-2132. doi: 10.4155/bio-2019-0270. Epub 2019 Dec 9.

PMID: 31833782

 

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).

Piccoli S, Mehta D, Vitaliti A, Allinson J, Amur S, Eck S, Green C, Hedrick M, Hopper S, Ji A, Joyce A, Litwin V, Maher K, Mathews J, Peng K, Safavi A, Wang YM, Zhang Y, Amaravadi L, Palackal N, Thankamony S, Beaver C, Bame E, Emrich T, Grimaldi C, Haulenbeek J, Joyce A, Kakkanaiah V, Lanham D, Maher K, Mayer A, Trampont PC, Vermet L, Dakappagari N, Fleener C, Garofolo F, Rogers C, Tangri S, Xu Y, Liang M, Rajadhyaksha M, Richards S, Schweighardt B, Purushothama S, Baltrukonis D, Brumm J, Cherry E, Delcarpini J, Gleason C, Kirshner S, Kubiak R, Pan L, Partridge M, Pedras-Vasconcelos J, Qu Q, Skibeli V, Saunders TS, Staack RF, Stubenrauch K, Torri A, Verthelyi D, Yan H, Gorovits B, Palmer R, Milton M, Long B, Corsaro B, Farrokhi V, Fiscella M, Henderson N, Jawa V, McNally J, Murphy R, Waldner H, Yang TY.

Bioanalysis. 2019 Dec;11(24):2207-2244. doi: 10.4155/bio-2019-0271. Epub 2019 Dec 10.

PMID: 31820675

 

Exploratory biomarker assays: key assay parameters to evaluate in the face of evolving biomarker context-of-use.

Thankamony SP, Zhang Y.

Bioanalysis. 2019 Dec;11(23):2095-2097. doi: 10.4155/bio-2019-0223. Epub 2019 Nov 28. No abstract available.

PMID: 31777269

 

Development of a prognostic model for overall survival in multiple myeloma using the Connect_® MM Patient Registry.

Terebelo HR, Abonour R, Gasparetto CJ, Toomey K, Durie BGM, Hardin JW, Jagannath S, Wagner L, Narang M, Flick ED, Srinivasan S, Yue L, Kitali A, Agarwal A, Rifkin RM; CONNECT MM Registry Investigators.

Br J Haematol. 2019 Dec;187(5):602-614. doi: 10.1111/bjh.16139. Epub 2019 Aug 5.

PMID: 31382320

 

Safety, effectiveness, and health care cost comparisons among elderly patients with venous thromboembolism prescribed warfarin or apixaban in the United States Medicare population.

Hlavacek P, Guo JD, Rosenblatt L, Keshishian A, Russ C, Mardekian J, Ferri M, Poretta T, Yuce H, McBane R.

Curr Med Res Opin. 2019 Dec;35(12):2043-2051. doi: 10.1080/03007995.2019.1653067. Epub 2019 Sep 3.

PMID: 31387467

 

Chemical and physical instabilities in manufacturing and storage of therapeutic proteins.

Krause ME, Sahin E.

Curr Opin Biotechnol. 2019 Dec;60:159-167. doi: 10.1016/j.copbio.2019.01.014. Epub 2019 Mar 9. Review.

PMID: 30861476

 

Early Access to Medicines Scheme: real-world data collection.

Pang H, Wang M, Kiff C, Soni M, Stein D, Tyas D.

Drug Discov Today. 2019 Dec;24(12):2231-2233. doi: 10.1016/j.drudis.2019.06.009. Epub 2019 Jun 19.

PMID: 31228615

 

Apremilast Normalizes Gene Expression of Inflammatory Mediators in Human Keratinocytes and Reduces Antigen-Induced Atopic Dermatitis in Mice.

Schafer PH, Adams M, Horan G, Truzzi F, Marconi A, Pincelli C.

Drugs R D. 2019 Dec;19(4):329-338. doi: 10.1007/s40268-019-00284-1.

PMID: 31598889

 

Report of the European Society of Cardiology Cardiovascular Round Table regulatory workshop update of the evaluation of new agents for the treatment of acute coronary syndrome: Executive summary.

Bueno H, de Graeff P, Richard-Lordereau I, Emmerich J, Fox KA, Friedman CP, Gaudin C, El-Gazayerly A, Goldman S, Hemmrich M, Henderson RA, Himmelmann A, Irs A, Jackson N, James SK, Katus HA, Laslop A, Laws I, Mehran R, Ong S, Prasad K, Roffi M, Rosano GM, Rose M, Sinnaeve PR, Stough WG, Thygesen K, Van de Werf F, Varin C, Verheugt FW, de Los Angeles Alonso García M.

Eur Heart J Acute Cardiovasc Care. 2019 Dec;8(8):745-754. doi: 10.1177/2048872616649859. Epub 2016 Jun 29.

PMID: 27357206

 

Phase II study of CC-486 (oral azacitidine) in previously treated patients with locally advanced or metastatic nasopharyngeal carcinoma.

Mesia R, Bossi P, Hansen AR, Hsieh CY, Licitra LF, Tan EH, Chen P, Miller J, Siu LL, Haddad RI.

Eur J Cancer. 2019 Dec;123:138-145. doi: 10.1016/j.ejca.2019.10.002. Epub 2019 Nov 4.

PMID: 31698327

 

Considering B7-CD28 as a family through sequence and structure.

West SM, Deng XA.

Exp Biol Med (Maywood). 2019 Dec;244(17):1577-1583. doi: 10.1177/1535370219855970. Epub 2019 Jun 17. No abstract available.

PMID: 31208204

 

Lenalidomide maintenance post-transplantation in newly diagnosed multiple myeloma: real-world outcomes and costs.

Hari P, Ung B, Abouzaid S, Agarwal A, Parikh K.

Future Oncol. 2019 Dec;15(35):4045-4056. doi: 10.2217/fon-2019-0422. Epub 2019 Oct 18.

PMID: 31625415

 

Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease.

Vos MB, Dimick-Santos L, Mehta R, Omokaro SO, Taminiau J, Schabel E, Kleiner DE, Szitanyi P, Socha P, Schwimmer JB, Noviello S, Silberg DG, Torstenson R, Miller V, Lavine JE; Liver Forum Pediatric Working Group.

Gastroenterology. 2019 Dec;157(6):1448-1456.e1. doi: 10.1053/j.gastro.2019.08.048. Epub 2019 Sep 12. No abstract available.

PMID: 31520612

 

Improving health determinants outside of the clinic does not mean outside of clinical science.

Smith T, Mattingly TJ, Slabaugh L.

Healthc (Amst). 2019 Dec;7(4). pii: S2213-0764(19)30148-4. doi: 10.1016/j.hjdsi.2019.06.001. Epub 2019 Jun 27.

PMID: 31257162

 

Hydrogen-Deuterium Exchange and Hydroxyl Radical Footprinting for Mapping Hydrophobic Interactions of Human Bromodomain with a Small Molecule Inhibitor.

Li KS, Schaper Bergman ET, Beno BR, Huang RY, Deyanova E, Chen G, Gross ML.

J Am Soc Mass Spectrom. 2019 Dec;30(12):2795-2804. doi: 10.1007/s13361-019-02316-1. Epub 2019 Nov 12.

PMID: 31720974

Drug-Drug Interaction Study to Assess the Effect of Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of the Novel Cereblon Modulator Avadomide (CC-122) in Healthy Adult Subjects.

Ogasawara K, MacGorman K, Liu L, Chen J, Carayannopoulos LN, Zhou S, Palmisano M, Li Y.

J Clin Pharmacol. 2019 Dec;59(12):1620-1631. doi: 10.1002/jcph.1453. Epub 2019 Jun 6.

PMID: 31172535

 

Adjuvant therapy with nivolumab versus ipilimumab after complete resection of stage III/IV melanoma: Japanese subgroup analysis from the phase 3 CheckMate 238 study.

Yokota K, Uchi H, Uhara H, Yoshikawa S, Takenouchi T, Inozume T, Ozawa K, Ihn H, Fujisawa Y, Qureshi A, de Pril V, Otsuka Y, Weber J, Yamazaki N.

J Dermatol. 2019 Dec;46(12):1197-1201. doi: 10.1111/1346-8138.15103. Epub 2019 Oct 22.

PMID: 31638282

 

Apremilast mechanism of efficacy in systemic-naive patients with moderate plaque psoriasis: Pharmacodynamic results from the UNVEIL study.

Strober B, Alikhan A, Lockshin B, Shi R, Cirulli J, Schafer P.

J Dermatol Sci. 2019 Dec;96(3):126-133. doi: 10.1016/j.jdermsci.2019.09.003. Epub 2019 Sep 10.

PMID: 31787506

 

Qualitative analysis and reproducibility assessment of the Scalp Itch Numeric Rating Scale among patients with moderate to severe plaque psoriasis of the scalp.

Wang Y, Coyne K, Sofen H, Santanello N, Currie B, Zhang Z, Nograles K.

J Dermatolog Treat. 2019 Dec;30(8):775-783. doi: 10.1080/09546634.2019.1577546. Epub 2019 Mar 5.

PMID: 30747550

 

Corrigendum to "Nivolumab in advanced hepatocellular carcinoma: Sorafenib-experienced Asian cohort analysis" [J Hepatol 71 (2019) 543-552].

Yau T, Hsu C, Kim TY, Choo SP, Kang YK, Hou MM, Numata K, Yeo W, Chopra A, Ikeda M, Kuromatsu R, Moriguchi M, Chao Y, Zhao H, Anderson J, Dela Cruz C, Kudo M.

J Hepatol. 2019 Dec;71(6):1278. doi: 10.1016/j.jhep.2019.09.013. Epub 2019 Oct 25. No abstract available.

PMID: 31668671

 

Meeting Report of the 34th Annual Meeting of the Academy of Surgical Research: Summary of Presentations, Labs, and Workshops, Focusing on Experimental Surgery, Charleston, SC, September 26-28, 2018.

Graham ML, Stoll LJ, Ehrmann J.

J Invest Surg. 2019 Dec;32(8):773-784. doi: 10.1080/08941939.2019.1649767. Epub 2019 Aug 28.

PMID: 31455106

 

Total costs of treating venous thromboembolism: implication of different cost perspectives in a Danish setting.

Nielsen A, Poulsen PB, Dybro L, Kloster B, Lorentzen A, Olsen J, Kümler T.

J Med Econ. 2019 Dec;22(12):1321-1327. doi: 10.1080/13696998.2019.1668193. Epub 2019 Sep 27.

PMID: 31516054

 

Assessing an ASCO Decision Aid for Improving the Accuracy and Attribution of Serious Adverse Event Reporting From Investigators to Sponsors.

Mileham KF, Schenkel C, Chuk MK, Buchmeier A, Perez RP, Hurley P, Levit LA, Garrett-Mayer E, Davis C, Bruinooge SS, Vose J.

J Oncol Pract. 2019 Dec;15(12):e1050-e1065. doi: 10.1200/JOP.19.00366. Epub 2019 Oct 24.

PMID: 31647695

 

Emerging Immunotherapy Options for bacillus Calmette-Guérin Unresponsive Nonmuscle Invasive Bladder Cancer.

Meng MV, Gschwend JE, Shore N, Grossfeld GD, Mostafid H, Black PC.

J Urol. 2019 Dec;202(6):1111-1119. doi: 10.1097/JU.0000000000000297. Epub 2019 May 1. Review.

PMID: 31042108

 

Clinical Characteristics and Natural History of Autoimmune Forms of Interstitial Lung Disease: A Single-Center Experience.

Chartrand S, Lee JS, Swigris JJ, Stanchev L, Fischer A.

Lung. 2019 Dec;197(6):709-713. doi: 10.1007/s00408-019-00276-7. Epub 2019 Oct 3.

PMID: 31583453

 

Prevalence of Sexual Dysfunction in Women with Multiple Sclerosis: a Systematic Review and Meta-Analysis.

Azimi A, Hanaei S, Sahraian MA, Mohammadifar M, Ramagopalan SV, Ghajarzadeh M.

Maedica (Buchar). 2019 Dec;14(4):408-412. doi: 10.26574/maedica.2019.14.4.408.

PMID: 32153674

 

Immunotargeted therapy in melanoma: patient, provider preferences, and willingness to pay at an academic cancer center.

Stenehjem DD, Au TH, Ngorsuraches S, Ma J, Bauer H, Wanishayakorn T, Nelson RS, Pfeiffer CM, Schwartz J, Korytowsky B, Oderda G, Brixner DI.

Melanoma Res. 2019 Dec;29(6):626-634. doi: 10.1097/CMR.0000000000000572.

PMID: 30688762

 

Anti-B-cell Maturation Antigen Chimeric Antigen Receptor T cell Function against Multiple Myeloma Is Enhanced in the Presence of Lenalidomide.

Works M, Soni N, Hauskins C, Sierra C, Baturevych A, Jones JC, Curtis W, Carlson P, Johnstone TG, Kugler D, Hause RJ, Jiang Y, Wimberly L, Clouser CR, Jessup HK, Sather B, Salmon RA, Ports MO.

Mol Cancer Ther. 2019 Dec;18(12):2246-2257. doi: 10.1158/1535-7163.MCT-18-1146. Epub 2019 Aug 8.

PMID: 31395689

 

Expedited mapping of the ligandable proteome using fully functionalized enantiomeric probe pairs.

Wang Y, Dix MM, Bianco G, Remsberg JR, Lee HY, Kalocsay M, Gygi SP, Forli S, Vite G, Lawrence RM, Parker CG, Cravatt BF.

Nat Chem. 2019 Dec;11(12):1113-1123. doi: 10.1038/s41557-019-0351-5. Epub 2019 Oct 28.

PMID: 31659311

 

Parameter estimation for roller compaction process using an instrumented vector TF mini roller compactor.

Reddy JP, Phanse R, Nesarikar V.

Pharm Dev Technol. 2019 Dec;24(10):1250-1257. doi: 10.1080/10837450.2019.1658775. Epub 2019 Sep 9.

PMID: 31437082

 

Efficacy of Abatacept and Adalimumab in Patients with Early Rheumatoid Arthritis With Multiple Poor Prognostic Factors: Post Hoc Analysis of a Randomized Controlled Clinical Trial (AMPLE).

Fleischmann R, Weinblatt M, Ahmad H, Maldonado MA, Alemao E, Ye J, Schiff M.

Rheumatol Ther. 2019 Dec;6(4):559-571. doi: 10.1007/s40744-019-00174-7. Epub 2019 Oct 22.

PMID: 31642045

 

Comparative safety of abatacept in rheumatoid arthritis with COPD: A real-world population-based observational study.

Suissa S, Hudson M, Dell'Aniello S, Shen S, Simon TA, Ernst P.

Semin Arthritis Rheum. 2019 Dec;49(3):366-372. doi: 10.1016/j.semarthrit.2019.03.007. Epub 2019 Mar 16.

PMID: 30979397

 

Identification of novel glutathione conjugates of terbinafine in liver microsomes and hepatocytes across species.

Patil A, Ladumor MK, Kamble SH, Johnson BM, Subramanian M, Sinz MW, Singh DK, Putlur S, Bhutani P, Ahire DS, Singh S.

Xenobiotica. 2019 Dec;49(12):1403-1413. doi: 10.1080/00498254.2019.1581959. Epub 2019 Mar 7.

PMID: 30747549

Protein aggregation and mitigation strategy in low pH viral inactivation for monoclonal antibody purification.

Jin W, Xing Z, Song Y, Huang C, Xu X, Ghose S, Li ZJ.

MAbs. 2019 Nov-Dec;11(8):1479-1491. doi: 10.1080/19420862.2019.1658493. Epub 2019 Sep 2.

PMID: 31441367

 

Process intensification in fed-batch production bioreactors using non-perfusion seed cultures.

Yongky A, Xu J, Tian J, Oliveira C, Zhao J, McFarland K, Borys MC, Li ZJ.

MAbs. 2019 Nov-Dec;11(8):1502-1514. doi: 10.1080/19420862.2019.1652075. Epub 2019 Aug 19.

PMID: 31379298

Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System.

Oni Y, Song X, Schrader M, Kulshrestha A, Franck J, Asselta R, Flores-Crespo C, Mantri RV.

PDA J Pharm Sci Technol. 2019 Nov-Dec;73(6):572-587. doi: 10.5731/pdajpst.2018.009670. Epub 2019 May 17.

PMID: 31101708

 

Determinants of treatment in patients with stage IV renal cell carcinoma.

Hollenbeak CS, Schaefer EW, Doan J, Raman JD.

BMC Urol. 2019 Nov 29;19(1):123. doi: 10.1186/s12894-019-0559-0.

PMID: 31783828

 

An observational study of INR control according to NICE criteria in patients with non-valvular atrial fibrillation-The SAIL Warfarin Out of Range Descriptors Study (SWORDS).

Harris DE, Thayer D, Wang T, Brooks C, Murley G, Gravenor M, Hill NR, Lister S, Halcox J.

Eur Heart J Cardiovasc Pharmacother. 2019 Nov 27. pii: pvz071. doi: 10.1093/ehjcvp/pvz071. [Epub ahead of print]

PMID: 31774502

 

Biphenyl Acid Derivatives as APJ Receptor Agonists.

Su S, Clarke A, Han Y, Chao HJ, Bostwick J, Schumacher W, Wang T, Yan M, Hsu MY, Simmons E, Luk C, Xu C, Dabros M, Galella M, Onorato J, Gordon D, Wexler R, Gargalovic PS, Lawrence RM.

J Med Chem. 2019 Nov 27;62(22):10456-10465. doi: 10.1021/acs.jmedchem.9b01513. Epub 2019 Nov 14.

PMID: 31724863

 

Lipid order and charge protect killer T cells from accidental death.

Rudd-Schmidt JA, Hodel AW, Noori T, Lopez JA, Cho HJ, Verschoor S, Ciccone A, Trapani JA, Hoogenboom BW, Voskoboinik I.

Nat Commun. 2019 Nov 27;10(1):5396. doi: 10.1038/s41467-019-13385-x.

PMID: 31776337

 

Safety and Efficacy Results of a Phase I, Open-Label Study of Concurrent and Delayed Nivolumab in Combination With nab-Paclitaxel and Carboplatin in Advanced Non-small Cell Lung Cancer.

Goldman JW, Waterhouse DM, George B, O'Dwyer PJ, Bhore R, Banerjee S, Lyons L, Louis CU, Ong TJ, Kelly K.

Front Oncol. 2019 Nov 26;9:1256. doi: 10.3389/fonc.2019.01256. eCollection 2019.

PMID: 31850192

 

Response to: Olry de Labry Lima A et al., Cost-effectiveness of lenalidomide maintenance in patients with multiple myeloma who have undergone autologous transplant hematopoietic progenitor cells.

Dhanasiri S.

Bone Marrow Transplant. 2019 Nov 21. doi: 10.1038/s41409-019-0749-0. [Epub ahead of print] No abstract available.

PMID: 31754250

 

Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer.

Hellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim SW, Carcereny Costa E, Park K, Alexandru A, Lupinacci L, de la Mora Jimenez E, Sakai H, Albert I, Vergnenegre A, Peters S, Syrigos K, Barlesi F, Reck M, Borghaei H, Brahmer JR, O'Byrne KJ, Geese WJ, Bhagavatheeswaran P, Rabindran SK, Kasinathan RS, Nathan FE, Ramalingam SS.

N Engl J Med. 2019 Nov 21;381(21):2020-2031. doi: 10.1056/NEJMoa1910231. Epub 2019 Sep 28.

PMID: 31562796

 

Nivolumab Combined With Brentuximab Vedotin for Relapsed/Refractory Primary Mediastinal Large B-Cell Lymphoma: Efficacy and Safety From the Phase II CheckMate 436 Study.

Zinzani PL, Santoro A, Gritti G, Brice P, Barr PM, Kuruvilla J, Cunningham D, Kline J, Johnson NA, Mehta-Shah N, Manley T, Francis S, Sharma M, Moskowitz AJ.

J Clin Oncol. 2019 Nov 20;37(33):3081-3089. doi: 10.1200/JCO.19.01492. Epub 2019 Aug 9.

PMID: 31398081

 

Palladium(0)-Catalyzed Directed syn-1,2-Carboboration and -Silylation: Alkene Scope, Applications in Dearomatization, and Stereocontrol by a Chiral Auxiliary.

Liu Z, Chen J, Lu HX, Li X, Gao Y, Coombs JR, Goldfogel MJ, Engle KM.

Angew Chem Int Ed Engl. 2019 Nov 18;58(47):17068-17073. doi: 10.1002/anie.201910304. Epub 2019 Oct 8. Review.

PMID: 31538388

 

Presence of anti-cyclic citrullinated peptide antibodies is associated with better treatment response to abatacept but not to TNF inhibitors in patients with rheumatoid arthritis: a meta-analysis.

Alemao E, Postema R, Elbez Y, Mamane C, Finckh A.

Clin Exp Rheumatol. 2019 Nov 16. [Epub ahead of print]

PMID: 31770089

 

An Integrative Approach to Inform Optimal Administration of OX40 Agonist Antibodies in Patients with Advanced Solid Tumors.

Wang R, Gao C, Raymond M, Dito G, Kabbabe D, Shao X, Hilt E, Sun Y, Pak I, Gutierrez M, Melero I, Spreafico A, Carvajal RD, Ong M, Olszanski AJ, Milburn C, Thudium K, Yang Z, Feng Y, Fracasso PM, Korman AJ, Aanur P, Huang SA, Quigley M.

Clin Cancer Res. 2019 Nov 15;25(22):6709-6720. doi: 10.1158/1078-0432.CCR-19-0526. Epub 2019 Oct 1.

PMID: 31573956

 

One-Step Diastereoselective Pyrrolidine Synthesis Using a Sulfinamide Annulating Reagent.

Shi Q, Greenwood NS, Meehan MC, Park H, Galella M, Sandhu B, Khandelwal P, Coombs JR, Gallagher WP, Guerrero CA, Hynes J Jr, Dhar TGM, Gonzalez Bobes F, Marcoux D.

Org Lett. 2019 Nov 15;21(22):9198-9202. doi: 10.1021/acs.orglett.9b03560. Epub 2019 Oct 24.

PMID: 31647672

 

Age at menarche and risk of multiple sclerosis (MS): a systematic review and meta-analysis.

Azimi A, Hanaei S, Sahraian MA, Mohammadifar M, Ramagopalan SV, Ghajarzadeh M.

BMC Neurol. 2019 Nov 14;19(1):286. doi: 10.1186/s12883-019-1473-5.

PMID: 31727014

 

Rationally Designed, Conformationally Constrained Inverse Agonists of RORγt-Identification of a Potent, Selective Series with Biologic-Like in Vivo Efficacy.

Marcoux D, Duan JJ, Shi Q, Cherney RJ, Srivastava AS, Cornelius L, Batt DG, Liu Q, Beaudoin-Bertrand M, Weigelt CA, Khandelwal P, Vishwakrishnan S, Selvakumar K, Karmakar A, Gupta AK, Basha M, Ramlingam S, Manjunath N, Vanteru S, Karmakar S, Maddala N, Vetrichelvan M, Gupta A, Rampulla RA, Mathur A, Yip S, Li P, Wu DR, Khan J, Ruzanov M, Sack JS, Wang J, Yarde M, Cvijic ME, Li S, Shuster DJ, Borowski V, Xie JH, McIntyre KW, Obermeier MT, Fura A, Stefanski K, Cornelius G, Hynes J Jr, Tino JA, Macor JE, Salter-Cid L, Denton R, Zhao Q, Carter PH, Dhar TGM.

J Med Chem. 2019 Nov 14;62(21):9931-9946. doi: 10.1021/acs.jmedchem.9b01369. Epub 2019 Oct 31.

PMID: 31638797

 

Clinical outcomes and treatment patterns among Medicare patients with nonvalvular atrial fibrillation (NVAF) and chronic kidney disease.

Wilson LE, Luo X, Li X, Mardekian J, Garcia Reeves AB, Skinner A.

PLoS One. 2019 Nov 14;14(11):e0225052. doi: 10.1371/journal.pone.0225052. eCollection 2019.

PMID: 31725743

 

Preservation of Post-Infarction Cardiac Structure and Function via Long-Term Oral Formyl Peptide Receptor Agonist Treatment.

García RA, Ito BR, Lupisella JA, Carson NA, Hsu MY, Fernando G, Heroux M, Bouvier M, Dierks E, Kick EK, Gordon DA, Chen J, Mintier G, Carrier M, St-Onge S, Shah H, Towne J, Bucardo MS, Ma X, Ryan CS, Wurtz NR, Ostrowski J, Villarreal FJ.

JACC Basic Transl Sci. 2019 Nov 13;4(8):905-920. doi: 10.1016/j.jacbts.2019.07.005. eCollection 2019 Dec.

PMID: 31909300

 

Tumor mutational burden in lung cancer: a systematic literature review.

Willis C, Fiander M, Tran D, Korytowsky B, Thomas JM, Calderon F, Zyczynski TM, Brixner D, Stenehjem DD.

Oncotarget. 2019 Nov 12;10(61):6604-6622. doi: 10.18632/oncotarget.27287. eCollection 2019 Nov 12. Review.

PMID: 31762941

 

Comparative risk of malignancies and infections in patients with rheumatoid arthritis initiating abatacept versus other biologics: a multi-database real-world study.

Simon TA, Boers M, Hochberg M, Baker N, Skovron ML, Ray N, Singhal S, Suissa S, Gomez-Caminero A.

Arthritis Res Ther. 2019 Nov 8;21(1):228. doi: 10.1186/s13075-019-1992-x.

PMID: 31703717

 

Author Correction: Targeting CLDN18.2 by CD3 Bispecific and ADC Modalities for the Treatments of Gastric and Pancreatic Cancer.

Zhu G, Foletti D, Liu X, Ding S, Melton Witt J, Hasa-Moreno A, Rickert M, Holz C, Aschenbrenner L, Yang AH, Kraynov E, Evering W, Obert L, Lee C, Sai T, Mistry T, Lindquist KC, Van Blarcom T, Strop P, Chaparro-Riggers J, Liu SH.

Sci Rep. 2019 Nov 8;9(1):16735. doi: 10.1038/s41598-019-53130-4.

PMID: 31700121

 

Safety, Tolerability, and Potential Clinical Activity of a Glucocorticoid-Induced TNF Receptor-Related Protein Agonist Alone or in Combination With Nivolumab for Patients With Advanced Solid Tumors: A Phase 1/2a Dose-Escalation and Cohort-Expansion Clinical Trial.

Heinhuis KM, Carlino M, Joerger M, Di Nicola M, Meniawy T, Rottey S, Moreno V, Gazzah A, Delord JP, Paz-Ares L, Britschgi C, Schilder RJ, O'Byrne K, Curigliano G, Romano E, Patah P, Wang R, Liu Y, Bajaj G, Siu LL.

JAMA Oncol. 2019 Nov 7:1-8. doi: 10.1001/jamaoncol.2019.3848. [Epub ahead of print]

PMID: 31697308

Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial.

Naumann RW, Hollebecque A, Meyer T, Devlin MJ, Oaknin A, Kerger J, López-Picazo JM, Machiels JP, Delord JP, Evans TRJ, Boni V, Calvo E, Topalian SL, Chen T, Soumaoro I, Li B, Gu J, Zwirtes R, Moore KN.

J Clin Oncol. 2019 Nov 1;37(31):2825-2834. doi: 10.1200/JCO.19.00739. Epub 2019 Sep 5.

PMID: 31487218

 

Pharmacological Characterization of GPCR Agonists, Antagonists, Allosteric Modulators and Biased Ligands from HTS Hits to Lead Optimization.

Sum CS, Murphy BJ, Li Z, Wang T, Zhang L, Cvijic ME.

In: Sittampalam GS, Grossman A, Brimacombe K, Arkin M, Auld D, Austin CP, Baell J, Bejcek B, Caaveiro JMM, Chung TDY, Coussens NP, Dahlin JL, Devanaryan V, Foley TL, Glicksman M, Hall MD, Haas JV, Hoare SRJ, Inglese J, Iversen PW, Kahl SD, Kales SC, Kirshner S, Lal-Nag M, Li Z, McGee J, McManus O, Riss T, Saradjian P, Trask OJ Jr., Weidner JR, Wildey MJ, Xia M, Xu X, editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004-2019 Nov 1.

PMID: 31693331

Predicting atrial fibrillation in primary care using machine learning.

Hill NR, Ayoubkhani D, McEwan P, Sugrue DM, Farooqui U, Lister S, Lumley M, Bakhai A, Cohen AT, O'Neill M, Clifton D, Gordon J.

PLoS One. 2019 Nov 1;14(11):e0224582. doi: 10.1371/journal.pone.0224582. eCollection 2019.

PMID: 31675367

 

Realized and Projected Cost-Savings from the Introduction of Generic Imatinib Through Formulary Management in Patients with Chronic Myelogenous Leukemia.

Campbell D, Blazer M, Bloudek L, Brokars J, Makenbaeva D.

Am Health Drug Benefits. 2019 Nov;12(7):333-342.

PMID: 32055281

 

A multi-national trial of a direct oral anticoagulant in children with cardiac disease: Design and rationale of the Safety of ApiXaban On Pediatric Heart disease On the preventioN of Embolism (SAXOPHONE) study.

Payne RM, Burns KM, Glatz AC, Li D, Li X, Monagle P, Newburger JW, Swan EA, Wheaton O, Male C; Pediatric Heart Network Investigators.

Am Heart J. 2019 Nov;217:52-63. doi: 10.1016/j.ahj.2019.08.002. Epub 2019 Aug 9.

PMID: 31493728

 

2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays (Part 1 - Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis).

Fandozzi C, Evans C, Wilson A, Su D, Anderson M, Clausen V, Dillen L, Garofolo F, Holliman C, Nickbarg E, Olah T, Ramanathan R, Zhang H, Kaur S, Pillutla R, Yu H, Bateman K, Donato LD, Hengel S, Jian W, Jones B, Kellie J, Lee A, Palandra J, Savoie N, Shipkova P, Spitz S, Su D, Szapacs M, Wang J, Wright K, Zeng J.

Bioanalysis. 2019 Nov;11(22):2029-2048. doi: 10.4155/bio-2019-0260. Epub 2019 Dec 6.

PMID: 31808716

 

Nivolumab Clearance Is Stationary in Patients With Resected Melanoma on Adjuvant Therapy: Implications of Disease Status on Time-Varying Clearance.

Hamuro L, Statkevich P, Bello A, Roy A, Bajaj G.

Clin Pharmacol Ther. 2019 Nov;106(5):1018-1027. doi: 10.1002/cpt.1502. Epub 2019 Jul 10.

PMID: 31090921

 

Abatacept retention and clinical outcomes in rheumatoid arthritis: real-world data from the German cohort of the ACTION study and a comparison with other participating countries.

Alten R, Feist E, Lorenz HM, Nüßlein H, Voll RE, Chartier M, Elbez Y, Rauch C.

Clin Rheumatol. 2019 Nov;38(11):3049-3059. doi: 10.1007/s10067-019-04648-5. Epub 2019 Jul 12.

PMID: 31300979

 

A Quantitative Systems Pharmacology Consortium Approach to Managing Immunogenicity of Therapeutic Proteins.

Kierzek AM, Hickling TP, Figueroa I, Kalvass JC, Nijsen M, Mohan K, Veldman GM, Yamada A, Sayama H, Yokoo S, Gulati A, Dhanikula RS, Gokemeijer J, Leil TA, Thalhauser CJ, Giorgi M, Swat MJ, Chelliah V, Small BG, Benson N, Walker M, Gadkar K, Quarmby V, Deng R, Ferrante A, Dickinson GL, Van Der Walt JS, Zhou L, Chen X, Jones HM, Narula J, Tourdot S, Lavé T, Ribba B, van der Graaf PH.

CPT Pharmacometrics Syst Pharmacol. 2019 Nov;8(11):773-776. doi: 10.1002/psp4.12465. Epub 2019 Oct 8. No abstract available.

PMID: 31529677

 

Linking Tumor Growth Dynamics to Survival in Ipilimumab-Treated Patients With Advanced Melanoma Using Mixture Tumor Growth Dynamic Modeling.

Feng Y, Wang X, Suryawanshi S, Bello A, Roy A.

CPT Pharmacometrics Syst Pharmacol. 2019 Nov;8(11):825-834. doi: 10.1002/psp4.12454. Epub 2019 Aug 13.

PMID: 31334596

 

Influence of Diabetes Complications on HbA_1c Treatment Goals Among Older U.S. Adults: A Cost-effectiveness Analysis.

Shao H, Lin J, Zhuo X, Rolka DB, Gregg EW, Zhang P.

Diabetes Care. 2019 Nov;42(11):2136-2142. doi: 10.2337/dc19-0381. Epub 2019 Sep 17.

PMID: 31530661

 

Enhanced and Persistent Inhibition of Organic Cation Transporter 1 Activity by Preincubation of Cyclosporine A.

Panfen E, Chen W, Zhang Y, Sinz M, Marathe P, Gan J, Shen H.

Drug Metab Dispos. 2019 Nov;47(11):1352-1360. doi: 10.1124/dmd.119.087197. Epub 2019 Aug 19.

PMID: 31427432

 

Characterization of therapeutic antibody fragmentation using automated capillary western blotting as an orthogonal analytical technique.

Zhu Y, Ahluwalia D, Chen Y, Belakavadi M, Katiyar A, Das TK.

Electrophoresis. 2019 Nov;40(21):2888-2898. doi: 10.1002/elps.201900119. Epub 2019 Jul 16.

PMID: 31271455

Safety and efficacy of nivolumab in challenging subgroups with advanced melanoma who progressed on or after ipilimumab treatment: A single-arm, open-label, phase II study (CheckMate 172).

Schadendorf D, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Muñoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Nathan P.

Eur J Cancer. 2019 Nov;121:144-153. doi: 10.1016/j.ejca.2019.08.014. Epub 2019 Sep 30.

PMID: 31581055

 

Fibroblast Growth Factor Receptor 3 Alterations and Response to PD-1/PD-L1 Blockade in Patients with Metastatic Urothelial Cancer.

Wang L, Gong Y, Saci A, Szabo PM, Martini A, Necchi A, Siefker-Radtke A, Pal S, Plimack ER, Sfakianos JP, Bhardwaj N, Horowitz A, Farkas AM, Mulholland D, Fischer BS, Oh WK, Sharma P, Zhu J, Galsky MD.

Eur Urol. 2019 Nov;76(5):599-603. doi: 10.1016/j.eururo.2019.06.025. Epub 2019 Jul 1.

PMID: 31272788

 

Suspected cancer symptoms and blood test results in primary care before a diagnosis of lung cancer: a case-control study.

McDonald L, Carroll R, Harish A, Tanna N, Mehmud F, Alikhan R, Ramagopalan SV.

Future Oncol. 2019 Nov;15(33):3755-3762. doi: 10.2217/fon-2019-0442. Epub 2019 Oct 31.

PMID: 31668096

 

Comparison of accelerometer-derived physical activity levels between individuals with and without cancer: a UK Biobank study.

McDonald L, Oguz M, Carroll R, Thakkar P, Yang F, Dhalwani N, Cox A, Merinopoulou E, Malcolm B, Mehmud F, Ramagopalan S.

Future Oncol. 2019 Nov;15(33):3763-3774. doi: 10.2217/fon-2019-0443. Epub 2019 Oct 22.

PMID: 31637942

 

Automated extraction of treatment patterns from social media posts: an exploratory analysis in renal cell carcinoma.

Ramagopalan SV, Malcolm B, Merinopoulou E, McDonald L, Cox A.

Future Oncol. 2019 Nov;15(31):3587-3596. doi: 10.2217/fon-2019-0406. Epub 2019 Sep 4.

PMID: 31483164

Japanese real-world study of sequential nivolumab and ipilimumab treament in melanoma.

Tsutsumida A, Fukushima S, Yokota K, Yoshikawa S, Yamasaki O, Tanemura A, Okuyama R, Uhara H, Muto Y, Miyashita A, Akiyama M, Kaji T, Koga H, Kato J, Katayama T, Itakura E, Yamazaki N, Kiyohara Y.

J Dermatol. 2019 Nov;46(11):947-955. doi: 10.1111/1346-8138.15073. Epub 2019 Sep 17.

PMID: 31531895

 

Economic modeling to evaluate the impact of chronic myeloid leukemia therapy management on the oncology care model in the US.

Jabbour EJ, Mendiola MF, Lingohr-Smith M, Lin J, Makenbaeva D.

J Med Econ. 2019 Nov;22(11):1113-1118. doi: 10.1080/13696998.2019.1618316. Epub 2019 May 31.

PMID: 31074658

  

Increasing value of autopsies in patients with brain tumors in the molecular era.

Ahrendsen JT, Filbin MG, Chi SN, Manley PE, Wright KD, Bandopadhayay P, Clymer JR, Yeo KK, Kieran MW, Jones R, Lidov HG, Ligon KL, Alexandrescu S.

J Neurooncol. 2019 Nov;145(2):349-355. doi: 10.1007/s11060-019-03302-z. Epub 2019 Sep 30.

PMID: 31571114

 

A Proposal for an Alternative Approach to Particle Size Method Development During Early-Stage Small Molecule Pharmaceutical Development.

Gamble JF, Dawson N, Murphy D, Theophilus A, Kippax P.

J Pharm Sci. 2019 Nov;108(11):3515-3520. doi: 10.1016/j.xphs.2019.08.007. Epub 2019 Aug 21.

PMID: 31445006

 

Two-year abatacept retention rate in clinical practice in the French ACTION cohort.

Mariette X, Schaeverbeke T, Gaudin P, Chartier M, Heitzmann J, Vannier-Moreau V, Hilliquin P, Cantagrel A.

Joint Bone Spine. 2019 Nov;86(6):753-759. doi: 10.1016/j.jbspin.2019.07.006. Epub 2019 Jul 25.

PMID: 31352138

 

Human or mouse? Practice makes perfect.

Stanislawczyk L.

Lab Anim (NY). 2019 Nov;48(11):319. doi: 10.1038/s41684-019-0419-2. No abstract available.

PMID: 31645691

 

Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial.

Kato K, Cho BC, Takahashi M, Okada M, Lin CY, Chin K, Kadowaki S, Ahn MJ, Hamamoto Y, Doki Y, Yen CC, Kubota Y, Kim SB, Hsu CH, Holtved E, Xynos I, Kodani M, Kitagawa Y.

Lancet Oncol. 2019 Nov;20(11):1506-1517. doi: 10.1016/S1470-2045(19)30626-6. Epub 2019 Sep 30. Erratum in: Lancet Oncol. 2019 Nov;20(11):e613.

PMID: 31582355

 

A Review of Survival Analysis Methods Used in NICE Technology Appraisals of Cancer Treatments: Consistency, Limitations, and Areas for Improvement.

Bell Gorrod H, Kearns B, Stevens J, Thokala P, Labeit A, Latimer N, Tyas D, Sowdani A.

Med Decis Making. 2019 Nov;39(8):899-909. doi: 10.1177/0272989X19881967. Epub 2019 Nov 9.

PMID: 31707911

 

Preclinical Efficacy and Safety Comparison of CD3 Bispecific and ADC Modalities Targeting BCMA for the Treatment of Multiple Myeloma.

Panowski SH, Kuo TC, Zhang Y, Chen A, Geng T, Aschenbrenner L, Kamperschroer C, Pascua E, Chen W, Delaria K, Farias S, Bateman M, Dushin RG, Chin SM, Van Blarcom TJ, Yeung YA, Lindquist KC, Chunyk AG, Kuang B, Han B, Mirsky M, Pardo I, Buetow B, Martin TG, Wolf JL, Shelton D, Rajpal A, Strop P, Chaparro-Riggers J, Sasu BJ.

Mol Cancer Ther. 2019 Nov;18(11):2008-2020. doi: 10.1158/1535-7163.MCT-19-0007. Epub 2019 Aug 21.

PMID: 31434693

 

Safety of Nivolumab plus Low-Dose Ipilimumab in Previously Treated Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer.

Morse MA, Overman MJ, Hartman L, Khoukaz T, Brutcher E, Lenz HJ, Atasoy A, Shangguan T, Zhao H, El-Rayes B.

Oncologist. 2019 Nov;24(11):1453-1461. doi: 10.1634/theoncologist.2019-0129. Epub 2019 May 30.

PMID: 31147488

 

Elucidating spray-dried dispersion dissolution mechanisms with focused beam reflectance measurement: contribution of polymer chemistry and particle properties to performance.

Rawlinson-Malone CF, Ferreira AP, Nicholls D, Nicholson S.

Pharm Dev Technol. 2019 Nov;24(9):1055-1062. doi: 10.1080/10837450.2018.1559189. Epub 2019 Jun 26.

PMID: 30640552

 

A comparison of self-rated health using EQ-5D VAS in the United States in 2002 and 2017.

Cha AS, Law EH, Shaw JW, Pickard AS.

Qual Life Res. 2019 Nov;28(11):3065-3069. doi: 10.1007/s11136-019-02249-y. Epub 2019 Jul 18.

PMID: 31321671

 

Daclatasvir and sofosbuvir with ribavirin for 24 weeks in chronic hepatitis C genotype-3-infected patients with cirrhosis: a Phase III study (ALLY-3C).

Poordad F, Shiffman ML, Ghesquiere W, Wong A, Huhn GD, Wong F, Ramji A, Shafran SD, McPhee F, Yang R, Noviello S, Linaberry M; ALLY-3C study team.

Antivir Ther. 2019 Nov;24(1):35-44. doi: 10.3851/IMP3278.

PMID: 30382942

 

Cost-Effectiveness Analysis of Apixaban Versus Edoxaban in Patients with Atrial Fibrillation for Stroke Prevention.

Oyagüez I, Suárez C, López-Sendón JL, González-Juanatey JR, de Andrés-Nogales F, Suárez J, Polanco C, Soto J.

Pharmacoecon Open. 2019 Oct 31. doi: 10.1007/s41669-019-00186-7. [Epub ahead of print]

PMID: 31673882

 

Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle.

Mathaes R, Narhi L, Hawe A, Matter A, Bechtold-Peters K, Kenrick S, Kar S, Laskina O, Carpenter J, Cavicchi R, Koepf E, Lewis EN, De Silva R, Ripple D.

AAPS J. 2019 Oct 30;22(1):1. doi: 10.1208/s12248-019-0384-0.

PMID: 31677011

 

Randomized phase-II evaluation of letrozole plus dasatinib in hormone receptor positive metastatic breast cancer patients.

Paul D, Vukelja SJ, Ann Holmes F, Blum JL, McIntyre KJ, Lindquist DL, Osborne CR, Sanchez IJ, Goldschmidt JH, Wang Y, Asmar L, Strauss L, O'Shaughnessy J.

NPJ Breast Cancer. 2019 Oct 28;5:36. doi: 10.1038/s41523-019-0132-8. eCollection 2019.

PMID: 31667338

 

Anti-Markovnikov Hydroamination of Unactivated Alkenes with Primary Alkyl Amines.

Miller DC, Ganley JM, Musacchio AJ, Sherwood TC, Ewing WR, Knowles RR.

J Am Chem Soc. 2019 Oct 23;141(42):16590-16594. doi: 10.1021/jacs.9b08746. Epub 2019 Oct 14.

PMID: 31603324

 

Utilization of In Vitro, In Vivo and In Silico Tools to Evaluate the pH-Dependent Absorption of a BCS Class II Compound and Identify a pH-Effect Mitigating Strategy.

Gesenberg C, Mathias NR, Xu Y, Crison J, Savant I, Saari A, Good DJ, Hemenway JN, Narang AS, Schartman RR, Zheng N, Buzescu A, Patel J.

Pharm Res. 2019 Oct 21;36(12):164. doi: 10.1007/s11095-019-2698-0.

PMID: 31637544

 

The hepatoprotective activities of Kalimeris indica ethanol extract against liver injury in vivo.

Wang GK, Zhang N, Wang Y, Liu JS, Wang G, Zhou ZY, Lu CC, Yang JS.

Food Sci Nutr. 2019 Oct 18;7(11):3797-3807. doi: 10.1002/fsn3.1241. eCollection 2019 Nov.

PMID: 31763029

 

Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.

Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hogg D, Hill A, Márquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schöffski P, Carlino MS, Lebbé C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bastholt L, Rizzo JI, Balogh A, Moshyk A, Hodi FS, Wolchok JD.

N Engl J Med. 2019 Oct 17;381(16):1535-1546. doi: 10.1056/NEJMoa1910836. Epub 2019 Sep 28.

PMID: 31562797

 

Resistance profile of the HIV-1 maturation inhibitor GSK3532795 in vitro and in a clinical study.

Dicker I, Zhang S, Ray N, Beno BR, Regueiro-Ren A, Joshi S, Cockett M, Krystal M, Lataillade M.

PLoS One. 2019 Oct 17;14(10):e0224076. doi: 10.1371/journal.pone.0224076. eCollection 2019. Erratum in: PLoS One. 2019 Nov 5;14(11):e0224976.

PMID: 31622432

 

Benzothiazole-based compounds as potent endothelial lipase inhibitors.

Meng W, Adam LP, Behnia K, Zhao L, Yang R, Kopcho LM, Locke GA, Taylor DS, Yin X, Wexler RR, Finlay H.

Bioorg Med Chem Lett. 2019 Oct 15;29(20):126673. doi: 10.1016/j.bmcl.2019.126673. Epub 2019 Sep 6.

PMID: 31519373

 

Germline-Encoded Affinity for Cognate Antigen Enables Vaccine Amplification of a Human Broadly Neutralizing Response against Influenza Virus.

Sangesland M, Ronsard L, Kazer SW, Bals J, Boyoglu-Barnum S, Yousif AS, Barnes R, Feldman J, Quirindongo-Crespo M, McTamney PM, Rohrer D, Lonberg N, Chackerian B, Graham BS, Kanekiyo M, Shalek AK, Lingwood D.

Immunity. 2019 Oct 15;51(4):735-749.e8. doi: 10.1016/j.immuni.2019.09.001. Epub 2019 Sep 25.

PMID: 31563464

 

Workshop Report: FDA Workshop on Improving Cardiotoxicity Assessment With Human-Relevant Platforms.

Pang L, Sager P, Yang X, Shi H, Sannajust F, Brock M, Wu JC, Abi-Gerges N, Lyn-Cook B, Berridge BR, Stockbridge N.

Circ Res. 2019 Oct 11;125(9):855-867. doi: 10.1161/CIRCRESAHA.119.315378. Epub 2019 Oct 10.

PMID: 31600125

 

Modelling Survival of Patients Treated with Adjuvant Nivolumab Who Have Melanoma with Lymph Node Involvement or Metastatic Disease After Complete Resection.

Batteson R, Hart R, Hemstock M, Gooden K, Kotapati S, Roze S, Lee D, Amadi A.

Pharmacoecon Open. 2019 Oct 5. doi: 10.1007/s41669-019-00181-y. [Epub ahead of print]

PMID: 31587138

 

Risk of Recurrent Bleeding Events in Nonvalvular Atrial Fibrillation Treated with Vitamin K Antagonists: A Clinical Practice Research Datalink Study.

Alikhan R, Lefevre C, Menown I, Lister S, Bird A, You M, Evans D, Sammon C.

TH Open. 2019 Oct 4;3(4):e316-e324. doi: 10.1055/s-0039-1698413. eCollection 2019 Oct.

PMID: 31592518

 

Hemilabile Benzyl Ether Enables γ-C(sp₃)-H Carbonylation and Olefination of Alcohols.

Tanaka K, Ewing WR, Yu JQ.

J Am Chem Soc. 2019 Oct 2;141(39):15494-15497. doi: 10.1021/jacs.9b08238. Epub 2019 Sep 18.

PMID: 31519108

Structure based design of macrocyclic factor XIa inhibitors: Discovery of cyclic P1 linker moieties with improved oral bioavailability.

Clark CG, Rossi KA, Corte JR, Fang T, Smallheer JM, De Lucca I, Nirschl DS, Orwat MJ, Pinto DJP, Hu Z, Wang Y, Yang W, Jeon Y, Ewing WR, Myers JE Jr, Sheriff S, Lou Z, Bozarth JM, Wu Y, Rendina A, Harper T, Zheng J, Xin B, Xiang Q, Luettgen JM, Seiffert DA, Wexler RR, Lam PYS.

Bioorg Med Chem Lett. 2019 Oct 1;29(19):126604. doi: 10.1016/j.bmcl.2019.08.008. Epub 2019 Aug 16.

PMID: 31445854

Allogeneic murine pregnancy models for assessing the developmental effects of immune-stimulating antibodies: Challenges in reproducibility.

Thompson KE, Danberry TL, Bunch RT, Graziano MJ, McNerney ME.

Birth Defects Res. 2019 Oct 1;111(16):1178-1191. doi: 10.1002/bdr2.1542. Epub 2019 Jun 22.

PMID: 31228335

Restricting Glycolysis Preserves T Cell Effector Functions and Augments Checkpoint Therapy.

Renner K, Bruss C, Schnell A, Koehl G, Becker HM, Fante M, Menevse AN, Kauer N, Blazquez R, Hacker L, Decking SM, Bohn T, Faerber S, Evert K, Aigle L, Amslinger S, Landa M, Krijgsman O, Rozeman EA, Brummer C, Siska PJ, Singer K, Pektor S, Miederer M, Peter K, Gottfried E, Herr W, Marchiq I, Pouyssegur J, Roush WR, Ong S, Warren S, Pukrop T, Beckhove P, Lang SA, Bopp T, Blank CU, Cleveland JL, Oefner PJ, Dettmer K, Selby M, Kreutz M.

Cell Rep. 2019 Oct 1;29(1):135-150.e9. doi: 10.1016/j.celrep.2019.08.068.

PMID: 31577944

Optimizing ethambutol dosing among HIV/tuberculosis co-infected patients: a population pharmacokinetic modelling and simulation study.

Mehta K, Ravimohan S, Pasipanodya JG, Srivastava S, Modongo C, Zetola NM, Weissman D, Ivaturi V, Gumbo T, Bisson GP, Vinnard C.

J Antimicrob Chemother. 2019 Oct 1;74(10):2994-3002. doi: 10.1093/jac/dkz265.

PMID: 31273386

 

Indirect Treatment Comparison of Nivolumab Versus Observation or Ipilimumab as Adjuvant Therapy in Resected Melanoma Using Pooled Clinical Trial Data.

Freeman M, Betts KA, Jiang S, Du EX, Gupte-Singh K, Lu Y, Rao S, Shoushtari AN.

Adv Ther. 2019 Oct;36(10):2783-2796. doi: 10.1007/s12325-019-01060-y. Epub 2019 Aug 22.

PMID: 31440980

 

Stereospecific interactions between histidine and monoclonal antibodies.

Baek Y, Emami P, Singh N, Ilott A, Sahin E, Zydney A.

Biotechnol Bioeng. 2019 Oct;116(10):2632-2639. doi: 10.1002/bit.27109. Epub 2019 Jul 24.

PMID: 31286487

 

Control of antibody high and low molecular weight species by depth filtration-based cell culture harvesting.

Yu D, Mayani M, Song Y, Xing Z, Ghose S, Li ZJ.

Biotechnol Bioeng. 2019 Oct;116(10):2610-2620. doi: 10.1002/bit.27081. Epub 2019 Jun 29.

PMID: 31184373

 

The effects of buffer condition on the fouling behavior of MVM virus filtration of an Fc-fusion protein.

Namila F, Zhang D, Traylor S, Nguyen T, Singh N, Wickramasinghe R, Qian X.

Biotechnol Bioeng. 2019 Oct;116(10):2621-2631. doi: 10.1002/bit.27085. Epub 2019 Jul 6.

PMID: 31184371

 

Enhanced SLAMF7 Homotypic Interactions by Elotuzumab Improves NK Cell Killing of Multiple Myeloma.

Pazina T, James AM, Colby KB, Yang Y, Gale A, Jhatakia A, Kearney AY, Graziano RF, Bezman NA, Robbins MD, Cohen AD, Campbell KS.

Cancer Immunol Res. 2019 Oct;7(10):1633-1646. doi: 10.1158/2326-6066.CIR-18-0579. Epub 2019 Aug 20.

PMID: 31431433

 

EvaluatioN of ApiXaban in strOke and systemic embolism prevention in patients with non-valvular atrial fibrillation in clinical practice Setting in France, rationale and design of the NAXOS: SNIIRAM study.

Picard F, Van Ganse E, Ducrocq G, Danchin N, Falissard B, Hanon O, Belhassen M, Ginoux M, Lefevre C, Cotte FE, Mahé I, Steg PG.

Clin Cardiol. 2019 Oct;42(10):851-859. doi: 10.1002/clc.23231. Epub 2019 Jul 17.

PMID: 31313832

 

A Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma (aRCC).

Shah R, Botteman M, Solem CT, Luo L, Doan J, Cella D, Motzer RJ.

Clin Genitourin Cancer. 2019 Oct;17(5):356-365.e1. doi: 10.1016/j.clgc.2019.05.010. Epub 2019 May 31.

PMID: 31272883

 

Treatment Patterns and Clinical and Economic Outcomes in Patients With Newly Diagnosed Multiple Myeloma Treated With Lenalidomide- and/or Bortezomib-containing Regimens Without Stem Cell Transplant in a Real-world Setting.

Chari A, Parikh K, Ni Q, Abouzaid S.

Clin Lymphoma Myeloma Leuk. 2019 Oct;19(10):645-655. doi: 10.1016/j.clml.2019.06.007. Epub 2019 Jun 18.

PMID: 31377207

 

Apixaban: A Clinical Pharmacokinetic and Pharmacodynamic Review.

Byon W, Garonzik S, Boyd RA, Frost CE.

Clin Pharmacokinet. 2019 Oct;58(10):1265-1279. doi: 10.1007/s40262-019-00775-z. Review.

PMID: 31089975

   

Exposure-Response Analysis for Efficacy of Daclatasvir, Asunaprevir, and Beclabuvir Combinations in HCV-Infected Patients.

Ueno T, Osawa M, Shiozaki T, Green M, Garimella T.

Clin Pharmacol Drug Dev. 2019 Oct;8(7):903-913. doi: 10.1002/cpdd.646. Epub 2019 Jan 22.

PMID: 30667592

 

Continuation with apixaban treatment is associated with lower risk for hospitalization and medical costs among elderly patients.

Dhamane AD, Baker CL, Rajpura J, Mardekian J, Dina O, Russ C, Rosenblatt L, Lingohr-Smith M, Lin J.

Curr Med Res Opin. 2019 Oct;35(10):1769-1776. doi: 10.1080/03007995.2019.1623187. Epub 2019 Jun 5.

PMID: 31120309

 

Developments in the treatment of HCV genotype 3 infection.

McPhee F.

Expert Rev Anti Infect Ther. 2019 Oct;17(10):775-785. doi: 10.1080/14787210.2019.1676730. Epub 2019 Oct 21. Review.

PMID: 31584833

 

Immune checkpoint inhibition in sepsis: a Phase 1b randomized study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of nivolumab.

Hotchkiss RS, Colston E, Yende S, Crouser ED, Martin GS, Albertson T, Bartz RR, Brakenridge SC, Delano MJ, Park PK, Donnino MW, Tidswell M, Mayr FB, Angus DC, Coopersmith CM, Moldawer LL, Catlett IM, Girgis IG, Ye J, Grasela DM.

Intensive Care Med. 2019 Oct;45(10):1360-1371. doi: 10.1007/s00134-019-05704-z. Epub 2019 Oct 1.

PMID: 31576433

 

Model-Based Population Pharmacokinetic Analysis of Nivolumab in Chinese Patients With Previously Treated Advanced Solid Tumors, Including Non-Small Cell Lung Cancer.

Zhang J, Cai J, Bello A, Roy A, Sheng J.

J Clin Pharmacol. 2019 Oct;59(10):1415-1424. doi: 10.1002/jcph.1432. Epub 2019 May 22.

PMID: 31115908

 

Systematic review of societal costs associated with stroke, bleeding and monitoring in atrial fibrillation.

Martin AL, Reeves AG, Berger SE, Fusco MD, Wygant GD, Savone M, Snook K, Nejati M, Lanitis T.

J Comp Eff Res. 2019 Oct;8(14):1147-1166. doi: 10.2217/cer-2019-0089. Epub 2019 Aug 22.

PMID: 31436488

 

Patient characteristics and stroke and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban and vitamin K antagonists: a Spanish real-world study.

Ramagopalan SV, Sicras-Mainar A, Polanco-Sanchez C, Carroll R, de Bobadilla JF.

J Comp Eff Res. 2019 Oct;8(14):1201-1212. doi: 10.2217/cer-2019-0079. Epub 2019 Jul 23.

PMID: 31333045

 

Electrostatic-field and surface-shape similarity for virtual screening and pose prediction.

Cleves AE, Johnson SR, Jain AN.

J Comput Aided Mol Des. 2019 Oct;33(10):865-886. doi: 10.1007/s10822-019-00236-6. Epub 2019 Oct 24.

PMID: 31650386

 

The global epidemiology of NAFLD and NASH in patients with type 2 diabetes: A systematic review and meta-analysis.

Younossi ZM, Golabi P, de Avila L, Paik JM, Srishord M, Fukui N, Qiu Y, Burns L, Afendy A, Nader F.

J Hepatol. 2019 Oct;71(4):793-801. doi: 10.1016/j.jhep.2019.06.021. Epub 2019 Jul 4.

PMID: 31279902

 

Forced Oxidative Degradation Pathways of the Imidazole Moiety of Daclatasvir.

Huang Y, Su BN, Marshall J, Miller SA.

J Pharm Sci. 2019 Oct;108(10):3312-3318. doi: 10.1016/j.xphs.2019.05.022. Epub 2019 May 27.

PMID: 31145924

 

Cyclization of N-Terminal Glutamic Acid to pyro-Glutamic Acid Impacts Monoclonal Antibody Charge Heterogeneity Despite Its Appearance as a Neutral Transformation.

Liu Z, Valente J, Lin S, Chennamsetty N, Qiu D, Bolgar M.

J Pharm Sci. 2019 Oct;108(10):3194-3200. doi: 10.1016/j.xphs.2019.05.023. Epub 2019 May 27.

PMID: 31145921

 

Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial.

Motzer RJ, Rini BI, McDermott DF, Arén Frontera O, Hammers HJ, Carducci MA, Salman P, Escudier B, Beuselinck B, Amin A, Porta C, George S, Neiman V, Bracarda S, Tykodi SS, Barthélémy P, Leibowitz-Amit R, Plimack ER, Oosting SF, Redman B, Melichar B, Powles T, Nathan P, Oudard S, Pook D, Choueiri TK, Donskov F, Grimm MO, Gurney H, Heng DYC, Kollmannsberger CK, Harrison MR, Tomita Y, Duran I, Grünwald V, McHenry MB, Mekan S, Tannir NM; CheckMate 214 investigators.

Lancet Oncol. 2019 Oct;20(10):1370-1385. doi: 10.1016/S1470-2045(19)30413-9. Epub 2019 Aug 16. Erratum in: Lancet Oncol. 2019 Aug 21;:.

PMID: 31427204

 

Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis.

Antonia SJ, Borghaei H, Ramalingam SS, Horn L, De Castro Carpeño J, Pluzanski A, Burgio MA, Garassino M, Chow LQM, Gettinger S, Crinò L, Planchard D, Butts C, Drilon A, Wojcik-Tomaszewska J, Otterson GA, Agrawal S, Li A, Penrod JR, Brahmer J.

Lancet Oncol. 2019 Oct;20(10):1395-1408. doi: 10.1016/S1470-2045(19)30407-3. Epub 2019 Aug 14.

PMID: 31422028

 

VISTA is an acidic pH-selective ligand for PSGL-1.

Johnston RJ, Su LJ, Pinckney J, Critton D, Boyer E, Krishnakumar A, Corbett M, Rankin AL, Dibella R, Campbell L, Martin GH, Lemar H, Cayton T, Huang RY, Deng X, Nayeem A, Chen H, Ergel B, Rizzo JM, Yamniuk AP, Dutta S, Ngo J, Shorts AO, Ramakrishnan R, Kozhich A, Holloway J, Fang H, Wang YK, Yang Z, Thiam K, Rakestraw G, Rajpal A, Sheppard P, Quigley M, Bahjat KS, Korman AJ.

Nature. 2019 Oct;574(7779):565-570. doi: 10.1038/s41586-019-1674-5. Epub 2019 Oct 23.

PMID: 31645726

 

Evaluation of the Implementation of Additional Risk Minimization Activities in Europe, the USA, and Japan.

Yasuoka Y, Kaneko M, Narukawa M.

Pharmaceut Med. 2019 Oct;33(5):417-424. doi: 10.1007/s40290-019-00303-1.

PMID: 31933232

 

Concordance of hospitalizations between Clinical Practice Research Datalink and linked Hospital Episode Statistics among patients treated with oral antidiabetic therapies.

Saine ME, Carbonari DM, Newcomb CW, Gallagher AM, Blak BT, Roy JA, Wood J, Cardillo S, Hennessy S, Strom BL, Lo Re V 3rd.

Pharmacoepidemiol Drug Saf. 2019 Oct;28(10):1328-1335. doi: 10.1002/pds.4853. Epub 2019 Jul 22.

PMID: 31328342

 

Exposure assessments in reproductive and developmental toxicity testing: An IQ-DruSafe industry survey on current practices and experiences in support of exposure-based high dose selection.

Andrews PA, McNerney ME, DeGeorge JJ.

Regul Toxicol Pharmacol. 2019 Oct;107:104413. doi: 10.1016/j.yrtph.2019.104413. Epub 2019 Jun 20.

PMID: 31229519

 

Genetic toxicology in silico protocol.

Hasselgren C, Ahlberg E, Akahori Y, Amberg A, Anger LT, Atienzar F, Auerbach S, Beilke L, Bellion P, Benigni R, Bercu J, Booth ED, Bower D, Brigo A, Cammerer Z, Cronin MTD, Crooks I, Cross KP, Custer L, Dobo K, Doktorova T, Faulkner D, Ford KA, Fortin MC, Frericks M, Gad-McDonald SE, Gellatly N, Gerets H, Gervais V, Glowienke S, Van Gompel J, Harvey JS, Hillegass J, Honma M, Hsieh JH, Hsu CW, Barton-Maclaren TS, Johnson C, Jolly R, Jones D, Kemper R, Kenyon MO, Kruhlak NL, Kulkarni SA, Kümmerer K, Leavitt P, Masten S, Miller S, Moudgal C, Muster W, Paulino A, Lo Piparo E, Powley M, Quigley DP, Reddy MV, Richarz AN, Schilter B, Snyder RD, Stavitskaya L, Stidl R, Szabo DT, Teasdale A, Tice RR, Trejo-Martin A, Vuorinen A, Wall BA, Watts P, White AT, Wichard J, Witt KL, Woolley A, Woolley D, Zwickl C, Myatt GJ.

Regul Toxicol Pharmacol. 2019 Oct;107:104403. doi: 10.1016/j.yrtph.2019.104403. Epub 2019 Jun 11.

PMID: 31195068

 

Comparison of immune system development in nonclinical species and humans: Closing information gaps for immunotoxicity testing and human translatability.

Skaggs H, Chellman GJ, Collinge M, Enright B, Fuller CL, Krayer J, Sivaraman L, Weinbauer GF.

Reprod Toxicol. 2019 Oct;89:178-188. doi: 10.1016/j.reprotox.2019.06.005. Epub 2019 Jun 21. Review. No abstract available.

PMID: 31233776

 

Retrospective Evaluation of Cycled Resin in Viral Clearance Studies-A Multiple Company Collaboration.

Mattila J, Curtis S, Webb-Vargas Y, Wilson E, Galperina O, Roush D, Tobler S, Stanley B, Clark M, Weaver J, Pike J, Yu D, Li X, Flicker A, Kindermann J, Schuelke N, Whitcombe R, Bennett L.

PDA J Pharm Sci Technol. 2019 Sep-Oct;73(5):470-486. doi: 10.5731/pdajpst.2018.009605. Epub 2019 May 17.

PMID: 31101706

 

Comparative electrophysiology and pharmacology of hiPSC cardiomyocyte 2D mono-cultures and 2D co-cultures with human ventricular fibroblasts.

Shi H, Huang M, Kwagh J, Levesque P.

J Pharmacol Toxicol Methods. 2019 Sep - Oct;99:106595. doi: 10.1016/j.vascn.2019.05.037. Epub 2019 Oct 17. No abstract available.

PMID: 31963065

 

Evaluating the use of microelectrode array technology and cell-based neuronal culture models for proconvulsant risk assessment: progress from the HESI NeuTox consortium.

Millard DC, Nicolini AM, Arrowood CA, Hayes HB, Bradley JA, Strock CJ, Freudenrich TM, Wallace K, Shafer TJ, Cato MJ, Chaudhary KW, Saavedra L, Haag D, Feaster TK, Anson BD, Luerman G, Hess D, Shi Y, Li J, Shi H, Levesque P, Kreir M, Lu HR, Suzuki I, Odawara A, Miyamoto N, Ojima A, Kanda Y, Blinova K, Herr D, Roberts R, Pierson J.

J Pharmacol Toxicol Methods. 2019 Sep - Oct;99:106595. doi: 10.1016/j.vascn.2019.05.076. Epub 2019 Oct 17. No abstract available.

PMID: 31963054

 

Characterization of a renal hypertensive model in telemetrized cynomolgus monkeys.

Arthur SR, Love A, Bounous DI, Ehrmann J, Lehman B, Johnson W, Smith R, Adamo R, Gill M, Hennan J.

J Pharmacol Toxicol Methods. 2019 Sep - Oct;99:106595. doi: 10.1016/j.vascn.2019.05.044. Epub 2019 Oct 17. No abstract available.

PMID: 31963043

 

Characterization of contractile properties of hIPSC-CMs cultured with or without fibroblast and chronic electrical stimulation.

Huang M, Shi H, Levesque P.

J Pharmacol Toxicol Methods. 2019 Sep - Oct;99:106595. doi: 10.1016/j.vascn.2019.05.164. Epub 2019 Oct 17. No abstract available.

PMID: 31962937

GSK3732394: a Multi-specific Inhibitor of HIV Entry.

Wensel D, Sun Y, Davis J, Li Z, Zhang S, McDonagh T, Langley D, Mitchell T, Tabruyn S, Nef P, Cockett M, Krystal M.

J Virol. 2019 Sep 30;93(20). pii: e00907-19. doi: 10.1128/JVI.00907-19. Print 2019 Oct 15.

PMID: 31375580

 

Mechanistic modeling based process development for monoclonal antibody monomer-aggregate separations in multimodal cation exchange chromatography.

Zhang L, Parasnavis S, Li Z, Chen J, Cramer S.

J Chromatogr A. 2019 Sep 27;1602:317-325. doi: 10.1016/j.chroma.2019.05.056. Epub 2019 Jun 6.

PMID: 31248584

 

Discovery of Pyridazinone and Pyrazolo[1,5-a]pyridine Inhibitors of C-Terminal Src Kinase.

O'Malley DP, Ahuja V, Fink B, Cao C, Wang C, Swanson J, Wee S, Gavai AV, Tokarski J, Critton D, Paiva AA, Johnson BM, Szapiel N, Xie D.

ACS Med Chem Lett. 2019 Sep 25;10(10):1486-1491. doi: 10.1021/acsmedchemlett.9b00354. eCollection 2019 Oct 10.

PMID: 31620238

 

Metabolomic adaptations and correlates of survival to immune checkpoint blockade.

Li H, Bullock K, Gurjao C, Braun D, Shukla SA, Bossé D, Lalani AA, Gopal S, Jin C, Horak C, Wind-Rotolo M, Signoretti S, McDermott DF, Freeman GJ, Van Allen EM, Schreiber SL, Stephen Hodi F, Sellers WR, Garraway LA, Clish CB, Choueiri TK, Giannakis M.

Nat Commun. 2019 Sep 25;10(1):4346. doi: 10.1038/s41467-019-12361-9.

PMID: 31554815

 

Baseline Objective Inflammation by Magnetic Resonance Imaging as a Predictor of Therapeutic Benefit in Early, Poor Prognosis Rheumatoid Arthritis.

Ahmad HA, Baker JF, Østergaard M, Emery P, Durez P, Ye J, Banerjee S, Conaghan PG.

Arthritis Care Res (Hoboken). 2019 Sep 24. doi: 10.1002/acr.24072. [Epub ahead of print]

PMID: 31549793

 

Comparing record linkage software programs and algorithms using real-world data.

Karr AF, Taylor MT, West SL, Setoguchi S, Kou TD, Gerhard T, Horton DB.

PLoS One. 2019 Sep 24;14(9):e0221459. doi: 10.1371/journal.pone.0221459. eCollection 2019.

PMID: 31550255

 

Reduced Compensatory β-Cell Proliferation in Nfatc3-Deficient Mice Fed on High-Fat Diet.

Hu L, He F, Luo Y, Luo H, Hai L, Li Y, Zhou Z, Liu F, Dai YS.

Exp Clin Endocrinol Diabetes. 2019 Sep 23. doi: 10.1055/a-1008-9110. [Epub ahead of print]

PMID: 31546271

 

Viral Infections and Autoimmune Disease: Roles of LCMV in Delineating Mechanisms of Immune Tolerance.

Fousteri G, Dave Jhatakia A.

Viruses. 2019 Sep 21;11(10). pii: E885. doi: 10.3390/v11100885. Review.

PMID: 31546586

 

meta C-H Arylation of Electron-Rich Arenes: Reversing the Conventional Site Selectivity.

Liu LY, Qiao JX, Yeung KS, Ewing WR, Yu JQ.

J Am Chem Soc. 2019 Sep 18;141(37):14870-14877. doi: 10.1021/jacs.9b07887. Epub 2019 Sep 6.

PMID: 31449745

 

Rapid, direct, and sensitive determination of aziridine and 2-chloroethylamine by hydrophilic interaction liquid chromatography-mass spectrometry.

Shackman JG.

MethodsX. 2019 Sep 18;6:2176-2180. doi: 10.1016/j.mex.2019.09.017. eCollection 2019.

PMID: 31667117

 

Cost-effectiveness of apixaban compared to other anticoagulants in patients with atrial fibrillation in the real-world and trial settings.

de Jong LA, Groeneveld J, Stevanovic J, Rila H, Tieleman RG, Huisman MV, Postma MJ, van Hulst M.

PLoS One. 2019 Sep 17;14(9):e0222658. doi: 10.1371/journal.pone.0222658. eCollection 2019.

PMID: 31527894

 

Nivolumab treatment beyond RECIST-defined progression in recurrent or metastatic squamous cell carcinoma of the head and neck in CheckMate 141: A subgroup analysis of a randomized phase 3 clinical trial.

Haddad R, Concha-Benavente F, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Kasper S, Vokes EE, Worden F, Saba NF, Tahara M, Jayaprakash V, Lynch M, Li L, Gillison ML, Harrington KJ, Ferris RL.

Cancer. 2019 Sep 15;125(18):3208-3218. doi: 10.1002/cncr.32190. Epub 2019 Jun 27.

PMID: 31246283

 

To Go or Stay: The Development, Benefit, and Detriment of Tissue-Resident Memory CD8 T Cells during Central Nervous System Viral Infections.

Mockus TE, Ren HM; Shwetank, Lukacher AE.

Viruses. 2019 Sep 11;11(9). pii: E842. doi: 10.3390/v11090842. Review.

PMID: 31514273

 

A note on the empirical Bayes heterogeneity variance estimator in meta-analysis.

Sidik K, Jonkman JN.

Stat Med. 2019 Sep 10;38(20):3804-3816. doi: 10.1002/sim.8197. Epub 2019 Jun 18.

PMID: 31209917

 

Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.

Bines J, Procter M, Restuccia E, Viale G, Zardavas D, Suter T, Arahmani A, Van Dooren V, Baselga J, Clark E, Eng-Wong J, Gelber RD, Piccart M, Mobus V, de Azambuja E; APHINITY Steering Committee and Investigators.

Clin Breast Cancer. 2019 Sep 5. pii: S1526-8209(19)30656-1. doi: 10.1016/j.clbc.2019.06.016. [Epub ahead of print]

PMID: 31924513

 

Clinical Validation of PBRM1 Alterations as a Marker of Immune Checkpoint Inhibitor Response in Renal Cell Carcinoma.

Braun DA, Ishii Y, Walsh AM, Van Allen EM, Wu CJ, Shukla SA, Choueiri TK.

JAMA Oncol. 2019 Sep 5. doi: 10.1001/jamaoncol.2019.3158. [Epub ahead of print] No abstract available.

PMID: 31486842

 

Supplementing Claims Data with Electronic Medical Records to Improve Estimation and Classification of Rheumatoid Arthritis Disease Activity: A Machine Learning Approach.

Feldman CH, Yoshida K, Xu C, Frits ML, Shadick NA, Weinblatt ME, Connolly SE, Alemao E, Solomon DH.

ACR Open Rheumatol. 2019 Sep 4;1(9):552-559. doi: 10.1002/acr2.11068. eCollection 2019 Nov.

PMID: 31777839

 

Validity of social media for assessing treatment patterns in oncology patients: a case study in melanoma.

McDonald L, Behl V, Sundar V, Mehmud F, Malcolm B, Ramagopalan S.

JAMIA Open. 2019 Sep 3;2(4):416-422. doi: 10.1093/jamiaopen/ooz013. eCollection 2019 Dec.

PMID: 32025637

 

Renal Excretion of Dabigatran: The Potential Role of Multidrug and Toxin Extrusion (MATE) Proteins.

Shen H, Yao M, Sinz M, Marathe P, Rodrigues AD, Zhu M.

Mol Pharm. 2019 Sep 3;16(9):4065-4076. doi: 10.1021/acs.molpharmaceut.9b00472. Epub 2019 Aug 7.

PMID: 31335150

Emerging biomaterials for downstream manufacturing of therapeutic proteins.

Li Y, Stern D, Lock LL, Mills J, Ou SH, Morrow M, Xu X, Ghose S, Li ZJ, Cui H.

Acta Biomater. 2019 Sep 1;95:73-90. doi: 10.1016/j.actbio.2019.03.015. Epub 2019 Mar 9. Review.

PMID: 30862553

Nivolumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: Efficacy and Safety in CheckMate 141 by Prior Cetuximab Use.

Ferris RL, Licitra L, Fayette J, Even C, Blumenschein G Jr, Harrington KJ, Guigay J, Vokes EE, Saba NF, Haddad R, Ramkumar S, Russell J, Brossart P, Tahara M, Colevas AD, Concha-Benavente F, Lynch M, Li L, Gillison ML.

Clin Cancer Res. 2019 Sep 1;25(17):5221-5230. doi: 10.1158/1078-0432.CCR-18-3944. Epub 2019 Jun 25.

PMID: 31239321

 

Determining MRI Inflammation Targets When Considering a Rheumatoid Arthritis Treat-to-Target Strategy: Results of a Randomized, Placebo-Controlled Trial.

Ahmad HA, Baker JF, Østergaard M, Ye J, Emery P, Conaghan PG.

Adv Ther. 2019 Sep;36(9):2384-2393. doi: 10.1007/s12325-019-01020-6. Epub 2019 Jul 5.

PMID: 31278695

 

Timing of Abatacept Before Elective Arthroplasty and Risk of Postoperative Outcomes.

George MD, Baker JF, Winthrop K, Alemao E, Chen L, Connolly S, Hsu JY, Simon TA, Wu Q, Xie F, Yang S, Curtis JR.

Arthritis Care Res (Hoboken). 2019 Sep;71(9):1224-1233. doi: 10.1002/acr.23843. Epub 2019 Jul 11.

PMID: 30740938

 

Perspectives on exploring hybrid LBA/LC-MS approach for clinical immunogenicity testing.

Jiang H, Myler H, Zeng J, Mora J, Kolaitis G, Pillutla R.

Bioanalysis. 2019 Sep;11(17):1605-1617. doi: 10.4155/bio-2018-0107. Epub 2019 Jun 18. Review.

PMID: 31208198

 

Best practices in bioassay development to support registration of biopharmaceuticals.

White JR, Abodeely M, Ahmed S, Debauve G, Johnson E, Meyer DM, Mozier NM, Naumer M, Pepe A, Qahwash I, Rocnik E, Smith JG, Stokes ES, Talbot JJ, Wong PY.

Biotechniques. 2019 Sep;67(3):126-137. doi: 10.2144/btn-2019-0031. Epub 2019 Aug 5.

PMID: 31379198

 

Virus clearance validation across continuous capture chromatography.

Angelo J, Chollangi S, Müller-Späth T, Jusyte S, Xu X, Ghose S, Li Z.

Biotechnol Bioeng. 2019 Sep;116(9):2275-2284. doi: 10.1002/bit.27012. Epub 2019 May 27.

PMID: 31062872

 

Suitability of a generic virus safety evaluation for monoclonal antibody investigational new drug applications.

Sipple P, Nguyen T, Patel K, Jaffe N, Chen Y, Khetan A.

Biotechnol Prog. 2019 Sep;35(5):e2850. doi: 10.1002/btpr.2850. Epub 2019 Jun 9.

PMID: 31125511

 

Evaluation of covariate effects on pharmacokinetics of monoclonal antibodies in oncology.

Bajaj G, Suryawanshi S, Roy A, Gupta M.

Br J Clin Pharmacol. 2019 Sep;85(9):2045-2058. doi: 10.1111/bcp.13996. Epub 2019 Jul 17.

PMID: 31140642

 

Recommendations for the Design of Clinical Drug-Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically-Based Pharmacokinetic Model.

Chen Y, Cabalu TD, Callegari E, Einolf H, Liu L, Parrott N, Peters SA, Schuck E, Sharma P, Tracey H, Upreti VV, Zheng M, Zhu AZX, Hall SD.

CPT Pharmacometrics Syst Pharmacol. 2019 Sep;8(9):685-695. doi: 10.1002/psp4.12449. Epub 2019 Aug 7.

PMID: 31215774

 

Safety and efficacy of nivolumab in patients with rare melanoma subtypes who progressed on or after ipilimumab treatment: a single-arm, open-label, phase II study (CheckMate 172).

Nathan P, Ascierto PA, Haanen J, Espinosa E, Demidov L, Garbe C, Guida M, Lorigan P, Chiarion-Sileni V, Gogas H, Maio M, Fierro MT, Hoeller C, Terheyden P, Gutzmer R, Guren TK, Bafaloukos D, Rutkowski P, Plummer R, Waterston A, Kaatz M, Mandala M, Marquez-Rodas I, Muñoz-Couselo E, Dummer R, Grigoryeva E, Young TC, Schadendorf D.

Eur J Cancer. 2019 Sep;119:168-178. doi: 10.1016/j.ejca.2019.07.010. Epub 2019 Aug 21.

PMID: 31445199

 

Adjuvant ipilimumab versus placebo after complete resection of stage III melanoma: long-term follow-up results of the European Organisation for Research and Treatment of Cancer 18071 double-blind phase 3 randomised trial.

Eggermont AMM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbe C, Ferraresi V, Smylie M, Weber JS, Maio M, Hosein F, de Pril V, Kicinski M, Suciu S, Testori A.

Eur J Cancer. 2019 Sep;119:1-10. doi: 10.1016/j.ejca.2019.07.001. Epub 2019 Aug 7.

PMID: 31400634

 

In vivo models and decision trees for formulation development in early drug development: A review of current practices and recommendations for biopharmaceutical development.

Zane P, Gieschen H, Kersten E, Mathias N, Ollier C, Johansson P, Van den Bergh A, Van Hemelryck S, Reichel A, Rotgeri A, Schäfer K, Müllertz A, Langguth P.

Eur J Pharm Biopharm. 2019 Sep;142:222-231. doi: 10.1016/j.ejpb.2019.06.010. Epub 2019 Jun 21. Review.

PMID: 31233862

 

Nivolumab in patients with unresectable locally advanced or metastatic urothelial carcinoma: CheckMate 275 2-year global and Japanese patient population analyses.

Ohyama C, Kojima T, Kondo T, Naya Y, Inoue T, Tomita Y, Eto M, Hisasue S, Uemura H, Obara W, Kikuchi E, Sharma P, Galsky MD, Siefker-Radtke A, Grossfeld G, Collette S, Gooden K, Kimura G.

Int J Clin Oncol. 2019 Sep;24(9):1089-1098. doi: 10.1007/s10147-019-01450-w. Epub 2019 Jun 19.

PMID: 31218529

 

Commonly used definitions in real-world studies may underestimate the prevalence of renal disease among nonvalvular atrial fibrillation patients.

Schultze A, Graham S, Nordstrom BL, Mehmud F, Ramagopalan SV.

J Comp Eff Res. 2019 Sep;8(12):961-968. doi: 10.2217/cer-2019-0070. Epub 2019 Jul 18.

PMID: 31317772

 

Nivolumab in advanced hepatocellular carcinoma: Sorafenib-experienced Asian cohort analysis.

Yau T, Hsu C, Kim TY, Choo SP, Kang YK, Hou MM, Numata K, Yeo W, Chopra A, Ikeda M, Kuromatsu R, Moriguchi M, Chao Y, Zhao H, Anderson J, Cruz CD, Kudo M.

J Hepatol. 2019 Sep;71(3):543-552. doi: 10.1016/j.jhep.2019.05.014. Epub 2019 Jun 7. Erratum in: J Hepatol. 2019 Dec;71(6):1278.

PMID: 31176752

 

Deuterated active pharmaceutical ingredients: A science-based proposal for synthesis, analysis, and control. Part 1: Framing the problem.

Czeskis B, Elmore CS, Haight A, Hesk D, Maxwell BD, Miller SA, Raglione T, Schildknegt K, Traverse JF, Wang P.

J Labelled Comp Radiopharm. 2019 Sep;62(11):690-694. doi: 10.1002/jlcr.3743. Epub 2019 Jun 18.

PMID: 31034626

 

Reliable Gene Expression Profiling from Small and Hematoxylin and Eosin-Stained Clinical Formalin-Fixed, Paraffin-Embedded Specimens Using the HTG EdgeSeq Platform.

Qi Z, Wang L, Desai K, Cogswell J, Stern M, Lawson B, Kerkar SP, Vitazka P.

J Mol Diagn. 2019 Sep;21(5):796-807. doi: 10.1016/j.jmoldx.2019.04.011. Epub 2019 Jun 27.

PMID: 31255795

 

Safety, Efficacy, and Patient-Reported Health-Related Quality of Life and Symptom Burden with Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer, Including Patients Aged 70 Years or Older or with Poor Performance Status (CheckMate 153).

Spigel DR, McCleod M, Jotte RM, Einhorn L, Horn L, Waterhouse DM, Creelan B, Babu S, Leighl NB, Chandler JC, Couture F, Keogh G, Goss G, Daniel DB, Garon EB, Schwartzberg LS, Sen R, Korytowsky B, Li A, Aanur N, Hussein MA.

J Thorac Oncol. 2019 Sep;14(9):1628-1639. doi: 10.1016/j.jtho.2019.05.010. Epub 2019 May 20.

PMID: 31121324

 

Neoadjuvant letrozole plus taselisib versus letrozole plus placebo in postmenopausal women with oestrogen receptor-positive, HER2-negative, early-stage breast cancer (LORELEI): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.

Saura C, Hlauschek D, Oliveira M, Zardavas D, Jallitsch-Halper A, de la Peña L, Nuciforo P, Ballestrero A, Dubsky P, Lombard JM, Vuylsteke P, Castaneda CA, Colleoni M, Santos Borges G, Ciruelos E, Fornier M, Boer K, Bardia A, Wilson TR, Stout TJ, Hsu JY, Shi Y, Piccart M, Gnant M, Baselga J, de Azambuja E.

Lancet Oncol. 2019 Sep;20(9):1226-1238. doi: 10.1016/S1470-2045(19)30334-1. Epub 2019 Aug 8.

PMID: 31402321

 

Efficacy and safety of first-line carboplatin-versus cisplatin-based chemotherapy for non-small cell lung cancer: A meta-analysis.

Griesinger F, Korol EE, Kayaniyil S, Varol N, Ebner T, Goring SM.

Lung Cancer. 2019 Sep;135:196-204. doi: 10.1016/j.lungcan.2019.07.010. Epub 2019 Jul 13.

PMID: 31446995

 

Safety and effectiveness of abatacept in Japanese non-elderly and elderly patients with rheumatoid arthritis in an all-cases post-marketing surveillance.

Harigai M, Ishiguro N, Inokuma S, Mimori T, Ryu J, Takei S, Takeuchi T, Tanaka Y, Takasaki Y, Yamanaka H, Yoshizawa Y, Chinen I, Nakao T, Koike T.

Mod Rheumatol. 2019 Sep;29(5):747-755. doi: 10.1080/14397595.2018.1524998. Epub 2018 Oct 25.

PMID: 30217117

 

Hindered dialkyl ether synthesis with electrogenerated carbocations.

Xiang J, Shang M, Kawamata Y, Lundberg H, Reisberg SH, Chen M, Mykhailiuk P, Beutner G, Collins MR, Davies A, Del Bel M, Gallego GM, Spangler JE, Starr J, Yang S, Blackmond DG, Baran PS.

Nature. 2019 Sep;573(7774):398-402. doi: 10.1038/s41586-019-1539-y. Epub 2019 Sep 9.

PMID: 31501569

 

Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age.

Saba NF, Blumenschein G Jr, Guigay J, Licitra L, Fayette J, Harrington KJ, Kiyota N, Gillison ML, Ferris RL, Jayaprakash V, Li L, Brossart P.

Oral Oncol. 2019 Sep;96:7-14. doi: 10.1016/j.oraloncology.2019.06.017. Epub 2019 Jul 3.

PMID: 31422216

 

Economic Evaluation of Nivolumab Plus Ipilimumab Combination as First-Line Treatment for Patients with Advanced Melanoma in Canada.

Quon PL, Xiao Y, Sorensen S, Monfared AAT.

Pharmacoecon Open. 2019 Sep;3(3):321-331. doi: 10.1007/s41669-018-0112-1.

PMID: 30617952

 

Cost per response for abatacept versus adalimumab in patients with seropositive, erosive early rheumatoid arthritis in the US, Germany, Spain, and Canada.

Foo J, Morel C, Bergman M, Baerwald C, Rodriguez-Heredia JM, Marshall A, Polanco-Sánchez C, Postema R.

Rheumatol Int. 2019 Sep;39(9):1621-1630. doi: 10.1007/s00296-019-04352-2. Epub 2019 Jun 25.

PMID: 31240388

 

Overview and considerations for the reporting of clinical pathology interpretations in nonclinical toxicology studies.

Aulbach A, Vitsky A, Arndt T, Ramaiah L, Logan M, Siska W, Cregar L, Tripathi N, Adedeji A, Provencher A, Gupta A, Jordan H, Bounous D, Boone L.

Vet Clin Pathol. 2019 Sep;48(3):389-399. doi: 10.1111/vcp.12772. Review.

PMID: 31556157

 

Interpretative considerations for clinical pathology findings in nonclinical toxicology studies.

Aulbach A, Vitsky A, Arndt T, Ramaiah L, Logan M, Siska W, Cregar L, Tripathi N, Adedeji A, Provencher A, Gupta A, Jordan H, Bounous D, Boone L.

Vet Clin Pathol. 2019 Sep;48(3):383-388. doi: 10.1111/vcp.12773. Epub 2019 Sep 24. Review.

PMID: 31549731

 

Real-world clinical outcomes among individuals with chronic HCV infection in China: CCgenos study.

Rao H, Xie Q, Shang J, Gao Z, Chen H, Sun Y, Jiang J, Niu J, Zhang L, Wang L, Zhao L, Li J, Yang R, Zhu S, Li R, Wei L.

Antivir Ther. 2019 Sept;24(7):473-483. doi: 10.3851/IMP3334.

PMID: 31566575

 

Treatment sequences for advanced renal cell carcinoma: A health economic assessment.

Deniz B, Ambavane A, Yang S, Altincatal A, Doan J, Rao S, Michaelson MD.

PLoS One. 2019 Aug 29;14(8):e0215761. doi: 10.1371/journal.pone.0215761. eCollection 2019.

PMID: 31465470

 

Blood-brain barrier permeable nano immunoconjugates induce local immune responses for glioma therapy.

Galstyan A, Markman JL, Shatalova ES, Chiechi A, Korman AJ, Patil R, Klymyshyn D, Tourtellotte WG, Israel LL, Braubach O, Ljubimov VA, Mashouf LA, Ramesh A, Grodzinski ZB, Penichet ML, Black KL, Holler E, Sun T, Ding H, Ljubimov AV, Ljubimova JY.

Nat Commun. 2019 Aug 28;10(1):3850. doi: 10.1038/s41467-019-11719-3. Erratum in: Nat Commun. 2020 Jan 30;11(1):701.

PMID: 31462642

 

Discovery of Potent Protease-Activated Receptor 4 Antagonists with in Vivo Antithrombotic Efficacy.

Miller MM, Banville J, Friends TJ, Gagnon M, Hangeland JJ, Lavallée JF, Martel A, O'Grady H, Rémillard R, Ruediger E, Tremblay F, Posy SL, Allegretto NJ, Guarino VR, Harden DG, Harper TW, Hartl K, Josephs J, Malmstrom S, Watson C, Yang Y, Zhang G, Wong P, Yang J, Bouvier M, Seiffert DA, Wexler RR, Lawrence RM, Priestley ES, Marinier A.

J Med Chem. 2019 Aug 22;62(16):7400-7416. doi: 10.1021/acs.jmedchem.9b00186. Epub 2019 Aug 5.

PMID: 31246024

 

Mitogenic and progenitor gene programmes in single pilocytic astrocytoma cells.

Reitman ZJ, Paolella BR, Bergthold G, Pelton K, Becker S, Jones R, Sinai CE, Malkin H, Huang Y, Grimmet L, Herbert ZT, Sun Y, Weatherbee JL, Alberta JA, Daley JF, Rozenblatt-Rosen O, Condurat AL, Qian K, Khadka P, Segal RA, Haas-Kogan D, Filbin MG, Suva ML, Regev A, Stiles CD, Kieran MW, Goumnerova L, Ligon KL, Shalek AK, Bandopadhayay P, Beroukhim R.

Nat Commun. 2019 Aug 19;10(1):3731. doi: 10.1038/s41467-019-11493-2.

PMID: 31427603

 

Identification of potent, selective and orally bioavailable phenyl ((R)-3-phenylpyrrolidin-3-yl)sulfone analogues as RORγt inverse agonists.

Lu Z, Duan JJ, Xiao H, Neels J, Wu DR, Weigelt CA, Sack JS, Khan J, Ruzanov M, An Y, Yarde M, Karmakar A, Vishwakrishnan S, Baratam V, Shankarappa H, Vanteru S, Babu V, Basha M, Kumar Gupta A, Kumaravel S, Mathur A, Zhao Q, Salter-Cid LM, Carter PH, Murali Dhar TG.

Bioorg Med Chem Lett. 2019 Aug 15;29(16):2265-2269. doi: 10.1016/j.bmcl.2019.06.036. Epub 2019 Jun 20.

PMID: 31257087

 

Association Between Bilirubin, Atazanavir, and Cardiovascular Disease Events Among People Living With HIV Across the United States.

Crane HM, Nance RM, Heckbert SR, Ritchings C, Rosenblatt L, Budoff M, Wood BR, Tirschwell DL, Kim HN, Mathews WC, Geng E, Moore RD, Hunt PW, Eron JJ, Burkholder GA, Drozd DR, Chow FC, Becker KJ, Zunt JR, Ho EL, Kalani R, Huffer A, Whitney BM, Saag MS, Kitahata MM, Delaney JAC.

J Acquir Immune Defic Syndr. 2019 Aug 15;81(5):e141-e147. doi: 10.1097/QAI.0000000000002071.

PMID: 31135582

 

RNA sequencing of transplant-stage idiopathic pulmonary fibrosis lung reveals unique pathway regulation.

Sivakumar P, Thompson JR, Ammar R, Porteous M, McCoubrey C, Cantu E 3rd, Ravi K, Zhang Y, Luo Y, Streltsov D, Beers MF, Jarai G, Christie JD.

ERJ Open Res. 2019 Aug 12;5(3). pii: 00117-2019. doi: 10.1183/23120541.00117-2019. eCollection 2019 Jul.

PMID: 31423451

 

Nivolumab for Newly Diagnosed Advanced-Stage Classic Hodgkin Lymphoma: Safety and Efficacy in the Phase II CheckMate 205 Study.

Ramchandren R, Domingo-Domènech E, Rueda A, Trněný M, Feldman TA, Lee HJ, Provencio M, Sillaber C, Cohen JB, Savage KJ, Willenbacher W, Ligon AH, Ouyang J, Redd R, Rodig SJ, Shipp MA, Sacchi M, Sumbul A, Armand P, Ansell SM.

J Clin Oncol. 2019 Aug 10;37(23):1997-2007. doi: 10.1200/JCO.19.00315. Epub 2019 May 21.

PMID: 31112476

 

Evolution of the burden of active hepatitis C virus infection in England from September 2015 to September 2016: a repeated cross-sectional analysis.

Lacoin L, Hurst M, Hill NR, Gordon J, Geretti AM, Aspinall R, Corless L, Gao-Du Y, Mistry L, Mutimer D.

BMJ Open. 2019 Aug 5;9(8):e029066. doi: 10.1136/bmjopen-2019-029066.

PMID: 31383704

 

Oxidative degradation pathways of beclabuvir hydrochloride mediated by hydrogen peroxide and UV/Vis light.

Ye Q, Huang Y, Grier S, Miller SA.

J Pharm Biomed Anal. 2019 Aug 5;172:388-394. doi: 10.1016/j.jpba.2019.05.017. Epub 2019 May 8.

PMID: 31100536

 

Development of simple isocratic HPLC methods for siRNA quantitation in lipid-based nanoparticles.

Huang Z, Fish WP.

J Pharm Biomed Anal. 2019 Aug 5;172:253-258. doi: 10.1016/j.jpba.2019.04.026. Epub 2019 Apr 27.

PMID: 31071650

 

Streamlining the polishing step development process via physicochemical characterization of monoclonal antibody aggregates.

Doss HR, Raman M, Knihtila R, Chennamsetty N, Wang D, Shupe A, Mussa N.

J Chromatogr A. 2019 Aug 2;1598:101-112. doi: 10.1016/j.chroma.2019.03.044. Epub 2019 Mar 22.

PMID: 30954243

 

Identification of substituted benzothiazole sulfones as potent and selective inhibitors of endothelial lipase.

Kim SH, Johnson JA, Jiang J, Parkhurst B, Phillips M, Pi Z, Qiao JX, Tora G, Ye Chen A, Liu E, Yin X, Yang R, Zhao L, Taylor DS, Basso M, Behnia K, Onorato J, Chen XQ, Abell LM, Lu H, Locke G, Caporuscio C, Adam LP, Gordon D, Wexler RR, Finlay HJ.

Bioorg Med Chem Lett. 2019 Aug 1;29(15):1918-1921. doi: 10.1016/j.bmcl.2019.05.048. Epub 2019 May 25. Erratum in: Bioorg Med Chem Lett. 2019 Sep 1;29(17):2525.

PMID: 31176700

 

Therapeutic protein purity and fragmented species characterization by capillary electrophoresis sodium dodecyl sulfate using systematic hybrid cleavage and forced degradation.

Duhamel L, Gu Y, Barnett G, Tao Y, Voronov S, Ding J, Mussa N, Li ZJ.

Anal Bioanal Chem. 2019 Aug;411(21):5617-5629. doi: 10.1007/s00216-019-01942-8. Epub 2019 Jun 18.

PMID: 31214752

 

Methadone and buprenorphine pharmacokinetics and pharmacodynamics when coadministered with fostemsavir to opioid-dependent, human immunodeficiency virus seronegative participants.

Moore K, Magee M, Sevinsky H, Chang M, Lubin S, Myers E, Ackerman P, Llamoso C.

Br J Clin Pharmacol. 2019 Aug;85(8):1771-1780. doi: 10.1111/bcp.13964. Epub 2019 Jun 5.

PMID: 30980734

 

The effects of lapatinib on cardiac repolarization: results from a placebo controlled, single sequence, crossover study in patients with advanced solid tumors.

Coker SA, Hurwitz HI, Sharma S, Wang D, Jordaan P, Zarate JP, Lewis LD.

Cancer Chemother Pharmacol. 2019 Aug;84(2):383-392. doi: 10.1007/s00280-019-03880-9. Epub 2019 Jun 11.

PMID: 31187169

 

Cross-Species Single-Cell Analysis of Pancreatic Ductal Adenocarcinoma Reveals Antigen-Presenting Cancer-Associated Fibroblasts.

Elyada E, Bolisetty M, Laise P, Flynn WF, Courtois ET, Burkhart RA, Teinor JA, Belleau P, Biffi G, Lucito MS, Sivajothi S, Armstrong TD, Engle DD, Yu KH, Hao Y, Wolfgang CL, Park Y, Preall J, Jaffee EM, Califano A, Robson P, Tuveson DA.

Cancer Discov. 2019 Aug;9(8):1102-1123. doi: 10.1158/2159-8290.CD-19-0094. Epub 2019 Jun 13.

PMID: 31197017

 

Population Pharmacokinetic Analysis of Daclatasvir, Asunaprevir, and Beclabuvir Combination in HCV-Infected Subjects.

Osawa M, Ueno T, Shiozaki T, Ishikawa H, Li H, Garimella T.

Clin Pharmacol Drug Dev. 2019 Aug;8(6):802-817. doi: 10.1002/cpdd.649. Epub 2019 Jan 10.

PMID: 30629858

 

Pancreatitis Incidence in the Exenatide BID, Exenatide QW, and Exenatide QW Suspension Development Programs: Pooled Analysis of 35 Clinical Trials.

Vetter ML, Johnsson K, Hardy E, Wang H, Iqbal N.

Diabetes Ther. 2019 Aug;10(4):1249-1270. doi: 10.1007/s13300-019-0627-1. Epub 2019 May 10.

PMID: 31077072

 

Rationale and design for the development of a novel nitroxyl donor in patients with acute heart failure.

Felker GM, Borentain M, Cleland JG, DeSouza MM, Kessler PD, O'Connor CM, Seiffert D, Teerlink JR, Voors AA, McMurray JJV.

Eur J Heart Fail. 2019 Aug;21(8):1022-1031. doi: 10.1002/ejhf.1504. Epub 2019 Jun 6.

PMID: 31168885

 

Health and functional status, health events, use of healthcare services and costs associated with overactive bladder among the medically complex vulnerable elderly in the US.

Chuang CC, Yang E, Zou KH, Araiza A, Wang A, Luo X.

Int J Clin Pract. 2019 Aug;73(8):e13207. doi: 10.1111/ijcp.13207. Epub 2018 Jul 16.

PMID: 30011108

 

Comparisons between Oral Anticoagulants among Older Nonvalvular Atrial Fibrillation Patients.

Deitelzweig S, Keshishian A, Li X, Kang A, Dhamane AD, Luo X, Balachander N, Rosenblatt L, Mardekian J, Pan X, Nadkarni A, Di Fusco M, Garcia Reeves AB, Yuce H, Lip GYH.

J Am Geriatr Soc. 2019 Aug;67(8):1662-1671. doi: 10.1111/jgs.15956. Epub 2019 May 21.

PMID: 31112292

 

Comparative clinical outcomes between direct oral anticoagulants and warfarin among elderly patients with non-valvular atrial fibrillation in the CMS medicare population.

Amin A, Keshishian A, Dina O, Dhamane A, Nadkarni A, Carda E, Russ C, Rosenblatt L, Mardekian J, Yuce H, Baker CL.

J Thromb Thrombolysis. 2019 Aug;48(2):240-249. doi: 10.1007/s11239-019-01838-5.

PMID: 30924051

 

Cellular proliferation by multiplex immunohistochemistry identifies aggressive disease behavior in relapsed multiple myeloma.

Forsberg PA, Hammes A, Abbott D, Sherbenou DW, Rossi A, Jayabalan D, Niesvizky R, Mark TM, Ely S.

Leuk Lymphoma. 2019 Aug;60(8):2085-2087. doi: 10.1080/10428194.2018.1551537. Epub 2019 Jan 11. No abstract available.

PMID: 30632821

 

A nondestructive and noninvasive method to determine water content in lyophilized proteins using low-field time-domain NMR.

Abraham A, Elkassabany O, Krause ME, Ott A.

Magn Reson Chem. 2019 Aug;57(10):873-877. doi: 10.1002/mrc.4864. Epub 2019 Apr 29.

PMID: 30861192

 

Bioinformatic Methods and Bridging of Assay Results for Reliable Tumor Mutational Burden Assessment in Non-Small-Cell Lung Cancer.

Chang H, Sasson A, Srinivasan S, Golhar R, Greenawalt DM, Geese WJ, Green G, Zerba K, Kirov S, Szustakowski J.

Mol Diagn Ther. 2019 Aug;23(4):507-520. doi: 10.1007/s40291-019-00408-y.

PMID: 31250328

 

The trials and tribulations of CAR-T cell development for cancer and AIDS.

Hege K.

Nat Med. 2019 Aug;25(8):1183. doi: 10.1038/s41591-019-0538-8. No abstract available.

PMID: 31388173

 

A Q-TWiST Analysis Comparing Nivolumab and Therapy of Investigator's Choice in Patients with Recurrent/Metastatic Platinum-Refractory Squamous Cell Carcinoma of the Head and Neck.

Cocks K, Contente M, Simpson S, DeRosa M, Taylor FC, Shaw JW.

Pharmacoeconomics. 2019 Aug;37(8):1041-1047. doi: 10.1007/s40273-019-00798-1.

PMID: 30972702

 

Addition of Optimized Bovine Serum Albumin Level in a High-Throughput Caco-2 Assay Enabled Accurate Permeability Assessment for Lipophilic Compounds.

Cai X, Madari S, Walker A, Paiva A, Li Y, Herbst J, Shou W, Weller H.

SLAS Discov. 2019 Aug;24(7):738-744. doi: 10.1177/2472555219848483. Epub 2019 May 10.

PMID: 31076010

 

United States Valuation of EQ-5D-5L Health States Using an International Protocol.

Pickard AS, Law EH, Jiang R, Pullenayegum E, Shaw JW, Xie F, Oppe M, Boye KS, Chapman RH, Gong CL, Balch A, Busschbach JJV.

Value Health. 2019 Aug;22(8):931-941. doi: 10.1016/j.jval.2019.02.009. Epub 2019 May 25.

PMID: 31426935

 

Five-Year Survival and Correlates Among Patients With Advanced Melanoma, Renal Cell Carcinoma, or Non-Small Cell Lung Cancer Treated With Nivolumab.

Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Drilon A, Wolchok JD, Carvajal RD, McHenry MB, Hosein F, Harbison CT, Grosso JF, Sznol M.

JAMA Oncol. 2019 Jul 25. doi: 10.1001/jamaoncol.2019.2187. [Epub ahead of print]

PMID: 31343665

 

Evaluating a Multiscale Mechanistic Model of the Immune System to Predict Human Immunogenicity for a Biotherapeutic in Phase 1.

Hamuro L, Tirucherai GS, Crawford SM, Nayeem A, Pillutla RC, DeSilva BS, Leil TA, Thalhauser CJ.

AAPS J. 2019 Jul 24;21(5):94. doi: 10.1208/s12248-019-0361-7.

PMID: 31342199

 

Autoimmune pathways in mice and humans are blocked by pharmacological stabilization of the TYK2 pseudokinase domain.

Burke JR, Cheng L, Gillooly KM, Strnad J, Zupa-Fernandez A, Catlett IM, Zhang Y, Heimrich EM, McIntyre KW, Cunningham MD, Carman JA, Zhou X, Banas D, Chaudhry C, Li S, D'Arienzo C, Chimalakonda A, Yang X, Xie JH, Pang J, Zhao Q, Rose SM, Huang J, Moslin RM, Wrobleski ST, Weinstein DS, Salter-Cid LM.

Sci Transl Med. 2019 Jul 24;11(502). pii: eaaw1736. doi: 10.1126/scitranslmed.aaw1736.

PMID: 31341059

 

A Fit-for-Purpose Method for the Detection of Human Antibodies to Surface-Exposed Components of BMS-986263, a Lipid Nanoparticle-Based Drug Product Containing a siRNA Drug Substance.

Kavita U, Miller W, Ji QC, Pillutla RC.

AAPS J. 2019 Jul 22;21(5):92. doi: 10.1208/s12248-019-0360-8.

PMID: 31332587

 

Implementation of a mathematical model for the photochemical kinetics of a solid form active pharmaceutical ingredient.

La Cruz TE, Carvalho TC, Ramírez A, Tábora JE.

Int J Pharm. 2019 Jul 20;566:500-512. doi: 10.1016/j.ijpharm.2019.05.054. Epub 2019 May 23.

PMID: 31129341

 

In Praise of Remarkably Powerful Centamolecular Therapeutic Agents.

Meanwell NA, Ewing WR.

ACS Med Chem Lett. 2019 Jul 18;10(8):1094-1097. doi: 10.1021/acsmedchemlett.9b00286. eCollection 2019 Aug 8.

PMID: 31413789

 

Real-world effectiveness and tolerability of small-cell lung cancer (SCLC) treatments: A systematic literature review (SLR).

Povsic M, Enstone A, Wyn R, Kornalska K, Penrod JR, Yuan Y.

PLoS One. 2019 Jul 18;14(7):e0219622. doi: 10.1371/journal.pone.0219622. eCollection 2019.

PMID: 31318909

 

Lysosomal P-gp-MDR1 Confers Drug Resistance of Brentuximab Vedotin and Its Cytotoxic Payload Monomethyl Auristatin E in Tumor Cells.

Liu-Kreyche P, Shen H, Marino AM, Iyer RA, Humphreys WG, Lai Y.

Front Pharmacol. 2019 Jul 17;10:749. doi: 10.3389/fphar.2019.00749. eCollection 2019.

PMID: 31379564

 

Pharmacokinetics of 40 kDa PEG in rodents using high-field NMR spectroscopy.

Khandelwal P, Zhang L, Chimalakonda A, Caceres-Cortes J, Huang C, Marathe P, Reily MD.

J Pharm Biomed Anal. 2019 Jul 15;171:30-34. doi: 10.1016/j.jpba.2019.03.066. Epub 2019 Apr 1.

PMID: 30959317

 

Predicting High-Concentration Interactions of Monoclonal Antibody Solutions: Comparison of Theoretical Approaches for Strongly Attractive Versus Repulsive Conditions.

Calero-Rubio C, Saluja A, Sahin E, Roberts CJ.

J Phys Chem B. 2019 Jul 11;123(27):5709-5720. doi: 10.1021/acs.jpcb.9b03779. Epub 2019 Jun 26.

PMID: 31241333

 

The development of resilience among rheumatoid arthritis patients: a qualitative study.

Shaw Y, Bradley M, Zhang C, Dominique A, Michaud K, McDonald D, Simon TA.

Arthritis Care Res (Hoboken). 2019 Jul 8. doi: 10.1002/acr.24024. [Epub ahead of print]

PMID: 31282121

Phase II trial of AKT inhibitor MK-2206 in patients with advanced breast cancer who have tumors with PIK3CA or AKT mutations, and/or PTEN loss/PTEN mutation.

Xing Y, Lin NU, Maurer MA, Chen H, Mahvash A, Sahin A, Akcakanat A, Li Y, Abramson V, Litton J, Chavez-MacGregor M, Valero V, Piha-Paul SA, Hong D, Do KA, Tarco E, Riall D, Eterovic AK, Wulf GM, Cantley LC, Mills GB, Doyle LA, Winer E, Hortobagyi GN, Gonzalez-Angulo AM, Meric-Bernstam F.

Breast Cancer Res. 2019 Jul 5;21(1):78. doi: 10.1186/s13058-019-1154-8.

PMID: 31277699

 

Identification and biochemical analyses of selective CB₂ agonists.

Scott CE, Tang Y, Alt A, Burford NT, Gerritz SW, Ogawa LM, Zhang L, Kendall DA.

Eur J Pharmacol. 2019 Jul 5;854:1-8. doi: 10.1016/j.ejphar.2019.03.054. Epub 2019 Apr 3.

PMID: 30951717

 

Decarboxylative Intramolecular Arene Alkylation Using N-(Acyloxy)phthalimides, an Organic Photocatalyst, and Visible Light.

Sherwood TC, Xiao HY, Bhaskar RG, Simmons EM, Zaretsky S, Rauch MP, Knowles RR, Dhar TGM.

J Org Chem. 2019 Jul 5;84(13):8360-8379. doi: 10.1021/acs.joc.9b00432. Epub 2019 Mar 27.

PMID: 30905152

 

Differential left ventricular and left atrial remodelling in heart failure with preserved ejection fraction patients with and without diabetes.

Gulsin GS, Kanagala P, Chan DCS, Cheng ASH, Athithan L, Graham-Brown MPM, Singh A, Yang J, Li Z, Khunti K, Davies MJ, Arnold JR, Squire IB, Ng LL, McCann GP.

Ther Adv Endocrinol Metab. 2019 Jul 5;10:2042018819861593. doi: 10.1177/2042018819861593. eCollection 2019.

PMID: 31308926

 

Correction to: Toward a comprehensive view of cancer immune responsiveness: a synopsis from the SITC workshop.

Bedognetti D, Ceccarelli M, Galluzzi L, Lu R, Palucka K, Samayoa J, Spranger S, Warren S, Wong KK, Ziv E, Chowell D, Coussens LM, De Carvalho DD, DeNardo DG, Galon J, Kaufman HL, Kirchhoff T, Lotze MT, Luke JJ, Minn AJ, Politi K, Shultz LD, Simon R, Thórsson V, Weidhaas JB, Ascierto ML, Ascierto PA, Barnes JM, Barsan V, Bommareddy PK, Bot A, Church SE, Ciliberto G, De Maria A, Draganov D, Ho WS, McGee HM, Monette A, Murphy JF, Nisticò P, Park W, Patel M, Quigley M, Radvanyi L, Raftopoulos H, Rudqvist NP, Snyder A, Sweis RF, Valpione S, Zappasodi R, Butterfield LH, Disis ML, Fox BA, Cesano A, Marincola FM; Society for Immunotherapy of Cancer (SITC) Cancer Immune Responsiveness Task Force and Working Groups.

J Immunother Cancer. 2019 Jul 4;7(1):167. doi: 10.1186/s40425-019-0640-y.

PMID: 31272507

 

Healthcare cost comparison analysis of nivolumab in combination with ipilimumab versus nivolumab monotherapy and ipilimumab monotherapy in advanced melanoma.

Potluri R, Ranjan S, Bhandari H, Johnson H, Moshyk A, Kotapati S.

Exp Hematol Oncol. 2019 Jul 3;8:14. doi: 10.1186/s40164-019-0138-9. eCollection 2019.

PMID: 31312536

Near-Complete Genome Sequence of a Hepatitis A Subgenotype IB Virus Isolated from Frozen Raspberries.

Chen H, Wang W, Wang S, Hu Y.

Microbiol Resour Announc. 2019 Jul 3;8(27). pii: e00522-19. doi: 10.1128/MRA.00522-19.

PMID: 31270195

 

Eliminating Preparation of Multisample External Calibration Curves and Dilution of Study Samples Using the Multiple Isotopologue Reaction Monitoring (MIRM) Technique in Quantitative LC-MS/MS Bioanalysis.

Gu H, Zhao Y, DeMichele M, Zheng N, Zhang YJ, Pillutla R, Zeng J.

Anal Chem. 2019 Jul 2;91(13):8652-8659. doi: 10.1021/acs.analchem.9b02136. Epub 2019 Jun 21.

PMID: 31180205

Nivolumab Alone and With Ipilimumab in Previously Treated Metastatic Urothelial Carcinoma: CheckMate 032 Nivolumab 1 mg/kg Plus Ipilimumab 3 mg/kg Expansion Cohort Results.

Sharma P, Siefker-Radtke A, de Braud F, Basso U, Calvo E, Bono P, Morse MA, Ascierto PA, Lopez-Martin J, Brossart P, Rohrberg K, Mellado B, Fischer BS, Meadows-Shropshire S, Abdel Saci, Callahan MK, Rosenberg J.

J Clin Oncol. 2019 Jul 1;37(19):1608-1616. doi: 10.1200/JCO.19.00538. Epub 2019 May 17. Erratum in: J Clin Oncol. 2019 Aug 10;37(23):2094.

PMID: 31100038

Microbiota Metabolite Short-Chain Fatty Acids Facilitate Mucosal Adjuvant Activity of Cholera Toxin through GPR43.

Yang W, Xiao Y, Huang X, Chen F, Sun M, Bilotta AJ, Xu L, Lu Y, Yao S, Zhao Q, Liu Z, Cong Y.

J Immunol. 2019 Jul 1;203(1):282-292. doi: 10.4049/jimmunol.1801068. Epub 2019 May 10.

PMID: 31076530

 

Impact of depth filtration on disulfide bond reduction during downstream processing of monoclonal antibodies from CHO cell cultures.

O'Mara B, Gao ZH, Kuruganti M, Mallett R, Nayar G, Smith L, Meyer JD, Therriault J, Miller C, Cisney J, Fann J.

Biotechnol Bioeng. 2019 Jul;116(7):1669-1683. doi: 10.1002/bit.26964. Epub 2019 Apr 4.

PMID: 30883673

 

Mass Balance Model with Donnan Equilibrium Accurately Describes Unusual pH and Excipient Profiles during Diafiltration of Monoclonal Antibodies.

Baek Y, Singh N, Arunkumar A, Borwankar A, Zydney AL.

Biotechnol J. 2019 Jul;14(7):e1800517. doi: 10.1002/biot.201800517. Epub 2019 May 20.

PMID: 30791230

 

Real-World Clinical Impact of Immune Checkpoint Inhibitors in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer After Platinum Chemotherapy.

Schwartzberg L, Korytowsky B, Penrod JR, Zhang Y, Le TK, Batenchuk C, Krug L.

Clin Lung Cancer. 2019 Jul;20(4):287-296.e4. doi: 10.1016/j.cllc.2019.04.004. Epub 2019 Apr 19.

PMID: 31130450

 

Low-Dose Lenalidomide After Nonmyeloablative Allogeneic Hematopoietic Cell Transplantation With Bortezomib as Graft-Versus-Host Disease Prophylaxis in High-Risk Multiple Myeloma.

Khouri J, Reu F, Majhail NS, Gerds A, Jagadeesh D, Dean R, Sobecks R, Hamilton BK, Pohlman B, Hill BT, Corrigan D, Kalaycio M, Bolwell BJ, Liu HD.

Clin Lymphoma Myeloma Leuk. 2019 Jul;19(7):e374-e376. doi: 10.1016/j.clml.2019.03.019. Epub 2019 Apr 8. No abstract available.

PMID: 31053548

 

Interindividual and Regional Variability in Drug Transporter Abundance at the Human Blood-Brain Barrier Measured by Quantitative Targeted Proteomics.

Billington S, Salphati L, Hop CECA, Chu X, Evers R, Burdette D, Rowbottom C, Lai Y, Xiao G, Humphreys WG, Nguyen TB, Prasad B, Unadkat JD.

Clin Pharmacol Ther. 2019 Jul;106(1):228-237. doi: 10.1002/cpt.1373. Epub 2019 Mar 18.

PMID: 30673124

 

Organic Anion Transporter Polypeptide 1B1 Polymorphism Modulates the Extent of Drug-Drug Interaction and Associated Biomarker Levels in Healthy Volunteers.

Yee SW, Giacomini MM, Shen H, Humphreys WG, Horng H, Brian W, Lai Y, Kroetz DL, Giacomini KM.

Clin Transl Sci. 2019 Jul;12(4):388-399. doi: 10.1111/cts.12625. Epub 2019 Apr 13.

PMID: 30982223

 

Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial.

Reck M, Schenker M, Lee KH, Provencio M, Nishio M, Lesniewski-Kmak K, Sangha R, Ahmed S, Raimbourg J, Feeney K, Corre R, Franke FA, Richardet E, Penrod JR, Yuan Y, Nathan FE, Bhagavatheeswaran P, DeRosa M, Taylor F, Lawrance R, Brahmer J.

Eur J Cancer. 2019 Jul;116:137-147. doi: 10.1016/j.ejca.2019.05.008. Epub 2019 Jun 11.

PMID: 31195357

 

Real-world treatment patterns, resource use and cost burden of multiple myeloma in Portugal.

Antunes L, Rocha-Gonçalves F, Chacim S, Lefèvre C, Pereira M, Pereira S, Zagorska A, Bento MJ.

Eur J Cancer Care (Engl). 2019 Jul;28(4):e13026. doi: 10.1111/ecc.13026. Epub 2019 Mar 3.

PMID: 30828907

 

Biorelevant dissolution testing of a weak base: Interlaboratory reproducibility and investigation of parameters controlling in vitro precipitation.

Berben P, Ashworth L, Beato S, Bevernage J, Bruel JL, Butler J, Dressman J, Schäfer K, Hutchins P, Klumpp L, Mann J, Nicolai J, Ojala K, Patel S, Powell S, Rosenblatt K, Tomaszewska I, Williams J, Augustijns P.

Eur J Pharm Biopharm. 2019 Jul;140:141-148. doi: 10.1016/j.ejpb.2019.04.017. Epub 2019 Apr 30.

PMID: 31051249

 

Impact of atrial fibrillation awareness campaigns: interrupted time series using the Clinical Practice Research Datalink.

Allan V, Sammon CJ, McDonald L, Mehmud F, Alikhan R, Ramagopalan SV.

Future Cardiol. 2019 Jul;15(4):311-318. doi: 10.2217/fca-2019-0025. Epub 2019 Jun 26.

PMID: 31241353

 

Renal function and oral anticoagulant treatment of incident non-valvular atrial fibrillation: a retrospective study.

Ramagopalan SV, Stamp E, Sammon CJ, Besford M, Carroll R, Mehmud F, Alikhan R.

Future Cardiol. 2019 Jul;15(4):301-309. doi: 10.2217/fca-2019-0012. Epub 2019 May 29.

PMID: 31140872

 

Extracting data from a chemotherapy prescription platform for real-world oncology research in the UK: a pilot study.

McDonald L, Stein D, Carroll R, Soni M, Schultze A, Ramagopalan S, Wagstaff J.

Future Oncol. 2019 Jul;15(21):2471-2477. doi: 10.2217/fon-2019-0150. Epub 2019 Jun 4.

PMID: 31161801

 

Indirect comparison of nivolumab ± ipilimumab (CheckMate 032) versus other treatments for recurrent small-cell lung cancer.

Cope S, Keeping ST, Goldgrub R, Ayers D, Jansen JP, Penrod JR, Korytowsky B, Juarez-Garcia A, Yuan Y.

J Comp Eff Res. 2019 Jul;8(10):733-751. doi: 10.2217/cer-2018-0130. Epub 2019 Jun 25.

PMID: 31237143

 

Economic burden of chemotherapy-treated recurrent and/or metastatic squamous cell carcinoma of the head and neck in France: real-world data from the permanent sample of national health insurance beneficiaries.

Lafuma A, Cotté FE, Le Tourneau C, Emery C, Gaudin AF, Torreton E, Gourmelen J, Bonastre J.

J Med Econ. 2019 Jul;22(7):698-705. doi: 10.1080/13696998.2019.1594837. Epub 2019 Apr 2.

PMID: 30895832

 

Overall survival, costs, and healthcare resource use by line of therapy in Medicare patients with newly diagnosed metastatic urothelial carcinoma.

Aly A, Johnson C, Yang S, Botteman MF, Rao S, Hussain A.

J Med Econ. 2019 Jul;22(7):662-670. doi: 10.1080/13696998.2019.1591424. Epub 2019 Mar 25.

PMID: 30836812

 

International normalized ratio control and subsequent clinical outcomes in patients with atrial fibrillation using warfarin.

Guimarães PO, Lopes RD, Alexander JH, Thomas L, Hellkamp AS, Hijazi Z, Hylek EM, Gersh BJ, Garcia DA, Verheugt FWA, Hanna M, Flaker G, Vinereanu D, Granger CB.

J Thromb Thrombolysis. 2019 Jul;48(1):27-34. doi: 10.1007/s11239-019-01858-1.

PMID: 30972712

 

A Phase I/II Open-Label Study of Nivolumab in Previously Treated Advanced or Recurrent Nasopharyngeal Carcinoma and Other Solid Tumors.

Ma Y, Fang W, Zhang Y, Yang Y, Hong S, Zhao Y, Tendolkar A, Chen L, Xu D, Sheng J, Zhao H, Zhang L.

Oncologist. 2019 Jul;24(7):891-e431. doi: 10.1634/theoncologist.2019-0284. Epub 2019 May 2.

PMID: 31048330

 

The humanistic burden of advanced non-small cell lung cancer (NSCLC) in Europe: a real-world survey linking patient clinical factors to patient and caregiver burden.

Wood R, Taylor-Stokes G, Smith F, Chaib C.

Qual Life Res. 2019 Jul;28(7):1849-1861. doi: 10.1007/s11136-019-02152-6. Epub 2019 Mar 2.

PMID: 30825160

 

Analysis of exposure margins in developmental toxicity studies for detection of human teratogens.

Andrews PA, Blanset D, Costa PL, Green M, Green ML, Jacobs A, Kadaba R, Lebron JA, Mattson B, McNerney ME, Minck D, Oliveira LC, Theunissen PT, DeGeorge JJ.

Regul Toxicol Pharmacol. 2019 Jul;105:62-68. doi: 10.1016/j.yrtph.2019.04.005. Epub 2019 Apr 11.

PMID: 30981719

 

An IQ Consortium Perspective on The Scientific Committee on Health, Environmental and Emerging Risks Final Opinion on the Need for Nonhuman Primates in Biomedical Research, Production and Testing of Products and Devices (Update 2017).

Adams K, Clemons D, Impelluso LC, Lee D, Maguire S, Myers A, Petursson C, Schulingkamp R, Trouba K, Wright M.

Toxicol Pathol. 2019 Jul;47(5):649-655. doi: 10.1177/0192623319857976. Epub 2019 Jul 7.

PMID: 31280699

Apixaban for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation in France: The PAROS cross-sectional study of routine clinical practice.

Falissard B, Picard F, Mahe I, Hanon O, Touzé E, Danchin N, Lamy FX, Ricci L, Steg PG.

Arch Cardiovasc Dis. 2019 Jun - Jul;112(6-7):400-409. doi: 10.1016/j.acvd.2019.02.003. Epub 2019 Apr 20.

PMID: 31014991

Utilizing Native Directing Groups: Mechanistic Understanding of a Direct Arylation Leads to Formation of Tetracyclic Heterocycles via Tandem Intermolecular, Intramolecular C-H Activation.

Wisniewski SR, Savage SA, Romero EO, Eastgate MD, Tan Y, Simmons EM, Plata RE, Sowa JR Jr, Blackmond DG.

J Org Chem. 2019 Jun 21;84(12):7961-7970. doi: 10.1021/acs.joc.9b00823. Epub 2019 Jun 4.

PMID: 31117568

Four Yellow Monoterpenoid Quinoline Alkaloids from the Stem of Tabernaemontana bovina.

Wu J, Yu Y, Wang Y, Bao MF, Shi BB, Schinnerl J, Cai XH.

Org Lett. 2019 Jun 21;21(12):4554-4558. doi: 10.1021/acs.orglett.9b01453. Epub 2019 Jun 10.

PMID: 31179705

 

Risk of Biologics and Glucocorticoids in Patients With Rheumatoid Arthritis Undergoing Arthroplasty: A Cohort Study.

George MD, Baker JF, Winthrop K, Alemao E, Chen L, Connolly S, Hsu JY, Simon TA, Wu Q, Xie F, Yang S, Curtis JR.

Ann Intern Med. 2019 Jun 18;170(12):825-836. doi: 10.7326/M18-2217. Epub 2019 May 21.

PMID: 31108503

 

Effectiveness and safety of direct oral anticoagulants compared to warfarin in treatment naïve non-valvular atrial fibrillation patients in the US Department of defense population.

Gupta K, Trocio J, Keshishian A, Zhang Q, Dina O, Mardekian J, Nadkarni A, Shank TC.

BMC Cardiovasc Disord. 2019 Jun 13;19(1):142. doi: 10.1186/s12872-019-1116-1.

PMID: 31195999

 

Trends in kidney function testing in UK primary care since the introduction of the quality and outcomes framework: a retrospective cohort study using CPRD.

Feakins B, Oke J, McFadden E, Aronson J, Lasserson D, O'Callaghan C, Taylor C, Hill N, Stevens R, Perera R.

BMJ Open. 2019 Jun 12;9(6):e028062. doi: 10.1136/bmjopen-2018-028062. Erratum in: BMJ Open. 2019 Jul 1;9(7):e028062corr1.

PMID: 31196901

 

Cooperation between Constitutive and Inducible Chemokines Enables T Cell Engraftment and Immune Attack in Solid Tumors.

Dangaj D, Bruand M, Grimm AJ, Ronet C, Barras D, Duttagupta PA, Lanitis E, Duraiswamy J, Tanyi JL, Benencia F, Conejo-Garcia J, Ramay HR, Montone KT, Powell DJ Jr, Gimotty PA, Facciabene A, Jackson DG, Weber JS, Rodig SJ, Hodi SF, Kandalaft LE, Irving M, Zhang L, Foukas P, Rusakiewicz S, Delorenzi M, Coukos G.

Cancer Cell. 2019 Jun 10;35(6):885-900.e10. doi: 10.1016/j.ccell.2019.05.004.

PMID: 31185212

 

Polymersome nanoreactors with tumor pH-triggered selective membrane permeability for prodrug delivery, activation, and combined oxidation-chemotherapy.

Mukerabigwi JF, Yin W, Zha Z, Ke W, Wang Y, Chen W, Japir AAMM, Wang Y, Ge Z.

J Control Release. 2019 Jun 10;303:209-222. doi: 10.1016/j.jconrel.2019.04.032. Epub 2019 Apr 23.

PMID: 31026547

 

Targeting CLDN18.2 by CD3 Bispecific and ADC Modalities for the Treatments of Gastric and Pancreatic Cancer.

Zhu G, Foletti D, Liu X, Ding S, Melton Witt J, Hasa-Moreno A, Rickert M, Holz C, Aschenbrenner L, Yang AH, Kraynov E, Evering W, Obert L, Lee C, Sai T, Mistry T, Lindquist KC, Van Blarcom T, Strop P, Chaparro-Riggers J, Liu SH.

Sci Rep. 2019 Jun 10;9(1):8420. doi: 10.1038/s41598-019-44874-0. Erratum in: Sci Rep. 2019 Nov 8;9(1):16735.

PMID: 31182754

 

Safety of abatacept compared with other biologic and conventional synthetic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis: data from an observational study.

Ozen G, Pedro S, Schumacher R, Simon TA, Michaud K.

Arthritis Res Ther. 2019 Jun 7;21(1):141. doi: 10.1186/s13075-019-1921-z.

PMID: 31174592

 

Persistence rates of abatacept and TNF inhibitors used as first or second biologic DMARDs in the treatment of rheumatoid arthritis: 9 years of experience from the Rhumadata® clinical database and registry.

Choquette D, Bessette L, Alemao E, Haraoui B, Postema R, Raynauld JP, Coupal L.

Arthritis Res Ther. 2019 Jun 6;21(1):138. doi: 10.1186/s13075-019-1917-8.

PMID: 31171024

 

Catalytic Ring Expansions of Cyclic Alcohols Enabled by Proton-Coupled Electron Transfer.

Zhao K, Yamashita K, Carpenter JE, Sherwood TC, Ewing WR, Cheng PTW, Knowles RR.

J Am Chem Soc. 2019 Jun 5;141(22):8752-8757. doi: 10.1021/jacs.9b03973. Epub 2019 May 23.

PMID: 31117664

 

Interlaboratory Comparison of Hydrogen-Deuterium Exchange Mass Spectrometry Measurements of the Fab Fragment of NISTmAb.

Hudgens JW, Gallagher ES, Karageorgos I, Anderson KW, Filliben JJ, Huang RY, Chen G, Bou-Assaf GM, Espada A, Chalmers MJ, Harguindey E, Zhang HM, Walters BT, Zhang J, Venable J, Steckler C, Park I, Brock A, Lu X, Pandey R, Chandramohan A, Anand GS, Nirudodhi SN, Sperry JB, Rouse JC, Carroll JA, Rand KD, Leurs U, Weis DD, Al-Naqshabandi MA, Hageman TS, Deredge D, Wintrode PL, Papanastasiou M, Lambris JD, Li S, Urata S.

Anal Chem. 2019 Jun 4;91(11):7336-7345. doi: 10.1021/acs.analchem.9b01100. Epub 2019 May 14.

PMID: 31045344

 

Induction of a Th17 Phenotype in Human Skin-A Mimic of Dermal Inflammatory Diseases.

Garrett SM, Zhao Q, Feghali-Bostwick C.

Methods Protoc. 2019 Jun 4;2(2). pii: E45. doi: 10.3390/mps2020045.

PMID: 31164624

 

Investigations on the Relationship between Ovarian, Endocrine, and Renal Findings in Nonclinical Safety Studies of the γ-secretase Inhibitor Avagacestat.

Simutis FJ, Sanderson TP, Pilcher GD, Graziano MJ.

Toxicol Sci. 2019 Jun 4. pii: kfz129. doi: 10.1093/toxsci/kfz129. [Epub ahead of print]

PMID: 31165171

 

Dissecting the Contribution of OATP1B1 to Hepatic Uptake of Statins Using the OATP1B1 Selective Inhibitor Estropipate.

Zhang Y, Panfen E, Fancher M, Sinz M, Marathe P, Shen H.

Mol Pharm. 2019 Jun 3;16(6):2342-2353. doi: 10.1021/acs.molpharmaceut.8b01226. Epub 2019 May 13.

PMID: 31039308

 

A survey of core replacements in indole-based HIV-1 attachment inhibitors.

Wang T, Wallace OB, Zhang Z, Fang H, Yang Z, Robinson BA, Spicer TP, Gong YF, Blair WS, Shi PY, Lin PF, Deshpande M, Meanwell NA, Kadow JF.

Bioorg Med Chem Lett. 2019 Jun 1;29(11):1423-1429. doi: 10.1016/j.bmcl.2019.03.018. Epub 2019 Mar 28.

PMID: 30940396

 

Long-term treatment with atazanavir (ATV) in real life in Belgium: a retrospective observational cohort of 2264 HIV patients.

De Wit S, Florence E, Vandekerkhove L, Goffard JC, Vandercam B, Van Wijngaerden E, Moutschen M, Demeester R, Lacor P, Delforge M, van Frankenhuijsen M, Lacante P.

Acta Clin Belg. 2019 Jun;74(3):143-150. doi: 10.1080/17843286.2018.1462753. Epub 2018 May 2.

PMID: 29718781

 

Optimization of microflow LC-MS/MS and its utility in quantitative discovery bioanalysis.

Zhang J, Shou W, Ogura T, Li S, Weller H.

Bioanalysis. 2019 Jun;11(11):1117-1127. doi: 10.4155/bio-2019-0076.

PMID: 31251100

 

Oncology Therapy Drugs in China, Japan, and the United States: Pharmacokinetic Characteristics, Dose Regimens, and Development Strategies.

Zhou L, Higashimori M, Shen K, Zhang Z, Sheng J, Xu H, Horiuchi M, Ichikawa K, Al-Huniti N, Zhou D.

Clin Pharmacol Ther. 2019 Jun;105(6):1303-1320. doi: 10.1002/cpt.1352. Epub 2019 Feb 25. Review. No abstract available.

PMID: 30802932

 

Association of Changes in Anticitrullinated Protein Antibody Levels With Resource Use and Disease Activity Measures in Rheumatoid Arthritis Patients a US Observational Cohort.

Alemao E, Iannaccone CK, Weinblatt ME, Shadick NA.

Clin Ther. 2019 Jun;41(6):1057-1065.e3. doi: 10.1016/j.clinthera.2019.04.029. Epub 2019 May 23.

PMID: 31130229

 

 A Flexible Approach for Context-Dependent Assessment of Quantitative Systems Pharmacology Models.

Ramanujan S, Chan JR, Friedrich CM, Thalhauser CJ.

CPT Pharmacometrics Syst Pharmacol. 2019 Jun;8(6):340-343. doi: 10.1002/psp4.12409. Epub 2019 May 14. No abstract available. Erratum in: CPT Pharmacometrics Syst Pharmacol. 2020 Feb;9(2):124.

PMID: 30983158

 

Cyt-Geist: Current and Future Challenges in Cytometry: Reports of the CYTO 2018 Conference Workshops.

Czechowska K, Lannigan J, Wang L, Arcidiacono J, Ashhurst TM, Barnard RM, Bauer S, Bispo C, Bonilla DL, Brinkman RR, Cabanski M, Chang HD, Chakrabarti L, Chojnowski G, Cotleur B, Degheidy H, Dela Cruz GV, Eck S, Elliott J, Errington R, Filby A, Gagnon D, Gardner R, Green C, Gregory M, Groves CJ, Hall C, Hammes F, Hedrick M, Hoffman R, Icha J, Ivaska J, Jenner DC, Jones D, Kerckhof FM, Kukat C, Lanham D, Leavesley S, Lee M, Lin-Gibson S, Litwin V, Liu Y, Molloy J, Moore JS, Müller S, Nedbal J, Niesner R, Nitta N, Ohlsson-Wilhelm B, Paul NE, Perfetto S, Portat Z, Props R, Radtke S, Rayanki R, Rieger A, Rogers S, Rubbens P, Salomon R, Schiemann M, Sharpe J, Sonder SU, Stewart JJ, Sun Y, Ulrich H, Van Isterdael G, Vitaliti A, van Vreden C, Weber M, Zimmermann J, Vacca G, Wallace P, Tárnok A.

Cytometry A. 2019 Jun;95(6):598-644. doi: 10.1002/cyto.a.23777. No abstract available.

PMID: 31207046

 

 Cost-effectiveness analysis of Daclatasvir/Sofosbuvir for the treatment of the HCV patients failed after the first line with second generation of DAAs in Italy.

Ruggeri M, Rolli FR, Kondili LA, Drago C, De Solda F, Nappi C, Cicchetti A.

Expert Rev Pharmacoecon Outcomes Res. 2019 Jun;19(3):363-374. doi: 10.1080/14737167.2019.1537784. Epub 2018 Oct 31.

PMID: 30351994

 

Cohort versus patient level simulation for the economic evaluation of single versus combination immuno-oncology therapies in metastatic melanoma.

Gibson EJ, Begum N, Koblbauer I, Dranitsaris G, Liew D, McEwan P, Yuan Y, Juarez-Garcia A, Tyas D, Pritchard C.

J Med Econ. 2019 Jun;22(6):531-544. doi: 10.1080/13696998.2019.1569446. Epub 2019 Jan 30.

PMID: 30638416

 

 Combination anti-CXCR4 and anti-PD-1 immunotherapy provides survival benefit in glioblastoma through immune cell modulation of tumor microenvironment.

Wu A, Maxwell R, Xia Y, Cardarelli P, Oyasu M, Belcaid Z, Kim E, Hung A, Luksik AS, Garzon-Muvdi T, Jackson CM, Mathios D, Theodros D, Cogswell J, Brem H, Pardoll DM, Lim M.

J Neurooncol. 2019 Jun;143(2):241-249. doi: 10.1007/s11060-019-03172-5. Epub 2019 Apr 25.

PMID: 31025274

 

Probing the Tryptophan Environment in Therapeutic Proteins: Implications for Higher Order Structure on Tryptophan Oxidation.

Barnett GV, Balakrishnan G, Chennamsetty N, Hoffman L, Bongers J, Tao L, Huang Y, Slaney T, Das TK, Leone A, Kar SR.

J Pharm Sci. 2019 Jun;108(6):1944-1952. doi: 10.1016/j.xphs.2018.12.027. Epub 2019 Jan 11.

PMID: 30639740

 

Safety of the tau-directed monoclonal antibody BIIB092 in progressive supranuclear palsy: a randomised, placebo-controlled, multiple ascending dose phase 1b trial.

Boxer AL, Qureshi I, Ahlijanian M, Grundman M, Golbe LI, Litvan I, Honig LS, Tuite P, McFarland NR, O'Suilleabhain P, Xie T, Tirucherai GS, Bechtold C, Bordelon Y, Geldmacher DS, Grossman M, Isaacson S, Zesiewicz T, Olsson T, Muralidharan KK, Graham DL, O'Gorman J, Haeberlein SB, Dam T.

Lancet Neurol. 2019 Jun;18(6):549-558. doi: 10.1016/S1474-4422(19)30139-5.

PMID: 31122495

 

Applications of machine learning in drug discovery and development.

Vamathevan J, Clark D, Czodrowski P, Dunham I, Ferran E, Lee G, Li B, Madabhushi A, Shah P, Spitzer M, Zhao S.

Nat Rev Drug Discov. 2019 Jun;18(6):463-477. doi: 10.1038/s41573-019-0024-5. Review.

PMID: 30976107

 

High Proportion of Subjective Component to the Disease Activity Score is Associated with Favorable Response to Abatacept in Rheumatoid Arthritis.

Lee JS, Ahmad H, Shim SC, Bae SC, Song YW, Lee EY.

Patient. 2019 Jun;12(3):319-326. doi: 10.1007/s40271-018-0347-z.

PMID: 30484084

 

Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona Registry.

Harrold LR, Litman HJ, Connolly SE, Alemao E, Kelly S, Rebello S, Hua W, Kremer JM.

Rheumatol Ther. 2019 Jun;6(2):217-230. doi: 10.1007/s40744-019-0149-3. Epub 2019 Mar 13.

PMID: 30868550

 

Abatacept initiation in rheumatoid arthritis and the risk of serious infection: A population-based cohort study.

Montastruc F, Renoux C, Hudson M, Dell'Aniello S, Simon TA, Suissa S.

Semin Arthritis Rheum. 2019 Jun;48(6):1053-1058. doi: 10.1016/j.semarthrit.2019.01.009. Epub 2019 Jan 25.

PMID: 30772001

 

Scientific and Regulatory Policy Committee Points to Consider*: Review of Scientific and Regulatory Policy Committee Points to Consider: Review of Current Practices for Ultrastructural Pathology Evaluations in Support of Nonclinical Toxicology Studies.

Keirstead ND, Janovitz EB, Meehan JT, LeRoy BE, Megill JR, Peterson RA, Masson RG, Marxfeld HA.

Toxicol Pathol. 2019 Jun;47(4):461-468. doi: 10.1177/0192623319835170. Epub 2019 Apr 24.

PMID: 31018785

 

Effect of pretreatment regimens of 1-aminobenzotriazole on metabolism and gastric emptying of probe compounds in rat.

Padmanabhan S, Kaur H, Rao A, Saxena A, Gupta YK, Mariappan TT, Holenarsipur VK.

Xenobiotica. 2019 Jun;49(6):646-654. doi: 10.1080/00498254.2018.1489166. Epub 2018 Sep 7.

PMID: 29898636

 

Treatment patterns and economic outcomes in patients with juvenile idiopathic arthritis.

Marshall A, Gupta K, Pazirandeh M, Bonafede M, McMorrow D.

Clinicoecon Outcomes Res. 2019 May 31;11:361-371. doi: 10.2147/CEOR.S197117. eCollection 2019.

PMID: 31213863

 

Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis.

Arroyo R, Bury DP, Guo JD, Margolin DH, Melanson M, Daizadeh N, Cella D.

Mult Scler. 2019 May 30:1352458519849796. doi: 10.1177/1352458519849796. [Epub ahead of print]

PMID: 31144568

 

Body mass index and treatment response to subcutaneous abatacept in patients with psoriatic arthritis: a post hoc analysis of a phase III trial.

McInnes IB, Ferraccioli G, D'Agostino MA, Le Bars M, Banerjee S, Ahmad HA, Elbez Y, Mease PJ.

RMD Open. 2019 May 30;5(1):e000934. doi: 10.1136/rmdopen-2019-000934. eCollection 2019.

PMID: 31245054

 

Safety of Abatacept Versus Placebo in Rheumatoid Arthritis: Integrated Data Analysis of Nine Clinical Trials.

Simon TA, Soule BP, Hochberg M, Fleming D, Torbeyns A, Banerjee S, Boers M.

ACR Open Rheumatol. 2019 May 29;1(4):251-257. doi: 10.1002/acr2.1034. eCollection 2019 Jun.

PMID: 31777801

 

Application of ultrasound-guided cholecystocentesis to the evaluation of the metabolite profiling in bile of dogs and cynomolgus monkeys.

Dierks EA, Luk CE, Cai H, MacGuire J, Fox M, Smalley J, Fancher RM, Janovitz E, Foster K, Sun Q.

Pharmacol Res Perspect. 2019 May 27;7(3):e00488. doi: 10.1002/prp2.488. eCollection 2019 Jun.

PMID: 31149343

 

Toward a comprehensive view of cancer immune responsiveness: a synopsis from the SITC workshop.

Bedognetti D, Ceccarelli M, Galluzzi L, Lu R, Palucka K, Samayoa J, Spranger S, Warren S, Wong KK, Ziv E, Chowell D, Coussens LM, De Carvalho DD, DeNardo DG, Galon J, Kaufman HL, Kirchhoff T, Lotze MT, Luke JJ, Minn AJ, Politi K, Shultz LD, Simon R, Thórsson V, Weidhaas JB, Ascierto ML, Ascierto PA, Barnes JM, Barsan V, Bommareddy PK, Bot A, Church SE, Ciliberto G, De Maria A, Draganov D, Ho WS, McGee HM, Monette A, Murphy JF, Nisticò P, Park W, Patel M, Quigley M, Radvanyi L, Raftopoulos H, Rudqvist NP, Snyder A, Sweis RF, Valpione S, Zappasodi R, Butterfield LH, Disis ML, Fox BA, Cesano A, Marincola FM; Society for Immunotherapy of Cancer (SITC) Cancer Immune Responsiveness Task Force and Working Groups.

J Immunother Cancer. 2019 May 22;7(1):131. doi: 10.1186/s40425-019-0602-4. Review. Erratum in: J Immunother Cancer. 2019 Jul 4;7(1):167.

PMID: 31113486

 

Pan-TAM Tyrosine Kinase Inhibitor BMS-777607 Enhances Anti-PD-1 mAb Efficacy in a Murine Model of Triple-Negative Breast Cancer.

Kasikara C, Davra V, Calianese D, Geng K, Spires TE, Quigley M, Wichroski M, Sriram G, Suarez-Lopez L, Yaffe MB, Kotenko SV, De Lorenzo MS, Birge RB.

Cancer Res. 2019 May 15;79(10):2669-2683. doi: 10.1158/0008-5472.CAN-18-2614. Epub 2019 Mar 15.

PMID: 30877108

 

Efficacy and Safety of Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Extremes in Body Weight.

Hohnloser SH, Fudim M, Alexander JH, Wojdyla DM, Ezekowitz JA, Hanna M, Atar D, Hijazi Z, Bahit MC, Al-Khatib SM, Lopez-Sendon JL, Wallentin L, Granger CB, Lopes RD.

Circulation. 2019 May 14;139(20):2292-2300. doi: 10.1161/CIRCULATIONAHA.118.037955.

PMID: 30773022

 

Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study.

Inoue H, Umeyama M, Yamada T, Hashimoto H, Komoto A, Yasaka M.

J Arrhythm. 2019 May 9;35(3):506-514. doi: 10.1002/joa3.12184. eCollection 2019 Jun.

PMID: 31293700

 

Small-Scale Tools to Assess the Impact of Interfacial and Shear Stress on Biologic Drug Products.

Ogunyankin MO, Deshmukh S, Krause ME, Carvalho T, Huang M, Ilott A, Remy B, Khossravi M.

AAPS PharmSciTech. 2019 May 6;20(5):184. doi: 10.1208/s12249-019-1378-z.

PMID: 31062111

 

Identification of RIPK3 Type II Inhibitors Using High-Throughput Mechanistic Studies in Hit Triage.

Hart AC, Abell L, Guo J, Mertzman ME, Padmanabha R, Macor JE, Chaudhry C, Lu H, O'Malley K, Shaw PJ, Weigelt C, Pokross M, Kish K, Kim KS, Cornelius L, Douglas AE, Calambur D, Zhang P, Carpenter B, Pitts WJ.

ACS Med Chem Lett. 2019 May 6;11(3):266-271. doi: 10.1021/acsmedchemlett.9b00065. eCollection 2020 Mar 12.

PMID: 32184955

 

Discovery of a Lead Triphenylethanamine Cholesterol Ester Transfer Protein (CETP) Inhibitor.

Finlay HJ, Jiang J, Rampulla R, Salvati ME, Qiao JX, Wang TC, Lawrence RM, Harikrishnan LS, Kamau MG, Taylor DS, Chen AYA, Yin X, Huang CS, Chang M, Chen XQ, Sleph PG, Xu C, Li J, Levesque P, Adam LP, Wexler RR.

ACS Med Chem Lett. 2019 May 6;10(6):911-916. doi: 10.1021/acsmedchemlett.9b00086. eCollection 2019 Jun 13.

PMID: 31223447

 

And They Said It Couldn't Be Done: Predicting Known Driver Mutations From H&E Slides.

Montalto MC, Edwards R.

J Pathol Inform. 2019 May 6;10:17. doi: 10.4103/jpi.jpi_91_18. eCollection 2019. No abstract available.

PMID: 31149368

 

Deamidation Can Compromise Antibody Colloidal Stability and Enhance Aggregation in a pH-Dependent Manner.

Alam ME, Barnett GV, Slaney TR, Starr CG, Das TK, Tessier PM.

Mol Pharm. 2019 May 6;16(5):1939-1949. doi: 10.1021/acs.molpharmaceut.8b01311. Epub 2019 Apr 16.

PMID: 30916563

 

The impact of increased post-progression survival on the cost-effectiveness of interventions in oncology.

Retzler J, Davies H, Jenks M, Kiff C, Taylor M.

Clinicoecon Outcomes Res. 2019 May 3;11:309-324. doi: 10.2147/CEOR.S191382. eCollection 2019.

PMID: 31118714

 

Treatment Patterns in Patients with Chronic-Phase Chronic Myeloid Leukaemia in Routine Clinical Practice: the SIMPLICITY Italian Population.

Abruzzese E, Bosi A, Breccia M, D'Adda M, Di Renzo N, Liberati AM, Porrini R, Orlandi EM, Pane F, Pungolino E, Sorà F, Stagno F, Sen GP, Gentilini F, De Solda F, Gambacorti-Passerini C.

Mediterr J Hematol Infect Dis. 2019 May 1;11(1):e2019025. doi: 10.4084/MJHID.2019.025. eCollection 2019.

PMID: 31205629

 

Phase II study of carfilzomib and dexamethasone therapy for newly diagnosed multiple myeloma.

Forsberg PA, Rossi AC, Boyer A, Tegnestam L, Pearse RN, Perry A, Pekle KA, Jayabalan D, Ely S, Boussi L, Sherbenou DW, Williams C, Allan JN, Coleman M, Niesvizky R, Mark TM.

Am J Hematol. 2019 May;94(5):539-545. doi: 10.1002/ajh.25435. Epub 2019 Feb 25.

PMID: 30740766

 

Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair: Insights from the ARISTOTLE trial.

Guimarães PO, Pokorney SD, Lopes RD, Wojdyla DM, Gersh BJ, Giczewska A, Carnicelli A, Lewis BS, Hanna M, Wallentin L, Vinereanu D, Alexander JH, Granger CB.

Clin Cardiol. 2019 May;42(5):568-571. doi: 10.1002/clc.23178. Epub 2019 Apr 9.

PMID: 30907005

 

Correction to: Predictors of abatacept retention over 2 years in patients with rheumatoid arthritis: results from the real-world ACTION study.

Alten R, Mariette X, Lorenz HM, Nüßlein H, Galeazzi M, Navarro F, Chartier M, Heitzmann J, Poncet C, Rauch C, Le Bars M.

Clin Rheumatol. 2019 May;38(5):1535. doi: 10.1007/s10067-019-04545-x.

PMID: 30972577

 

Predictors of abatacept retention over 2 years in patients with rheumatoid arthritis: results from the real-world ACTION study.

Alten R, Mariette X, Lorenz HM, Nüßlein H, Galeazzi M, Navarro F, Chartier M, Heitzmann J, Poncet C, Rauch C, Le Bars M.

Clin Rheumatol. 2019 May;38(5):1413-1424. doi: 10.1007/s10067-019-04449-w. Epub 2019 Feb 21. Erratum in: Clin Rheumatol. 2019 Apr 11;:.

PMID: 30790095

 

Immune Checkpoint Inhibition in Sepsis: A Phase 1b Randomized, Placebo-Controlled, Single Ascending Dose Study of Antiprogrammed Cell Death-Ligand 1 Antibody (BMS-936559).

Hotchkiss RS, Colston E, Yende S, Angus DC, Moldawer LL, Crouser ED, Martin GS, Coopersmith CM, Brakenridge S, Mayr FB, Park PK, Ye J, Catlett IM, Girgis IG, Grasela DM.

Crit Care Med. 2019 May;47(5):632-642. doi: 10.1097/CCM.0000000000003685.

PMID: 30747773

 

Immune-checkpoint inhibitors and candidate surrogate endpoints for overall survival across tumour types: A systematic literature review.

Branchoux S, Bellera C, Italiano A, Rustand D, Gaudin AF, Rondeau V.

Crit Rev Oncol Hematol. 2019 May;137:35-42. doi: 10.1016/j.critrevonc.2019.02.013. Epub 2019 Mar 1.

PMID: 31014514

 

Some observations on the liquid crystalline and gel behaviors of aqueous dispersions of a prodrug.

Tao L, Li J, Pinamanenni S, Raghavan K.

Drug Dev Ind Pharm. 2019 May;45(5):819-825. doi: 10.1080/03639045.2019.1576721. Epub 2019 Feb 13.

PMID: 30715959

 

The changing face of venous thromboembolism management in England.

Ramagopalan SV, Carroll R, Ulvestad M, Mehmud F, Alikhan R.

Future Cardiol. 2019 May;15(3):183-185. doi: 10.2217/fca-2019-0003. Epub 2019 Mar 25. Review.

PMID: 30907131

 

I-O Optimise: a novel multinational real-world research platform in thoracic malignancies.

Ekman S, Griesinger F, Baas P, Chao D, Chouaid C, O'Donnell JC, Penrod JR, Daumont M, Lacoin L, McKenney A, Khovratovich M, Munro RE, Durand-Zaleski I, Johnsen SP.

Future Oncol. 2019 May;15(14):1551-1563. doi: 10.2217/fon-2019-0025. Epub 2019 Mar 11.

PMID: 30852916

 

Comparative efficacy of combination immunotherapy and targeted therapy in the treatment of BRAF-mutant advanced melanoma: a matching-adjusted indirect comparison.

Atkins MB, Tarhini A, Rael M, Gupte-Singh K, O'Brien E, Ritchings C, Rao S, McDermott DF.

Immunotherapy. 2019 May;11(7):617-629. doi: 10.2217/imt-2018-0208. Epub 2019 Mar 11.

PMID: 30852924

 

Whose Benchmark Is Right? Validating Venous Thromboembolism Events Between Trauma Registries and Hospital Administrative Databases.

Miano TA, Abelian G, Seamon MJ, Chreiman K, Reilly PM, Martin ND.

J Am Coll Surg. 2019 May;228(5):752-759.e3. doi: 10.1016/j.jamcollsurg.2019.02.037. Epub 2019 Feb 15.

PMID: 30772443

 

Treatment patterns and outcomes for patients with unresectable stage III and metastatic melanoma in the USA.

Tarhini A, Atzinger C, Gupte-Singh K, Johnson C, Macahilig C, Rao S.

J Comp Eff Res. 2019 May;8(7):461-473. doi: 10.2217/cer-2019-0003. Epub 2019 Mar 5.

PMID: 30832505

 

Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced NSCLC: CheckMate 078 Randomized Phase III Clinical Trial.

Wu YL, Lu S, Cheng Y, Zhou C, Wang J, Mok T, Zhang L, Tu HY, Wu L, Feng J, Zhang Y, Luft AV, Zhou J, Ma Z, Lu Y, Hu C, Shi Y, Baudelet C, Cai J, Chang J.

J Thorac Oncol. 2019 May;14(5):867-875. doi: 10.1016/j.jtho.2019.01.006. Epub 2019 Jan 17.

PMID: 30659987

 

Anticoagulant selection for patients with VTE-Evidence from a systematic literature review of network meta-analyses.

Cohen AT, Berger SE, Milenković D, Hill NR, Lister S.

Pharmacol Res. 2019 May;143:166-177. doi: 10.1016/j.phrs.2019.03.017. Epub 2019 Mar 21.

PMID: 30905806

Diagnostic Performance of 4D CT and Sestamibi SPECT/CT in Localizing Parathyroid Adenomas in Primary Hyperparathyroidism.

Yeh R, Tay YD, Tabacco G, Dercle L, Kuo JH, Bandeira L, McManus C, Leung DK, Lee JA, Bilezikian JP.

Radiology. 2019 May;291(2):469-476. doi: 10.1148/radiol.2019182122. Epub 2019 Mar 5.

PMID: 30835187

 

Correction to: On-drug and drug-free remission by baseline symptom duration: abatacept with methotrexate in patients with early rheumatoid arthritis.

Bykerk VP, Burmester GR, Combe BG, Furst DE, Huizinga TWJ, Ahmad HA, Emery P.

Rheumatol Int. 2019 May;39(5):945. doi: 10.1007/s00296-018-4232-9.

PMID: 30721326

 

The humanistic burden associated with caring for patients with advanced non-small cell lung cancer (NSCLC) in three European countries-a real-world survey of caregivers.

Wood R, Taylor-Stokes G, Lees M.

Support Care Cancer. 2019 May;27(5):1709-1719. doi: 10.1007/s00520-018-4419-3. Epub 2018 Aug 18.

PMID: 30121787

 

Pharma Collaboration for Transparent Medical Information (phactMI) Benchmark Study: Trends, Drivers, Success Factors, and Value of Globalization in Medical Information.

Giffin SA, Shah R, Soloff A, Vaysman AM, Oreper J, Gažo A, Gandhi P, Shah I, Malieckal T, Boulos D, Flowers T, Stevens CA, Rocco MS, Patel AS, Albano D.

Ther Innov Regul Sci. 2019 May;53(3):332-339. doi: 10.1177/2168479018779920. Epub 2018 Jun 19.

PMID: 29916261

 

PREVAPIX-ALL: Apixaban Compared to Standard of Care for Prevention of Venous Thrombosis in Paediatric Acute Lymphoblastic Leukaemia (ALL)-Rationale and Design.

O'Brien SH, Li D, Mitchell LG, Hess T, Zee P, Yee DL, Newburger JW, Sung L, Rodriguez V.

Thromb Haemost. 2019 May;119(5):844-853. doi: 10.1055/s-0039-1679938. Epub 2019 Mar 12.

PMID: 30861550

Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study.

Hara R, Umebayashi H, Takei S, Okamoto N, Iwata N, Yamasaki Y, Nakagishi Y, Kizawa T, Kobayashi I, Imagawa T, Kinjo N, Amano N, Takahashi Y, Mori M, Itoh Y, Yokota S.

Pediatr Rheumatol Online J. 2019 Apr 30;17(1):17. doi: 10.1186/s12969-019-0319-4.

PMID: 31039807

 

A Radical Approach to Anionic Chemistry: Synthesis of Ketones, Alcohols, and Amines.

Ni S, Padial NM, Kingston C, Vantourout JC, Schmitt DC, Edwards JT, Kruszyk MM, Merchant RR, Mykhailiuk PK, Sanchez BB, Yang S, Perry MA, Gallego GM, Mousseau JJ, Collins MR, Cherney RJ, Lebed PS, Chen JS, Qin T, Baran PS.

J Am Chem Soc. 2019 Apr 24;141(16):6726-6739. doi: 10.1021/jacs.9b02238. Epub 2019 Apr 16.

PMID: 30943023

 

Role of Cdc23/Mcm10 in generating the ribonucleotide imprint at the mat1 locus in fission yeast.

Singh B, Bisht KK, Upadhyay U, Kushwaha AC, Nanda JS, Srivastava S, Saini JK, Klar AJS, Singh J.

Nucleic Acids Res. 2019 Apr 23;47(7):3422-3433. doi: 10.1093/nar/gkz092.

PMID: 30759238

 

First-Line Nivolumab Plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer (CheckMate 568): Outcomes by Programmed Death Ligand 1 and Tumor Mutational Burden as Biomarkers.

Ready N, Hellmann MD, Awad MM, Otterson GA, Gutierrez M, Gainor JF, Borghaei H, Jolivet J, Horn L, Mates M, Brahmer J, Rabinowitz I, Reddy PS, Chesney J, Orcutt J, Spigel DR, Reck M, O'Byrne KJ, Paz-Ares L, Hu W, Zerba K, Li X, Lestini B, Geese WJ, Szustakowski JD, Green G, Chang H, Ramalingam SS.

J Clin Oncol. 2019 Apr 20;37(12):992-1000. doi: 10.1200/JCO.18.01042. Epub 2019 Feb 20.

PMID: 30785829

 

Sustainability Challenges in Peptide Synthesis and Purification: From R&D to Production.

Isidro-Llobet A, Kenworthy MN, Mukherjee S, Kopach ME, Wegner K, Gallou F, Smith AG, Roschangar F.

J Org Chem. 2019 Apr 19;84(8):4615-4628. doi: 10.1021/acs.joc.8b03001. Epub 2019 Mar 22.

PMID: 30900880

 

Utilizing Native Directing Groups: Synthesis of a Selective I_Kur Inhibitor, BMS-919373, via a Regioselective C-H Arylation.

Wisniewski SR, Stevens JM, Yu M, Fraunhoffer KJ, Romero EO, Savage SA.

J Org Chem. 2019 Apr 19;84(8):4704-4714. doi: 10.1021/acs.joc.8b02254. Epub 2018 Nov 15.

PMID: 30395712

C-H Arylation in the Formation of a Complex Pyrrolopyridine, the Commercial Synthesis of the Potent JAK2 Inhibitor, BMS-911543.

Fox RJ, Cuniere NL, Bakrania L, Wei C, Strotman NA, Hay M, Fanfair D, Regens C, Beutner GL, Lawler M, Lobben P, Soumeillant MC, Cohen B, Zhu K, Skliar D, Rosner T, Markwalter CE, Hsiao Y, Tran K, Eastgate MD.

J Org Chem. 2019 Apr 19;84(8):4661-4669. doi: 10.1021/acs.joc.8b02383. Epub 2018 Nov 12.

PMID: 30388009

 

Effects of Multiple Catalyst Deactivation Pathways and Continuous Ligand Recycling on the Kinetics of Pd-Catalyzed C-N Coupling Reactions.

Strotman NA, Soumeillant MC, Zhu K, Markwalter CE, Wei CS, Hsiao Y, Eastgate MD.

J Org Chem. 2019 Apr 19;84(8):4653-4660. doi: 10.1021/acs.joc.8b02214. Epub 2018 Oct 24.

PMID: 30336032

 

Synthesis of 2'-Methyl-6-methoxyguanosine from the Parent Ribonucleoside Guanosine.

Yuan C, Chen K, Eastgate M.

J Org Chem. 2019 Apr 19;84(8):4646-4652. doi: 10.1021/acs.joc.8b02194. Epub 2018 Oct 11.

PMID: 30253104

 

Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation.

Lopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, Goodman SG, Windecker S, Darius H, Li J, Averkov O, Bahit MC, Berwanger O, Budaj A, Hijazi Z, Parkhomenko A, Sinnaeve P, Storey RF, Thiele H, Vinereanu D, Granger CB, Alexander JH; AUGUSTUS Investigators.

N Engl J Med. 2019 Apr 18;380(16):1509-1524. doi: 10.1056/NEJMoa1817083. Epub 2019 Mar 17.

PMID: 30883055

 

A robust data-driven genomic signature for idiopathic pulmonary fibrosis with applications for translational model selection.

Ammar R, Sivakumar P, Jarai G, Thompson JR.

PLoS One. 2019 Apr 18;14(4):e0215565. doi: 10.1371/journal.pone.0215565. eCollection 2019.

PMID: 30998768

 

Report on the AAPS Immunogenicity Guidance Forum.

Myler H, Gorovits B, Phillips K, Devanarayan V, Clements-Egan A, Gunn GR, Kirshner S, DeSilva B, Shah VP.

AAPS J. 2019 Apr 16;21(4):55. doi: 10.1208/s12248-019-0328-8.

PMID: 30993501

 

Quadrupole Dalton-Based Controlled Proteolysis Method for Characterization of Higher Order Protein Structure.

Cao X, Flagg SC, Li X, Chennamsetty N, Balakrishnan G, Das TK.

Anal Chem. 2019 Apr 16;91(8):5339-5345. doi: 10.1021/acs.analchem.9b00306. Epub 2019 Apr 4.

PMID: 30915848

 

CD28 Signaling Controls Metabolic Fitness of Pathogenic T Cells in Medium and Large Vessel Vasculitis.

Zhang H, Watanabe R, Berry GJ, Nadler SG, Goronzy JJ, Weyand CM.

J Am Coll Cardiol. 2019 Apr 16;73(14):1811-1823. doi: 10.1016/j.jacc.2019.01.049.

PMID: 30975299

 

Safety of Apixaban Administered via Nasogastric Tube.

Odell K, Costello J.

Cardiology. 2019 April 12;142(1):39. doi: 10.1159/000495577. Epub 2019 Apr 12. No abstract available.

PMID: 30982047

Discovery of Branebrutinib (BMS-986195): A Strategy for Identifying a Highly Potent and Selective Covalent Inhibitor Providing Rapid in Vivo Inactivation of Bruton's Tyrosine Kinase (BTK).

Watterson SH, Liu Q, Beaudoin Bertrand M, Batt DG, Li L, Pattoli MA, Skala S, Cheng L, Obermeier MT, Moore R, Yang Z, Vickery R, Elzinga PA, Discenza L, D'Arienzo C, Gillooly KM, Taylor TL, Pulicicchio C, Zhang Y, Heimrich E, McIntyre KW, Ruan Q, Westhouse RA, Catlett IM, Zheng N, Chaudhry C, Dai J, Galella MA, Tebben AJ, Pokross M, Li J, Zhao R, Smith D, Rampulla R, Allentoff A, Wallace MA, Mathur A, Salter-Cid L, Macor JE, Carter PH, Fura A, Burke JR, Tino JA.

J Med Chem. 2019 Apr 11;62(7):3228-3250. doi: 10.1021/acs.jmedchem.9b00167. Epub 2019 Mar 29.

 

Aryl hydrocarbon receptor acts as a tumor suppressor in a syngeneic MC38 colon carcinoma tumor model.

Yakkundi P, Gonsalves E, Galou-Lameyer M, Selby MJ, Chan WK.

Hypoxia (Auckl). 2019 Apr 10;7:1-16. doi: 10.2147/HP.S196301. eCollection 2019.

PMID: 31119183

 

Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial.

Lebbé C, Meyer N, Mortier L, Marquez-Rodas I, Robert C, Rutkowski P, Menzies AM, Eigentler T, Ascierto PA, Smylie M, Schadendorf D, Ajaz M, Svane IM, Gonzalez R, Rollin L, Lord-Bessen J, Saci A, Grigoryeva E, Pigozzo J.

J Clin Oncol. 2019 Apr 10;37(11):867-875. doi: 10.1200/JCO.18.01998. Epub 2019 Feb 27.

PMID: 30811280

 

Pharmacological Optimization for Successful Traumatic Brain Injury Drug Development.

Poloyac SM, Bertz RJ, McDermott LA, Marathe P.

J Neurotrauma. 2019 Apr 10. doi: 10.1089/neu.2018.6295. [Epub ahead of print]

PMID: 30816062

 

Recent advances in 3Rs and laboratory animal science: Report on the International Conference of LASA (India).

Singh VP, Yadav S, Joshi H, Devan SRK, Yadav DK, Singh RP.

ALTEX. 2019 April 10;36(2):322-328. doi: 10.14573/altex.1901041. No abstract available.

PMID: 31032864

 

High-Throughput Analysis of Clinical Flow Cytometry Data by Automated Gating.

Lee H, Sun Y, Patti-Diaz L, Hedrick M, Ehrhardt AG.

Bioinform Biol Insights. 2019 Apr 3;13:1177932219838851. doi: 10.1177/1177932219838851. eCollection 2019.

PMID: 30983860

Major pathologic response on biopsy (MPRbx) in patients with advanced melanoma treated with anti-PD-1: evidence for an early, on-therapy biomarker of response.

Stein JE, Soni A, Danilova L, Cottrell TR, Gajewski TF, Hodi FS, Bhatia S, Urba WJ, Sharfman WH, Wind-Rotolo M, Edwards R, Lipson EJ, Taube JM.

Ann Oncol. 2019 Apr 1;30(4):589-596. doi: 10.1093/annonc/mdz019.

PMID: 30689736

irRECIST for the Evaluation of Candidate Biomarkers of Response to Nivolumab in Metastatic Clear Cell Renal Cell Carcinoma: Analysis of a Phase II Prospective Clinical Trial.

Pignon JC, Jegede O, Shukla SA, Braun DA, Horak CE, Wind-Rotolo M, Ishii Y, Catalano PJ, Grosha J, Flaifel A, Novak JS, Mahoney KM, Freeman GJ, Sharpe AH, Hodi FS, Motzer RJ, Choueiri TK, Wu CJ, Atkins MB, McDermott DF, Signoretti S.

Clin Cancer Res. 2019 Apr 1;25(7):2174-2184. doi: 10.1158/1078-0432.CCR-18-3206. Epub 2019 Jan 22.

PMID: 30670497

Abatacept initiation in rheumatoid arthritis and the risk of cancer: a population-based comparative cohort study.

Montastruc F, Renoux C, Dell'Aniello S, Simon TA, Azoulay L, Hudson M, Suissa S.

Rheumatology (Oxford). 2019 Apr 1;58(4):683-691. doi: 10.1093/rheumatology/key352.

PMID: 30535094

 

Phase I study of single-dose pharmacokinetics and pharmacodynamics of belatacept in adolescent kidney transplant recipients.

Moudgil A, Dharnidharka VR, Feig DI, Warshaw BL, Perera V, Murthy B, Roberts ME, Polinsky MS, Ettenger RB.

Am J Transplant. 2019 Apr;19(4):1218-1223. doi: 10.1111/ajt.15236. Epub 2019 Jan 22.

PMID: 30582294

Assessment of CE-based baseline disturbances using simulation and targeted experimental evaluation-impact on the purity determination of therapeutic proteins.

Gu Y, Voronov S, Ding J, Mussa N, Li ZJ.

Anal Bioanal Chem. 2019 Apr;411(11):2425-2437. doi: 10.1007/s00216-019-01704-6. Epub 2019 Mar 18.

PMID: 30880351

 

Perspectives on gender parity in bioanalysis: an interview with Binodh DeSilva.

De Silva B.

Bioanalysis. 2019 Apr;11(7):663-664. doi: 10.4155/bio-2019-0068. Epub 2019 Apr 18.

PMID: 30997822

 

Critical reagent screening and characterization: benefits and approaches for protein biomarker assays by hybrid LC-MS.

Santockyte R, Zeng J, Zheng N.

Bioanalysis. 2019 Apr;11(8):785-795. doi: 10.4155/bio-2018-0277. Epub 2019 Apr 17.

PMID: 30994008

 

Population pharmacokinetics analysis of nivolumab in Asian and non-Asian patients with gastric and gastro-esophageal junction cancers.

Osawa M, Hasegawa M, Bello A, Roy A, Hruska MW.

Cancer Chemother Pharmacol. 2019 Apr;83(4):705-715. doi: 10.1007/s00280-019-03771-z. Epub 2019 Jan 21.

PMID: 30666395

 

CD96 Is an Immune Checkpoint That Regulates CD8₊ T-cell Antitumor Function.

Mittal D, Lepletier A, Madore J, Aguilera AR, Stannard K, Blake SJ, Whitehall VLJ, Liu C, Bettington ML, Takeda K, Long GV, Scolyer RA, Lan R, Siemers N, Korman A, Teng MWL, Johnston RJ, Dougall WC, Smyth MJ.

Cancer Immunol Res. 2019 Apr;7(4):559-571. doi: 10.1158/2326-6066.CIR-18-0637. Epub 2019 Mar 20.

PMID: 30894377

 

Elbasvir/Grazoprevir in People With Hepatitis C Genotype 1 Infection and Child-Pugh Class B Cirrhosis: The C-SALT Study.

Jacobson IM, Poordad F, Firpi-Morell R, Everson GT, Verna EC, Bhanja S, Hwang P, Caro L, Robertson M, Charles ED, Platt H.

Clin Transl Gastroenterol. 2019 Apr;10(4):e00007. doi: 10.14309/ctg.0000000000000007.

PMID: 30939489

 

Real-world systemic therapy treatment patterns for squamous cell carcinoma of the head and neck in Canada.

Byrne K, Hallworth P, Monfared AAT, Moshyk A, Shaw JW.

Curr Oncol. 2019 Apr;26(2):e167-e174. doi: 10.3747/co.26.3946. Epub 2019 Apr 1.

PMID: 31043823

 

A Comparison of Total and Plasma Membrane Abundance of Transporters in Suspended, Plated, Sandwich-Cultured Human Hepatocytes Versus Human Liver Tissue Using Quantitative Targeted Proteomics and Cell Surface Biotinylation.

Kumar V, Salphati L, Hop CECA, Xiao G, Lai Y, Mathias A, Chu X, Humphreys WG, Liao M, Heyward S, Unadkat JD.

Drug Metab Dispos. 2019 Apr;47(4):350-357. doi: 10.1124/dmd.118.084988. Epub 2019 Jan 8.

PMID: 30622164

 

Idealhalers Versus Realhalers: Is It Possible to Bypass Deposition in the Upper Respiratory Tract?

Weers JG, Son YJ, Glusker M, Haynes A, Huang D, Kadrichu N, Le J, Li X, Malcolmson R, Miller DP, Tarara TE, Ung K, Clark A.

J Aerosol Med Pulm Drug Deliv. 2019 Apr;32(2):55-69. doi: 10.1089/jamp.2018.1497. Epub 2018 Dec 6.

PMID: 30481087

 

Safety Exposure-Response Analysis for Daclatasvir, Asunaprevir, and Beclabuvir Combinations in HCV-Infected Subjects.

Osawa M, Ueno T, Shiozaki T, Li H, Garimella T.

J Clin Pharmacol. 2019 Apr;59(4):557-565. doi: 10.1002/jcph.1347. Epub 2018 Dec 19.

PMID: 30566237

 

Discontinuation and primary care visits in nonvalvular atrial fibrillation patients treated with apixaban or warfarin.

Ramagopalan SV, Graham S, Carroll R, Raluy-Callado M, Nordstrom BL, Donaldson R, Colby C, Mehmud F, Alikhan R.

J Comp Eff Res. 2019 Apr;8(6):371-379. doi: 10.2217/cer-2019-0005. Epub 2019 Feb 8.

PMID: 30734571

 

A Real-World Claims Analysis of Costs and Patterns of Care in Treated Patients with Glioblastoma Multiforme in the United States.

Norden AD, Korytowsky B, You M, Kim Le T, Dastani H, Bobiak S, Singh P.

J Manag Care Spec Pharm. 2019 Apr;25(4):428-436. doi: 10.18553/jmcp.2019.25.4.428.

PMID: 30917077

 

Economic Evaluation of Anticyclic Citrullinated Peptide Positivity in Rheumatoid Arthritis.

An J, Bider-Canfield Z, Kang J, Alemao E, Connolly SE, Lin AT, Cheetham TC.

J Manag Care Spec Pharm. 2019 Apr;25(4):469-477. doi: 10.18553/jmcp.2019.25.4.469.

PMID: 30917075

 

The economic burden of switching targeted disease-modifying anti-rheumatic drugs among rheumatoid arthritis patients.

Shahabi A, Shafrin J, Zhao L, Green S, Curtice T, Marshall A, Paul D.

J Med Econ. 2019 Apr;22(4):350-358. doi: 10.1080/13696998.2019.1571498. Epub 2019 Feb 12.

PMID: 30653389

 

Expectations for Phase-Appropriate Drug Substance and Drug Product Specifications for Early-Stage Protein Therapeutics.

Kretsinger J, Frantz N, Hart SA, Kelley WP, Kitchen B, Novick S, Rellahan B, Stranges D, Stroop CJM, Yin P, Gastens MH.

J Pharm Sci. 2019 Apr;108(4):1442-1452. doi: 10.1016/j.xphs.2018.11.042. Epub 2018 Dec 6.

PMID: 30528942

 

Representative Scale-Down Lyophilization Cycle Development Using a Seven-Vial Freeze-Dryer (MicroFD_®).

Goldman JM, Chen X, Register JT, Nesarikar V, Iyer L, Wu Y, Mugheirbi N, Rowe J.

J Pharm Sci. 2019 Apr;108(4):1486-1495. doi: 10.1016/j.xphs.2018.11.018. Epub 2018 Nov 20.

PMID: 30468831

 

Unmasking of oestrogen-dependent changes in left ventricular structure and function in aged female rats: a potential model for pre-heart failure with preserved ejection fraction.

Bustamante M, Garate-Carrillo A, R Ito B, Garcia R, Carson N, Ceballos G, Ramirez-Sanchez I, Omens J, Villarreal F.

J Physiol. 2019 Apr;597(7):1805-1817. doi: 10.1113/JP277479. Epub 2019 Feb 12.

PMID: 30681142

 

Interacting medication use and the treatment effects of apixaban versus warfarin: results from the ARISTOTLE Trial.

Washam JB, Hohnloser SH, Lopes RD, Wojdyla DM, Vinereanu D, Alexander JH, Gersh BJ, Hanna M, Horowitz J, Hylek EM, Xavier D, Verheugt FWA, Wallentin L, Granger CB; ARISTOTLE Committees and Investigators.

J Thromb Thrombolysis. 2019 Apr;47(3):345-352. doi: 10.1007/s11239-019-01823-y.

PMID: 30790160

 

Immune associated LncRNAs identify novel prognostic subtypes of renal clear cell carcinoma.

Khadirnaikar S, Kumar P, Pandi SN, Malik R, Dhanasekaran SM, Shukla SK.

Mol Carcinog. 2019 Apr;58(4):544-553. doi: 10.1002/mc.22949. Epub 2018 Dec 21.

PMID: 30520148

 

Single-cell transcriptomic analysis of the lateral hypothalamic area reveals molecularly distinct populations of inhibitory and excitatory neurons.

Mickelsen LE, Bolisetty M, Chimileski BR, Fujita A, Beltrami EJ, Costanzo JT, Naparstek JR, Robson P, Jackson AC.

Nat Neurosci. 2019 Apr;22(4):642-656. doi: 10.1038/s41593-019-0349-8. Epub 2019 Mar 11.

PMID: 30858605

A changing landscape: Temporal trends in incidence and characteristics of patients hospitalized with venous thromboembolism 2006-2015.

Münster AM, Rasmussen TB, Falstie-Jensen AM, Harboe L, Stynes G, Dybro L, Hansen ML, Brandes A, Grove EL, Johnsen SP.

Thromb Res. 2019 Apr;176:46-53. doi: 10.1016/j.thromres.2019.02.009. Epub 2019 Feb 13.

PMID: 30776687

 

A mouse model of heart failure exhibiting pulmonary edema and pleural effusion: Useful for testing new drugs.

Ma X, Tannu S, Allocco J, Pan J, Dipiero J, Wong P.

J Pharmacol Toxicol Methods. 2019 Mar - Apr;96:78-86. doi: 10.1016/j.vascn.2019.02.001. Epub 2019 Feb 6.

PMID: 30738210

 

Toxicity of Pexacerfont, a Corticotropin-Releasing Factor Type 1 Receptor Antagonist, in Rats and Dogs.

White MR, Graziano MJ, Sanderson TP.

Int J Toxicol. 2019 Mar/Apr;38(2):110-120. doi: 10.1177/1091581819827501. Epub 2019 Feb 13.

PMID: 30760067

 

Assessing the risk of drug crystallization in vivo.

Ruepp S, Janovitz E, Brodie T, White R, Santella J, Hynes J, Carman J, Pan D, Wu Y, Hanumegowda U, Gemzik B, Megill J, DiPiero J, Drexler D, Su CC, Hageman M.

J Pharmacol Toxicol Methods. 2019 Mar - Apr;96:1-8. doi: 10.1016/j.vascn.2018.12.003. Epub 2018 Dec 13.

PMID: 30553974

Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing.

Weber J, Hauschild J, Ijzerman-Boon P, Forng RY, Horsch J, Yan L, Prasad A, Henry RB, Claassen M, Villari P, Shereefa S, Wyatt J, Bolden JS, Pycke JT, Dassu D.

PDA J Pharm Sci Technol. 2019 Mar-Apr;73(2):121-134. doi: 10.5731/pdajpst.2018.008722. Epub 2018 Oct 25.

PMID: 30361285

 

Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing.

Barone PW, Avgerinos S, Ballard R, Brussel A, Clark P, Dowd C, Gerentes L, Hart I, Keumurian FJ, Kindermann J, Leung JC, Ly N, Mink S, Minning S, Mullberg J, Murphy M, Nöske K, Parriott S, Shum B, Wiebe ME, Springs SL.

PDA J Pharm Sci Technol. 2019 Mar-Apr;73(2):191-203. doi: 10.5731/pdajpst.2018.008862. Epub 2018 Oct 25.

PMID: 30361281

Case-control Indian buffet process identifies biomarkers of response to Codrituzumab.

Pradier MF, Reis B, Jukofsky L, Milletti F, Ohtomo T, Perez-Cruz F, Puig O.

BMC Cancer. 2019 Mar 28;19(1):278. doi: 10.1186/s12885-019-5472-0.

PMID: 30922327

 

Congruent release of drug and polymer: A "sweet spot" in the dissolution of amorphous solid dispersions.

Saboo S, Mugheirbi NA, Zemlyanov DY, Kestur US, Taylor LS.

J Control Release. 2019 Mar 28;298:68-82. doi: 10.1016/j.jconrel.2019.01.039. Epub 2019 Feb 4.

PMID: 30731151

 

Impact of Preexisting Hepatitis C Virus Genotype 6 NS3, NS5A, and NS5B Polymorphisms on the In Vitro Potency of Direct-Acting Antiviral Agents.

McPhee F, Ueland J, Vellucci V, Bowden S, Sievert W, Zhou N.

Antimicrob Agents Chemother. 2019 Mar 27;63(4). pii: e02205-18. doi: 10.1128/AAC.02205-18. Print 2019 Apr.

PMID: 30718256

 

Interfacial Stress in the Development of Biologics: Fundamental Understanding, Current Practice, and Future Perspective.

Li J, Krause ME, Chen X, Cheng Y, Dai W, Hill JJ, Huang M, Jordan S, LaCasse D, Narhi L, Shalaev E, Shieh IC, Thomas JC, Tu R, Zheng S, Zhu L.

AAPS J. 2019 Mar 26;21(3):44. doi: 10.1208/s12248-019-0312-3.

PMID: 30915582

 

Critical role of kinase activity of hematopoietic progenitor kinase 1 in anti-tumor immune surveillance.

Liu J, Curtin J, You D, Hillerman S, Li-Wang B, Eraslan R, Xie J, Swanson J, Ho CP, Oppenheimer S, Warrack BM, McNaney CA, Nelson DM, Blum J, Kim T, Fereshteh M, Reily M, Shipkova P, Murtaza A, Sanjuan M, Hunt JT, Salter-Cid L.

PLoS One. 2019 Mar 26;14(3):e0212670. doi: 10.1371/journal.pone.0212670. eCollection 2019.

PMID: 30913212

 

Effectiveness and safety of oral anticoagulants in older adults with non-valvular atrial fibrillation and heart failure.

Amin A, Garcia Reeves AB, Li X, Dhamane A, Luo X, Di Fusco M, Nadkarni A, Friend K, Rosenblatt L, Mardekian J, Pan X, Yuce H, Keshishian A.

PLoS One. 2019 Mar 25;14(3):e0213614. doi: 10.1371/journal.pone.0213614. eCollection 2019.

PMID: 30908512

 

Stability behaviour of antiretroviral drugs and their combinations. 9: Identification of incompatible excipients.

Kurmi M, Sahu A, Ladumor MK, Kumar Bansal A, Singh S.

J Pharm Biomed Anal. 2019 Mar 20;166:174-182. doi: 10.1016/j.jpba.2019.01.009. Epub 2019 Jan 8.

PMID: 30654205

 

Relative value assessment: characterizing the benefit of oncology therapies through diverse survival metrics from a US perspective.

Macaulay R, Ahuja A, Ademisoye E, Juarez-Garcia A, Shaw JW.

Clinicoecon Outcomes Res. 2019 Mar 19;11:199-219. doi: 10.2147/CEOR.S177343. eCollection 2019.

PMID: 30936729

 

Development and validation of an in vitro 3D model of NASH with severe fibrotic phenotype.

Mukherjee S, Zhelnin L, Sanfiz A, Pan J, Li Z, Yarde M, McCarty J, Jarai G.

Am J Transl Res. 2019 Mar 15;11(3):1531-1540. eCollection 2019.

PMID: 30972180

 

Correction to: Safety and efficacy of nivolumab in combination with sunitinib or pazopanib in advanced or metastatic renal cell carcinoma: the CheckMate 016 study.

Amin A, Plimack ER, Ernstoff MS, Lewis LD, Bauer TM, McDermott DF, Carducci M, Kollmannsberger C, Rini BI, Heng DYC, Knox J, Voss MH, Spratlin J, Berghorn E, Yang L, Hammers HJ.

J Immunother Cancer. 2019 Mar 14;7(1):73. doi: 10.1186/s40425-019-0559-3.

PMID: 30871617

 

Identification and Preclinical Pharmacology of ((1 R,3 S)-1-Amino-3-(( S)-6-(2-methoxyphenethyl)-5,6,7,8-tetrahydronaphthalen-2-yl)cyclopentyl)methanol (BMS-986166): A Differentiated Sphingosine-1-phosphate Receptor 1 (S1P₁) Modulator Advanced into Clinical Trials.

Gilmore JL, Xiao HY, Dhar TGM, Yang MG, Xiao Z, Xie J, Lehman-McKeeman LD, Gong L, Sun H, Lecureux L, Chen C, Wu DR, Dabros M, Yang X, Taylor TL, Zhou XD, Heimrich EM, Thomas R, McIntyre KW, Borowski V, Warrack BM, Li Y, Shi H, Levesque PC, Yang Z, Marino AM, Cornelius G, D'Arienzo CJ, Mathur A, Rampulla R, Gupta A, Pragalathan B, Shen DR, Cvijic ME, Salter-Cid LM, Carter PH, Dyckman AJ.

J Med Chem. 2019 Mar 14;62(5):2265-2285. doi: 10.1021/acs.jmedchem.8b01695. Epub 2019 Mar 6.

PMID: 30785748

 

New epitopes in ovalbumin provide insights for cancer neoepitopes.

Karandikar SH, Sidney J, Sette A, Selby MJ, Korman AJ, Srivastava PK.

JCI Insight. 2019 Mar 14;5. pii: 127882. doi: 10.1172/jci.insight.127882.

PMID: 30869653

 

Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: is aromatic N-oxide a structural alert for predicting DNA-reactive mutagenicity?

Amberg A, Anger LT, Bercu J, Bower D, Cross KP, Custer L, Harvey JS, Hasselgren C, Honma M, Johnson C, Jolly R, Kenyon MO, Kruhlak NL, Leavitt P, Quigley DP, Miller S, Snodin D, Stavitskaya L, Teasdale A, Trejo-Martin A, White AT, Wichard J, Myatt GJ.

Mutagenesis. 2019 Mar 6;34(1):67-82. doi: 10.1093/mutage/gey020.

PMID: 30189015

 

Exceptional response and multisystem autoimmune-like toxicities associated with the same T cell clone in a patient with uveal melanoma treated with immune checkpoint inhibitors.

Rapisuwon S, Izar B, Batenchuk C, Avila A, Mei S, Sorger P, Parks JM, Cooper SJ, Wagner D, Zeck JC, Charabaty AJ, Atkins MB.

J Immunother Cancer. 2019 Mar 4;7(1):61. doi: 10.1186/s40425-019-0533-0.

PMID: 30832716

 

Linking (Pyr)₁apelin-13 pharmacokinetics to efficacy: Stabilization and measurement of a high clearance peptide in rodents.

Onorato JM, Xu C, Chen XQ, Rose AV, Generaux C, Lentz K, Shipkova P, Arthur S, Hennan JK, Haskell R, Myers MC, Lawrence RM, Finlay HJ, Basso M, Bostwick J, Fernando G, Garcia R, Hellings S, Hsu MY, Zhang R, Zhao L, Gargalovic P.

Anal Biochem. 2019 Mar 1;568:41-50. doi: 10.1016/j.ab.2018.12.022. Epub 2018 Dec 31.

PMID: 30605634

IL-17A Recruits Rab35 to IL-17R to Mediate PKCα-Dependent Stress Fiber Formation and Airway Smooth Muscle Contractility.

Bulek K, Chen X, Parron V, Sundaram A, Herjan T, Ouyang S, Liu C, Majors A, Zepp J, Gao J, Dongre A, Bodaszewska-Lubas M, Echard A, Aronica M, Carman J, Garantziotis S, Sheppard D, Li X.

J Immunol. 2019 Mar 1;202(5):1540-1548. doi: 10.4049/jimmunol.1801025. Epub 2019 Jan 25.

PMID: 30683702

Author Correction: A shape-shifting redox foldase contributes to Proteus mirabilis copper resistance.

Furlong EJ, Lo AW, Kurth F, Premkumar L, Totsika M, Achard MES, Halili MA, Heras B, Whitten AE, Choudhury HG, Schembri MA, Martin JL.

Nat Commun. 2019 Mar 1;10(1):976. doi: 10.1038/s41467-019-08920-9.

PMID: 30824772

 

Bioanalytical challenges and unique considerations to support pharmacokinetic characterization of bispecific biotherapeutics.

Ma M, Colletti K, Yang TY, Leung S, Pederson S, Hottenstein CS, Xu X, Warrino D, Wakshull E.

Bioanalysis. 2019 Mar;11(5):427-435. doi: 10.4155/bio-2018-0146. Epub 2019 Mar 19.

PMID: 30887822

 

Systematic Interpolation Method Predicts Antibody Monomer-Dimer Separation by Gradient Elution Chromatography at High Protein Loads.

Creasy A, Reck J, Pabst T, Hunter A, Barker G, Carta G.

Biotechnol J. 2019 Mar;14(3):e1800132. doi: 10.1002/biot.201800132. Epub 2018 Jun 11.

PMID: 29809318

 

Association of Tumor Microenvironment T-cell Repertoire and Mutational Load with Clinical Outcome after Sequential Checkpoint Blockade in Melanoma.

Yusko E, Vignali M, Wilson RK, Mardis ER, Hodi FS, Horak C, Chang H, Woods DM, Robins H, Weber J.

Cancer Immunol Res. 2019 Mar;7(3):458-465. doi: 10.1158/2326-6066.CIR-18-0226. Epub 2019 Jan 11.

PMID: 30635271

 

The use of fast photochemical oxidation of proteins coupled with mass spectrometry in protein therapeutics discovery and development.

Li J, Chen G.

Drug Discov Today. 2019 Mar;24(3):829-834. doi: 10.1016/j.drudis.2018.12.008. Epub 2018 Dec 21. Review.

PMID: 30583089

 

Clinical and economic outcomes associated with treatment sequences in patients with BRAF-mutant advanced melanoma.

Tarhini A, McDermott D, Ambavane A, Gupte-Singh K, Aponte-Ribero V, Ritchings C, Benedict A, Rao S, Regan MM, Atkins M.

Immunotherapy. 2019 Mar;11(4):283-295. doi: 10.2217/imt-2018-0168. Epub 2018 Dec 19.

PMID: 30563395

 

Population Pharmacokinetics and Exposure - Safety Analyses of Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma.

Wang X, Ludwig EA, Passarell J, Bello A, Roy A, Hruska MW.

J Clin Pharmacol. 2019 Mar;59(3):364-373. doi: 10.1002/jcph.1324. Epub 2018 Oct 19.

PMID: 30339279

 

Impact of earlier versus later monitoring on disease progression and healthcare costs among patients with chronic myeloid leukemia in the United States.

Jabbour EJ, Siegartel LR, Lin J, Lingohr-Smith M, Menges B, Makenbaeva D.

Leuk Lymphoma. 2019 Mar;60(3):668-674. doi: 10.1080/10428194.2018.1492124. Epub 2018 Aug 20.

PMID: 30124372

 

Preclinical assessment of an antibody-PBD conjugate that targets BCMA on multiple myeloma and myeloma progenitor cells.

Kinneer K, Flynn M, Thomas SB, Meekin J, Varkey R, Xiao X, Zhong H, Breen S, Hynes PG, Fleming R, Bezabeh B, Chen CT, Wetzel L, Chen R, Dimasi N, Tai YT, Anderson KC, Herbst R, Howard PW, Hurt EM, Tice DA.

Leukemia. 2019 Mar;33(3):766-771. doi: 10.1038/s41375-018-0278-7. Epub 2018 Oct 12. No abstract available.

PMID: 30315237

 

A single dose of neoadjuvant PD-1 blockade predicts clinical outcomes in resectable melanoma.

Huang AC, Orlowski RJ, Xu X, Mick R, George SM, Yan PK, Manne S, Kraya AA, Wubbenhorst B, Dorfman L, D'Andrea K, Wenz BM, Liu S, Chilukuri L, Kozlov A, Carberry M, Giles L, Kier MW, Quagliarello F, McGettigan S, Kreider K, Annamalai L, Zhao Q, Mogg R, Xu W, Blumenschein WM, Yearley JH, Linette GP, Amaravadi RK, Schuchter LM, Herati RS, Bengsch B, Nathanson KL, Farwell MD, Karakousis GC, Wherry EJ, Mitchell TC.

Nat Med. 2019 Mar;25(3):454-461. doi: 10.1038/s41591-019-0357-y. Epub 2019 Feb 25.

PMID: 30804515

 

On estimands and the analysis of adverse events in the presence of varying follow-up times within the benefit assessment of therapies.

Unkel S, Amiri M, Benda N, Beyersmann J, Knoerzer D, Kupas K, Langer F, Leverkus F, Loos A, Ose C, Proctor T, Schmoor C, Schwenke C, Skipka G, Unnebrink K, Voss F, Friede T.

Pharm Stat. 2019 Mar;18(2):166-183. doi: 10.1002/pst.1915. Epub 2018 Nov 20.

PMID: 30458579

 

Correction to: Can We Accurately Predict Cost Effectiveness Without Access to Overall Survival Data? The Case Study of Nivolumab in Combination with Ipilimumab for the Treatment of Patients with Advanced Melanoma in England.

Lee D, Amadi A, Sabater J, Ellis J, Johnson H, Kotapati S, McNamara S, Walker A, Cooper M, Patterson K, Roskell N, Meng Y.

Pharmacoecon Open. 2019 Mar;3(1):127. doi: 10.1007/s41669-018-0096-x.

PMID: 30206825

 

Can We Accurately Predict Cost Effectiveness Without Access to Overall Survival Data? The Case Study of Nivolumab in Combination with Ipilimumab for the Treatment of Patients with Advanced Melanoma in England.

Lee D, Amadi A, Sabater J, Ellis J, Johnson H, Kotapati S, McNamara S, Walker A, Cooper M, Patterson K, Roskell N, Meng Y.

Pharmacoecon Open. 2019 Mar;3(1):43-54. doi: 10.1007/s41669-018-0080-5. Erratum in: Pharmacoecon Open. 2018 Sep 11;:.

PMID: 29790020

 

Pharmaceutical industry perspective on combination toxicity studies: Results from an intra-industry survey conducted by IQ DruSafe Leadership Group.

Birkebak J, Buckley LA, Dambach D, Musvasva E, Price K, Ralston S, Sacaan A.

Regul Toxicol Pharmacol. 2019 Mar;102:40-46. doi: 10.1016/j.yrtph.2018.12.012. Epub 2018 Dec 19.

PMID: 30576687

 

Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses.

Amberg A, Andaya RV, Anger LT, Barber C, Beilke L, Bercu J, Bower D, Brigo A, Cammerer Z, Cross KP, Custer L, Dobo K, Gerets H, Gervais V, Glowienke S, Gomez S, Van Gompel J, Harvey J, Hasselgren C, Honma M, Johnson C, Jolly R, Kemper R, Kenyon M, Kruhlak N, Leavitt P, Miller S, Muster W, Naven R, Nicolette J, Parenty A, Powley M, Quigley DP, Reddy MV, Sasaki JC, Stavitskaya L, Teasdale A, Trejo-Martin A, Weiner S, Welch DS, White A, Wichard J, Woolley D, Myatt GJ.

Regul Toxicol Pharmacol. 2019 Mar;102:53-64. doi: 10.1016/j.yrtph.2018.12.007. Epub 2018 Dec 15.

PMID: 30562600

 

Xenobiotic Transporters in the Kidney: Function and Role in Toxicity.

Shen H, Scialis RJ, Lehman-McKeeman L.

Semin Nephrol. 2019 Mar;39(2):159-175. doi: 10.1016/j.semnephrol.2018.12.010. Review.

PMID: 30827339

 

Kidney Safety Assessment: Current Practices in Drug Development.

Troth SP, Simutis F, Friedman GS, Todd S, Sistare FD.

Semin Nephrol. 2019 Mar;39(2):120-131. doi: 10.1016/j.semnephrol.2018.12.002. Review.

PMID: 30827335

 

Assessing seizure liability using multi-electrode arrays (MEA).

Fan J, Thalody G, Kwagh J, Burnett E, Shi H, Lewen G, Chen SJ, Levesque P.

Toxicol In Vitro. 2019 Mar;55:93-100. doi: 10.1016/j.tiv.2018.12.001. Epub 2018 Dec 4.

PMID: 30528373

Structure, heterogeneity and developability assessment of therapeutic antibodies.

Xu Y, Wang D, Mason B, Rossomando T, Li N, Liu D, Cheung JK, Xu W, Raghava S, Katiyar A, Nowak C, Xiang T, Dong DD, Sun J, Beck A, Liu H.

MAbs. 2019 Feb/Mar;11(2):239-264. doi: 10.1080/19420862.2018.1553476. Epub 2018 Dec 17. Review.

PMID: 30543482

 

Adherence to recommended clinical guidelines in extensive disease small-cell lung cancer across the US, Europe, and Japan.

DiBonaventura MD, Shah-Manek B, Higginbottom K, Penrod JR, Yuan Y.

Ther Clin Risk Manag. 2019 Feb 28;15:355-366. doi: 10.2147/TCRM.S183216. eCollection 2019.

PMID: 30881001

 

Structure-based Discovery of Phenyl (3-Phenylpyrrolidin-3-yl)sulfones as Selective, Orally Active RORγt Inverse Agonists.

Duan JJ, Lu Z, Jiang B, Stachura S, Weigelt CA, Sack JS, Khan J, Ruzanov M, Galella MA, Wu DR, Yarde M, Shen DR, Shuster DJ, Borowski V, Xie JH, Zhang L, Vanteru S, Gupta AK, Mathur A, Zhao Q, Foster W, Salter-Cid LM, Carter PH, Dhar TGM.

ACS Med Chem Lett. 2019 Feb 26;10(3):367-373. doi: 10.1021/acsmedchemlett.9b00010. eCollection 2019 Mar 14.

PMID: 30891142

 

Role of FcγRs in Antibody-Based Cancer Therapy.

Graziano RF, Engelhardt JJ.

Curr Top Microbiol Immunol. 2019 Feb 22;423:13-34. doi: 10.1007/82_2019_150. Review.

PMID: 30790079

 

First-Principles and Empirical Approaches to Predicting In Vitro Dissolution for Pharmaceutical Formulation and Process Development and for Product Release Testing.

Zaborenko N, Shi Z, Corredor CC, Smith-Goettler BM, Zhang L, Hermans A, Neu CM, Alam MA, Cohen MJ, Lu X, Xiong L, Zacour BM.

AAPS J. 2019 Feb 21;21(3):32. doi: 10.1208/s12248-019-0297-y. Review.

PMID: 30790200

 

Identification of Imidazo[1,2-b]pyridazine Derivatives as Potent, Selective, and Orally Active Tyk2 JH2 Inhibitors.

Liu C, Lin J, Moslin R, Tokarski JS, Muckelbauer J, Chang C, Tredup J, Xie D, Park H, Li P, Wu DR, Strnad J, Zupa-Fernandez A, Cheng L, Chaudhry C, Chen J, Chen C, Sun H, Elzinga P, D'arienzo C, Gillooly K, Taylor TL, McIntyre KW, Salter-Cid L, Lombardo LJ, Carter PH, Aranibar N, Burke JR, Weinstein DS.

ACS Med Chem Lett. 2019 Feb 21;10(3):383-388. doi: 10.1021/acsmedchemlett.9b00035. eCollection 2019 Mar 14.

PMID: 30891145

 

Optimal design, anti-tumour efficacy and tolerability of anti-CXCR4 antibody drug conjugates.

Costa MJ, Kudaravalli J, Ma JT, Ho WH, Delaria K, Holz C, Stauffer A, Chunyk AG, Zong Q, Blasi E, Buetow B, Tran TT, Lindquist K, Dorywalska M, Rajpal A, Shelton DL, Strop P, Liu SH.

Sci Rep. 2019 Feb 21;9(1):2443. doi: 10.1038/s41598-019-38745-x.

PMID: 30792442

 

Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study.

Ansell SM, Minnema MC, Johnson P, Timmerman JM, Armand P, Shipp MA, Rodig SJ, Ligon AH, Roemer MGM, Reddy N, Cohen JB, Assouline S, Poon M, Sharma M, Kato K, Samakoglu S, Sumbul A, Grigg A.

J Clin Oncol. 2019 Feb 20;37(6):481-489. doi: 10.1200/JCO.18.00766. Epub 2019 Jan 8.

PMID: 30620669

 

A convenient strategy to overcome interference in LC-MS/MS analysis: Application in a microdose absolute bioavailability study.

Yuan L, Huang C, Liu-Kreyche P, Voronin K, Fancher RM, Allentoff A, Zheng N, Iyer R, Zhu L, Pillutla R, Ji QC.

J Pharm Biomed Anal. 2019 Feb 20;165:198-206. doi: 10.1016/j.jpba.2018.12.014. Epub 2018 Dec 10.

PMID: 30553110

 

Targeting DDR2 enhances tumor response to anti-PD-1 immunotherapy.

Tu MM, Lee FYF, Jones RT, Kimball AK, Saravia E, Graziano RF, Coleman B, Menard K, Yan J, Michaud E, Chang H, Abdel-Hafiz HA, Rozhok AI, Duex JE, Agarwal N, Chauca-Diaz A, Johnson LK, Ng TL, Cambier JC, Clambey ET, Costello JC, Korman AJ, Theodorescu D.

Sci Adv. 2019 Feb 20;5(2):eaav2437. doi: 10.1126/sciadv.aav2437. eCollection 2019 Feb.

PMID: 30801016

 

Identification and Preclinical Evaluation of the Bicyclic Pyrimidine γ-Secretase Modulator BMS-932481.

Boy KM, Guernon JM, Zuev DS, Xu L, Zhang Y, Shi J, Marcin LR, Higgins MA, Wu YJ, Krishnananthan S, Li J, Trehan A, Smith D, Toyn JH, Meredith JE, Burton CR, Kimura SR, Zvyaga T, Zhuo X, Lentz KA, Grace JE, Denton R, Morrison JS, Mathur A, Albright CF, Ahlijanian MK, Olson RE, Thompson LA, Macor JE.

ACS Med Chem Lett. 2019 Feb 17;10(3):312-317. doi: 10.1021/acsmedchemlett.8b00541. eCollection 2019 Mar 14.

PMID: 30891132

 

A practical workflow for capillary microsampling in nonclinical studies.

Wang L, Wang B, Chadwick KD, Su T, Mangipudy R, Pillutla RC, Ji QC.

Bioanalysis. 2019 Feb 15. doi: 10.4155/bio-2018-0224. [Epub ahead of print]

PMID: 30767556

 

Discovery of new indole-based acylsulfonamide Na_v1.7 inhibitors.

Wu YJ, Venables B, Guernon J, Chen J, Sit SY, Rajamani R, Knox RJ, Matchett M, Pieschl RL, Herrington J, Bristow LJ, Meanwell NA, Thompson LA, Dzierba C.

Bioorg Med Chem Lett. 2019 Feb 15;29(4):659-663. doi: 10.1016/j.bmcl.2018.12.013. Epub 2018 Dec 6.

PMID: 30638874

 

Discovery of a JAK1/3 Inhibitor and Use of a Prodrug To Demonstrate Efficacy in a Model of Rheumatoid Arthritis.

Spergel SH, Mertzman ME, Kempson J, Guo J, Stachura S, Haque L, Lippy JS, Zhang RF, Galella M, Pitt S, Shen G, Fura A, Gillooly K, McIntyre KW, Tang V, Tokarski J, Sack JS, Khan J, Carter PH, Barrish JC, Nadler SG, Salter-Cid LM, Schieven GL, Wrobleski ST, Pitts WJ.

ACS Med Chem Lett. 2019 Feb 13;10(3):306-311. doi: 10.1021/acsmedchemlett.8b00508. eCollection 2019 Mar 14.

PMID: 30891131

 

Pd_II -Catalyzed Enantioselective C(sp₃ )-H Activation/Cross-Coupling Reactions of Free Carboxylic Acids.

Hu L, Shen PX, Shao Q, Hong K, Qiao JX, Yu JQ.

Angew Chem Int Ed Engl. 2019 Feb 11;58(7):2134-2138. doi: 10.1002/anie.201813055. Epub 2019 Jan 16.

PMID: 30536546

 

Ligand-Promoted Non-Directed C-H Cyanation of Arenes.

Liu LY, Yeung KS, Yu JQ.

Chemistry. 2019 Feb 11;25(9):2199-2202. doi: 10.1002/chem.201805772. Epub 2019 Jan 16.

PMID: 30478935

 

Degradation of the extracellular matrix is part of the pathology of ulcerative colitis.

Kirov S, Sasson A, Zhang C, Chasalow S, Dongre A, Steen H, Stensballe A, Andersen V, Birkelund S, Bennike TB.

Mol Omics. 2019 Feb 11;15(1):67-76. doi: 10.1039/c8mo00239h.

PMID: 30702115

 

Second Generation Inhibitors of HIV-1 Maturation.

Regueiro-Ren A, Dicker IB, Hanumegowda U, Meanwell NA.

ACS Med Chem Lett. 2019 Feb 8;10(3):287-294. doi: 10.1021/acsmedchemlett.8b00656. eCollection 2019 Mar 14.

PMID: 30891128

 

Separation of Bruton's tyrosine kinase inhibitor atropisomers by supercritical fluid chromatography.

Yip SH, Wu DR, Li P, Sun D, Watterson SH, Zhao R, Tino J, Mathur A.

J Chromatogr A. 2019 Feb 8;1586:106-115. doi: 10.1016/j.chroma.2018.12.006. Epub 2018 Dec 14.

PMID: 30578026

 

Re-treatment with abatacept plus methotrexate for disease flare after complete treatment withdrawal in patients with early rheumatoid arthritis: 2-year results from the AVERT study.

Emery P, Burmester GR, Bykerk VP, Combe BG, Furst DE, Maldonado MA, Huizinga TW.

RMD Open. 2019 Feb 8;5(1):e000840. doi: 10.1136/rmdopen-2018-000840. eCollection 2019.

PMID: 30997151

 

In-Sample Calibration Curve Using Multiple Isotopologue Reaction Monitoring of a Stable Isotopically Labeled Analyte for Instant LC-MS/MS Bioanalysis and Quantitative Proteomics.

Gu H, Zhao Y, DeMichele M, Zheng N, Zhang YJ, Pillutla R, Zeng J.

Anal Chem. 2019 Feb 5;91(3):2536-2543. doi: 10.1021/acs.analchem.8b05656. Epub 2019 Jan 22.

PMID: 30615432

Molecular characterization of a precision-cut rat lung slice model for the evaluation of antifibrotic drugs.

Huang X, Li L, Ammar R, Zhang Y, Wang Y, Ravi K, Thompson J, Jarai G.

Am J Physiol Lung Cell Mol Physiol. 2019 Feb 1;316(2):L348-L357. doi: 10.1152/ajplung.00339.2018. Epub 2018 Nov 29.

PMID: 30489156

Uncialamycin as a novel payload for antibody drug conjugate (ADC) based targeted cancer therapy.

Chowdari NS, Pan C, Rao C, Langley DR, Sivaprakasam P, Sufi B, Derwin D, Wang Y, Kwok E, Passmore D, Rangan VS, Deshpande S, Cardarelli P, Vite G, Gangwar S.

Bioorg Med Chem Lett. 2019 Feb 1;29(3):466-470. doi: 10.1016/j.bmcl.2018.12.021. Epub 2018 Dec 11.

PMID: 30579797

Relative quantitation of endogenous proteins by quadrupole-time of flight and tandem mass spectrometry.

Gautam SS, Wagh S, Babu S, Gudihal R, Rajagopalan S, Kole P, Mandlekar S, Subramanian M.

J Chromatogr B Analyt Technol Biomed Life Sci. 2019 Feb 1;1106-1107:11-18. doi: 10.1016/j.jchromb.2018.12.023. Epub 2018 Dec 28. No abstract available.

PMID: 30615973

Seamless Designs: Current Practice and Considerations for Early-Phase Drug Development in Oncology.

Hobbs BP, Barata PC, Kanjanapan Y, Paller CJ, Perlmutter J, Pond GR, Prowell TM, Rubin EH, Seymour LK, Wages NA, Yap TA, Feltquate D, Garrett-Mayer E, Grossman W, Hong DS, Ivy SP, Siu LL, Reeves SA, Rosner GL.

J Natl Cancer Inst. 2019 Feb 1;111(2):118-128. doi: 10.1093/jnci/djy196. Review.

PMID: 30561713

Comparison of Immediate vs Deferred Cytoreductive Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma Receiving Sunitinib: The SURTIME Randomized Clinical Trial.

Bex A, Mulders P, Jewett M, Wagstaff J, van Thienen JV, Blank CU, van Velthoven R, Del Pilar Laguna M, Wood L, van Melick HHE, Aarts MJ, Lattouf JB, Powles T, de Jong Md PhD IJ, Rottey S, Tombal B, Marreaud S, Collette S, Collette L, Haanen J.

JAMA Oncol. 2019 Feb 1;5(2):164-170. doi: 10.1001/jamaoncol.2018.5543. Erratum in: JAMA Oncol. 2019 Feb 1;5(2):271.

PMID: 30543350

 

Survival Outcomes in Patients With Previously Untreated BRAF Wild-Type Advanced Melanoma Treated With Nivolumab Therapy: Three-Year Follow-up of a Randomized Phase 3 Trial.

Ascierto PA, Long GV, Robert C, Brady B, Dutriaux C, Di Giacomo AM, Mortier L, Hassel JC, Rutkowski P, McNeil C, Kalinka-Warzocha E, Savage KJ, Hernberg MM, Lebbé C, Charles J, Mihalcioiu C, Chiarion-Sileni V, Mauch C, Cognetti F, Ny L, Arance A, Svane IM, Schadendorf D, Gogas H, Saci A, Jiang J, Rizzo J, Atkinson V.

JAMA Oncol. 2019 Feb 1;5(2):187-194. doi: 10.1001/jamaoncol.2018.4514. Erratum in: JAMA Oncol. 2019 Feb 1;5(2):271.

PMID: 30422243

 

Safety and Efficacy of Durvalumab With or Without Tremelimumab in Patients With PD-L1-Low/Negative Recurrent or Metastatic HNSCC: The Phase 2 CONDOR Randomized Clinical Trial.

Siu LL, Even C, Mesía R, Remenar E, Daste A, Delord JP, Krauss J, Saba NF, Nabell L, Ready NE, Braña I, Kotecki N, Zandberg DP, Gilbert J, Mehanna H, Bonomi M, Jarkowski A, Melillo G, Armstrong JM, Wildsmith S, Fayette J.

JAMA Oncol. 2019 Feb 1;5(2):195-203. doi: 10.1001/jamaoncol.2018.4628.

PMID: 30383184

 

Environmental risk assessment of metformin and its transformation product guanylurea. I. Environmental fate.

Straub JO, Caldwell DJ, Davidson T, D'Aco V, Kappler K, Robinson PF, Simon-Hettich B, Tell J.

Chemosphere. 2019 Feb;216:844-854. doi: 10.1016/j.chemosphere.2018.10.036. Epub 2018 Oct 9.

PMID: 30449313

 

Environmental risk assessment of metformin and its transformation product guanylurea: II. Occurrence in surface waters of Europe and the United States and derivation of predicted no-effect concentrations.

Caldwell DJ, D'Aco V, Davidson T, Kappler K, Murray-Smith RJ, Owen SF, Robinson PF, Simon-Hettich B, Straub JO, Tell J.

Chemosphere. 2019 Feb;216:855-865. doi: 10.1016/j.chemosphere.2018.10.038. Epub 2018 Oct 15.

PMID: 30385066

 

Challenges and Opportunities With Oncology Drug Development in China.

Bajaj G, Gupta M, Wang HH, Barrett JS, Tan M, Rupalla K, Bertz R, Sheng J.

Clin Pharmacol Ther. 2019 Feb;105(2):363-375. doi: 10.1002/cpt.1017. Epub 2018 Mar 8. Review.

PMID: 29328503

 

A Survey of Software Tool Utilization and Capabilities for Quantitative Systems Pharmacology: What We Have and What We Need.

Ermakov S, Schmidt BJ, Musante CJ, Thalhauser CJ.

CPT Pharmacometrics Syst Pharmacol. 2019 Feb;8(2):62-76. doi: 10.1002/psp4.12373. Epub 2019 Jan 30.

PMID: 30417600

 

Effect of apixaban compared with warfarin on coagulation markers in atrial fibrillation.

Christersson C, Wallentin L, Andersson U, Alexander JH, Alings M, De Caterina R, Gersh BJ, Granger CB, Halvorsen S, Hanna M, Huber K, Hylek EM, Lopes RD, Oh BH, Siegbahn A.

Heart. 2019 Feb;105(3):235-242. doi: 10.1136/heartjnl-2018-313351. Epub 2018 Sep 12.

PMID: 30209126

 

Treatment patterns and outcomes in patients with unresectable or metastatic renal cell carcinoma in Japan.

Harada K, Nozawa M, Uemura M, Tatsugami K, Osawa T, Yamana K, Kimura G, Fujisawa M, Nonomura N, Eto M, Shinohara N, Tomita Y, Kondo Y, Ochi K, Anazawa Y, Uemura H.

Int J Urol. 2019 Feb;26(2):202-210. doi: 10.1111/iju.13830. Epub 2018 Oct 21.

PMID: 30345560

 

Population Pharmacokinetics and Exposure-Response Relationship of Intravenous and Subcutaneous Abatacept in Patients With Rheumatoid Arthritis.

Li X, Roy A, Murthy B.

J Clin Pharmacol. 2019 Feb;59(2):245-257. doi: 10.1002/jcph.1308. Epub 2018 Sep 19.

PMID: 30229926

 

Current Trends in the Surgical Treatment of Open-Book Pelvic Ring Injuries: An International Survey Among Experienced Trauma Surgeons.

Moed BR, Barla J, Israel HA, Tovar S, Joeris A.

J Orthop Trauma. 2019 Feb;33 Suppl 2:S61-S65. doi: 10.1097/BOT.0000000000001411.

PMID: 30688862

 

Pulse Proteolysis: An Orthogonal Tool for Protein Formulation Screening.

Iyer LK, Phanse R, Xu M, Lan W, Krause ME, Bolgar M, Hart S.

J Pharm Sci. 2019 Feb;108(2):842-850. doi: 10.1016/j.xphs.2018.09.018. Epub 2018 Sep 23.

PMID: 30257193

Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032.

Ready N, Farago AF, de Braud F, Atmaca A, Hellmann MD, Schneider JG, Spigel DR, Moreno V, Chau I, Hann CL, Eder JP, Steele NL, Pieters A, Fairchild J, Antonia SJ.

J Thorac Oncol. 2019 Feb;14(2):237-244. doi: 10.1016/j.jtho.2018.10.003. Epub 2018 Oct 10.

PMID: 30316010

 

Safety and activity of ibrutinib in combination with nivolumab in patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukaemia: a phase 1/2a study.

Younes A, Brody J, Carpio C, Lopez-Guillermo A, Ben-Yehuda D, Ferhanoglu B, Nagler A, Ozcan M, Avivi I, Bosch F, Caballero Barrigón MD, Hellmann A, Kuss B, Ma DDF, Demirkan F, Yağci M, Horowitz NA, Marlton P, Cordoba R, Wrobel T, Buglio D, Streit M, Hodkinson BP, Schaffer M, Alvarez J, Ceulemans R, Balasubramanian S, de Jong J, Wang SS, Fourneau N, Jurczak W.

Lancet Haematol. 2019 Feb;6(2):e67-e78. doi: 10.1016/S2352-3026(18)30217-5. Epub 2019 Jan 11.

PMID: 30642819

 

Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial.

Cella D, Grünwald V, Escudier B, Hammers HJ, George S, Nathan P, Grimm MO, Rini BI, Doan J, Ivanescu C, Paty J, Mekan S, Motzer RJ.

Lancet Oncol. 2019 Feb;20(2):297-310. doi: 10.1016/S1470-2045(18)30778-2. Epub 2019 Jan 15. Erratum in: Lancet Oncol. 2019 Jun;20(6):e293.

PMID: 30658932

 

Can switching to abatacept therapy in patients with rheumatoid arthritis on background methotrexate reverse TNF-inhibitor-induced antinuclear autoantibody/double-stranded DNA autoantibody conversion? An analysis of the AMPLE and ATTEST trials.

Buch MH, Johnsen A, Schiff M.

Clin Exp Rheumatol. 2019 Jan-Feb;37(1):127-132. Epub 2018 Aug 21.

PMID: 30148437

 

Dissolution Testing in Drug Product Development: Workshop Summary Report.

Abend A, Curran D, Kuiper J, Lu X, Li H, Hermans A, Kotwal P, Diaz DA, Cohen MJ, Zhang L, Stippler E, Drazer G, Lin Y, Raines K, Yu L, Coutant CA, Grady H, Krämer J, Pope-Miksinski S, Suarez-Sharp S.

AAPS J. 2019 Jan 28;21(2):21. doi: 10.1208/s12248-018-0288-4.

PMID: 30690680

 

Blockade of the PD-1 axis alone is not sufficient to activate HIV-1 virion production from CD4+ T cells of individuals on suppressive ART.

Bui JK, Cyktor JC, Fyne E, Campellone S, Mason SW, Mellors JW.

PLoS One. 2019 Jan 25;14(1):e0211112. doi: 10.1371/journal.pone.0211112. eCollection 2019.

PMID: 30682108

 

Discovery of Indole- and Indazole-acylsulfonamides as Potent and Selective Na_V1.7 Inhibitors for the Treatment of Pain.

Luo G, Chen L, Easton A, Newton A, Bourin C, Shields E, Mosure K, Soars MG, Knox RJ, Matchett M, Pieschl RL, Post-Munson DJ, Wang S, Herrington J, Graef J, Newberry K, Sivarao DV, Senapati A, Bristow LJ, Meanwell NA, Thompson LA, Dzierba C.

J Med Chem. 2019 Jan 24;62(2):831-856. doi: 10.1021/acs.jmedchem.8b01550. Epub 2019 Jan 8. Erratum in: J Med Chem. 2019 Feb 28;62(4):2213.

PMID: 30576602

 

PBPK Absorption Modeling: Establishing the In Vitro-In Vivo Link-Industry Perspective.

Stillhart C, Pepin X, Tistaert C, Good D, Van Den Bergh A, Parrott N, Kesisoglou F.

AAPS J. 2019 Jan 23;21(2):19. doi: 10.1208/s12248-019-0292-3.

PMID: 30673891

 

Review of Biomarkers in Ocular Matrices: Challenges and Opportunities.

Tamhane M, Cabrera-Ghayouri S, Abelian G, Viswanath V.

Pharm Res. 2019 Jan 23;36(3):40. doi: 10.1007/s11095-019-2569-8. Review.

PMID: 30673862

 

Therapeutic strategies utilization and resource consumption in patients treated for psoriatic arthritis: findings from a real-world analysis in an Italian setting.

Degli Esposti L, Perrone V, Sangiorgi D, Alessandrini D, Buda S, Cantini F, Mazzini E, Toma C, De Solda F.

Patient Prefer Adherence. 2019 Jan 22;13:187-194. doi: 10.2147/PPA.S178603. eCollection 2019.

PMID: 30774314

 

Bringing Macrolactamization Full Circle: Self-Cleaving Head-to-Tail Macrocyclization of Unprotected Peptides via Mild N-Acyl Urea Activation.

Arbour CA, Belavek KJ, Tariq R, Mukherjee S, Tom JK, Isidro-Llobet A, Kopach ME, Stockdill JL.

J Org Chem. 2019 Jan 18;84(2):1035-1041. doi: 10.1021/acs.joc.8b02418. Epub 2019 Jan 2.

PMID: 30566351

 

Use of a Conformational-Switching Mechanism to Modulate Exposed Polarity: Discovery of CCR2 Antagonist BMS-741672.

Yang MG, Xiao Z, Cherney RJ, Tebben AJ, Batt DG, Brown GD, Chen J, Cvijic ME, Dabros M, Duncia JV, Galella M, Gardner DS, Khandelwal P, Ko SS, Malley MF, Mo R, Pang J, Rose AV, Santella JB 3rd, Shi H, Srivastava A, Traeger SC, Wang B, Xu S, Zhao R, Barrish JC, Mandlekar S, Zhao Q, Carter PH.

ACS Med Chem Lett. 2019 Jan 16;10(3):300-305. doi: 10.1021/acsmedchemlett.8b00439. eCollection 2019 Mar 14.

PMID: 30891130

 

Real-world data and the patient perspective: the PROmise of social media?

McDonald L, Malcolm B, Ramagopalan S, Syrad H.

BMC Med. 2019 Jan 16;17(1):11. doi: 10.1186/s12916-018-1247-8.

PMID: 30646913

 

Direct Carbon Isotope Exchange through Decarboxylative Carboxylation.

Kingston C, Wallace MA, Allentoff AJ, deGruyter JN, Chen JS, Gong SX, Bonacorsi S Jr, Baran PS.

J Am Chem Soc. 2019 Jan 16;141(2):774-779. doi: 10.1021/jacs.8b12035. Epub 2019 Jan 3.

PMID: 30605319

 

The discovery of VU0652957 (VU2957, Valiglurax): SAR and DMPK challenges en route to an mGlu₄ PAM development candidate.

Panarese JD, Engers DW, Wu YJ, Guernon JM, Chun A, Gregro AR, Bender AM, Capstick RA, Wieting JM, Bronson JJ, Macor JE, Westphal R, Soars M, Engers JE, Felts AS, Rodriguez AL, Emmitte KA, Jones CK, Blobaum AL, Conn PJ, Niswender CM, Hopkins CR, Lindsley CW.

Bioorg Med Chem Lett. 2019 Jan 15;29(2):342-346. doi: 10.1016/j.bmcl.2018.10.050. Epub 2018 Nov 1.

PMID: 30503632

 

PTEN Expression, Not Mutation Status in TSC1, TSC2, or mTOR, Correlates with the Outcome on Everolimus in Patients with Renal Cell Carcinoma Treated on the Randomized RECORD-3 Trial.

Voss MH, Chen D, Reising A, Marker M, Shi J, Xu J, Ostrovnaya I, Seshan VE, Redzematovic A, Chen YB, Patel P, Han X, Hsieh JJ, Hakimi AA, Motzer RJ.

Clin Cancer Res. 2019 Jan 15;25(2):506-514. doi: 10.1158/1078-0432.CCR-18-1833. Epub 2018 Oct 16.

PMID: 30327302

 

Comparison of imaged capillary isoelectric focusing and cation exchange chromatography for monitoring dextrose-mediated glycation of monoclonal antibodies in infusion solutions.

Demirdirek B, Lan W, Qiu D, Ding W, Iyer LK, Bolgar MS, Valente JJ.

J Chromatogr B Analyt Technol Biomed Life Sci. 2019 Jan 15;1105:156-163. doi: 10.1016/j.jchromb.2018.12.021. Epub 2018 Dec 17.

PMID: 30594826

 

DNA RETENTION ON DEPTH FILTERS.

Khanal O, Xu X, Singh N, Traylor SJ, Huang C, Ghose S, Li ZJ, Lenhoff AM.

J Memb Sci. 2019 Jan 15;570-571:464-471. doi: 10.1016/j.memsci.2018.10.058. Epub 2018 Oct 24.

PMID: 31223185

 

Subunit mass analysis for monitoring multiple attributes of monoclonal antibodies.

Liu P, Zhu X, Wu W, Ludwig R, Song H, Li R, Zhou J, Tao L, Leone AM.

Rapid Commun Mass Spectrom. 2019 Jan 15;33(1):31-40. doi: 10.1002/rcm.8301.

PMID: 30286260

 

Lattice engineering enables definition of molecular features allowing for potent small-molecule inhibition of HIV-1 entry.

Lai YT, Wang T, O'Dell S, Louder MK, Schön A, Cheung CSF, Chuang GY, Druz A, Lin B, McKee K, Peng D, Yang Y, Zhang B, Herschhorn A, Sodroski J, Bailer RT, Doria-Rose NA, Mascola JR, Langley DR, Kwong PD.

Nat Commun. 2019 Jan 3;10(1):47. doi: 10.1038/s41467-018-07851-1.

PMID: 30604750

Molecular characterization of a precision-cut rat liver slice model for the evaluation of antifibrotic compounds.

Huang X, Cai H, Ammar R, Zhang Y, Wang Y, Ravi K, Thompson J, Jarai G.

Am J Physiol Gastrointest Liver Physiol. 2019 Jan 1;316(1):G15-G24. doi: 10.1152/ajpgi.00281.2018. Epub 2018 Nov 8.

PMID: 30406699

 

Assessment of liver fibrosis progression and regression by a serological collagen turnover profile.

Karsdal MA, Hjuler ST, Luo Y, Rasmussen DGK, Nielsen MJ, Holm Nielsen S, Leeming DJ, Goodman Z, Arch RH, Patel K, Schuppan D.

Am J Physiol Gastrointest Liver Physiol. 2019 Jan 1;316(1):G25-G31. doi: 10.1152/ajpgi.00158.2018. Epub 2018 Aug 30.

PMID: 30160980

Trial Reporting in Immuno-Oncology (TRIO): An American Society of Clinical Oncology-Society for Immunotherapy of Cancer Statement.

Tsimberidou AM, Levit LA, Schilsky RL, Averbuch SD, Chen D, Kirkwood JM, McShane LM, Sharon E, Mileham KF, Postow MA.

J Clin Oncol. 2019 Jan 1;37(1):72-80. doi: 10.1200/JCO.18.00145. Epub 2018 Oct 19.

PMID: 30339040

Characterization of Mauritian Cynomolgus Macaque FcγR Alleles Using Long-Read Sequencing.

Haj AK, Arbanas JM, Yamniuk AP, Karl JA, Bussan HE, Drinkwater KY, Graham ME, Ericsen AJ, Prall TM, Moore K, Cheng L, Gao M, Graziano RF, Loffredo JT, Wiseman RW, O'Connor DH.

J Immunol. 2019 Jan 1;202(1):151-159. doi: 10.4049/jimmunol.1800843. Epub 2018 Dec 10.

PMID: 30530595

 

RORγt Represses IL-10 Production in Th17 Cells To Maintain Their Pathogenicity in Inducing Intestinal Inflammation.

Sun M, He C, Chen L, Yang W, Wu W, Chen F, Cao AT, Yao S, Dann SM, Dhar TGM, Salter-Cid L, Zhao Q, Liu Z, Cong Y.

J Immunol. 2019 Jan 1;202(1):79-92. doi: 10.4049/jimmunol.1701697. Epub 2018 Nov 26.

PMID: 30478092

 

Comparison of Drug Switching and Discontinuation Rates in Patients with Nonvalvular Atrial Fibrillation Treated with Direct Oral Anticoagulants in the United States.

Baker CL, Dhamane AD, Mardekian J, Dina O, Russ C, Rosenblatt L, Lingohr-Smith M, Menges B, Lin J, Nadkarni A.

Adv Ther. 2019 Jan;36(1):162-174. doi: 10.1007/s12325-018-0840-8. Epub 2018 Nov 29.

PMID: 30499067

 

Tyrosine kinase inhibitor interruptions, discontinuations and switching in patients with chronic-phase chronic myeloid leukemia in routine clinical practice: SIMPLICITY.

Hehlmann R, Cortes JE, Zyczynski T, Gambacorti-Passerini C, Goldberg SL, Mauro MJ, Michallet M, Simonsson B, Williams LA, Gajavelli S, DeGutis I, Sen GP, Paquette RL.

Am J Hematol. 2019 Jan;94(1):46-54. doi: 10.1002/ajh.25306. Epub 2018 Oct 31.

PMID: 30290003

 

Salivary Gland Stem Cells Age Prematurely in Primary Sjögren's Syndrome.

Pringle S, Wang X, Verstappen GMPJ, Terpstra JH, Zhang CK, He A, Patel V, Jones RE, Baird DM, Spijkervet FKL, Vissink A, Bootsma H, Coppes RP, Kroese FGM.

Arthritis Rheumatol. 2019 Jan;71(1):133-142. doi: 10.1002/art.40659.

PMID: 29984480

 

Regulatory signaling network in the tumor microenvironment of prostate cancer bone and visceral organ metastases and the development of novel therapeutics.

Chu GC, Chung LWK, Gururajan M, Hsieh CL, Josson S, Nandana S, Sung SY, Wang R, Wu JB, Zhau HE.

Asian J Urol. 2019 Jan;6(1):65-81. doi: 10.1016/j.ajur.2018.11.003. Epub 2018 Nov 28. Review.

PMID: 30775250

 

Model-assisted process characterization and validation for a continuous two-column protein A capture process.

Baur D, Angelo J, Chollangi S, Müller-Späth T, Xu X, Ghose S, Li ZJ, Morbidelli M.

Biotechnol Bioeng. 2019 Jan;116(1):87-98. doi: 10.1002/bit.26849. Epub 2018 Nov 6.

PMID: 30298905

 

Modeling and measuring extracellular matrix alterations in fibrosis: challenges and perspectives for antifibrotic drug discovery.

Sivakumar P, Kitson C, Jarai G.

Connect Tissue Res. 2019 Jan;60(1):62-70. doi: 10.1080/03008207.2018.1500557. Epub 2018 Aug 3. Review.

PMID: 30071759

 

Preface.

Sinz M.

Curr Drug Metab. 2019;20(1):2. doi: 10.2174/138920022001190125110659. No abstract available.

PMID: 30887914

 

Separation, Characterization and Discriminant Analysis of Subvisible Particles in Biologics Formulations.

Akhunzada ZS, Hubert M, Sahin E, Pratt J.

Curr Pharm Biotechnol. 2019;20(3):232-244. doi: 10.2174/1389201020666190214100840.

PMID: 30767738

 

Incidence, outcomes, and risk factors of pleural effusion in patients receiving dasatinib therapy for Philadelphia chromosome-positive leukemia.

Hughes TP, Laneuville P, Rousselot P, Snyder DS, Rea D, Shah NP, Paar D, Abruzzese E, Hochhaus A, Lipton JH, Cortes JE.

Haematologica. 2019 Jan;104(1):93-101. doi: 10.3324/haematol.2018.188987. Epub 2018 Aug 9.

PMID: 30093398

Bioequivalence Comparison of Pediatric Dasatinib Formulations and Elucidation of Absorption Mechanisms Through Integrated PBPK Modeling.

Vaidhyanathan S, Wang X, Crison J, Varia S, Gao JZH, Saxena A, Good D.

J Pharm Sci. 2019 Jan;108(1):741-749. doi: 10.1016/j.xphs.2018.11.005. Epub 2018 Nov 13.

PMID: 30439460

 

Evidence for the Validity of Pyridoxic Acid (PDA) as a Plasma-Based Endogenous Probe for OAT1 and OAT3 Function in Healthy Subjects.

Shen H, Holenarsipur VK, Mariappan TT, Drexler DM, Cantone JL, Rajanna P, Singh Gautam S, Zhang Y, Gan J, Shipkova PA, Marathe P, Humphreys WG.

J Pharmacol Exp Ther. 2019 Jan;368(1):136-145. doi: 10.1124/jpet.118.252643. Epub 2018 Oct 25.

PMID: 30361237

 

Comprehensive Evaluation of the Utility of 20 Endogenous Molecules as Biomarkers of OATP1B Inhibition Compared with Rosuvastatin and Coproporphyrin I.

Barnett S, Ogungbenro K, Ménochet K, Shen H, Humphreys WG, Galetin A.

J Pharmacol Exp Ther. 2019 Jan;368(1):125-135. doi: 10.1124/jpet.118.253062. Epub 2018 Oct 12.

PMID: 30314992

 

Diminished responses to monoaminergic antidepressants but not ketamine in a mouse model for neuropsychiatric lupus.

Srikumar BN, Naidu PS, Kalidindi N, Paschapur M, Adepu B, Subramani S, Nagar J, Srivastava R, Sreedhara MV, Prasad DS, Das ML, Louis JV, Kuchibhotla VK, Dudhgaonkar S, Pieschl RL, Li YW, Bristow LJ, Ramarao M, Vikramadithyan RK.

J Psychopharmacol. 2019 Jan;33(1):25-36. doi: 10.1177/0269881118812102. Epub 2018 Nov 28.

PMID: 30484737

 

Symptom Onset in Aortic Stenosis: Relation to Sex Differences in Left Ventricular Remodeling.

Singh A, Chan DCS, Greenwood JP, Dawson DK, Sonecki P, Hogrefe K, Kelly DJ, Dhakshinamurthy V, Lang CC, Khoo JP, Sprigings D, Steeds RP, Zhang R, Ford I, Jerosch-Herold M, Yang J, Li Z, Ng LL, McCann GP.

JACC Cardiovasc Imaging. 2019 Jan;12(1):96-105. doi: 10.1016/j.jcmg.2017.09.019. Epub 2017 Dec 13.

PMID: 29248646

 

Modulating cell culture oxidative stress reduces protein glycation and acidic charge variant formation.

Chung S, Tian J, Tan Z, Chen J, Zhang N, Huang Y, Vandermark E, Lee J, Borys M, Li ZJ.

MAbs. 2019 Jan;11(1):205-216. doi: 10.1080/19420862.2018.1537533. Epub 2019 Jan 3.

PMID: 30602334

 

Systematic development of temperature shift strategies for Chinese hamster ovary cells based on short duration cultures and kinetic modeling.

Xu J, Tang P, Yongky A, Drew B, Borys MC, Liu S, Li ZJ.

MAbs. 2019 Jan;11(1):191-204. doi: 10.1080/19420862.2018.1525262. Epub 2018 Oct 2.

PMID: 30230966

 

Characterization of CD28_null T cells in idiopathic pulmonary fibrosis.

Habiel DM, Espindola MS, Kitson C, Azzara AV, Coelho AL, Stripp B, Hogaboam CM.

Mucosal Immunol. 2019 Jan;12(1):212-222. doi: 10.1038/s41385-018-0082-8. Epub 2018 Oct 12.

PMID: 30315241

 

Pegbelfermin (BMS-986036), PEGylated FGF21, in Patients with Obesity and Type 2 Diabetes: Results from a Randomized Phase 2 Study.

Charles ED, Neuschwander-Tetri BA, Pablo Frias J, Kundu S, Luo Y, Tirucherai GS, Christian R.

Obesity (Silver Spring). 2019 Jan;27(1):41-49. doi: 10.1002/oby.22344. Epub 2018 Dec 6.

PMID: 30520566

 

Adsorption of polypropylene oxide-polyethylene oxide type surfactants at surfaces of pharmaceutical relevant materials: effect of surface energetics and surfactant structures.

Li J, Rudraraju S, Zheng S, Jaiswal A.

Pharm Dev Technol. 2019 Jan;24(1):70-79. doi: 10.1080/10837450.2018.1425431. Epub 2018 Jan 18.

PMID: 29304723

 

Quality-adjusted survival of nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma: a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis.

McDermott DF, Shah R, Gupte-Singh K, Sabater J, Luo L, Botteman M, Rao S, Regan MM, Atkins M.

Qual Life Res. 2019 Jan;28(1):109-119. doi: 10.1007/s11136-018-1984-3. Epub 2018 Sep 6.

PMID: 30191365

 

Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges.

Polhemus AM, Kadhim H, Barnes S, Zebrowski SE, Simmonds A, Masand SN, Banner J, Dupont M.

Ther Innov Regul Sci. 2019 Jan;53(1):8-24. doi: 10.1177/2168479018801566. Epub 2018 Oct 29.

PMID: 30373404

 

Switching to Another Oral Anticoagulant and Drug Discontinuation Among Elderly Patients With Nonvalvular Atrial Fibrillation Treated With Different Direct Oral Anticoagulants.

Baker CL, Dhamane AD, Rajpura J, Mardekian J, Dina O, Russ C, Rosenblatt L, Lingohr-Smith M, Lin J.

Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619870249. doi: 10.1177/1076029619870249.

PMID: 31418293

 

Exercise Behaviors and Fatigue in Patients Receiving Immunotherapy for Advanced Melanoma: A Cross-Sectional Survey via Social Media.

Hyatt A, Drosdowsky A, Williams N, Paton E, Bennett F, Andersen H, Mathai J, Milne D.

Integr Cancer Ther. 2019 Jan-Dec;18:1534735419864431. doi: 10.1177/1534735419864431.

PMID: 31382768

Nickel-Catalyzed 1,2-Diarylation of Simple Alkenyl Amides.

Derosa J, Kleinmans R, Tran VT, Karunananda MK, Wisniewski SR, Eastgate MD, Engle KM.

J Am Chem Soc. 2018 Dec 26;140(51):17878-17883. doi: 10.1021/jacs.8b11942. Epub 2018 Dec 17.

PMID: 30525575

 

Overcoming the Limitations of γ- and δ-C-H Arylation of Amines through Ligand Development.

Chen YQ, Wang Z, Wu Y, Wisniewski SR, Qiao JX, Ewing WR, Eastgate MD, Yu JQ.

J Am Chem Soc. 2018 Dec 26;140(51):17884-17894. doi: 10.1021/jacs.8b07109. Epub 2018 Dec 14.

PMID: 30500192

 

Impact of electroviscous effect on viscosity in developing highly concentrated protein formulations: Lessons from non-protein charged colloids.

Li J, Cheng Y, Chen X, Zheng S.

Int J Pharm X. 2018 Dec 24;1:100002. doi: 10.1016/j.ijpx.2018.100002. eCollection 2019 Dec. Review.

PMID: 31545855

Systematic literature review of treatment patterns for venous thromboembolism patients during transitions from inpatient to post-discharge settings.

Trocio J, Rosen VM, Gupta A, Dina O, Vo L, Hlavacek P, Rosenblatt L.

Clinicoecon Outcomes Res. 2018 Dec 19;11:23-49. doi: 10.2147/CEOR.S179080. eCollection 2019.

PMID: 30588051

 

 A Middle-Up Approach with Online Capillary Isoelectric Focusing/Mass Spectrometry for In-Depth Characterization of Cetuximab Charge Heterogeneity.

Dai J, Zhang Y.

Anal Chem. 2018 Dec 18;90(24):14527-14534. doi: 10.1021/acs.analchem.8b04396. Epub 2018 Dec 4.

PMID: 30451489

 

A randomized, single ascending dose study of intravenous BIIB092 in healthy participants.

Qureshi IA, Tirucherai G, Ahlijanian MK, Kolaitis G, Bechtold C, Grundman M.

Alzheimers Dement (N Y). 2018 Dec 17;4:746-755. doi: 10.1016/j.trci.2018.10.007. eCollection 2018.

PMID: 30581980

 

A novel solution phase PAI-1/uPA-biotin complex assay for the measurement of active PAI-1 in plasma.

Ma Z, Cheng D.

Anal Biochem. 2018 Dec 15;563:35-39. doi: 10.1016/j.ab.2018.09.020. Epub 2018 Sep 29.

PMID: 30278155

 

Discovery and synthesis of tetrahydropyrimidinedione-4-carboxamides as endothelial lipase inhibitors.

Hu CH, Wang TC, Qiao JX, Haque L, Chen AYA, Taylor DS, Ying X, Onorato JM, Galella M, Shen H, Huang CS, Toussaint N, Li YX, Abell L, Adam LP, Gordon D, Wexler RR, Finlay HJ.

Bioorg Med Chem Lett. 2018 Dec 15;28(23-24):3721-3725. doi: 10.1016/j.bmcl.2018.10.022. Epub 2018 Oct 15.

PMID: 30348490

 

Expression of LAG-3 and efficacy of combination treatment with anti-LAG-3 and anti-PD-1 monoclonal antibodies in glioblastoma.

Harris-Bookman S, Mathios D, Martin AM, Xia Y, Kim E, Xu H, Belcaid Z, Polanczyk M, Barberi T, Theodros D, Kim J, Taube JM, Burger PC, Selby M, Taitt C, Korman A, Ye X, Drake CG, Brem H, Pardoll DM, Lim M.

Int J Cancer. 2018 Dec 15;143(12):3201-3208. doi: 10.1002/ijc.31661. Epub 2018 Sep 24.

PMID: 30248181

 

Impact of Tryptophan Oxidation in Complementarity-Determining Regions of Two Monoclonal Antibodies on Structure-Function Characterized by Hydrogen-Deuterium Exchange Mass Spectrometry and Surface Plasmon Resonance.

Hageman T, Wei H, Kuehne P, Fu J, Ludwig R, Tao L, Leone A, Zocher M, Das TK.

Pharm Res. 2018 Dec 10;36(1):24. doi: 10.1007/s11095-018-2545-8.

PMID: 30536043

 

Direct Lewis Acid Catalyzed Conversion of Enantioenriched N-Acyloxazolidinones to Chiral Esters, Amides, and Acids.

Stevens JM, Parra-Rivera AC, Dixon DD, Beutner GL, DelMonte AJ, Frantz DE, Janey JM, Paulson J, Talley MR.

J Org Chem. 2018 Dec 7;83(23):14245-14261. doi: 10.1021/acs.joc.8b02451. Epub 2018 Nov 19.

PMID: 30412670

 

Methods for determining key components in a mathematical model for tumor-immune dynamics in multiple myeloma.

Gallaher J, Larripa K, Renardy M, Shtylla B, Tania N, White D, Wood K, Zhu L, Passey C, Robbins M, Bezman N, Shelat S, Jay Cho H, Moore H.

J Theor Biol. 2018 Dec 7;458:31-46. doi: 10.1016/j.jtbi.2018.08.037. Epub 2018 Aug 30.

PMID: 30172689

 

Improved patient-reported outcomes in patients with psoriatic arthritis treated with abatacept: results from a phase 3 trial.

Strand V, Alemao E, Lehman T, Johnsen A, Banerjee S, Ahmad HA, Mease PJ.

Arthritis Res Ther. 2018 Dec 6;20(1):269. doi: 10.1186/s13075-018-1769-7.

PMID: 30522501

 

Abatacept in combination with methotrexate in Japanese biologic-naive patients with active rheumatoid arthritis: a randomised placebo-controlled phase IV study.

Matsubara T, Inoue H, Nakajima T, Tanimura K, Sagawa A, Sato Y, Osano K, Nagano S, Ueki Y, Hanyu T, Hashizume K, Amano N, Tanaka Y, Takeuchi T.

RMD Open. 2018 Dec 4;4(2):e000813. doi: 10.1136/rmdopen-2018-000813. eCollection 2018. Erratum in: RMD Open. 2019 Dec 5;5(2):e000813corr1.

PMID: 30622737

 

TLR-stimulated IRAKM activates caspase-8 inflammasome in microglia and promotes neuroinflammation.

Zhang CJ, Jiang M, Zhou H, Liu W, Wang C, Kang Z, Han B, Zhang Q, Chen X, Xiao J, Fisher A, Kaiser WJ, Murayama MA, Iwakura Y, Gao J, Carman J, Dongre A, Dubyak G, Abbott DW, Shi FD, Ransohoff RM, Li X.

J Clin Invest. 2018 Dec 3;128(12):5399-5412. doi: 10.1172/JCI121901. Epub 2018 Oct 29.

PMID: 30372424

 

Impact of elotuzumab treatment on pain and health-related quality of life in patients with relapsed or refractory multiple myeloma: results from the ELOQUENT-2 study.

Cella D, McKendrick J, Kudlac A, Palumbo A, Oukessou A, Vij R, Zyczynski T, Davis C.

Ann Hematol. 2018 Dec;97(12):2455-2463. doi: 10.1007/s00277-018-3469-4. Epub 2018 Sep 4.

PMID: 30178193

 

Role of Macrophage Migration Inhibitory Factor in Granulomatosis With Polyangiitis.

Sreih AG, Ezzedine R, Leng L, Fan J, Yao J, Reid D, Piecychna M, Carette S, Cuthbertson D, Dellaripa P, Hoffman GS, Khalidi NA, Koening CL, Langford CA, Mahr A, McAlear CA, Maksimowicz-Mckinnon K, Monach PA, Seo P, Specks U, St Clair EW, Stone JH, Ytterberg SR, Edberg J, Merkel PA, Bucala R.

Arthritis Rheumatol. 2018 Dec;70(12):2077-2086. doi: 10.1002/art.40655. Epub 2018 Oct 22.

PMID: 29953750

 

Real-world benefit of nivolumab in a Canadian non-small-cell lung cancer cohort.

Juergens RA, Mariano C, Jolivet J, Finn N, Rothenstein J, Reaume MN, Faghih A, Labbé C, Owen S, Shepherd FA, Villeneuve J, Romeyer F, Pettersson F, Butts C.

Curr Oncol. 2018 Dec;25(6):384-392. doi: 10.3747/co.25.4287. Epub 2018 Dec 1.

PMID: 30607113

 

Evaluation of a tiered in vitro testing strategy for assessing the ocular and dermal irritation/corrosion potential of pharmaceutical compounds for worker safety.

Graham JC, Wilt N, Costin GE, Villano C, Bader J, Krawiec L, Sly E, Gould J.

Cutan Ocul Toxicol. 2018 Dec;37(4):380-390. doi: 10.1080/15569527.2018.1483944. Epub 2018 Jul 23.

PMID: 30035615

 

Management of challenging immune-related gastrointestinal adverse events associated with immune checkpoint inhibitors.

Hamamoto Y, Shin N, Hoshino T, Kanai T.

Future Oncol. 2018 Dec;14(30):3187-3198. doi: 10.2217/fon-2018-0509. Epub 2018 Sep 6. Review.

PMID: 30188189

 

A multi-arm phase I dose escalating study of an oral NOTCH inhibitor BMS-986115 in patients with advanced solid tumours.

Aung KL, El-Khoueiry AB, Gelmon K, Tran B, Bajaj G, He B, Chen T, Zhu L, Poojary S, Basak S, Qi Z, Spreafico A, Fischer BS, Desai J.

Invest New Drugs. 2018 Dec;36(6):1026-1036. doi: 10.1007/s10637-018-0597-6. Epub 2018 Apr 10.

PMID: 29637471

 

A real-world, comparative study of FDA-approved diagnostic assays PD-L1 IHC 28-8 and 22C3 in lung cancer and other malignancies.

Batenchuk C, Albitar M, Zerba K, Sudarsanam S, Chizhevsky V, Jin C, Burns V.

J Clin Pathol. 2018 Dec;71(12):1078-1083. doi: 10.1136/jclinpath-2018-205362. Epub 2018 Oct 1.

PMID: 30275099

 

Current Status and Future Perspectives on Neoadjuvant Therapy in Lung Cancer.

Blumenthal GM, Bunn PA Jr, Chaft JE, McCoach CE, Perez EA, Scagliotti GV, Carbone DP, Aerts HJWL, Aisner DL, Bergh J, Berry DA, Jarkowski A, Botwood N, Cross DAE, Diehn M, Drezner NL, Doebele RC, Blakely CM, Eberhardt WEE, Felip E, Gianni L, Keller SP, Leavey PJ, Malik S, Pignatti F, Prowell TM, Redman MW, Rizvi NA, Rosell R, Rusch V, de Ruysscher D, Schwartz LH, Sridhara R, Stahel RA, Swisher S, Taube JM, Travis WD, Keegan P, Wiens JR, Wistuba II, Wynes MW, Hirsch FR, Kris MG.

J Thorac Oncol. 2018 Dec;13(12):1818-1831. doi: 10.1016/j.jtho.2018.09.017. Epub 2018 Sep 27. Review.

PMID: 30268698

 

Manufacturing classification system in the real world: factors influencing manufacturing process choices for filed commercial oral solid dosage formulations, case studies from industry and considerations for continuous processing.

Leane M, Pitt K, Reynolds GK, Dawson N, Ziegler I, Szepes A, Crean AM, Dall Agnol R, The Manufacturing Classification System McS Working Group.

Pharm Dev Technol. 2018 Dec;23(10):964-977. doi: 10.1080/10837450.2018.1534863. Epub 2018 Nov 13. Review.

PMID: 30320539

 

Multivariate analysis as a method to understand variability in a complex excipient, and its contribution to formulation performance.

Tobyn M, Ferreira AP, Lightfoot J, Martin EB, Ghimire M, Vesey C, Kasuboski-Freeman A, Rajabi-Siahboomi A.

Pharm Dev Technol. 2018 Dec;23(10):1146-1155. doi: 10.1080/10837450.2018.1534862. Epub 2018 Nov 14.

PMID: 30303433

 

Bioavailability of protein therapeutics in rats following inhalation exposure: Relevance to occupational exposure limit calculations.

Gould JC, Carvajal I, Davidson T, Graham J, Hillegass J, Julien S, Kozhich A, Wang B, Wei H, Yamniuk AP, Mathias N, Haggerty HG, Graziano M.

Regul Toxicol Pharmacol. 2018 Dec;100:35-44. doi: 10.1016/j.yrtph.2018.10.003. Epub 2018 Oct 3.

PMID: 30291877

On-drug and drug-free remission by baseline symptom duration: abatacept with methotrexate in patients with early rheumatoid arthritis.

Bykerk VP, Burmester GR, Combe BG, Furst DE, Huizinga TWJ, Ahmad HA, Emery P.

Rheumatol Int. 2018 Dec;38(12):2225-2231. doi: 10.1007/s00296-018-4173-3. Epub 2018 Oct 20. Erratum in: Rheumatol Int. 2019 Feb 5;:.

PMID: 30341453

 

Use of prognostic factors of rheumatoid arthritis in clinical practice and perception of their predictive capacity before and after exposure to evidence.

Muñoz-Fernández S, Otón-Sánchez T, Carmona L, Calvo-Alén J, Escudero A, Narváez J, Rodríguez Heredia JM, Romero Yuste S, Vela P, Luján Valdés S, Royo García A, Baquero JL.

Rheumatol Int. 2018 Dec;38(12):2289-2296. doi: 10.1007/s00296-018-4152-8. Epub 2018 Sep 24.

PMID: 30251128

 

Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients.

Lip GYH, Keshishian A, Li X, Hamilton M, Masseria C, Gupta K, Luo X, Mardekian J, Friend K, Nadkarni A, Pan X, Baser O, Deitelzweig S.

Stroke. 2018 Dec;49(12):2933-2944. doi: 10.1161/STROKEAHA.118.020232. Erratum in: Stroke. 2020 Feb;51(2):e44. Stroke. 2020 Apr;51(4):e71.

PMID: 30571400

Practical Strategies for Navigating Toxicologic Pathology in One's Early Career…and Beyond!

Carreira V, Palanisamy G, Quist E, Nelson K, Fossey S, Zimmerman B, Ramaiah L, Schafer KA.

Toxicol Pathol. 2018 Dec;46(8):1037-1048. doi: 10.1177/0192623318805716. Epub 2018 Oct 23.

PMID: 30352538

 

Bioactivation of cyclopropyl rings by P450: an observation encountered during the optimisation of a series of hepatitis C virus NS5B inhibitors.

Zhuo X, Wang YZ, Yeung KS, Zhu J, Huang XS, Parcella KE, Eastman KJ, Kadow JF, Meanwell NA, Shu YZ, Johnson BM.

Xenobiotica. 2018 Dec;48(12):1215-1226. doi: 10.1080/00498254.2017.1409915. Epub 2017 Dec 12.

PMID: 29182424

 

Evaluation of an ATP-Bioluminescence Rapid Microbial Screening Method for In-Process Biologics.

Spaeth S, Tran Q, Liu Z.

PDA J Pharm Sci Technol. 2018 Nov-Dec;72(6):574-583. doi: 10.5731/pdajpst.2018.008557. Epub 2018 Jun 27.

PMID: 29954921

 

Tetrahydroisoquinoline CXCR4 Antagonists Adopt a Hybrid Binding Mode within the Peptide Subpocket of the CXCR4 Receptor.

Katzman BM, Cox BD, Prosser AR, Alcaraz AA, Murat B, Héroux M, Tebben A, Zhang Y, Schroeder GM, Snyder JP, Wilson LJ, Liotta DC.

ACS Med Chem Lett. 2018 Nov 30;10(1):67-73. doi: 10.1021/acsmedchemlett.8b00441. eCollection 2019 Jan 10.

PMID: 30655949

Gradient elution behavior of proteins in hydrophobic interaction chromatography with a U-shaped retention factor curve under overloaded conditions.

Creasy A, Lomino J, Carta G.

J Chromatogr A. 2018 Nov 30;1578:28-34. doi: 10.1016/j.chroma.2018.10.003. Epub 2018 Oct 7.

PMID: 30316612

 

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).

Neubert H, Olah T, Lee A, Fraser S, Dodge R, Laterza O, Szapacs M, Alley SC, Saad OM, Amur S, Chen L, Cherry E, Cho SJ, Cludts I, Donato LD, Edmison A, Ferrari L, Garofolo F, Haidar S, Hopper S, Hottenstein S, Ishii-Watabe A, Kassim S, Kurki P, Lima Santos GM, Miscoria G, Palandra J, Pedras-Vasconcelos J, Piccoli S, Rogstad S, Saito Y, Savoie N, Sikorski T, Spitz S, Staelens L, Verthelyi D, Vinter S, Wadhwa M, Wang YM, Welink J, Weng N, Whale E, Woolf E, Wu J, Yan H, Yu H, Zhou S.

Bioanalysis. 2018 Nov 29. doi: 10.4155/bio-2018-0285. [Epub ahead of print]

 

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).

Stevenson L, Richards S, Pillutla R, Torri A, Kamerud J, Mehta D, Keller S, Purushothama S, Gorovits B, Litwin V, Stebbins C, Marini J, Beaver C, Sperinde G, Siguenza P, Staack RF, Qiu Y, Amaravadi L, Amur S, Fleener CA, Baltrukonis D, Catlett I, Cherry E, Chung S, Cludts I, Donato LD, Fischer S, Fraser S, Garofolo F, Green C, Gunn G, Haidar S, Haulenbeek J, Henderson N, Hopper S, Ishii-Watabe A, Islam R, Janelsins B, Jawa V, Kakkanaiah V, Kamondi S, Kolaitis G, Kubiak RJ, Kumar S, Kurki P, Liang M, Liu P, Maxfield K, Myler H, Palackal N, Palmer R, Pedras-Vasconcelos J, Piccoli S, Rhyne P, Saito Y, Savoie N, Schick E, Schweighardt B, Shih J, Song A, Sriraman P, Staelens L, Sumner G, Sun Y, Ullmann M, Verthelyi D, Wadhwa M, Wang YM, Xu Y, Yan H, Yang TY, Zeng R.

Bioanalysis. 2018 Nov 29. doi: 10.4155/bio-2018-0287. [Epub ahead of print]

PMID: 30488726

 

Renal Cell Carcinoma (RCC) Tumors Display Large Expansion of Double Positive (DP) CD4+CD8+ T Cells With Expression of Exhaustion Markers.

Menard LC, Fischer P, Kakrecha B, Linsley PS, Wambre E, Liu MC, Rust BJ, Lee D, Penhallow B, Manjarrez Orduno N, Nadler SG.

Front Immunol. 2018 Nov 26;9:2728. doi: 10.3389/fimmu.2018.02728. eCollection 2018.

PMID: 30534127

 

The present and future burden of previously treated advanced non-small cell lung cancer (NSCLC) by histology and line of therapy in France, Germany, Italy, and Spain: model-based predictions.

Campbell D, O'Day K, Hertel N, Penrod JR, Manley Daumont M, Lees M.

Popul Health Metr. 2018 Nov 26;16(1):17. doi: 10.1186/s12963-018-0174-4.

PMID: 30477516

 

Development of a Chemiluminescent ELISA Method for the Detection of Total Anti-Adeno Associated Virus Serotype 9 (AAV9) Antibodies.

Kavita U, Dai Y, Salvador L, Miller W, Adam LP, Levesque PC, Zhang YJ, Ji QC, Pillutla RC.

Hum Gene Ther Methods. 2018 Nov 22. doi: 10.1089/hgtb.2018.131. [Epub ahead of print]

PMID: 30351228

 

Sulfonylated Benzothiazoles as Inhibitors of Endothelial Lipase.

Johnson JA, Tora G, Pi Z, Phillips M, Yin X, Yang R, Zhao L, Chen AY, Taylor DS, Basso M, Rose A, Behnia K, Onorato J, Chen XQ, Abell LM, Lu H, Locke G, Caporuscio C, Galella M, Adam LP, Gordon D, Wexler RR, Finlay HJ.

ACS Med Chem Lett. 2018 Nov 21;9(12):1263-1268. doi: 10.1021/acsmedchemlett.8b00424. eCollection 2018 Dec 13.

PMID: 30613337

 

Detection of correlated hidden factors from single cell transcriptomes using Iteratively Adjusted-SVA (IA-SVA).

Lee D, Cheng A, Lawlor N, Bolisetty M, Ucar D.

Sci Rep. 2018 Nov 19;8(1):17040. doi: 10.1038/s41598-018-35365-9.

PMID: 30451954

 

Hospital Resource Utilization and Costs Associated With Warfarin Versus Apixaban Treatment Among Patients Hospitalized for Venous Thromboembolism in the United States.

Deitelzweig S, Guo JD, Hlavacek P, Lin J, Wygant G, Rosenblatt L, Gupta A, Pan X, Mardekian J, Lingohr-Smith M, Menges B, Marshall A, Nadkarni A.

Clin Appl Thromb Hemost. 2018 Nov 15:1076029618800806. doi: 10.1177/1076029618800806. [Epub ahead of print]

PMID: 30433823

 

Intermolecular Reductive C-N Cross Coupling of Nitroarenes and Boronic Acids by P_III/P_V═O Catalysis.

Nykaza TV, Cooper JC, Li G, Mahieu N, Ramirez A, Luzung MR, Radosevich AT.

J Am Chem Soc. 2018 Nov 14;140(45):15200-15205. doi: 10.1021/jacs.8b10769. Epub 2018 Nov 2.

PMID: 30372615

 

Discovery of Clinical Candidate BMS-823778 as an Inhibitor of Human 11β-Hydroxysteroid Dehydrogenase Type 1 (11β-HSD-1).

Li J, Kennedy LJ, Walker SJ, Wang H, Li JJ, Hong Z, O'Connor SP, Ye XY, Chen S, Wu S, Yoon DS, Nayeem A, Camac DM, Ramamurthy V, Morin PE, Sheriff S, Wang M, Harper TW, Golla R, Seethala R, Harrity T, Ponticiello RP, Morgan NN, Taylor JR, Zebo R, Maxwell B, Moulin F, Gordon DA, Robl JA.

ACS Med Chem Lett. 2018 Nov 13;9(12):1170-1174. doi: 10.1021/acsmedchemlett.8b00307. eCollection 2018 Dec 13.

PMID: 30613321

 

Model assisted comparison of Protein A resins and multi-column chromatography for capture processes.

Baur D, Angelo JM, Chollangi S, Xu X, Müller-Späth T, Zhang N, Ghose S, Li ZJ, Morbidelli M.

J Biotechnol. 2018 Nov 10;285:64-73. doi: 10.1016/j.jbiotec.2018.08.014. Epub 2018 Aug 27.

PMID: 30165118

 

Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma.

Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Shelat SG, Robbins M, Rafferty B, San-Miguel J.

N Engl J Med. 2018 Nov 8;379(19):1811-1822. doi: 10.1056/NEJMoa1805762.

PMID: 30403938

 

Structure of the 4-1BB/4-1BBL complex and distinct binding and functional properties of utomilumab and urelumab.

Chin SM, Kimberlin CR, Roe-Zurz Z, Zhang P, Xu A, Liao-Chan S, Sen D, Nager AR, Oakdale NS, Brown C, Wang F, Yang Y, Lindquist K, Yeung YA, Salek-Ardakani S, Chaparro-Riggers J.

Nat Commun. 2018 Nov 8;9(1):4679. doi: 10.1038/s41467-018-07136-7.

PMID: 30410017

 

Whole body PD-1 and PD-L1 positron emission tomography in patients with non-small-cell lung cancer.

Niemeijer AN, Leung D, Huisman MC, Bahce I, Hoekstra OS, van Dongen GAMS, Boellaard R, Du S, Hayes W, Smith R, Windhorst AD, Hendrikse NH, Poot A, Vugts DJ, Thunnissen E, Morin P, Lipovsek D, Donnelly DJ, Bonacorsi SJ, Velasquez LM, de Gruijl TD, Smit EF, de Langen AJ.

Nat Commun. 2018 Nov 7;9(1):4664. doi: 10.1038/s41467-018-07131-y.

PMID: 30405135

 

Structure-Property Basis for Solving Transporter-Mediated Efflux and Pan-Genotypic Inhibition in HCV NS5B Inhibitors.

Yeung KS, Beno BR, Mosure K, Zhu J, Grant-Young KA, Parcella K, Anjanappa P, Bora RO, Selvakumar K, Wang YK, Fang H, Krause R, Rigat K, Liu M, Lemm J, Sheriff S, Witmer M, Tredup J, Jardel A, Kish K, Parker D, Haskell R, Santone K, Meanwell NA, Soars MG, Roberts SB, Kadow JF.

ACS Med Chem Lett. 2018 Nov 5;9(12):1217-1222. doi: 10.1021/acsmedchemlett.8b00379. eCollection 2018 Dec 13.

PMID: 30613329

 

Mass Transport Analysis of the Enhanced Buffer Capacity of the Bicarbonate-CO₂ Buffer in a Phase-Heterogenous System: Physiological and Pharmaceutical Significance.

Al-Gousous J, Sun KX, McNamara DP, Hens B, Salehi N, Langguth P, Bermejo M, Amidon GE, Amidon GL.

Mol Pharm. 2018 Nov 5;15(11):5291-5301. doi: 10.1021/acs.molpharmaceut.8b00783. Epub 2018 Oct 26.

PMID: 30362350

 

Phase Diagrams of Polymer-Dispersed Liquid Crystal Systems of Itraconazole/Component Immiscibility Induced by Molecular Anisotropy.

Kozyra A, Mugheirbi NA, Paluch KJ, Garbacz G, Tajber L.

Mol Pharm. 2018 Nov 5;15(11):5192-5206. doi: 10.1021/acs.molpharmaceut.8b00724. Epub 2018 Oct 10.

PMID: 30252481

 

Nanocrystallization of Rare Tolbutamide Form V in Mesoporous MCM-41 Silica.

Nartowski KP, Malhotra D, Hawarden LE, Fábián L, Khimyak YZ.

Mol Pharm. 2018 Nov 5;15(11):4926-4932. doi: 10.1021/acs.molpharmaceut.8b00575. Epub 2018 Oct 8.

PMID: 30247039

 

The Journey to AAPS 2020: a Reflection from Strategic Planning to PharmSci 360.

Polli JW, McCurdy CR, Wurster DE, DeSilva BS, Bak A, Bendayan R, Meibohm B, Templeton AC, Weiser W; AAPS Leadership.

AAPS J. 2018 Nov 3;21(1):2. doi: 10.1208/s12248-018-0273-y. No abstract available.

PMID: 30392015

 

Clinical and virological properties of hepatitis C virus genotype 4 infection in patients treated with different direct-acting antiviral agents.

Minosse C, Selleri M, Giombini E, Bartolini B, Capobianchi MR, Cerilli S, Loiacono L, Taibi C, D'Offizi G, McPhee F, Garbuglia A.

Infect Drug Resist. 2018 Nov 2;11:2117-2127. doi: 10.2147/IDR.S179158. eCollection 2018.

PMID: 30464554

 

Potent Triazolopyridine Myeloperoxidase Inhibitors.

Wurtz NR, Viet A, Shaw SA, Dilger A, Valente MN, Khan JA, Jusuf S, Narayanan R, Fernando G, Lo F, Liu X, Locke GA, Kopcho L, Abell LM, Sleph P, Basso M, Zhao L, Wexler RR, Duclos F, Kick EK.

ACS Med Chem Lett. 2018 Nov 1;9(12):1175-1180. doi: 10.1021/acsmedchemlett.8b00308. eCollection 2018 Dec 13.

PMID: 30613322

 

Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer.

Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X.

Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

PMID: 30215677

 

2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).

Welink J, Xu Y, Yang E, Wilson A, Henderson N, Luo L, Fraser S, Kavita U, Musuku A, James C, Fraier D, Zhang Y, Goykhman D, Summerfield S, Woolf E, Verhaeghe T, Hughes N, Behling A, Brown K, Bulychev A, Buonarati M, Cherry E, Cho SJ, Cludts I, Dillen L, Dodge R, Edmison A, Garofolo F, Green R, Haidar S, Hottenstein C, Ishii-Watabe A, Jang HG, Ji A, Jones B, Kassim S, Ma M, Lima Santos GM, Norris DA, Owen T, Piccoli S, Ramanathan R, Röhl I, Rosenbaum AI, Saito Y, Sangster T, Savoie N, Stebbins C, Sydor J, de Merbel NV, Verthelyi D, Vinter S, Whale E.

Bioanalysis. 2018 Nov 1;10(22):1781-1801. doi: 10.4155/bio-2018-0268. Epub 2018 Nov 29.

PMID: 30488725

 

IL-2/CD25: A Long-Acting Fusion Protein That Promotes Immune Tolerance by Selectively Targeting the IL-2 Receptor on Regulatory T Cells.

Ward NC, Yu A, Moro A, Ban Y, Chen X, Hsiung S, Keegan J, Arbanas JM, Loubeau M, Thankappan A, Yamniuk AP, Davis JH, Struthers M, Malek TR.

J Immunol. 2018 Nov 1;201(9):2579-2592. doi: 10.4049/jimmunol.1800907. Epub 2018 Oct 3.

PMID: 30282751

 

Obesity paradox on outcome in atrial fibrillation maintained even considering the prognostic influence of biomarkers: insights from the ARISTOTLE trial.

Sandhu RK, Ezekowitz JA, Hijazi Z, Westerbergh J, Aulin J, Alexander JH, Granger CB, Halvorsen S, Hanna MS, Lopes RD, Siegbahn A, Wallentin L.

Open Heart. 2018 Nov 1;5(2):e000908. doi: 10.1136/openhrt-2018-000908. eCollection 2018.

PMID: 30487982

 

Real-world comparison of bleeding risks among non-valvular atrial fibrillation patients prescribed apixaban, dabigatran, or rivaroxaban.

Tepper PG, Mardekian J, Masseria C, Phatak H, Kamble S, Abdulsattar Y, Petkun W, Lip GYH.

PLoS One. 2018 Nov 1;13(11):e0205989. doi: 10.1371/journal.pone.0205989. eCollection 2018.

PMID: 30383768

 

Enhanced Understanding of Pharmaceutical Materials Through Advanced Characterisation and Analysis.

Ferreira AP, Gamble JF, Leane MM, Park H, Olusanmi D, Tobyn M.

AAPS PharmSciTech. 2018 Nov;19(8):3462-3480. doi: 10.1208/s12249-018-1198-6. Epub 2018 Nov 8. Review.

PMID: 30411240

 

The Journey to AAPS 2020: a Reflection from Strategic Planning to PharmSci 360.

Polli JW, McCurdy CR, Wurster DE, DeSilva BS, Bak A, Bendayan R, Meibohm B, Templeton AC, Weiser W; AAPS Leadership.

AAPS PharmSciTech. 2018 Nov;19(8):3325-3327. doi: 10.1208/s12249-018-1200-3. Epub 2018 Nov 3. No abstract available.

PMID: 30390237

 

Differentiation of Type 1 and Type 2 Myocardial Infarctions Among HIV-Infected Patients Requires Adjudication Due to Overlap in Risk Factors.

Nance RM, Crane HM, Ritchings C, Rosenblatt L, Budoff M, Heckbert SR, Drozd DR, Mathews WC, Geng E, Hunt PW, Feinstein MJ, Moore RD, Hsue P, Eron JJ, Burkholder GA, Rodriguez B, Mugavero MJ, Saag MS, Kitahata MM, Delaney JAC.

AIDS Res Hum Retroviruses. 2018 Nov;34(11):916-921. doi: 10.1089/AID.2018.0053. Epub 2018 Aug 21.

PMID: 29984593

 

Cell culture media for recombinant protein expression in Chinese hamster ovary (CHO) cells: History, key components, and optimization strategies.

Ritacco FV, Wu Y, Khetan A.

Biotechnol Prog. 2018 Nov;34(6):1407-1426. doi: 10.1002/btpr.2706. Epub 2018 Oct 5. Review.

PMID: 30290072

 

Patient-reported outcomes with nivolumab in advanced solid cancers.

Tykodi SS, Schadendorf D, Cella D, Reck M, Harrington K, Wagner S, Shaw JW.

Cancer Treat Rev. 2018 Nov;70:75-87. doi: 10.1016/j.ctrv.2018.08.001. Epub 2018 Aug 2. Review.

PMID: 30125799

 

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of BMS-986020, a Lysophosphatidic Acid Receptor Antagonist for the Treatment of Idiopathic Pulmonary Fibrosis.

Palmer SM, Snyder L, Todd JL, Soule B, Christian R, Anstrom K, Luo Y, Gagnon R, Rosen G.

Chest. 2018 Nov;154(5):1061-1069. doi: 10.1016/j.chest.2018.08.1058. Epub 2018 Sep 7.

PMID: 30201408

 

Clinical Probes and Endogenous Biomarkers as Substrates for Transporter Drug-Drug Interaction Evaluation: Perspectives From the International Transporter Consortium.

Chu X, Liao M, Shen H, Yoshida K, Zur AA, Arya V, Galetin A, Giacomini KM, Hanna I, Kusuhara H, Lai Y, Rodrigues D, Sugiyama Y, Zamek-Gliszczynski MJ, Zhang L; International Transporter Consortium.

Clin Pharmacol Ther. 2018 Nov;104(5):836-864. doi: 10.1002/cpt.1216. Review.

PMID: 30347454

 

Population Pharmacokinetics of Apixaban in Subjects With Nonvalvular Atrial Fibrillation.

Cirincione B, Kowalski K, Nielsen J, Roy A, Thanneer N, Byon W, Boyd R, Wang X, Leil T, LaCreta F, Ueno T, Oishi M, Frost C.

CPT Pharmacometrics Syst Pharmacol. 2018 Nov;7(11):728-738. doi: 10.1002/psp4.12347. Epub 2018 Sep 30.

PMID: 30259707

 

The Fast Real-time Assessment of Combination Therapies in Immuno-ONcology (FRACTION) program: innovative, high-throughput clinical screening of immunotherapies.

Simonsen KL, Fracasso PM, Bernstein SH, Wind-Rotolo M, Gupta M, Comprelli A, Reilly TP, Cassidy J.

Eur J Cancer. 2018 Nov;103:259-266. doi: 10.1016/j.ejca.2018.07.127. Epub 2018 Oct 3.

PMID: 30292142

 

The cost-effectiveness of nivolumab monotherapy for the treatment of advanced melanoma patients in England.

Meng Y, Hertel N, Ellis J, Morais E, Johnson H, Philips Z, Roskell N, Walker A, Lee D.

Eur J Health Econ. 2018 Nov;19(8):1163-1172. doi: 10.1007/s10198-018-0964-4. Epub 2018 Mar 9.

PMID: 29524005

 

Population Pharmacokinetic Analysis for Daclatasvir and Asunaprevir in Japanese Subjects With Chronic Hepatitis C Virus Infection.

Osawa M, Ueno T, Ishikawa H, Imai Y, Garimella T.

J Clin Pharmacol. 2018 Nov;58(11):1468-1478. doi: 10.1002/jcph.1274. Epub 2018 Jul 31.

PMID: 30063254

 

Exposure-Response (Efficacy) Analysis of Daclatasvir and Asunaprevir in Japanese Patients With Hepatitis C Virus Infection.

Ueno T, Osawa M, Imai Y, Ishikawa H, Garimella T.

J Clin Pharmacol. 2018 Nov;58(11):1479-1488. doi: 10.1002/jcph.1262. Epub 2018 Jul 31.

PMID: 30063245

 

Patient characteristics and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban or vitamin K antagonists: real-world evidence from Italian administrative databases.

Ramagopalan S, Allan V, Saragoni S, Esposti LD, Alessandrini D, Perrone V, Buda S, Stynes G, Toma C, DeSolda F; a LHUs group.

J Comp Eff Res. 2018 Nov;7(11):1063-1071. doi: 10.2217/cer-2018-0054. Epub 2018 Aug 13.

PMID: 30101611

 

Bead-extraction and heat-dissociation (BEHD): A novel way to overcome drug and matrix interference in immunogenicity testing.

Xu W, Sank M, Cummings J, Carl S, Juhel M, Gleason C, Dodge R, DeSilva BS, Kolaitis G, Pillutla R.

J Immunol Methods. 2018 Nov;462:34-41. doi: 10.1016/j.jim.2018.08.003. Epub 2018 Aug 9.

PMID: 30099014

 

Real-World Comparative Effectiveness, Safety, and Health Care Costs of Oral Anticoagulants in Nonvalvular Atrial Fibrillation Patients in the U.S. Department of Defense Population.

Gupta K, Trocio J, Keshishian A, Zhang Q, Dina O, Mardekian J, Rosenblatt L, Liu X, Hede S, Nadkarni A, Shank T.

J Manag Care Spec Pharm. 2018 Nov;24(11):1116-1127. doi: 10.18553/jmcp.2018.17488. Epub 2018 Sep 13.

PMID: 30212268

 

Optimization of combination therapy for chronic myeloid leukemia with dosing constraints.

Moore H, Strauss L, Ledzewicz U.

J Math Biol. 2018 Nov;77(5):1533-1561. doi: 10.1007/s00285-018-1262-6. Epub 2018 Jul 10.

PMID: 29992481

 

Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial.

Hodi FS, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Cowey CL, Lao CD, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hill A, Hogg D, Marquez-Rodas I, Jiang J, Rizzo J, Larkin J, Wolchok JD.

Lancet Oncol. 2018 Nov;19(11):1480-1492. doi: 10.1016/S1470-2045(18)30700-9. Epub 2018 Oct 22. Erratum in: Lancet Oncol. 2018 Dec;19(12):e668. Lancet Oncol. 2018 Nov;19(11):e581.

PMID: 30361170

 

Unique pattern of neutrophil migration and function during tumor progression.

Patel S, Fu S, Mastio J, Dominguez GA, Purohit A, Kossenkov A, Lin C, Alicea-Torres K, Sehgal M, Nefedova Y, Zhou J, Languino LR, Clendenin C, Vonderheide RH, Mulligan C, Nam B, Hockstein N, Masters G, Guarino M, Schug ZT, Altieri DC, Gabrilovich DI.

Nat Immunol. 2018 Nov;19(11):1236-1247. doi: 10.1038/s41590-018-0229-5. Epub 2018 Oct 15.

PMID: 30323345

 

Extended release of flurbiprofen from tromethamine-buffered HPMC hydrophilic matrix tablets.

Pygall S, Kujawinski S, Timmins P, Melia C.

Pharm Dev Technol. 2018 Nov;23(9):874-881. doi: 10.1080/10837450.2017.1301470. Epub 2017 Mar 16.

PMID: 28298171

 

AggScore: Prediction of aggregation-prone regions in proteins based on the distribution of surface patches.

Sankar K, Krystek SR Jr, Carl SM, Day T, Maier JKX.

Proteins. 2018 Nov;86(11):1147-1156. doi: 10.1002/prot.25594. Epub 2018 Sep 27.

PMID: 30168197

 

Erratum: Effectiveness and Safety of Apixaban versus Warfarin as Outpatient Treatment of Venous Thromboembolism in U.S. Clinical Practice.

Weycker D, Li X, Wygant GD, Lee T, Hamilton M, Luo X, Vo L, Mardekian J, Pan X, Burns L, Atwood M, Hanau A, Cohen AT.

Thromb Haemost. 2018 Nov;118(11):e1-e2. doi: 10.1055/s-0039-3400530. Epub 2020 Jan 27. No abstract available.

PMID: 31986533

 

Effectiveness and Safety of Apixaban versus Warfarin as Outpatient Treatment of Venous Thromboembolism in U.S. Clinical Practice.

Weycker D, Li X, Wygant GD, Lee T, Hamilton M, Luo X, Vo L, Mardekian J, Pan X, Burns L, Atwood M, Hanau A, Cohen AT.

Thromb Haemost. 2018 Nov;118(11):1951-1961. doi: 10.1055/s-0038-1673689. Epub 2018 Oct 24. Erratum in: Thromb Haemost. 2018 Nov;118(11):e1-e2.

PMID: 30357780

 

A General Amino Acid Synthesis Enabled by Innate Radical Cross-Coupling.

Ni S, Garrido-Castro AF, Merchant RR, de Gruyter JN, Schmitt DC, Mousseau JJ, Gallego GM, Yang S, Collins MR, Qiao JX, Yeung KS, Langley DR, Poss MA, Scola PM, Qin T, Baran PS.

Angew Chem Int Ed Engl. 2018 Oct 26;57(44):14560-14565. doi: 10.1002/anie.201809310. Epub 2018 Oct 15.

PMID: 30212610

 

Evaluation of the single-dose pharmacokinetics and pharmacodynamics of apixaban in healthy Japanese and Caucasian subjects.

Frost C, Shenker A, Jhee S, Yu Z, Wang J, Bragat A, Pursley J, LaCreta F.

Clin Pharmacol. 2018 Oct 24;10:153-163. doi: 10.2147/CPAA.S169505. eCollection 2018.

PMID: 30498375

 

Safety, efficacy, and dose response of the maturation inhibitor GSK3532795 (formerly known as BMS-955176) plus tenofovir/emtricitabine once daily in treatment-naive HIV-1-infected adults: Week 24 primary analysis from a randomized Phase IIb trial.

Morales-Ramirez J, Bogner JR, Molina JM, Lombaard J, Dicker IB, Stock DA, DeGrosky M, Gartland M, Pene Dumitrescu T, Min S, Llamoso C, Joshi SR, Lataillade M.

PLoS One. 2018 Oct 23;13(10):e0205368. doi: 10.1371/journal.pone.0205368. eCollection 2018.

PMID: 30352054

 

Access to innovative drugs for metastatic lung cancer treatment in a French nationwide cohort: the TERRITOIRE study.

Scherpereel A, Durand-Zaleski I, Cotté FE, Fernandes J, Debieuvre D, Blein C, Gaudin AF, Tournier C, Vainchtock A, Chauvin P, Souquet PJ, Westeel V, Chouaïd C.

BMC Cancer. 2018 Oct 22;18(1):1013. doi: 10.1186/s12885-018-4958-5.

PMID: 30348130

 

Safety and efficacy of nivolumab in combination with sunitinib or pazopanib in advanced or metastatic renal cell carcinoma: the CheckMate 016 study.

Amin A, Plimack ER, Ernstoff MS, Lewis LD, Bauer TM, McDermott DF, Carducci M, Kollmannsberger C, Rini BI, Heng DYC, Knox J, Voss MH, Spratlin J, Berghorn E, Yang L, Hammers HJ.

J Immunother Cancer. 2018 Oct 22;6(1):109. doi: 10.1186/s40425-018-0420-0. Erratum in: J Immunother Cancer. 2019 Mar 14;7(1):73.

PMID: 30348216

 

Trial Reporting in Immuno-Oncology (TRIO): an American society of clinical oncology-society for immunotherapy of cancer statement.

Tsimberidou AM, Levit LA, Schilsky RL, Averbuch SD, Chen D, Kirkwood JM, McShane LM, Sharon E, Mileham KF, Postow MA.

J Immunother Cancer. 2018 Oct 19;6(1):108. doi: 10.1186/s40425-018-0426-7.

PMID: 30340549

 

Discovery of 4-Azaindole Inhibitors of TGFβRI as Immuno-oncology Agents.

Zhang Y, Zhao Y, Tebben AJ, Sheriff S, Ruzanov M, Fereshteh MP, Fan Y, Lippy J, Swanson J, Ho CP, Wautlet BS, Rose A, Parrish K, Yang Z, Donnell AF, Zhang L, Fink BE, Vite GD, Augustine-Rauch K, Fargnoli J, Borzilleri RM.

ACS Med Chem Lett. 2018 Oct 17;9(11):1117-1122. doi: 10.1021/acsmedchemlett.8b00357. eCollection 2018 Nov 8.

PMID: 30429955

Discovery of VU2957 (Valiglurax): An mGlu₄ Positive Allosteric Modulator Evaluated as a Preclinical Candidate for the Treatment of Parkinson's Disease.

Panarese JD, Engers DW, Wu YJ, Bronson JJ, Macor JE, Chun A, Rodriguez AL, Felts AS, Engers JL, Loch MT, Emmitte KA, Castelhano AL, Kates MJ, Nader MA, Jones CK, Blobaum AL, Conn PJ, Niswender CM, Hopkins CR, Lindsley CW.

ACS Med Chem Lett. 2018 Oct 16;10(3):255-260. doi: 10.1021/acsmedchemlett.8b00426. eCollection 2019 Mar 14.

PMID: 30891122

 

Use of Biomarkers to Predict Specific Causes of Death in Patients With Atrial Fibrillation.

Sharma A, Hijazi Z, Andersson U, Al-Khatib SM, Lopes RD, Alexander JH, Held C, Hylek EM, Leonardi S, Hanna M, Ezekowitz JA, Siegbahn A, Granger CB, Wallentin L.

Circulation. 2018 Oct 16;138(16):1666-1676. doi: 10.1161/CIRCULATIONAHA.118.034125.

PMID: 29871978

 

Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial.

Dimopoulos MA, Lonial S, Betts KA, Chen C, Zichlin ML, Brun A, Signorovitch JE, Makenbaeva D, Mekan S, Sy O, Weisel K, Richardson PG.

Cancer. 2018 Oct 15;124(20):4032-4043. doi: 10.1002/cncr.31680. Epub 2018 Sep 11.

PMID: 30204239

 

A Novel, Fully Human Anti-fucosyl-GM1 Antibody Demonstrates Potent In Vitro and In Vivo Antitumor Activity in Preclinical Models of Small Cell Lung Cancer.

Ponath P, Menezes D, Pan C, Chen B, Oyasu M, Strachan D, LeBlanc H, Sun H, Wang XT, Rangan VS, Deshpande S, Cristea S, Park KS, Sage J, Cardarelli PM.

Clin Cancer Res. 2018 Oct 15;24(20):5178-5189. doi: 10.1158/1078-0432.CCR-18-0018. Epub 2018 Jul 18.

PMID: 30021910

 

A systematic review of network meta-analyses among patients with nonvalvular atrial fibrillation: A comparison of efficacy and safety following treatment with direct oral anticoagulants.

Cohen AT, Hill NR, Luo X, Masseria C, Abariga SA, Ashaye AO.

Int J Cardiol. 2018 Oct 15;269:174-181. doi: 10.1016/j.ijcard.2018.06.114. Epub 2018 Jun 30.

PMID: 30037626

 

Erratum: Drug Discovery Approaches to Target Wnt Signaling in Cancer Stem Cells.

Curtin JC, Lorenzi MV.

Oncotarget. 2018 Oct 5;9(78):34856. doi: 10.18632/oncotarget.26220. eCollection 2018 Oct 5.

PMID: 30410683

 

Conceptual model for the health technology assessment of current and novel interventions in rheumatoid arthritis.

Alemao E, Al MJ, Boonen AA, Stevenson MD, Verstappen SMM, Michaud K, Weinblatt ME, Rutten-van Mölken MPMH.

PLoS One. 2018 Oct 5;13(10):e0205013. doi: 10.1371/journal.pone.0205013. eCollection 2018.

PMID: 30289926

Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis.

Papp K, Gordon K, Thaçi D, Morita A, Gooderham M, Foley P, Girgis IG, Kundu S, Banerjee S.

N Engl J Med. 2018 Oct 4;379(14):1313-1321. doi: 10.1056/NEJMoa1806382. Epub 2018 Sep 11.

PMID: 30205746

canvasDesigner: a versatile interactive high-resolution scientific multi-panel visualization toolkit.

Zhang B, Zhao S, Neuhaus I.

Bioinformatics. 2018 Oct 1;34(19):3419-3420. doi: 10.1093/bioinformatics/bty377.

PMID: 29726919

 

Conversion of carbazole carboxamide based reversible inhibitors of Bruton's tyrosine kinase (BTK) into potent, selective irreversible inhibitors in the carbazole, tetrahydrocarbazole, and a new 2,3-dimethylindole series.

Liu Q, Batt DG, Chaudhry C, Lippy JS, Pattoli MA, Surti N, Xu S, Carter PH, Burke JR, Tino JA.

Bioorg Med Chem Lett. 2018 Oct 1;28(18):3080-3084. doi: 10.1016/j.bmcl.2018.07.041. Epub 2018 Jul 30.

PMID: 30097367

 

Inhibition of Casein Kinase 2 Disrupts Differentiation of Myeloid Cells in Cancer and Enhances the Efficacy of Immunotherapy in Mice.

Hashimoto A, Gao C, Mastio J, Kossenkov A, Abrams SI, Purandare AV, Desilva H, Wee S, Hunt J, Jure-Kunkel M, Gabrilovich DI.

Cancer Res. 2018 Oct 1;78(19):5644-5655. doi: 10.1158/0008-5472.CAN-18-1229. Epub 2018 Aug 23.

PMID: 30139814

 

Development and Characterization of a Model for Inducing Fetal Hemoglobin Production in Cynomolgus Macaques (Macaca fasicularis).

Kundu MC, Gore LR, Maguire S, Gilmartin AG.

Comp Med. 2018 Oct 1;68(5):396-402. doi: 10.30802/AALAS-CM-17-000124. Epub 2018 Aug 9.

PMID: 30092854

 

CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer.

Janjigian YY, Bendell J, Calvo E, Kim JW, Ascierto PA, Sharma P, Ott PA, Peltola K, Jaeger D, Evans J, de Braud F, Chau I, Harbison CT, Dorange C, Tschaika M, Le DT.

J Clin Oncol. 2018 Oct 1;36(28):2836-2844. doi: 10.1200/JCO.2017.76.6212. Epub 2018 Aug 15. Erratum in: J Clin Oncol. 2019 Feb 10;37(5):443.

PMID: 30110194

 

Understanding total cost of care in advanced non-small cell lung cancer pre- and postapproval of immuno-oncology therapies.

Korytowsky B, Radtchenko J, Nwokeji ED, Tuell KW, Kish JK, Feinberg BA.

Am J Manag Care. 2018 Oct;24(20 Suppl):S439-S447.

PMID: 30362811

 

Mechanisms of precipitate formation during the purification of an Fc-fusion protein.

Greene DG, Traylor SJ, Guo J, Choe LH, Modla S, Xu X, Singh N, Lock LL, Ghose S, Li ZJ, Lee KH, Wagner NJ, Lenhoff AM.

Biotechnol Bioeng. 2018 Oct;115(10):2489-2503. doi: 10.1002/bit.26746. Epub 2018 Jul 25.

PMID: 29896879

 

Time to Treatment Intensification After Monotherapy Failure and Its Association With Subsequent Glycemic Control Among 93,515 Patients With Type 2 Diabetes.

Desai U, Kirson NY, Kim J, Khunti K, King S, Trieschman E, Hellstern M, Hunt PR, Mukherjee J.

Diabetes Care. 2018 Oct;41(10):2096-2104. doi: 10.2337/dc17-0662. Epub 2018 Aug 21.

PMID: 30131396

 

A novel co-processing method to manufacture an API for extended release formulation via formation of agglomerates of active ingredient and hydroxypropyl methylcellulose during crystallization.

Rosenbaum T, Erdemir D, Chang SY, Kientzler D, Wang S, Chan SH, Brown J, Hanley S, Kiang S.

Drug Dev Ind Pharm. 2018 Oct;44(10):1606-1612. doi: 10.1080/03639045.2018.1483386. Epub 2018 Aug 14.

PMID: 29916275

 

Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057.

Reck M, Brahmer J, Bennett B, Taylor F, Penrod JR, DeRosa M, Dastani H, Spigel DR, Gralla RJ.

Eur J Cancer. 2018 Oct;102:23-30. doi: 10.1016/j.ejca.2018.05.005. Epub 2018 Aug 10.

PMID: 30103096

 

Buffer exchange path influences the stability and viscosity upon storage of a high concentration protein.

Krause ME, Narang AS, Barker G, Herzer S, Deshmukh S, Lan W, Fichana D, Wasylyk JM, Demirdirek B, Zhang L, Fiske J, McGann M, Adams ML, Gandhi RB.

Eur J Pharm Biopharm. 2018 Oct;131:60-69. doi: 10.1016/j.ejpb.2018.07.014. Epub 2018 Jul 18.

PMID: 30031090

 

Sequential treatment approaches in  the management of BRAF wild-type advanced melanoma: a cost-effectiveness analysis.

Tarhini A, Benedict A, McDermott D, Rao S, Ambavane A, Gupte-Singh K, Sabater J, Ritchings C, Aponte-Ribero V, Regan MM, Atkins M.

Immunotherapy. 2018 Oct;10(14):1241-1252. doi: 10.2217/imt-2018-0085. Epub 2018 Sep 3.

PMID: 30175642

 

Health Care Costs in a Cohort of HIV-Infected U.S. Veterans Receiving Regimens Containing Tenofovir Disoproxil Fumarate/Emtricitabine.

Nelson RE, Ma J, Crook J, Knippenberg K, Nyman H, Paul D, Esker S, LaFleur J.

J Manag Care Spec Pharm. 2018 Oct;24(10):1052-1066. doi: 10.18553/jmcp.2018.24.10.1052.

PMID: 30247099

 

Economic value of regular monitoring of response to treatment among US patients with chronic myeloid leukemia based on an economic model.

Jabbour EJ, Siegartel LR, Lin J, Lingohr-Smith M, Menges B, Makenbaeva D.

J Med Econ. 2018 Oct;21(10):1036-1040. doi: 10.1080/13696998.2018.1508023. Epub 2018 Aug 15.

PMID: 30071761

 

Neuronal calcineurin transcriptional targets parallel changes observed in Alzheimer disease brain.

Hopp SC, Bihlmeyer NA, Corradi JP, Vanderburg C, Cacace AM, Das S, Clark TW, Betensky RA, Hyman BT, Hudry E.

J Neurochem. 2018 Oct;147(1):24-39. doi: 10.1111/jnc.14469. Epub 2018 Sep 7.

PMID: 29806693

 

Enhanced Precision of Circular Dichroism Spectral Measurements Permits Detection of Subtle Higher Order Structural Changes in Therapeutic Proteins.

Barnett GV, Balakrishnan G, Chennamsetty N, Meengs B, Meyer J, Bongers J, Ludwig R, Tao L, Das TK, Leone A, Kar SR.

J Pharm Sci. 2018 Oct;107(10):2559-2569. doi: 10.1016/j.xphs.2018.06.007. Epub 2018 Jun 18.

PMID: 29913140

 

Optimization of Primary Drying in Lyophilization During Early-Phase Drug Development Using a Definitive Screening Design With Formulation and Process Factors.

Goldman JM, More HT, Yee O, Borgeson E, Remy B, Rowe J, Sadineni V.

J Pharm Sci. 2018 Oct;107(10):2592-2600. doi: 10.1016/j.xphs.2018.06.001. Epub 2018 Jun 8.

PMID: 29890172

 

Data standards for model-informed drug development: an ISoP initiative.

Radivojevic A, Corrigan B, Downie N, Fox R, Fiedler-Kelly J, Liu H, Melhem M, Radke D, Schaefer P, Su J, Swat MJ, Teuscher NS, Thanneer N, Zong A, Wilkins JJ.

J Pharmacokinet Pharmacodyn. 2018 Oct;45(5):659-661. doi: 10.1007/s10928-018-9595-8. Epub 2018 Jul 25. No abstract available.

PMID: 30046963

Do Poor Prognostic Factors in Rheumatoid Arthritis Affect Treatment Choices and Outcomes? Analysis of a US Rheumatoid Arthritis Registry.

Alemao E, Litman HJ, Connolly SE, Kelly S, Hua W, Rosenblatt L, Rebello S, Kremer JM, Harrold LR.

J Rheumatol. 2018 Oct;45(10):1353-1360. doi: 10.3899/jrheum.171050. Epub 2018 Jul 1.

PMID: 29961696

 

Mixed-methods development of a new patient-reported outcome instrument for chronic low back pain: part 2-The Patient Assessment for Low Back Pain-Impacts (PAL-I).

Bushnell DM, Blum SI, Liedgens H, Martin ML, Freynhagen R, Wallace M, Argoff C, Eerdekens M, Kok M, Patrick DL.

Pain. 2018 Oct;159(10):2066-2075. doi: 10.1097/j.pain.0000000000001309.

PMID: 29889120

 

End-to-End Sample Tracking in the Laboratory Using a Custom Internet of Things Device.

Neil W, Zipp G, Nemeth G, Russo MF, Nirschl DS.

SLAS Technol. 2018 Oct;23(5):412-422. doi: 10.1177/2472630318783979. Epub 2018 Jul 17.

PMID: 30016131

 

Retention and clinical response to abatacept in patients with rheumatoid arthritis: an Italian perspective.

Galeazzi M, Alten R, Chartier M, Elbez Y, Fusaro E, Le Bars M, Lorenz HM, Pagano Mariano G, Muratore M, Nüßlein HG, Patanè G.

Clin Exp Rheumatol. 2018 Sep-Oct;36(5):935-936. Epub 2018 Mar 21. No abstract available.

PMID: 29600933

 

International Multisite Study of Human-Induced Pluripotent Stem Cell-Derived Cardiomyocytes for Drug Proarrhythmic Potential Assessment.

Blinova K, Dang Q, Millard D, Smith G, Pierson J, Guo L, Brock M, Lu HR, Kraushaar U, Zeng H, Shi H, Zhang X, Sawada K, Osada T, Kanda Y, Sekino Y, Pang L, Feaster TK, Kettenhofen R, Stockbridge N, Strauss DG, Gintant G.

Cell Rep. 2018 Sep 25;24(13):3582-3592. doi: 10.1016/j.celrep.2018.08.079.

PMID: 30257217

 

Differential sensitivity of chronic high-fat-diet-induced obesity in Sprague-Dawley rats.

Devan SRK, Arumugam S, Shankar G, Poosala S.

J Basic Clin Physiol Pharmacol. 2018 Sep 25;29(5):553-563. doi: 10.1515/jbcpp-2017-0030. No abstract available.

PMID: 30076779

 

Evaluation of chromatofocusing as a capture method for monoclonal antibody products.

Liu Y, Deldari S, Guo H, Narahari CR, Bates RC, Swanson R, Ghose S, Li ZJ, Frey DD.

J Chromatogr A. 2018 Sep 21;1568:108-122. doi: 10.1016/j.chroma.2018.07.028. Epub 2018 Jul 6.

PMID: 30072232

 

Enantioselective Synthesis of a γ-Secretase Modulator via Vinylogous Dynamic Kinetic Resolution.

Strotman NA, Ramirez A, Simmons EM, Soltani O, Parsons AT, Fan Y, Sawyer JR, Rosner T, Janey JM, Tran K, Li J, La Cruz TE, Pathirana C, Ng AT, Deerberg J.

J Org Chem. 2018 Sep 21;83(18):11133-11144. doi: 10.1021/acs.joc.8b01734. Epub 2018 Aug 13.

PMID: 30102035

 

Unlocking P(V): Reagents for chiral phosphorothioate synthesis.

Knouse KW, deGruyter JN, Schmidt MA, Zheng B, Vantourout JC, Kingston C, Mercer SE, Mcdonald IM, Olson RE, Zhu Y, Hang C, Zhu J, Yuan C, Wang Q, Park P, Eastgate MD, Baran PS.

Science. 2018 Sep 21;361(6408):1234-1238. doi: 10.1126/science.aau3369. Epub 2018 Aug 2.

PMID: 30072577

 

A Glycomarker for Short-term Prediction of Hepatocellular Carcinoma: A Longitudinal Study With Serial Measurements.

Lin YJ, Chang CL, Chen LC, Hu HH, Liu J, Korenaga M, Huang YH, Jen CL, Su CY, Nishida N, Sugiyama M, Lu SN, Wang LY, Yuan Y, L'Italien G, Yang HI, Mizokami M, Chen CJ, Lee MH.

Clin Transl Gastroenterol. 2018 Sep 20;9(9):183. doi: 10.1038/s41424-018-0050-3.

PMID: 30237482

Fucosyl monosialoganglioside: Quantitative analysis of specific potential biomarkers of lung cancer in biological matrices using immunocapture extraction/tandem mass spectrometry.

Ranasinghe A, Mehl J, D'Arienzo C, Nabbie F, Chiu C, Thevanayagam L, Srinivasan M, Hogan J, Ponath P, Olah T.

Rapid Commun Mass Spectrom. 2018 Sep 15;32(17):1481-1490. doi: 10.1002/rcm.8194.

PMID: 29876976

 

Factor XIa Inhibitors as New Anticoagulants.

Quan ML, Pinto DJP, Smallheer JM, Ewing WR, Rossi KA, Luettgen JM, Seiffert DA, Wexler RR.

J Med Chem. 2018 Sep 13;61(17):7425-7447. doi: 10.1021/acs.jmedchem.8b00173. Epub 2018 May 18. Review.

PMID: 29775297

 

Inosine Triphosphate Pyrophosphatase Dephosphorylates Ribavirin Triphosphate and Reduced Enzymatic Activity Potentiates Mutagenesis in Hepatitis C Virus.

Nyström K, Wanrooij PH, Waldenström J, Adamek L, Brunet S, Said J, Nilsson S, Wind-Rotolo M, Hellstrand K, Norder H, Tang KW, Lagging M.

J Virol. 2018 Sep 12;92(19). pii: e01087-18. doi: 10.1128/JVI.01087-18. Print 2018 Oct 1.

PMID: 30045981

 

Evidence-based pregnancy testing in clinical trials: Recommendations from a multi-stakeholder development process.

Morse JE, Calvert SB, Jurkowski C, Tassinari M, Sewell CA, Myers ER.

PLoS One. 2018 Sep 12;13(9):e0202474. doi: 10.1371/journal.pone.0202474. eCollection 2018.

PMID: 30208049

 

RN765C, a low affinity EGFR antibody drug conjugate with potent anti-tumor activity in preclinical solid tumor models.

Wong OK, Tran TT, Ho WH, Casas MG, Au M, Bateman M, Lindquist KC, Rajpal A, Shelton DL, Strop P, Liu SH.

Oncotarget. 2018 Sep 11;9(71):33446-33458. doi: 10.18632/oncotarget.26002. eCollection 2018 Sep 11.

PMID: 30323890

 

In Vivo Predictive Dissolution and Simulation Workshop Report: Facilitating the Development of Oral Drug Formulation and the Prediction of Oral Bioperformance.

Tsume Y, Patel S, Fotaki N, Bergstrӧm C, Amidon GL, Brasseur JG, Mudie DM, Sun D, Bermejo M, Gao P, Zhu W, Sperry DC, Vertzoni M, Parrott N, Lionberger R, Kambayashi A, Hermans A, Lu X, Amidon GE.

AAPS J. 2018 Sep 6;20(6):100. doi: 10.1208/s12248-018-0260-3. No abstract available.

PMID: 30191341

 

Google searches do not correlate with melanoma incidence in majority English speaking countries.

McDonald L, Simpson A, Graham S, Schultze A, Nordstrom B, Durani P, Mehmud F, Ramagopalan SV.

NPJ Digit Med. 2018 Sep 5;1:44. doi: 10.1038/s41746-018-0050-4. eCollection 2018.

PMID: 31304324

 

Under-recording of hospital bleeding events in UK primary care: a linked Clinical Practice Research Datalink and Hospital Episode Statistics study.

McDonald L, Sammon CJ, Samnaliev M, Ramagopalan S.

Clin Epidemiol. 2018 Sep 4;10:1155-1168. doi: 10.2147/CLEP.S170304. eCollection 2018.

PMID: 30233250

 

Long-term efficacy and safety of dasatinib in patients with chronic myeloid leukemia in accelerated phase who are resistant to or intolerant of imatinib.

Ottmann O, Saglio G, Apperley JF, Arthur C, Bullorsky E, Charbonnier A, Dipersio JF, Kantarjian H, Khoury HJ, Kim DW, Healey D, Strauss L, Cortes JE.

Blood Cancer J. 2018 Sep 3;8(9):88. doi: 10.1038/s41408-018-0122-3. No abstract available.

PMID: 30190469

 

Microbiota-derived short-chain fatty acids promote Th1 cell IL-10 production to maintain intestinal homeostasis.

Sun M, Wu W, Chen L, Yang W, Huang X, Ma C, Chen F, Xiao Y, Zhao Y, Ma C, Yao S, Carpio VH, Dann SM, Zhao Q, Liu Z, Cong Y.

Nat Commun. 2018 Sep 3;9(1):3555. doi: 10.1038/s41467-018-05901-2.

PMID: 30177845

 

LC-MS/MS bioanalysis of plasma 1, 14-tetradecanedioic acid and 1, 16-hexadecanedioic acid as candidate biomarkers for organic anion-transporting polypeptide mediated drug-drug interactions.

Santockyte R, Kandoussi H, Chen W, Zheng N, Venkatarangan L, Gan J, Shen H, Bonacorsi SJ, Easter J, Burrell R, Zhang YJ, Zeng J.

Bioanalysis. 2018 Sep 1;10(18):1473-1485. doi: 10.4155/bio-2018-0170. Epub 2018 Sep 14.

PMID: 30215261

 

Effectiveness and Safety of Anticoagulants in Adults with Non-valvular Atrial Fibrillation and Concomitant Coronary/Peripheral Artery Disease.

Lopes RD, Steffel J, Di Fusco M, Keshishian A, Luo X, Li X, Masseria C, Hamilton M, Friend K, Gupta K, Mardekian J, Pan X, Baser O, Jones WS.

Am J Med. 2018 Sep;131(9):1075-1085.e4. doi: 10.1016/j.amjmed.2018.05.007. Epub 2018 May 26.

PMID: 29807001

 

Comparison of de novo IgM and IgG anti-HLA DSAs between belatacept- and calcineurin-treated patients: An analysis of the BENEFIT and BENEFIT-EXT trial cohorts.

Everly MJ, Roberts M, Townsend R, Bray RA, Gebel HM.

Am J Transplant. 2018 Sep;18(9):2305-2313. doi: 10.1111/ajt.14939. Epub 2018 Jun 16.

PMID: 29767445

 

Bioinspired supramolecular engineering of self-assembling immunofibers for high affinity binding of immunoglobulin G.

Li Y, Lock LL, Wang Y, Ou SH, Stern D, Schön A, Freire E, Xu X, Ghose S, Li ZJ, Cui H.

Biomaterials. 2018 Sep;178:448-457. doi: 10.1016/j.biomaterials.2018.04.032. Epub 2018 Apr 16.

PMID: 29706234

 

Early identification of unusually clustered mutations and root causes in therapeutic antibody development.

Qian Y, Chen Z, Huang X, Wang X, Xu X, Kirov S, Ludwig R, Qian NX, Ravi K, Tao L, Borys MC, Li ZJ.

Biotechnol Bioeng. 2018 Sep;115(9):2377-2382. doi: 10.1002/bit.26728. Epub 2018 Jun 6.

PMID: 29777592

 

Ultrafiltration behavior of partially retained proteins and completely retained proteins using equally-staged single pass tangential flow filtration membranes.

Arunkumar A, Zhang J, Singh N, Ghose S, Li ZJ.

Biotechnol Prog. 2018 Sep;34(5):1137-1148. doi: 10.1002/btpr.2671. Epub 2018 Jul 27.

PMID: 30019541

Gaining Mechanistic Insight Into Coproporphyrin I as Endogenous Biomarker for OATP1B-Mediated Drug-Drug Interactions Using Population Pharmacokinetic Modeling and Simulation.

Barnett S, Ogungbenro K, Ménochet K, Shen H, Lai Y, Humphreys WG, Galetin A.

Clin Pharmacol Ther. 2018 Sep;104(3):564-574. doi: 10.1002/cpt.983. Epub 2018 Jan 17.

PMID: 29243231

 

Assay Guidance Manual: Quantitative Biology and Pharmacology in Preclinical Drug Discovery.

Coussens NP, Sittampalam GS, Guha R, Brimacombe K, Grossman A, Chung TDY, Weidner JR, Riss T, Trask OJ, Auld D, Dahlin JL, Devanaryan V, Foley TL, McGee J, Kahl SD, Kales SC, Arkin M, Baell J, Bejcek B, Gal-Edd N, Glicksman M, Haas JV, Iversen PW, Hoeppner M, Lathrop S, Sayers E, Liu H, Trawick B, McVey J, Lemmon VP, Li Z, McManus O, Minor L, Napper A, Wildey MJ, Pacifici R, Chin WW, Xia M, Xu X, Lal-Nag M, Hall MD, Michael S, Inglese J, Simeonov A, Austin CP.

Clin Transl Sci. 2018 Sep;11(5):461-470. doi: 10.1111/cts.12570. Epub 2018 Jul 24. Review.

PMID: 29877628

 

Safety and effectiveness of apixaban in comparison to warfarin in patients with nonvalvular atrial fibrillation: a propensity-matched analysis from Japanese administrative claims data.

Kohsaka S, Katada J, Saito K, Terayama Y.

Curr Med Res Opin. 2018 Sep;34(9):1627-1634. doi: 10.1080/03007995.2018.1478282. Epub 2018 May 30.

PMID: 29772946

 

Costs associated with adverse events for systemic therapies in metastatic melanoma.

Fu AZ, Li Z, Tang J, Mahmood S, Whisman T, Qiu Y.

J Comp Eff Res. 2018 Sep;7(9):867-879. doi: 10.2217/cer-2018-0022. Epub 2018 Sep 7.

PMID: 30192155

 

Potent viral suppression and improvements in alpha-fetoprotein and measures of fibrosis in Japanese patients receiving a daclatasvir/asunaprevir/beclabuvir fixed-dose combination for the treatment of HCV genotype-1 infection.

Akuta N, Toyota J, Karino Y, Ikeda F, Ido A, Tanaka K, Takaguchi K, Naganuma A, Tomita E, Chayama K, Fujiyama S, Inada Y, Yoshiji H, Watanabe H, Ishikawa H, McPhee F, Noviello S, Kumada H.

J Gastroenterol. 2018 Sep;53(9):1089-1097. doi: 10.1007/s00535-018-1445-3. Epub 2018 Mar 2.

PMID: 29500489

 

A Real-World Observational Study of Hospitalization and Health Care Costs Among Nonvalvular Atrial Fibrillation Patients Prescribed Oral Anticoagulants in the U.S. Medicare Population.

Amin A, Keshishian A, Trocio J, Dina O, Le H, Rosenblatt L, Liu X, Mardekian J, Zhang Q, Baser O, Nadkarni A, Vo L.

J Manag Care Spec Pharm. 2018 Sep;24(9):911-920. doi: 10.18553/jmcp.2018.24.9.911.

PMID: 30156450

 

Sticking and Picking in Pharmaceutical Tablet Compression: An IQ Consortium Review.

Chattoraj S, Daugherity P, McDermott T, Olsofsky A, Roth WJ, Tobyn M.

J Pharm Sci. 2018 Sep;107(9):2267-2282. doi: 10.1016/j.xphs.2018.04.029. Epub 2018 May 8. Review.

PMID: 29751009

 

An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment.

Boetzel R, Ceszlak A, Day C, Drumm P, Gil Bejar J, Glennon J, Harris L, Heghes CI, Horga R, Jacobs PL, Keurentjes WJTM, King F, Lee CW, Lewen N, Marchant CA, Maris FA, Nye W, Powell S, Rockstroh H, Rutter L, Schweitzer M, Shannon E, Smallshaw L, Teasdale A, Thompson S, Wilkinson D.

J Pharm Sci. 2018 Sep;107(9):2335-2340. doi: 10.1016/j.xphs.2018.04.009. Epub 2018 Apr 18.

PMID: 29679706

 

Nivolumab Plus Erlotinib in Patients With EGFR-Mutant Advanced NSCLC.

Gettinger S, Hellmann MD, Chow LQM, Borghaei H, Antonia S, Brahmer JR, Goldman JW, Gerber DE, Juergens RA, Shepherd FA, Laurie SA, Young TC, Li X, Geese WJ, Rizvi N.

J Thorac Oncol. 2018 Sep;13(9):1363-1372. doi: 10.1016/j.jtho.2018.05.015. Epub 2018 May 23.

PMID: 29802888

 

Comment on structural basis of DUX4/IGH-driven transactivation.

Aihara H, Shi K, Lee JK, Bosnakovski D, Kyba M.

Leukemia. 2018 Sep;32(9):2090-2092. doi: 10.1038/s41375-018-0217-7. Epub 2018 Jul 27. No abstract available.

PMID: 30054554

 

CheckMate 141: 1-Year Update and Subgroup Analysis of Nivolumab as First-Line Therapy in Patients with Recurrent/Metastatic Head and Neck Cancer.

Gillison ML, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington KJ, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Li L, Ferris RL.

Oncologist. 2018 Sep;23(9):1079-1082. doi: 10.1634/theoncologist.2017-0674. Epub 2018 Jun 4.

PMID: 29866947

 

Phase II Study of Irinotecan Plus Panitumumab as Second-Line Therapy for Patients with Advanced Esophageal Adenocarcinoma.

Yoon H, Karapetyan L, Choudhary A, Kosozi R, Bali GS, Zaidi AH, Atasoy A, Forastiere AA, Gibson MK.

Oncologist. 2018 Sep;23(9):1004-e102. doi: 10.1634/theoncologist.2017-0657. Epub 2018 May 16.

PMID: 29769385

 

Solubility enhancement and solid-state characterisation.

Tobyn M.

Pharm Dev Technol. 2018 Sep;23(7):663. doi: 10.1080/10837450.2018.1505305. No abstract available.

PMID: 30106327

 

The Near-Term Viability and Benefits of eLabels for Patients, Clinical Sites, and Sponsors.

Smith-Gick J, Barnes N, Barone R, Bedford J, James JR, Reisner SF, Stephenson M.

Ther Innov Regul Sci. 2018 Sep;52(5):537-545. doi: 10.1177/2168479018765463. Epub 2018 Apr 2.

PMID: 29714582

 

Application of dynamic modeling for survival estimation in advanced renal cell carcinoma.

Deniz B, Altincatal A, Ambavane A, Rao S, Doan J, Malcolm B, Michaelson MD, Yang S.

PLoS One. 2018 Aug 30;13(8):e0203406. doi: 10.1371/journal.pone.0203406. eCollection 2018.

PMID: 30161244

 

EMT- and stroma-related gene expression and resistance to PD-1 blockade in urothelial cancer.

Wang L, Saci A, Szabo PM, Chasalow SD, Castillo-Martin M, Domingo-Domenech J, Siefker-Radtke A, Sharma P, Sfakianos JP, Gong Y, Dominguez-Andres A, Oh WK, Mulholland D, Azrilevich A, Hu L, Cordon-Cardo C, Salmon H, Bhardwaj N, Zhu J, Galsky MD.

Nat Commun. 2018 Aug 29;9(1):3503. doi: 10.1038/s41467-018-05992-x.

PMID: 30158554

 

Effects of tumor grade and dexamethasone on myeloid cells in patients with glioma.

Moyes KW, Davis A, Hoglund V, Haberthur K, Lieberman NA, Kreuser SA, Deutsch GH, Franco S, Locke D, Carleton MO, Gilbertson DG, Simmons R, Winter C, Silber J, Gonzalez-Cuyar LF, Ellenbogen RG, Crane CA.

Oncoimmunology. 2018 Aug 27;7(11):e1507668. doi: 10.1080/2162402X.2018.1507668. eCollection 2018.

PMID: 30377570

 

NF-κB inhibition rescues cardiac function by remodeling calcium genes in a Duchenne muscular dystrophy model.

Peterson JM, Wang DJ, Shettigar V, Roof SR, Canan BD, Bakkar N, Shintaku J, Gu JM, Little SC, Ratnam NM, Londhe P, Lu L, Gaw CE, Petrosino JM, Liyanarachchi S, Wang H, Janssen PML, Davis JP, Ziolo MT, Sharma SM, Guttridge DC.

Nat Commun. 2018 Aug 24;9(1):3431. doi: 10.1038/s41467-018-05910-1.

PMID: 30143619

 

Design, Synthesis, and Pharmacological Evaluation of Second-Generation Tetrahydroisoquinoline-Based CXCR4 Antagonists with Favorable ADME Properties.

Nguyen HH, Kim MB, Wilson RJ, Butch CJ, Kuo KM, Miller EJ, Tahirovic YA, Jecs E, Truax VM, Wang T, Sum CS, Cvijic ME, Schroeder GM, Wilson LJ, Liotta DC.

J Med Chem. 2018 Aug 23;61(16):7168-7188. doi: 10.1021/acs.jmedchem.8b00450. Epub 2018 Aug 15.

PMID: 30052039

 

Combined Nivolumab and Ipilimumab in Melanoma Metastatic to the Brain.

Tawbi HA, Forsyth PA, Algazi A, Hamid O, Hodi FS, Moschos SJ, Khushalani NI, Lewis K, Lao CD, Postow MA, Atkins MB, Ernstoff MS, Reardon DA, Puzanov I, Kudchadkar RR, Thomas RP, Tarhini A, Pavlick AC, Jiang J, Avila A, Demelo S, Margolin K.

N Engl J Med. 2018 Aug 23;379(8):722-730. doi: 10.1056/NEJMoa1805453.

PMID: 30134131

 

Integrating the patient voice with clinician reports to identify a hepatocellular carcinoma-specific subset of treatment-related symptomatic adverse events.

Speck RM, Lenderking WR, Shaw JW.

J Patient Rep Outcomes. 2018 Aug 22;2:35. doi: 10.1186/s41687-018-0063-4. eCollection 2017.

PMID: 30175317

 

Discovery of the Novel Entecavir-Resistant Hepatitis B Virus Reverse Transcriptase A181C Substitution From an Integrated Genotypic Analysis.

Rose RE, Hernandez D, Falk PJ, Ericson K, Zhou N, Thiry A, McPhee F.

Hepatol Commun. 2018 Aug 21;2(9):1123-1135. doi: 10.1002/hep4.1231. eCollection 2018 Sep.

PMID: 30202825

 

Quantitative prediction of long-term molecular response in TKI-treated CML - Lessons from an imatinib versus dasatinib comparison.

Glauche I, Kuhn M, Baldow C, Schulze P, Rothe T, Liebscher H, Roy A, Wang X, Roeder I.

Sci Rep. 2018 Aug 17;8(1):12330. doi: 10.1038/s41598-018-29923-4.

PMID: 30120281

 

An Evaluation of the Collagen Fragments Related to Fibrogenesis and Fibrolysis in Nonalcoholic Steatohepatitis.

Luo Y, Oseini A, Gagnon R, Charles ED, Sidik K, Vincent R, Collen R, Idowu M, Contos MJ, Mirshahi F, Daita K, Asgharpour A, Siddiqui MS, Jarai G, Rosen G, Christian R, Sanyal AJ.

Sci Rep. 2018 Aug 17;8(1):12414. doi: 10.1038/s41598-018-30457-y.

PMID: 30120271

 

Discovery and characterization of N-(1,3-dialkyl-1H-indazol-6-yl)-1H-pyrazolo[4,3-b]pyridin-3-amine scaffold as mGlu₄ positive allosteric modulators that mitigate CYP1A2 induction liability.

Engers DW, Bollinger SR, Engers JL, Panarese JD, Breiner MM, Gregro A, Blobaum AL, Bronson JJ, Wu YJ, Macor JE, Rodriguez AL, Zamorano R, Conn PJ, Lindsley CW, Niswender CM, Hopkins CR.

Bioorg Med Chem Lett. 2018 Aug 15;28(15):2641-2646. doi: 10.1016/j.bmcl.2018.06.034. Epub 2018 Jun 19.

PMID: 29958762

 

Multimonth Prescription of Antiretroviral Therapy Among Children and Adolescents: Experiences From the Baylor International Pediatric AIDS Initiative in 6 African Countries.

Kim MH, Wanless RS, Caviness AC, Golin R, Amzel A, Ahmed S, Mhango J, Damba D, Kayabu A, Chodota M, Dlamini S, Chidah N, Mokhali M, Calles NR, Abrams EJ.

J Acquir Immune Defic Syndr. 2018 Aug 15;78 Suppl 2:S71-S80. doi: 10.1097/QAI.0000000000001730. Erratum in: J Acquir Immune Defic Syndr. 2018 Nov 1;79(3):e107.

PMID: 29994828

 

Ligand-Enabled β-C(sp₃)-H Olefination of Free Carboxylic Acids.

Zhuang Z, Yu CB, Chen G, Wu QF, Hsiao Y, Joe CL, Qiao JX, Poss MA, Yu JQ.

J Am Chem Soc. 2018 Aug 15;140(32):10363-10367. doi: 10.1021/jacs.8b06527. Epub 2018 Aug 2.

PMID: 30029574

Asymmetric and Symmetric Dimethylarginine Predict Outcomes in Patients With Atrial Fibrillation: An ARISTOTLE Substudy.

Horowitz JD, De Caterina R, Heresztyn T, Alexander JH, Andersson U, Lopes RD, Steg PG, Hylek EM, Mohan P, Hanna M, Jansky P, Granger CB, Wallentin L; ARISTOTLE Investigators.

J Am Coll Cardiol. 2018 Aug 14;72(7):721-733. doi: 10.1016/j.jacc.2018.05.058.

PMID: 30092948

 

Tunable normal phase enantioselectivity of amino acid esters via mobile phase composition.

Yang A, Shackman JG, Ye YK.

J Chromatogr A. 2018 Aug 10;1562:128-133. doi: 10.1016/j.chroma.2018.05.054. Epub 2018 May 28.

PMID: 29859686

 

In Vitro Stimulation of Multidrug Resistance-Associated Protein 2 Function Is Not Reproduced In Vivo in Rats.

Gilibili RR, Kurawattimath V, Murali BV, Lai Y, Mariappan TT, Shen H, Chatterjee S.

Pharmaceutics. 2018 Aug 8;10(3). pii: E125. doi: 10.3390/pharmaceutics10030125.

PMID: 30096834

 

Overcoming the stability, solubility and extraction challenges in reversed-phase UHPLC-MS/MS bioanalysis of a phosphate drug and its prodrug in blood lysate.

Yuan L, Basdeo S, Ji QC.

J Pharm Biomed Anal. 2018 Aug 5;157:36-43. doi: 10.1016/j.jpba.2018.05.006. Epub 2018 May 5.

PMID: 29758468

 

Circulating T Cell Subpopulations Correlate With Immune Responses at the Tumor Site and Clinical Response to PD1 Inhibition in Non-Small Cell Lung Cancer.

Manjarrez-Orduño N, Menard LC, Kansal S, Fischer P, Kakrecha B, Jiang C, Cunningham M, Greenawalt D, Patel V, Yang M, Golhar R, Carman JA, Lezhnin S, Dai H, Kayne PS, Suchard SJ, Bernstein SH, Nadler SG.

Front Immunol. 2018 Aug 3;9:1613. doi: 10.3389/fimmu.2018.01613. eCollection 2018.

PMID: 30123214

 

Development and validation of a functional cell-based neutralizing antibody assay for ipilimumab.

Xu W, Cummings J, Sank M, Juhel M, Li X, Gleason C, DeSilva BS, Dodge RW, Pillutla R.

Bioanalysis. 2018 Aug 1;10(16):1273-1287. doi: 10.4155/bio-2018-0109. Epub 2018 Jun 27.

PMID: 29947549

 

Concerted application of LC-MS and ligand binding assays to better understand exposure of a large molecule drug.

Xu W, Jiang H, Titsch C, Gadkari S, Batog A, Wang B, Hippeli L, Yamamoto B, Chadwick K, Wheeler J, Thompson C, Stahl J, Willett S, DeSilva BS, Myler H, Dodge RW, Pillutla RC.

Bioanalysis. 2018 Aug 1;10(16):1261-1272. doi: 10.4155/bio-2018-0108. Epub 2018 Jun 20.

PMID: 29923414

 

Cross-Site Reliability of Human Induced Pluripotent stem cell-derived Cardiomyocyte Based Safety Assays Using Microelectrode Arrays: Results from a Blinded CiPA Pilot Study.

Millard D, Dang Q, Shi H, Zhang X, Strock C, Kraushaar U, Zeng H, Levesque P, Lu HR, Guillon JM, Wu JC, Li Y, Luerman G, Anson B, Guo L, Clements M, Abassi YA, Ross J, Pierson J, Gintant G.

Toxicol Sci. 2018 Aug 1;164(2):550-562. doi: 10.1093/toxsci/kfy110.

PMID: 29718449

 

Outcomes of switching to dasatinib after imatinib-related low-grade adverse events in patients with chronic myeloid leukemia in chronic phase: the DASPERSE study.

Kim DW, Saussele S, Williams LA, Mohamed H, Rong Y, Zyczynski T, Pinilla-Ibarz J, Abruzzese E.

Ann Hematol. 2018 Aug;97(8):1357-1367. doi: 10.1007/s00277-018-3295-8. Epub 2018 Mar 20.

PMID: 29556695

 

Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids.

Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG.

Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.

PMID: 29534336

 

Remodeling of the HDL proteome with treatment response to abatacept or adalimumab in the AMPLE trial of patients with rheumatoid arthritis.

Charles-Schoeman C, Gugiu GB, Ge H, Shahbazian A, Lee YY, Wang X, Furst DE, Ranganath VK, Maldonado M, Lee T, Reddy ST.

Atherosclerosis. 2018 Aug;275:107-114. doi: 10.1016/j.atherosclerosis.2018.04.003. Epub 2018 Apr 17.

PMID: 29886354

 

High-efficiency affinity precipitation of multiple industrial mAbs and Fc-fusion proteins from cell culture harvests using Z-ELP-E2 nanocages.

Swartz AR, Xu X, Traylor SJ, Li ZJ, Chen W.

Biotechnol Bioeng. 2018 Aug;115(8):2039-2047. doi: 10.1002/bit.26717. Epub 2018 May 9.

PMID: 29679468

 

Contributions of depth filter components to protein adsorption in bioprocessing.

Khanal O, Singh N, Traylor SJ, Xu X, Ghose S, Li ZJ, Lenhoff AM.

Biotechnol Bioeng. 2018 Aug;115(8):1938-1948. doi: 10.1002/bit.26707. Epub 2018 May 1.

PMID: 29663326

 

Elotuzumab monotherapy in patients with smouldering multiple myeloma: a phase 2 study.

Jagannath S, Laubach J, Wong E, Stockerl-Goldstein K, Rosenbaum C, Dhodapkar M, Jou YM, Lynch M, Robbins M, Shelat S, Anderson KC, Richardson PG.

Br J Haematol. 2018 Aug;182(4):495-503. doi: 10.1111/bjh.15384. Epub 2018 May 29.

PMID: 29808907

 

Daclatasvir: A Review of Preclinical and Clinical Pharmacokinetics.

Gandhi Y, Eley T, Fura A, Li W, Bertz RJ, Garimella T.

Clin Pharmacokinet. 2018 Aug;57(8):911-928. doi: 10.1007/s40262-017-0624-3. Review.

PMID: 29353349

 

Pharmacometric Applications and Challenges in the Development of Therapeutic Antibodies in Immuno-Oncology.

Diao L, Meibohm B.

Curr Pharmacol Rep. 2018 Aug;4(4):285-291. doi: 10.1007/s40495-018-0142-5. Epub 2018 May 3.

PMID: 30319936

 

Characterization of the Open-Label Lead-In Period of Two Randomized Controlled Phase 3 Trials Evaluating Dapagliflozin, Saxagliptin, and Metformin in Type 2 Diabetes.

Mathieu C, Catrinoiu D, Ranetti AE, Johnsson E, Hansen L, Chen H, Garcia-Sanchez R, Iqbal N, Celiñski A.

Diabetes Ther. 2018 Aug;9(4):1703-1711. doi: 10.1007/s13300-018-0445-x. Epub 2018 May 25.

PMID: 29802530

Further Studies to Support the Use of Coproporphyrin I and III as Novel Clinical Biomarkers for Evaluating the Potential for Organic Anion Transporting Polypeptide 1B1 and OATP1B3 Inhibition.

Shen H, Christopher L, Lai Y, Gong J, Kandoussi H, Garonzik S, Perera V, Garimella T, Humphreys WG.

Drug Metab Dispos. 2018 Aug;46(8):1075-1082. doi: 10.1124/dmd.118.081125. Epub 2018 May 18.

PMID: 29777022

 

Outcomes in anticoagulated patients with atrial fibrillation and with mitral or aortic valve disease.

Vinereanu D, Wang A, Mulder H, Lopes RD, Jansky P, Lewis BS, Gersh BJ, Avezum A, Hanna M, Held C, Wallentin L, Granger CB, Alexander JH.

Heart. 2018 Aug;104(15):1292-1299. doi: 10.1136/heartjnl-2017-312272. Epub 2018 Jan 19.

PMID: 29352007

 

Daclatasvir combined with asunaprevir is a cost-effective and cost-saving treatment for hepatitis C infection in China.

Chen W, Ward T, Tan MP, Yan J, Wang PF, Wygant GD, Gordon J.

J Comp Eff Res. 2018 Aug;7(8):785-795. doi: 10.2217/cer-2018-0005. Epub 2018 Jun 4.

PMID: 29860879

 

Longterm Safety and Efficacy of Subcutaneous Abatacept in Patients with Rheumatoid Arthritis: 5-year Results from a Phase IIIb Trial.

Genovese MC, Pacheco-Tena C, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente RM, Nash P, Simon-Campos JA, Box J, Legerton CW 3rd, Nasonov E, Durez P, Elegbe A, Wong R, Li X, Banerjee S, Alten R.

J Rheumatol. 2018 Aug;45(8):1085-1092. doi: 10.3899/jrheum.170344. Epub 2018 Apr 15.

PMID: 29657147

 

The expanding role of prodrugs in contemporary drug design and development.

Rautio J, Meanwell NA, Di L, Hageman MJ.

Nat Rev Drug Discov. 2018 Aug;17(8):559-587. doi: 10.1038/nrd.2018.46. Epub 2018 Apr 27. Review.

PMID: 29700501

 

Weight Loss and Timing of J Tube Removal in Biliopancreatic Diversion with Duodenal Switch Patients Who Report Physical or Sexual Abuse.

Hulme PA, Kupzyk KA, Anthone GJ, Capron KA, Nguyen T.

Obes Surg. 2018 Aug;28(8):2361-2367. doi: 10.1007/s11695-018-3166-3.

PMID: 29512037

 

Comparing the Relative Importance of Attributes of Metastatic Renal Cell Carcinoma Treatments to Patients and Physicians in the United States: A Discrete-Choice Experiment.

González JM, Doan J, Gebben DJ, Boeri M, Fishman M.

Pharmacoeconomics. 2018 Aug;36(8):973-986. doi: 10.1007/s40273-018-0640-7.

PMID: 29869777

 

Miniaturized High-Throughput Multiparameter Flow Cytometry Assays Measuring In Vitro Human Dendritic Cell Maturation and T-Cell Activation in Mixed Lymphocyte Reactions.

Fan Y, Naglich JG, Koenitzer JD, Ribeiro H, Lippy J, Blum J, Li X, Milburn C, Barnhart B, Zhang L, Fereshteh MP.

SLAS Discov. 2018 Aug;23(7):742-750. doi: 10.1177/2472555218775409. Epub 2018 Jun 6.

PMID: 29873570

 

Response to the Letter to the Editor Submitted by Dr. JoAnn C. L. Schuh.

Woicke J, Haile S, Mysore J, Peden M, Lejeune T, Sanderson TP, Brodie T.

Toxicol Pathol. 2018 Aug;46(6):721. doi: 10.1177/0192623318794180. No abstract available.

PMID: 30160207

 

Implementation of Plate Imaging for Demonstration of Monoclonality in Biologics Manufacturing Development.

Zingaro K, Shaw D, Carson J, Mayer-Bartschmid A, Bender C, Alves C, Mcvey D, Qian NX, Wei Q, Laird MW, Zhu Y, Emmins R, Follit JA, Porter A, Racher AJ, Milne S, Carubelli I, Du Z, Khatri A, Failly M, Broly H, Lee F, Reeser M, Spidel J, Anderson K, Demaria C, Di-Carlo J, Gill J, Lundquist A, Kumar SR, Gill T.

PDA J Pharm Sci Technol. 2018 Jul-Aug;72(4):438-450. doi: 10.5731/pdajpst.2018.008789. Epub 2018 Apr 18.

PMID: 29669815

 

Erratum for John Mattila, Mike Clark, Shengjiang Liu, et al.: "Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration".

Mattila J, Clark M, Liu S, Pieracci J, Gervais TR, Wilson E, Galperina O, Li X, Roush D, Zoeller K, Brough H, Simpson-Platre C.

PDA J Pharm Sci Technol. 2018 Jul-Aug;72(4):451. doi: 10.5731/pdajpst.2017.007963. Epub 2018 Mar 15. No abstract available.

PMID: 29545323

 

Fluorine and Fluorinated Motifs in the Design and Application of Bioisosteres for Drug Design.

Meanwell NA.

J Med Chem. 2018 Jul 26;61(14):5822-5880. doi: 10.1021/acs.jmedchem.7b01788. Epub 2018 Feb 5. Review.

PMID: 29400967

 

CD226 opposes TIGIT to disrupt Tregs in melanoma.

Fourcade J, Sun Z, Chauvin JM, Ka M, Davar D, Pagliano O, Wang H, Saada S, Menna C, Amin R, Sander C, Kirkwood JM, Korman AJ, Zarour HM.

JCI Insight. 2018 Jul 26;3(14). pii: 121157. doi: 10.1172/jci.insight.121157. eCollection 2018 Jul 26.

PMID: 30046006

TCFH-NMI: Direct Access to N-Acyl Imidazoliums for Challenging Amide Bond Formations.

Beutner GL, Young IS, Davies ML, Hickey MR, Park H, Stevens JM, Ye Q.

Org Lett. 2018 Jul 20;20(14):4218-4222. doi: 10.1021/acs.orglett.8b01591. Epub 2018 Jun 29.

PMID: 29956545

 

MHC proteins confer differential sensitivity to CTLA-4 and PD-1 blockade in untreated metastatic melanoma.

Rodig SJ, Gusenleitner D, Jackson DG, Gjini E, Giobbie-Hurder A, Jin C, Chang H, Lovitch SB, Horak C, Weber JS, Weirather JL, Wolchok JD, Postow MA, Pavlick AC, Chesney J, Hodi FS.

Sci Transl Med. 2018 Jul 18;10(450). pii: eaar3342. doi: 10.1126/scitranslmed.aar3342.

PMID: 30021886

 

Act1 is a negative regulator in T and B cells via direct inhibition of STAT3.

Zhang CJ, Wang C, Jiang M, Gu C, Xiao J, Chen X, Martin BN, Tang F, Yamamoto E, Xian Y, Wang H, Li F, Sartor RB, Smith H, Husni ME, Shi FD, Gao J, Carman J, Dongre A, McKarns SC, Coppieters K, Jørgensen TN, Leonard WJ, Li X.

Nat Commun. 2018 Jul 16;9(1):2745. doi: 10.1038/s41467-018-04974-3.

PMID: 30013031

 

Time to really share real-world data?

Graham S, McDonald L, Wasiak R, Lees M, Ramagopalan S.

F1000Res. 2018 Jul 11;7:1054. doi: 10.12688/f1000research.15517.1. eCollection 2018.

PMID: 30364186

 

Adventures in Atropisomerism: Total Synthesis of a Complex Active Pharmaceutical Ingredient with Two Chirality Axes.

Beutner G, Carrasquillo R, Geng P, Hsiao Y, Huang EC, Janey J, Katipally K, Kolotuchin S, La Porte T, Lee A, Lobben P, Lora-Gonzalez F, Mack B, Mudryk B, Qiu Y, Qian X, Ramirez A, Razler TM, Rosner T, Shi Z, Simmons E, Stevens J, Wang J, Wei C, Wisniewski SR, Zhu Y.

Org Lett. 2018 Jul 6;20(13):3736-3740. doi: 10.1021/acs.orglett.8b01218. Epub 2018 Jun 17.

PMID: 29909639

 

Directed, Palladium(II)-Catalyzed Intermolecular Aminohydroxylation of Alkenes Using a Mild Oxidation System.

Zeng T, Liu Z, Schmidt MA, Eastgate MD, Engle KM.

Org Lett. 2018 Jul 6;20(13):3853-3857. doi: 10.1021/acs.orglett.8b01440. Epub 2018 Jun 11.

PMID: 29888604

 

Single-crystal x-ray diffraction structures of covalent organic frameworks.

Ma T, Kapustin EA, Yin SX, Liang L, Zhou Z, Niu J, Li LH, Wang Y, Su J, Li J, Wang X, Wang WD, Wang W, Sun J, Yaghi OM.

Science. 2018 Jul 6;361(6397):48-52. doi: 10.1126/science.aat7679.

PMID: 29976818

Immune Checkpoint Blockade in Advanced Renal-Cell Carcinoma.

Motzer RJ, McHenry MB, Chen AC.

N Engl J Med. 2018 Jul 5;379(1):92-93. doi: 10.1056/NEJMc1805988. No abstract available.

PMID: 29972749

 

IL22 Inhibits Epithelial Stem Cell Expansion in an Ileal Organoid Model.

Zwarycz B, Gracz AD, Rivera KR, Williamson IA, Samsa LA, Starmer J, Daniele MA, Salter-Cid L, Zhao Q, Magness ST.

Cell Mol Gastroenterol Hepatol. 2018 Jul 4;7(1):1-17. doi: 10.1016/j.jcmgh.2018.06.008. eCollection 2019.

PMID: 30364840

 

Critical considerations for immunocapture enrichment LC-MS bioanalysis of protein therapeutics and biomarkers.

Zhao Y, Gu H, Zheng N, Zeng J.

Bioanalysis. 2018 Jul 1;10(13):987-995. doi: 10.4155/bio-2018-0062. Epub 2018 Jul 4.

PMID: 29972311

 

The discovery and preclinical evaluation of BMS-707035, a potent HIV-1 integrase strand transfer inhibitor.

Naidu BN, Walker MA, Sorenson ME, Ueda Y, Matiskella JD, Connolly TP, Dicker IB, Lin Z, Bollini S, Terry BJ, Higley H, Zheng M, Parker DD, Wu D, Adams S, Krystal MR, Meanwell NA.

Bioorg Med Chem Lett. 2018 Jul 1;28(12):2124-2130. doi: 10.1016/j.bmcl.2018.05.027. Epub 2018 May 14.

PMID: 29779976

 

Posttransplant reduction in preexisting donor-specific antibody levels after belatacept- versus cyclosporine-based immunosuppression: Post hoc analyses of BENEFIT and BENEFIT-EXT.

Bray RA, Gebel HM, Townsend R, Roberts ME, Polinsky M, Yang L, Meier-Kriesche HU, Larsen CP.

Am J Transplant. 2018 Jul;18(7):1774-1782. doi: 10.1111/ajt.14738. Epub 2018 Apr 17.

PMID: 29573335

 

De novo donor-specific antibodies in belatacept-treated vs cyclosporine-treated kidney-transplant recipients: Post hoc analyses of the randomized phase III BENEFIT and BENEFIT-EXT studies.

Bray RA, Gebel HM, Townsend R, Roberts ME, Polinsky M, Yang L, Meier-Kriesche HU, Larsen CP.

Am J Transplant. 2018 Jul;18(7):1783-1789. doi: 10.1111/ajt.14721. Epub 2018 Apr 2.

PMID: 29509295

Industrial bioprocessing perspectives on managing therapeutic protein charge variant profiles.

Chung S, Tian J, Tan Z, Chen J, Lee J, Borys M, Li ZJ.

Biotechnol Bioeng. 2018 Jul;115(7):1646-1665. doi: 10.1002/bit.26587. Epub 2018 Mar 31. Review.

PMID: 29532901

STK11/LKB1 Mutations and PD-1 Inhibitor Resistance in KRAS-Mutant Lung Adenocarcinoma.

Skoulidis F, Goldberg ME, Greenawalt DM, Hellmann MD, Awad MM, Gainor JF, Schrock AB, Hartmaier RJ, Trabucco SE, Gay L, Ali SM, Elvin JA, Singal G, Ross JS, Fabrizio D, Szabo PM, Chang H, Sasson A, Srinivasan S, Kirov S, Szustakowski J, Vitazka P, Edwards R, Bufill JA, Sharma N, Ou SI, Peled N, Spigel DR, Rizvi H, Aguilar EJ, Carter BW, Erasmus J, Halpenny DF, Plodkowski AJ, Long NM, Nishino M, Denning WL, Galan-Cobo A, Hamdi H, Hirz T, Tong P, Wang J, Rodriguez-Canales J, Villalobos PA, Parra ER, Kalhor N, Sholl LM, Sauter JL, Jungbluth AA, Mino-Kenudson M, Azimi R, Elamin YY, Zhang J, Leonardi GC, Jiang F, Wong KK, Lee JJ, Papadimitrakopoulou VA, Wistuba II, Miller VA, Frampton GM, Wolchok JD, Shaw AT, Jänne PA, Stephens PJ, Rudin CM, Geese WJ, Albacker LA, Heymach JV.

Cancer Discov. 2018 Jul;8(7):822-835. doi: 10.1158/2159-8290.CD-18-0099. Epub 2018 May 17.

PMID: 29773717

 

Tumor-Specific Inhibition of In Situ Vaccination by Distant Untreated Tumor Sites.

Morris ZS, Guy EI, Werner LR, Carlson PM, Heinze CM, Kler JS, Busche SM, Jaquish AA, Sriramaneni RN, Carmichael LL, Loibner H, Gillies SD, Korman AJ, Erbe AK, Hank JA, Rakhmilevich AL, Harari PM, Sondel PM.

Cancer Immunol Res. 2018 Jul;6(7):825-834. doi: 10.1158/2326-6066.CIR-17-0353. Epub 2018 May 10.

PMID: 29748391

 

Assessment and modelling of antibacterial combination regimens.

Rao GG, Li J, Garonzik SM, Nation RL, Forrest A.

Clin Microbiol Infect. 2018 Jul;24(7):689-696. doi: 10.1016/j.cmi.2017.12.004. Epub 2017 Dec 18. Review.

PMID: 29269090

 

Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.

Shebley M, Sandhu P, Emami Riedmaier A, Jamei M, Narayanan R, Patel A, Peters SA, Reddy VP, Zheng M, de Zwart L, Beneton M, Bouzom F, Chen J, Chen Y, Cleary Y, Collins C, Dickinson GL, Djebli N, Einolf HJ, Gardner I, Huth F, Kazmi F, Khalil F, Lin J, Odinecs A, Patel C, Rong H, Schuck E, Sharma P, Wu SP, Xu Y, Yamazaki S, Yoshida K, Rowland M.

Clin Pharmacol Ther. 2018 Jul;104(1):88-110. doi: 10.1002/cpt.1013. Epub 2018 Feb 2. Review.

PMID: 29315504

 

Abundance of Phase 1 and 2 Drug-Metabolizing Enzymes in Alcoholic and Hepatitis C Cirrhotic Livers: A Quantitative Targeted Proteomics Study.

Prasad B, Bhatt DK, Johnson K, Chapa R, Chu X, Salphati L, Xiao G, Lee C, Hop CECA, Mathias A, Lai Y, Liao M, Humphreys WG, Kumer SC, Unadkat JD.

Drug Metab Dispos. 2018 Jul;46(7):943-952. doi: 10.1124/dmd.118.080523. Epub 2018 Apr 25.

PMID: 29695616

 

Conformational Assessment of Adnectin and Adnectin-Drug Conjugate by Hydrogen/Deuterium Exchange Mass Spectrometry.

Huang RY, O'Neil SR, Lipovšek D, Chen G.

J Am Soc Mass Spectrom. 2018 Jul;29(7):1524-1531. doi: 10.1007/s13361-018-1966-2. Epub 2018 May 7.

PMID: 29736601

 

Regional Gastrointestinal Absorption of Apixaban in Healthy Subjects.

Byon W, Nepal S, Schuster AE, Shenker A, Frost CE.

J Clin Pharmacol. 2018 Jul;58(7):965-971. doi: 10.1002/jcph.1097. Epub 2018 Mar 26.

PMID: 29578609

 

Dapagliflozin as add-on therapy in Asian patients with type 2 diabetes inadequately controlled on insulin with or without oral antihyperglycemic drugs: A randomized controlled trial.

Yang W, Ma J, Li Y, Li Y, Zhou Z, Kim JH, Zhao J, Ptaszynska A.

J Diabetes. 2018 Jul;10(7):589-599. doi: 10.1111/1753-0407.12634. Epub 2018 Jan 25.

PMID: 29215189

 

Bioactive Lipid Mediator Profiles in Human Psoriasis Skin and Blood.

Sorokin AV, Domenichiello AF, Dey AK, Yuan ZX, Goyal A, Rose SM, Playford MP, Ramsden CE, Mehta NN.

J Invest Dermatol. 2018 Jul;138(7):1518-1528. doi: 10.1016/j.jid.2018.02.003. Epub 2018 Feb 15.

PMID: 29454560

 

Antibody-Dependent Cellular Phagocytosis by Macrophages is a Novel Mechanism of Action of Elotuzumab.

Kurdi AT, Glavey SV, Bezman NA, Jhatakia A, Guerriero JL, Manier S, Moschetta M, Mishima Y, Roccaro A, Detappe A, Liu CJ, Sacco A, Huynh D, Tai YT, Robbins MD, Azzi J, Ghobrial IM.

Mol Cancer Ther. 2018 Jul;17(7):1454-1463. doi: 10.1158/1535-7163.MCT-17-0998. Epub 2018 Apr 13.

PMID: 29654064

 

Transcriptome alterations of prefrontal cortical parvalbumin neurons in schizophrenia.

Enwright Iii JF, Huo Z, Arion D, Corradi JP, Tseng G, Lewis DA.

Mol Psychiatry. 2018 Jul;23(7):1606-1613. doi: 10.1038/mp.2017.216. Epub 2017 Nov 7.

PMID: 29112193

 

Thymic tuft cells promote an IL-4-enriched medulla and shape thymocyte development.

Miller CN, Proekt I, von Moltke J, Wells KL, Rajpurkar AR, Wang H, Rattay K, Khan IS, Metzger TC, Pollack JL, Fries AC, Lwin WW, Wigton EJ, Parent AV, Kyewski B, Erle DJ, Hogquist KA, Steinmetz LM, Locksley RM, Anderson MS.

Nature. 2018 Jul;559(7715):627-631. doi: 10.1038/s41586-018-0345-2. Epub 2018 Jul 18.

PMID: 30022164

 

Enhancing tablet disintegration characteristics of a highly water-soluble high-drug-loading formulation by granulation process.

Pandey P, Levins C, Pafiakis S, Zacour B, Bindra DS, Trinh J, Buckley D, Gour S, Sharif S, Stamato H.

Pharm Dev Technol. 2018 Jul;23(6):587-595. doi: 10.1080/10837450.2016.1264416. Epub 2016 Dec 15.

PMID: 27879156

 

In silico toxicology protocols.

Myatt GJ, Ahlberg E, Akahori Y, Allen D, Amberg A, Anger LT, Aptula A, Auerbach S, Beilke L, Bellion P, Benigni R, Bercu J, Booth ED, Bower D, Brigo A, Burden N, Cammerer Z, Cronin MTD, Cross KP, Custer L, Dettwiler M, Dobo K, Ford KA, Fortin MC, Gad-McDonald SE, Gellatly N, Gervais V, Glover KP, Glowienke S, Van Gompel J, Gutsell S, Hardy B, Harvey JS, Hillegass J, Honma M, Hsieh JH, Hsu CW, Hughes K, Johnson C, Jolly R, Jones D, Kemper R, Kenyon MO, Kim MT, Kruhlak NL, Kulkarni SA, Kümmerer K, Leavitt P, Majer B, Masten S, Miller S, Moser J, Mumtaz M, Muster W, Neilson L, Oprea TI, Patlewicz G, Paulino A, Lo Piparo E, Powley M, Quigley DP, Reddy MV, Richarz AN, Ruiz P, Schilter B, Serafimova R, Simpson W, Stavitskaya L, Stidl R, Suarez-Rodriguez D, Szabo DT, Teasdale A, Trejo-Martin A, Valentin JP, Vuorinen A, Wall BA, Watts P, White AT, Wichard J, Witt KL, Woolley A, Woolley D, Zwickl C, Hasselgren C.

Regul Toxicol Pharmacol. 2018 Jul;96:1-17. doi: 10.1016/j.yrtph.2018.04.014. Epub 2018 Apr 17.

PMID: 29678766

 

Predictive probability methods for interim monitoring in clinical trials with longitudinal outcomes.

Zhou M, Tang Q, Lang L, Xing J, Tatsuoka K.

Stat Med. 2018 Jun 30;37(14):2187-2207. doi: 10.1002/sim.7685. Epub 2018 Apr 17.

PMID: 29664214

 

A Combined In Vitro/In Silico Approach to Identifying Off-Target Receptor Toxicity.

Leedale J, Sharkey KJ, Colley HE, Norton ÁM, Peeney D, Mason CL, Sathish JG, Murdoch C, Sharma P, Webb SD.

iScience. 2018 Jun 29;4:84-96. doi: 10.1016/j.isci.2018.05.012. Epub 2018 May 18.

PMID: 30240756

A Novel gp41-Binding Adnectin with Potent Anti-HIV Activity Is Highly Synergistic when Linked to a CD4-Binding Adnectin.

Wensel D, Sun Y, Davis J, Li Z, Zhang S, McDonagh T, Fabrizio D, Cockett M, Krystal M.

J Virol. 2018 Jun 29;92(14). pii: e00421-18. doi: 10.1128/JVI.00421-18. Print 2018 Jul 15.

PMID: 29743355

 

The Replica Set Method: A High-throughput Approach to Quantitatively Measure Caenorhabditis elegans Lifespan.

Cornwell AB, Llop JR, Salzman P, Thakar J, Samuelson AV.

J Vis Exp. 2018 Jun 29;(136). doi: 10.3791/57819.

PMID: 30010651

 

PK/PD Disconnect Observed with a Reversible Endothelial Lipase Inhibitor.

Hangeland JJ, Abell LM, Adam LP, Jiang J, Friends TJ, Haque LE, Neels J, Onorato JM, Chen AYA, Taylor DS, Yin X, Harrity TW, Basso MD, Yang R, Sleph PG, Gordon DA, Huang CS, Wexler RR, Finlay HJ, Lawrence RM.

ACS Med Chem Lett. 2018 Jun 15;9(7):673-678. doi: 10.1021/acsmedchemlett.8b00138. eCollection 2018 Jul 12.

PMID: 30034599

The BCR-ABL1 Inhibitors Imatinib and Ponatinib Decrease Plasma Cholesterol and Atherosclerosis, and Nilotinib and Ponatinib Activate Coagulation in a Translational Mouse Model.

Pouwer MG, Pieterman EJ, Verschuren L, Caspers MPM, Kluft C, Garcia RA, Aman J, Jukema JW, Princen HMG.

Front Cardiovasc Med. 2018 Jun 12;5:55. doi: 10.3389/fcvm.2018.00055. eCollection 2018.

PMID: 29946549

 

Assessment of Density Functional Methods for Geometry Optimization of Bimolecular van der Waals Complexes.

Sirianni DA, Alenaizan A, Cheney DL, Sherrill CD.

J Chem Theory Comput. 2018 Jun 12;14(6):3004-3013. doi: 10.1021/acs.jctc.8b00114. Epub 2018 May 29.

PMID: 29763302

 

An open-label, multiple ascending dose study of the anti-CTLA-4 antibody ipilimumab in viremic HIV patients.

Colston E, Grasela D, Gardiner D, Bucy RP, Vakkalagadda B, Korman AJ, Lowy I.

PLoS One. 2018 Jun 7;13(6):e0198158. doi: 10.1371/journal.pone.0198158. eCollection 2018.

PMID: 29879143

 

Detection and Identification of the Vibrational Markers for the Quantification of Methionine Oxidation in Therapeutic Proteins.

Balakrishnan G, Barnett GV, Kar SR, Das TK.

Anal Chem. 2018 Jun 5;90(11):6959-6966. doi: 10.1021/acs.analchem.8b01238. Epub 2018 May 17.

PMID: 29741878

 

Discovery, identification and mitigation of isobaric sulfate metabolite interference to a phosphate prodrug in LC-MS/MS bioanalysis: Critical role of method development in ensuring assay quality.

Yuan L, Ji QC.

J Pharm Biomed Anal. 2018 Jun 5;155:141-147. doi: 10.1016/j.jpba.2018.03.064. Epub 2018 Apr 4.

PMID: 29631074

 

Evolution of fit-for-purpose biomarker validations: an LBA perspective.

Neely RJ.

Bioanalysis. 2018 Jun 1;10(12):905-907. doi: 10.4155/bio-2017-0267. Epub 2018 Jun 20.

PMID: 29923756

 

P3-P4 ureas and reverse carbamates as potent HCV NS3 protease inhibitors: Effective transposition of the P4 hydrogen bond donor.

Venables BL, Sin N, Wang AX, Sun LQ, Tu Y, Hernandez D, Sheaffer A, Lee M, Dunaj C, Zhai G, Barry D, Friborg J, Yu F, Knipe J, Sandquist J, Falk P, Parker D, Good AC, Rajamani R, McPhee F, Meanwell NA, Scola PM.

Bioorg Med Chem Lett. 2018 Jun 1;28(10):1853-1859. doi: 10.1016/j.bmcl.2018.04.009. Epub 2018 Apr 5.

PMID: 29650290

 

Rethinking developmental toxicity testing: Evolution or revolution?

Scialli AR, Daston G, Chen C, Coder PS, Euling SY, Foreman J, Hoberman AM, Hui J, Knudsen T, Makris SL, Morford L, Piersma AH, Stanislaus D, Thompson KE.

Birth Defects Res. 2018 Jun 1;110(10):840-850. doi: 10.1002/bdr2.1212. Epub 2018 Feb 12.

PMID: 29436169

Nonclinical Safety Assessment of the γ-Secretase Inhibitor Avagacestat.

Simutis FJ, Sanderson TP, Pilcher GD, Graziano MJ.

Toxicol Sci. 2018 Jun 1;163(2):525-542. doi: 10.1093/toxsci/kfy048.

PMID: 29529279

 

An open-Label, 2 × 2 factorial, randomized controlled trial to evaluate the safety of apixaban vs. vitamin K antagonist and aspirin vs. placebo in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention: Rationale and design of the AUGUSTUS trial.

Lopes RD, Vora AN, Liaw D, Granger CB, Darius H, Goodman SG, Mehran R, Windecker S, Alexander JH.

Am Heart J. 2018 Jun;200:17-23. doi: 10.1016/j.ahj.2018.03.001. Epub 2018 Mar 9.

PMID: 29898844

  

Prodromal symptoms of multiple sclerosis in primary care.

Disanto G, Zecca C, MacLachlan S, Sacco R, Handunnetthi L, Meier UC, Simpson A, McDonald L, Rossi A, Benkert P, Kuhle J, Ramagopalan SV, Gobbi C.

Ann Neurol. 2018 Jun;83(6):1162-1173. doi: 10.1002/ana.25247. Epub 2018 May 30.

PMID: 29740872

 

Physiologically-based pharmacokinetic modelling of a CYP2C19 substrate, BMS-823778, utilizing pharmacogenetic data.

Gong J, Iacono L, Iyer RA, Humphreys WG, Zheng M.

Br J Clin Pharmacol. 2018 Jun;84(6):1335-1345. doi: 10.1111/bcp.13565. Epub 2018 Apr 10.

PMID: 29469197

 

Safety and tolerability of dapagliflozin, saxagliptin and metformin in combination: Post-hoc analysis of concomitant add-on versus sequential add-on to metformin and of triple versus dual therapy with metformin.

Del Prato S, Rosenstock J, Garcia-Sanchez R, Iqbal N, Hansen L, Johnsson E, Chen H, Mathieu C.

Diabetes Obes Metab. 2018 Jun;20(6):1542-1546. doi: 10.1111/dom.13258. Epub 2018 Mar 25.

PMID: 29446523

 

Performing studies using the UK Clinical Practice Research Datalink: to link or not to link?

McDonald L, Schultze A, Carroll R, Ramagopalan SV.

Eur J Epidemiol. 2018 Jun;33(6):601-605. doi: 10.1007/s10654-018-0389-5. Epub 2018 Apr 4.

PMID: 29619668

 

Protection of therapeutic antibodies from visible light induced degradation: Use safe light in manufacturing and storage.

Du C, Barnett G, Borwankar A, Lewandowski A, Singh N, Ghose S, Borys M, Li ZJ.

Eur J Pharm Biopharm. 2018 Jun;127:37-43. doi: 10.1016/j.ejpb.2018.02.007. Epub 2018 Feb 7.

PMID: 29427628

 

An exploratory case study of the impact of expanding cost-effectiveness analysis for second-line nivolumab for patients with squamous non-small cell lung cancer in Canada: Does it make a difference?

Shafrin J, Skornicki M, Brauer M, Villeneuve J, Lees M, Hertel N, Penrod JR, Jansen J.

Health Policy. 2018 Jun;122(6):607-613. doi: 10.1016/j.healthpol.2018.04.008. Epub 2018 Apr 26.

PMID: 29731176

 

Population Pharmacokinetic Analysis of Asunaprevir in Subjects with Hepatitis C Virus Infection.

Zhu L, Li H, Chan P, Eley T, Gandhi Y, Bifano M, Osawa M, Ueno T, Hughes E, AbuTarif M, Bertz R, Garimella T.

Infect Dis Ther. 2018 Jun;7(2):261-275. doi: 10.1007/s40121-018-0197-y. Epub 2018 Mar 27.

PMID: 29589331

 

Tenofovir-Associated Bone Adverse Outcomes among a US National Historical Cohort of HIV-Infected Veterans: Risk Modification by Concomitant Antiretrovirals.

LaFleur J, Bress AP, Myers J, Rosenblatt L, Crook J, Knippenberg K, Bedimo R, Tebas P, Nyman H, Esker S.

Infect Dis Ther. 2018 Jun;7(2):293-308. doi: 10.1007/s40121-018-0194-1. Epub 2018 Feb 28.

PMID: 29492905

 

Real world treatment patterns in chronic myeloid leukemia patients newly initiated on tyrosine kinase inhibitors in an U.S. integrated healthcare system.

Rashid N, Koh HA, Lin KJ, Stwalley B, Felber E.

J Oncol Pharm Pract. 2018 Jun;24(4):253-263. doi: 10.1177/1078155217697484. Epub 2017 Mar 10.

PMID: 29284347

An Unexpected Degradation Pathway of a 1,2,4-Triazolo[4,3-a]pyridine Derivative: The Formation of 2 Cationic Pseudodimers of an 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor Drug Candidate in a Stressed Capsule Formulation.

Huang Y, Wang Q, Wu Y.

J Pharm Sci. 2018 Jun;107(6):1633-1641. doi: 10.1016/j.xphs.2018.02.009. Epub 2018 Feb 17.

PMID: 29458062

 

Making Lung Cancer Clinical Trials More Inclusive: Recommendations for Expanding Eligibility Criteria.

Bonomi P, Blumenthal G, Ferris AS, Stewart DJ, Selig WKD, Krug LM, Allen J, Ison G, Langer CJ, Melemed A, Odogwu L, Basu Roy U, Sandler A.

J Thorac Oncol. 2018 Jun;13(6):748-751. doi: 10.1016/j.jtho.2018.02.013. No abstract available.

PMID: 29793646

 

Analysis of the androgen receptor-regulated lncRNA landscape identifies a role for ARLNC1 in prostate cancer progression.

Zhang Y, Pitchiaya S, Cieślik M, Niknafs YS, Tien JC, Hosono Y, Iyer MK, Yazdani S, Subramaniam S, Shukla SK, Jiang X, Wang L, Liu TY, Uhl M, Gawronski AR, Qiao Y, Xiao L, Dhanasekaran SM, Juckette KM, Kunju LP, Cao X, Patel U, Batish M, Shukla GC, Paulsen MT, Ljungman M, Jiang H, Mehra R, Backofen R, Sahinalp CS, Freier SM, Watt AT, Guo S, Wei JT, Feng FY, Malik R, Chinnaiyan AM.

Nat Genet. 2018 Jun;50(6):814-824. doi: 10.1038/s41588-018-0120-1. Epub 2018 May 28.

PMID: 29808028

 

Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression.

Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington KJ, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Docampo LCI, Haddad R, Rordorf T, Kiyota N, Tahara M, Lynch M, Jayaprakash V, Li L, Gillison ML.

Oral Oncol. 2018 Jun;81:45-51. doi: 10.1016/j.oraloncology.2018.04.008. Epub 2018 Apr 17.

PMID: 29884413

 

Pharmacokinetics and Pharmacodynamics of Atazanavir in HIV-1-Infected Children Treated With Atazanavir Powder and Ritonavir: Combined Analysis of the PRINCE-1 and -2 Studies.

Sevinsky H, Zaru L, Wang R, Xu X, Pikora C, Correll TA, Eley T.

Pediatr Infect Dis J. 2018 Jun;37(6):e157-e165. doi: 10.1097/INF.0000000000001855.

PMID: 29206748

 

Safety and Efficacy of Atazanavir Powder and Ritonavir in HIV-1-Infected Infants and Children From 3 Months to <11 Years of Age: The PRINCE-2 Study.

Cotton MF, Liberty A, Torres-Escobar I, Gonzalez-Tome MI, Lissens J, Zaru L, Klauck I, Cambilargiu D, Pikora C, Correll TA.

Pediatr Infect Dis J. 2018 Jun;37(6):e149-e156. doi: 10.1097/INF.0000000000001856.

PMID: 29206747

 

The Economic Burden of Small Cell Lung Cancer: A Systematic Review of the Literature.

Enstone A, Greaney M, Povsic M, Wyn R, Penrod JR, Yuan Y.

Pharmacoecon Open. 2018 Jun;2(2):125-139. doi: 10.1007/s41669-017-0045-0. Review.

PMID: 29623624

 

Statistics and Biology: Not Your Average Relationship.

Nadon R, Kayne P.

SLAS Discov. 2018 Jun;23(5):437-439. doi: 10.1177/2472555218769904. No abstract available.

PMID: 29781352

 

Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden.

Hellmann MD, Ciuleanu TE, Pluzanski A, Lee JS, Otterson GA, Audigier-Valette C, Minenza E, Linardou H, Burgers S, Salman P, Borghaei H, Ramalingam SS, Brahmer J, Reck M, O'Byrne KJ, Geese WJ, Green G, Chang H, Szustakowski J, Bhagavatheeswaran P, Healey D, Fu Y, Nathan F, Paz-Ares L.

N Engl J Med. 2018 May 31;378(22):2093-2104. doi: 10.1056/NEJMoa1801946. Epub 2018 Apr 16.

PMID: 29658845

 

TIGIT and PD-1 dual checkpoint blockade enhances antitumor immunity and survival in GBM.

Hung AL, Maxwell R, Theodros D, Belcaid Z, Mathios D, Luksik AS, Kim E, Wu A, Xia Y, Garzon-Muvdi T, Jackson C, Ye X, Tyler B, Selby M, Korman A, Barnhart B, Park SM, Youn JI, Chowdhury T, Park CK, Brem H, Pardoll DM, Lim M.

Oncoimmunology. 2018 May 24;7(8):e1466769. doi: 10.1080/2162402X.2018.1466769. eCollection 2018.

PMID: 30221069

 

Considerations for the Use of Polysorbates in Biopharmaceuticals.

Jones MT, Mahler HC, Yadav S, Bindra D, Corvari V, Fesinmeyer RM, Gupta K, Harmon AM, Hinds KD, Koulov A, Liu W, Maloney K, Wang J, Yeh PY, Singh SK.

Pharm Res. 2018 May 24;35(8):148. doi: 10.1007/s11095-018-2430-5. Review.

PMID: 29797101

 

Tumor Mutational Burden and Efficacy of Nivolumab Monotherapy and in Combination with Ipilimumab in Small-Cell Lung Cancer.

Hellmann MD, Callahan MK, Awad MM, Calvo E, Ascierto PA, Atmaca A, Rizvi NA, Hirsch FR, Selvaggi G, Szustakowski JD, Sasson A, Golhar R, Vitazka P, Chang H, Geese WJ, Antonia SJ.

Cancer Cell. 2018 May 14;33(5):853-861.e4. doi: 10.1016/j.ccell.2018.04.001. Epub 2018 May 3. Erratum in: Cancer Cell. 2019 Feb 11;35(2):329.

PMID: 29731394

 

Genomic Features of Response to Combination Immunotherapy in Patients with Advanced Non-Small-Cell Lung Cancer.

Hellmann MD, Nathanson T, Rizvi H, Creelan BC, Sanchez-Vega F, Ahuja A, Ni A, Novik JB, Mangarin LMB, Abu-Akeel M, Liu C, Sauter JL, Rekhtman N, Chang E, Callahan MK, Chaft JE, Voss MH, Tenet M, Li XM, Covello K, Renninger A, Vitazka P, Geese WJ, Borghaei H, Rudin CM, Antonia SJ, Swanton C, Hammerbacher J, Merghoub T, McGranahan N, Snyder A, Wolchok JD.

Cancer Cell. 2018 May 14;33(5):843-852.e4. doi: 10.1016/j.ccell.2018.03.018. Epub 2018 Apr 12.

PMID: 29657128

 

Nivolumab for Relapsed/Refractory Classic Hodgkin Lymphoma After Failure of Autologous Hematopoietic Cell Transplantation: Extended Follow-Up of the Multicohort Single-Arm Phase II CheckMate 205 Trial.

Armand P, Engert A, Younes A, Fanale M, Santoro A, Zinzani PL, Timmerman JM, Collins GP, Ramchandren R, Cohen JB, De Boer JP, Kuruvilla J, Savage KJ, Trneny M, Shipp MA, Kato K, Sumbul A, Farsaci B, Ansell SM.

J Clin Oncol. 2018 May 10;36(14):1428-1439. doi: 10.1200/JCO.2017.76.0793. Epub 2018 Mar 27. Erratum in: J Clin Oncol. 2018 Sep 10;36(26):2748.

PMID: 29584546

 

A pharmaceutical industry perspective on transporter and CYP-mediated drug-drug interactions: kidney transporter biomarkers.

Shen H.

Bioanalysis. 2018 May 1;10(9):625-631. doi: 10.4155/bio-2017-0265. Epub 2018 May 16. No abstract available.

PMID: 29768022

 

UHPLC-MS/MS bioanalysis of human plasma coproporphyrins as potential biomarkers for organic anion-transporting polypeptide-mediated drug interactions.

Kandoussi H, Zeng J, Shah K, Paterson P, Santockyte R, Kadiyala P, Shen H, Shipkova P, Langish R, Burrrell R, Easter J, Mariannino T, Marathe P, Lai Y, Zhang Y, Pillutla R.

Bioanalysis. 2018 May 1;10(9):633-644. doi: 10.4155/bio-2017-0246. Epub 2018 May 11.

PMID: 29749254

 

Cancer subtype identification using somatic mutation data.

Kuijjer ML, Paulson JN, Salzman P, Ding W, Quackenbush J.

Br J Cancer. 2018 May;118(11):1492-1501. doi: 10.1038/s41416-018-0109-7. Epub 2018 May 16.

PMID: 29765148

 

Second-Generation Insulin Analogues - a Review of Recent Real-World Data and Forthcoming Head-to-Head Comparisons.

Mauricio D, Hramiak I.

Eur Endocrinol. 2018 May;14(Suppl1):2-9. doi: 10.17925/EE.2018.14supp1.2. Epub 2018 May 11. Review.

PMID: 30034546

 

Safety and effectiveness of daclatasvir and asunaprevir dual therapy in patients with genotype 1 chronic hepatitis C: results from postmarketing surveillance in Japan.

Suzuki F, Hatanaka N, Bando E, Nakamura K, Komoto A.

Hepatol Int. 2018 May;12(3):244-253. doi: 10.1007/s12072-018-9872-z. Epub 2018 Jun 9.

PMID: 29900486

 

Impact of CO₂-solvent separators on the degradation of benzyl-2,3-dihydroxypiperidine-1-carboxylate during preparative supercritical fluid chromatographic (SFC) purification.

Asokan K, Naidu H, Madam R, Shaikh KM, Reddy M, Kumar H, Shirude PS, Rajendran M, Sarabu R, Wu DR, Bajpai L, Zhang Y.

J Chromatogr A. 2017 Dec 29;1530:176-184. doi: 10.1016/j.chroma.2017.11.025. Epub 2017 Nov 14.

PMID: 29162234

Real-world predictors of 12-month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study.

Alten R, Mariette X, Lorenz HM, Galeazzi M, Cantagrel A, Nüßlein HG, Chartier M, Elbez Y, Rauch C, Le Bars M.

RMD Open. 2017 Dec 29;3(2):e000538. doi: 10.1136/rmdopen-2017-000538. eCollection 2017.

PMID: 29435360

Nivolumab and Ipilimumab in Advanced Melanoma.

Wolchok JD, Rollin L, Larkin J.

N Engl J Med. 2017 Dec 21;377(25):2503-2504. doi: 10.1056/NEJMc1714339. No abstract available.

PMID: 29262279

Identification of 5-(1-Methyl-5-(trifluoromethyl)-1H-pyrazol-3-yl)thiophene-2-Carboxamides as Novel and Selective Monoamine Oxidase B Inhibitors Used to Improve Memory and Cognition.

Kaplan AP, Keenan T, Scott R, Zhou X, Bourchouladze R, McRiner AJ, Wilson ME, Romashko D, Miller R, Bletsch M, Anderson G, Stanley J, Zhang A, Lee D, Nikpur J.

ACS Chem Neurosci. 2017 Dec 20;8(12):2746-2758. doi: 10.1021/acschemneuro.7b00282. Epub 2017 Sep 20.

PMID: 28857544

 

Synthesis of Novel Tetrahydroisoquinoline CXCR4 Antagonists with Rigidified Side-Chains.

Jecs E, Miller EJ, Wilson RJ, Nguyen HH, Tahirovic YA, Katzman BM, Truax VM, Kim MB, Kuo KM, Wang T, Sum CS, Cvijic ME, Schroeder GM, Wilson LJ, Liotta DC.

ACS Med Chem Lett. 2017 Dec 20;9(2):89-93. doi: 10.1021/acsmedchemlett.7b00406. eCollection 2018 Feb 8.

PMID: 29456793

 

Nicotinic alpha 7 receptor agonists EVP-6124 and BMS-933043, attenuate scopolamine-induced deficits in visuo-spatial paired associates learning.

Weed MR, Polino J, Signor L, Bookbinder M, Keavy D, Benitex Y, Morgan DG, King D, Macor JE, Zaczek R, Olson R, Bristow LJ.

PLoS One. 2017 Dec 19;12(12):e0187609. doi: 10.1371/journal.pone.0187609. eCollection 2017.

PMID: 29261656

Assessment and modelling of antibacterial combination regimens.

Rao GG, Li J, Garonzik SM, Nation RL, Forrest A.

Clin Microbiol Infect. 2017 Dec 18. pii: S1198-743X(17)30677-8. doi: 10.1016/j.cmi.2017.12.004. [Epub ahead of print] Review.

PMID: 29269090

 

Drug-target interactions that involve the replacement or displacement of magnesium ions.

Meanwell NA.

Bioorg Med Chem Lett. 2017 Dec 15;27(24):5355-5372. doi: 10.1016/j.bmcl.2017.11.002. Epub 2017 Nov 10. Review.

PMID: 29132752

Cost-effectiveness of early treatment of ACPA-positive rheumatoid arthritis patients with abatacept.

Neubauer AS, Minartz C, Herrmann KH, Baerwald CGO.

Clin Exp Rheumatol. 2017 Dec 15. [Epub ahead of print]

PMID: 29303709

Gaining Mechanistic Insight Into Coproporphyrin I as Endogenous Biomarker for OATP1B-Mediated Drug-Drug Interactions Using Population Pharmacokinetic Modeling and Simulation.

Barnett S, Ogungbenro K, Ménochet K, Shen H, Lai Y, Humphreys WG, Galetin A.

Clin Pharmacol Ther. 2017 Dec 15. doi: 10.1002/cpt.983. [Epub ahead of print]

PMID: 29243231

 

Na_V channel variants in patients with painful and nonpainful peripheral neuropathy.

Wadhawan S, Pant S, Golhar R, Kirov S, Thompson J, Jacobsen L, Qureshi I, Ajroud-Driss S, Freeman R, Simpson DM, Smith AG, Hoke A, Bristow LJ.

Neurol Genet. 2017 Dec 15;3(6):e207. doi: 10.1212/NXG.0000000000000207. eCollection 2017 Dec.

PMID: 29264398

Patient satisfaction after switching from warfarin to apixaban in patients with nonvalvular atrial fibrillation: AGAIN study.

Koretsune Y, Ikeda T, Kozuma K, Hirano T, Yasaka M, Kida M, Chachin M, Imura M.

Patient Prefer Adherence. 2017 Dec 15;11:1987-1996. doi: 10.2147/PPA.S152579. eCollection 2017.

PMID: 29290682

Discovery of a Parenteral Small Molecule Coagulation Factor XIa Inhibitor Clinical Candidate (BMS-962212).

Pinto DJP, Orwat MJ, Smith LM 2nd, Quan ML, Lam PYS, Rossi KA, Apedo A, Bozarth JM, Wu Y, Zheng JJ, Xin B, Toussaint N, Stetsko P, Gudmundsson O, Maxwell B, Crain EJ, Wong PC, Lou Z, Harper TW, Chacko SA, Myers JE Jr, Sheriff S, Zhang H, Hou X, Mathur A, Seiffert DA, Wexler RR, Luettgen JM, Ewing WR.

J Med Chem. 2017 Dec 14;60(23):9703-9723. doi: 10.1021/acs.jmedchem.7b01171. Epub 2017 Nov 17.

PMID: 29077405

Bioactivation of cyclopropyl rings by P450: an observation encountered during the optimisation of a series of hepatitis C virus NS5B inhibitors.

Zhuo X, Wang YZ, Yeung KS, Zhu J, Huang XS, Parcella KE, Eastman KJ, Kadow JF, Meanwell NA, Shu YZ, Johnson BM.

Xenobiotica. 2017 Dec 12:1-12. doi: 10.1080/00498254.2017.1409915. [Epub ahead of print]

PMID: 29182424

Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057).

Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, Poddubskaya E, Borghaei H, Felip E, Paz-Ares L, Pluzanski A, Reckamp KL, Burgio MA, Kohlhäeufl M, Waterhouse D, Barlesi F, Antonia S, Arrieta O, Fayette J, Crinò L, Rizvi N, Reck M, Hellmann MD, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Eberhardt WEE.

J Clin Oncol. 2017 Dec 10;35(35):3924-3933. doi: 10.1200/JCO.2017.74.3062. Epub 2017 Oct 12.

PMID: 29023213

Synthesis and SAR of 1,2,3,4-Tetrahydroisoquinoline-Based CXCR4 Antagonists.

Wilson RJ, Jecs E, Miller EJ, Nguyen HH, Tahirovic YA, Truax VM, Kim MB, Kuo KM, Wang T, Sum CS, Cvijic ME, Paiva AA, Schroeder GM, Wilson LJ, Liotta DC.

ACS Med Chem Lett. 2017 Dec 8;9(1):17-22. doi: 10.1021/acsmedchemlett.7b00381. eCollection 2018 Jan 11.

PMID: 29348805

Symptom Onset in Aortic Stenosis: Relation to Sex Differences in Left Ventricular Remodeling.

Singh A, Chan DCS, Greenwood JP, Dawson DK, Sonecki P, Hogrefe K, Kelly DJ, Dhakshinamurthy V, Lang CC, Khoo JP, Sprigings D, Steeds RP, Zhang R, Ford I, Jerosch-Herold M, Yang J, Li Z, Ng LL, McCann GP.

JACC Cardiovasc Imaging. 2017 Dec 8. pii: S1936-878X(17)30987-7. doi: 10.1016/j.jcmg.2017.09.019. [Epub ahead of print]

PMID: 29248646

Dapagliflozin as add-on therapy in Asian patients with type 2 diabetes inadequately controlled on insulin with or without oral antihyperglycemic drugs: A randomized controlled trial.

Yang W, Ma J, Li Y, Li Y, Zhou Z, Kim JH, Zhao J, Ptaszynska A.

J Diabetes. 2017 Dec 7. doi: 10.1111/1753-0407.12634. [Epub ahead of print]

PMID: 29215189

 

Codon-Directed Determination of the Biological Causes of Sequence Variants in Therapeutic Proteins.

Jiang T, Song H, Slaney TR, Wu W, Langsdorf E, Gupta G, Ludwig R, Tao L, McVey D, Das TK.

Anal Chem. 2017 Dec 5;89(23):12749-12755. doi: 10.1021/acs.analchem.7b02914. Epub 2017 Nov 14.

PMID: 29086552

 

Validation of Dissolution Testing with Biorelevant Media: An OrBiTo Study.

Mann J, Dressman J, Rosenblatt K, Ashworth L, Muenster U, Frank K, Hutchins P, Williams J, Klumpp L, Wielockx K, Berben P, Augustijns P, Holm R, Hofmann M, Patel S, Beato S, Ojala K, Tomaszewska I, Bruel JL, Butler J.

Mol Pharm. 2017 Dec 4;14(12):4192-4201. doi: 10.1021/acs.molpharmaceut.7b00198. Epub 2017 Aug 23.

PMID: 28737403

Pharmacokinetics and Pharmacodynamics of Atazanavir in HIV-1-Infected Children Treated With Atazanavir Powder and Ritonavir: Combined Analysis of the PRINCE-1 and -2 Studies.

Sevinsky H, Zaru L, Wang R, Xu X, Pikora C, Correll TA, Eley T.

Pediatr Infect Dis J. 2017 Dec 4. doi: 10.1097/INF.0000000000001855. [Epub ahead of print]

PMID: 29206748

 

Treatment patterns and clinical outcomes with pazopanib in patients with advanced soft tissue sarcomas in a compassionate use setting: results of the SPIRE study_.

Gelderblom H, Judson IR, Benson C, Merimsky O, Grignani G, Katz D, Freivogel KW, Stein D, Jobanputra M, Mungul A, Manson SC, Sanfilippo R.

Acta Oncol. 2017 Dec;56(12):1769-1775. doi: 10.1080/0284186X.2017.1332779. Epub 2017 Jul 19.

PMID: 28723233

Efficacy and Safety of Apixaban Versus Warfarin in Patients with Atrial Fibrillation and a History of Cancer: Insights from the ARISTOTLE Trial.

Melloni C, Dunning A, Granger CB, Thomas L, Khouri MG, Garcia DA, Hylek EM, Hanna M, Wallentin L, Gersh BJ, Douglas PS, Alexander JH, Lopes RD.

Am J Med. 2017 Dec;130(12):1440-1448.e1. doi: 10.1016/j.amjmed.2017.06.026. Epub 2017 Jul 21.

PMID: 28739198

 

Ten-year outcomes in a randomized phase II study of kidney transplant recipients administered belatacept 4-weekly or 8-weekly.

Vincenti F, Blancho G, Durrbach A, Grannas G, Grinyó J, Meier-Kriesche HU, Polinsky M, Yang L, Larsen CP.

Am J Transplant. 2017 Dec;17(12):3219-3227. doi: 10.1111/ajt.14452. Epub 2017 Sep 5.

PMID: 28758341

2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).

Gupta S, Richards S, Amaravadi L, Piccoli S, Desilva B, Pillutla R, Stevenson L, Mehta D, Carrasco-Triguero M, Neely R, Partridge M, Staack RF, Zhao X, Gorovits B, Kolaitis G, Sumner G, Stubenrauch KG, Zou L, Amur S, Beaver C, Berger I, Berisha F, Birnboeck H, Bower J, Cho SJ, Cludts I, Cocea L, Donato LD, Fischer S, Fraser S, Garofolo F, Haidar S, Haulenbeek J, Hottenstein C, Hu J, Ishii-Watabe A, Islam R, Jani D, Kadavil J, Kamerud J, Kramer D, Kurki P, MacMannis S, McNally J, Mullan A, Papadimitriou A, Pedras-Vasconcelos J, Ray S, Safavi A, Saito Y, Savoie N, Fjording MS, Scheibner K, Smeraglia J, Song A, Stouffer B, Tampal N, der Strate BV, Verch T, Welink J, Xu Y, Yang TY, Yengi L, Zeng J, Zhang Y, Zhang Y, Zoog S.

Bioanalysis. 2017 Dec;9(24):1967-1996. doi: 10.4155/bio-2017-4974. Epub 2017 Dec 5.

PMID: 29205064

2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).

Neubert H, Song A, Lee A, Wei C, Duggan J, Xu K, Woolf E, Evans C, Palandra J, Laterza O, Amur S, Berger I, Bustard M, Cancilla M, Chen SC, Cho SJ, Ciccimaro E, Cludts I, Cocea L, D'Arienzo C, Danan-Leon L, Donato LD, Garofolo F, Haidar S, Ishii-Watabe A, Jiang H, Kadavil J, Kassim S, Kurki P, Blaye OL, Liu K, Mathews R, Lima Santos GM, Niwa M, Pedras-Vasconcelos J, Qian M, Rago B, Saad O, Saito Y, Savoie N, Su D, Szapacs M, Tampal N, Vinter S, Wang J, Welink J, Whale E, Wilson A, Xue YJ.

Bioanalysis. 2017 Dec;9(23):1895-1912. doi: 10.4155/bio-2017-4973. Epub 2017 Dec 5.

PMID: 29205053

Analytical considerations for quantitative LC-MS strategies for measuring antibody drug-target engagement in tissues.

Shipkova P, Ciccimaro E, Olah TV.

Bioanalysis. 2017 Dec;9(23):1845-1847. doi: 10.4155/bio-2017-0215. Epub 2017 Nov 24. No abstract available.

PMID: 29171760

 

CRISPR-DAV: CRISPR NGS data analysis and visualization pipeline.

Wang X, Tilford C, Neuhaus I, Mintier G, Guo Q, Feder JN, Kirov S.

Bioinformatics. 2017 Dec 1;33(23):3811-3812. doi: 10.1093/bioinformatics/btx518.

PMID: 28961906

Macrocyclic pyrrolobenzodiazepine dimers as antibody-drug conjugate payloads.

Donnell AF, Zhang Y, Stang EM, Wei DD, Tebben AJ, Perez HL, Schroeder GM, Pan C, Rao C, Borzilleri RM, Vite GD, Gangwar S.

Bioorg Med Chem Lett. 2017 Dec 1;27(23):5267-5271. doi: 10.1016/j.bmcl.2017.10.028. Epub 2017 Oct 16.

PMID: 29102228

Combination of CD40 Agonism and CSF-1R Blockade Reconditions Tumor-Associated Macrophages and Drives Potent Antitumor Immunity.

Wiehagen KR, Girgis NM, Yamada DH, Smith AA, Chan SR, Grewal IS, Quigley M, Verona RI.

Cancer Immunol Res. 2017 Dec;5(12):1109-1121. doi: 10.1158/2326-6066.CIR-17-0258. Epub 2017 Nov 2.

PMID: 29097420

 

Efficacy and safety of entecavir versus lamivudine over 5 years of treatment: A randomized controlled trial in Korean patients with hepatitis B e antigen-negative chronic hepatitis B.

Lee KS, Kweon YO, Um SH, Kim BH, Lim YS, Paik SW, Heo J, Lee HJ, Kim DJ, Kim TH, Lee YS, Byun KS, Kim D, Lee MS, Yu K, Suh DJ.

Clin Mol Hepatol. 2017 Dec;23(4):331-339. doi: 10.3350/cmh.2016.0040. Epub 2017 Sep 26.

PMID: 28946736

Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis.

D'Agostino MA, Alten R, Mysler E, Le Bars M, Ye J, Murthy B, Heitzmann J, Vadanici R, Ferraccioli G.

Clin Rheumatol. 2017 Dec;36(12):2655-2665. doi: 10.1007/s10067-017-3788-1. Epub 2017 Aug 18.

PMID: 28822046

Use of Hybrid Capillary Tube Apparatus on 400 MHz NMR for Quantitation of Crucial Low-Quantity Metabolites Using aSICCO Signal.

Tiwari R, Ahire D, Kumar H, Sinha S, Chauthe SK, Subramanian M, Iyer R, Sarabu R, Bajpai L.

Drug Metab Dispos. 2017 Dec;45(12):1215-1224. doi: 10.1124/dmd.117.077073. Epub 2017 Sep 21.

PMID: 28935657

CheckMate 025 Randomized Phase 3 Study: Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma.

Escudier B, Sharma P, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Gurney H, Donskov F, Peltola K, Wagstaff J, Gauler TC, Ueda T, Zhao H, Waxman IM, Motzer RJ; CheckMate 025 investigators.

Eur Urol. 2017 Dec;72(6):962-971. doi: 10.1016/j.eururo.2017.02.010. Epub 2017 Mar 3. Erratum in: Eur Urol. 2018 Jan 3;:.

PMID: 28262413

Pooled Analysis Safety Profile of Nivolumab and Ipilimumab Combination Therapy in Patients With Advanced Melanoma.

Sznol M, Ferrucci PF, Hogg D, Atkins MB, Wolter P, Guidoboni M, Lebbé C, Kirkwood JM, Schachter J, Daniels GA, Hassel J, Cebon J, Gerritsen W, Atkinson V, Thomas L, McCaffrey J, Power D, Walker D, Bhore R, Jiang J, Hodi FS, Wolchok JD.

J Clin Oncol. 2017 Dec 1;35(34):3815-3822. doi: 10.1200/JCO.2016.72.1167. Epub 2017 Sep 15.

PMID: 28915085

Efficacy and Safety Outcomes in Patients With Advanced Melanoma Who Discontinued Treatment With Nivolumab and Ipilimumab Because of Adverse Events: A Pooled Analysis of Randomized Phase II and III Trials.

Schadendorf D, Wolchok JD, Hodi FS, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao CD, Chesney J, Robert C, Grossmann K, McDermott D, Walker D, Bhore R, Larkin J, Postow MA.

J Clin Oncol. 2017 Dec 1;35(34):3807-3814. doi: 10.1200/JCO.2017.73.2289. Epub 2017 Aug 25.

PMID: 28841387

 

Safety and Efficacy of Nivolumab in Combination With Ipilimumab in Metastatic Renal Cell Carcinoma: The CheckMate 016

Study.

Hammers HJ, Plimack ER, Infante JR, Rini BI, McDermott DF, Lewis LD, Voss MH, Sharma P, Pal SK, Razak ARA, Kollmannsberger C, Heng DYC, Spratlin J, McHenry MB, Amin A.

J Clin Oncol. 2017 Dec 1;35(34):3851-3858. doi: 10.1200/JCO.2016.72.1985. Epub 2017 Jul 5.

PMID: 28678668

Exposure-Response Analysis of Nivolumab in Patients With Previously Treated or Untreated Advanced Melanoma.

Bajaj G, Gupta M, Feng Y, Statkevich P, Roy A.

J Clin Pharmacol. 2017 Dec;57(12):1527-1533. doi: 10.1002/jcph.962. Epub 2017 Aug 11. No abstract available.

PMID: 28800166

A mechanistic kinetic description of lactate dehydrogenase elucidating cancer diagnosis and inhibitor evaluation.

Tang P, Xu J, Oliveira CL, Li ZJ, Liu S.

J Enzyme Inhib Med Chem. 2017 Dec;32(1):564-571. doi: 10.1080/14756366.2016.1275606.

PMID: 28114833

Daclatasvir/asunaprevir/beclabuvir, all-oral, fixed-dose combination for patients with chronic hepatitis C virus genotype 1.

Kao JH, Yu ML, Peng CY, Heo J, Chu CJ, Chang TT, Lee YJ, Hu TH, Yoon KT, Paik SW, Lim YS, Ahn SH, Isakov V, McPhee F, Hu W, Scott Swenson E, Yin PD, Treitel M.

J Gastroenterol Hepatol. 2017 Dec;32(12):1998-2005. doi: 10.1111/jgh.13796.

PMID: 28370350

IL-17A-Induced PLET1 Expression Contributes to Tissue Repair and Colon Tumorigenesis.

Zepp JA, Zhao J, Liu C, Bulek K, Wu L, Chen X, Hao Y, Wang Z, Wang X, Ouyang W, Kalady MF, Carman J, Yang WP, Zhu J, Blackburn C, Huang YH, Hamilton TA, Su B, Li X.

J Immunol. 2017 Dec 1;199(11):3849-3857. doi: 10.4049/jimmunol.1601540. Epub 2017 Oct 25.

PMID: 29070673

Industry Perspective on Contemporary Protein-Binding Methodologies: Considerations for Regulatory Drug-Drug Interaction and Related Guidelines on Highly Bound Drugs.

Di L, Breen C, Chambers R, Eckley ST, Fricke R, Ghosh A, Harradine P, Kalvass JC, Ho S, Lee CA, Marathe P, Perkins EJ, Qian M, Tse S, Yan Z, Zamek-Gliszczynski MJ.

J Pharm Sci. 2017 Dec;106(12):3442-3452. doi: 10.1016/j.xphs.2017.09.005. Epub 2017 Sep 18. Review.

PMID: 28927987

Preclinical Characterization of (R)-3-((3S,4S)-3-fluoro-4-(4-hydroxyphenyl)piperidin-1-yl)-1-(4-methylbenzyl)pyrrolidin-2-one (BMS-986169), a Novel, Intravenous, Glutamate N-Methyl-d-Aspartate 2B Receptor Negative Allosteric Modulator with Potential in Major Depressive Disorder.

Bristow LJ, Gulia J, Weed MR, Srikumar BN, Li YW, Graef JD, Naidu PS, Sanmathi C, Aher J, Bastia T, Paschapur M, Kalidindi N, Kumar KV, Molski T, Pieschl R, Fernandes A, Brown JM, Sivarao DV, Newberry K, Bookbinder M, Polino J, Keavy D, Newton A, Shields E, Simmermacher J, Kempson J, Li J, Zhang H, Mathur A, Kallem RR, Sinha M, Ramarao M, Vikramadithyan RK, Thangathirupathy S, Warrier J, Islam I, Bronson JJ, Olson RE, Macor JE, Albright CF, King D, Thompson LA, Marcin LR, Sinz M.

J Pharmacol Exp Ther. 2017 Dec;363(3):377-393. doi: 10.1124/jpet.117.242784. Epub 2017 Sep 27.

PMID: 28954811

Gamma Secretase Inhibition by BMS-906024 Enhances Efficacy of Paclitaxel in Lung Adenocarcinoma.

Morgan KM, Fischer BS, Lee FY, Shah JJ, Bertino JR, Rosenfeld J, Singh A, Khiabanian H, Pine SR.

Mol Cancer Ther. 2017 Dec;16(12):2759-2769. doi: 10.1158/1535-7163.MCT-17-0439. Epub 2017 Oct 4.

PMID: 28978720

Modelling the Survival Outcomes of Immuno-Oncology Drugs in Economic Evaluations: A Systematic Approach to Data Analysis and Extrapolation.

Gibson E, Koblbauer I, Begum N, Dranitsaris G, Liew D, McEwan P, Tahami Monfared AA, Yuan Y, Juarez-Garcia A, Tyas D, Lees M.

Pharmacoeconomics. 2017 Dec;35(12):1257-1270. doi: 10.1007/s40273-017-0558-5.

PMID: 28866758

Echocardiographic Risk Factors for Stroke and Outcomes in Patients With Atrial Fibrillation Anticoagulated With Apixaban or Warfarin.

Vinereanu D, Lopes RD, Mulder H, Gersh BJ, Hanna M, de Barros E Silva PGM, Atar D, Wallentin L, Granger CB, Alexander JH; ARISTOTLE Investigators.

Stroke. 2017 Dec;48(12):3266-3273. doi: 10.1161/STROKEAHA.117.017574. Epub 2017 Oct 31.

PMID: 29089455 

The effect of medication nonadherence on progression-free survival among patients with renal cell carcinoma.

Shafrin J, Sullivan J, Chou JW, Neely MN, Doan JF, Maclean JR.

Cancer Manag Res. 2017 Nov 29;9:731-739. doi: 10.2147/CMAR.S148199. eCollection 2017.

PMID: 29238223

On evaluation of consistency in multi-regional clinical trials.

Ying L, Song F, Chow SC, Zeng N, Zheng J, Li X, Henry D, Sethuraman V.

J Biopharm Stat. 2017 Nov 28:1-17. doi: 10.1080/10543406.2017.1397008. [Epub ahead of print]

PMID: 29182430

Ligand-accelerated non-directed C-H functionalization of arenes.

Wang P, Verma P, Xia G, Shi J, Qiao JX, Tao S, Cheng PTW, Poss MA, Farmer ME, Yeung KS, Yu JQ.

Nature. 2017 Nov 22;551(7681):489-493. doi: 10.1038/nature24632.

PMID: 29168802

Managing toxicities associated with immune checkpoint inhibitors: consensus recommendations from the Society for Immunotherapy of Cancer (SITC) Toxicity Management Working Group.

Puzanov I, Diab A, Abdallah K, Bingham CO 3rd, Brogdon C, Dadu R, Hamad L, Kim S, Lacouture ME, LeBoeuf NR, Lenihan D, Onofrei C, Shannon V, Sharma R, Silk AW, Skondra D, Suarez-Almazor ME, Wang Y, Wiley K, Kaufman HL, Ernstoff MS; Society for Immunotherapy of Cancer Toxicity Management Working Group.

J Immunother Cancer. 2017 Nov 21;5(1):95. doi: 10.1186/s40425-017-0300-z.

PMID: 29162153

Measurement of cAMP for G_αs- and G_αi Protein-Coupled Receptors (GPCRs).

Wang T, Li Z, Cvijic ME, Zhang L, Sum CS.

In: Sittampalam GS, Coussens NP, Brimacombe K, Grossman A, Arkin M, Auld D, Austin C, Baell J, Bejcek B, Chung TDY, Dahlin JL, Devanaryan V, Foley TL, Glicksman M, Hall MD, Hass JV, Inglese J, Iversen PW, Kahl SD, Kales SC, Lal-Nag M, Li Z, McGee J, McManus O, Riss T, Trask OJ Jr., Weidner JR, Xia M, Xu X, editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004-.
2017 Nov 20.

PMID: 29165978

Measurement of β-Arrestin Recruitment for GPCR Targets.

Wang T, Li Z, Cvijic ME, Krause C, Zhang L, Sum CS.

In: Sittampalam GS, Coussens NP, Brimacombe K, Grossman A, Arkin M, Auld D, Austin C, Baell J, Bejcek B, Chung TDY, Dahlin JL, Devanaryan V, Foley TL, Glicksman M, Hall MD, Hass JV, Inglese J, Iversen PW, Kahl SD, Kales SC, Lal-Nag M, Li Z, McGee J, McManus O, Riss T, Trask OJ Jr., Weidner JR, Xia M, Xu X, editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004-.
2017 Nov 20.

PMID: 29165975

Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group.

Lichtman SM, Harvey RD, Damiette Smit MA, Rahman A, Thompson MA, Roach N, Schenkel C, Bruinooge SS, Cortazar P, Walker D, Fehrenbacher L.

J Clin Oncol. 2017 Nov 20;35(33):3753-3759. doi: 10.1200/JCO.2017.74.4102. Epub 2017 Oct 2.

PMID: 28968172

 

CITU: A Peptide and Decarboxylative Coupling Reagent.

deGruyter JN, Malins LR, Wimmer L, Clay KJ, Lopez-Ogalla J, Qin T, Cornella J, Liu Z, Che G, Bao D, Stevens JM, Qiao JX, Allen MP, Poss MA, Baran PS.

Org Lett. 2017 Nov 17;19(22):6196-6199. doi: 10.1021/acs.orglett.7b03121. Epub 2017 Nov 8.

PMID: 29115835

Effectiveness of current and future regimens for treating genotype 3 hepatitis C virus infection: a large-scale systematic review.

Fathi H, Clark A, Hill NR, Dusheiko G.

BMC Infect Dis. 2017 Nov 16;17(1):722. doi: 10.1186/s12879-017-2820-z. Review.

PMID: 29145802

Utilization of Standard and Target-Specific Oral Anticoagulants Among Adults in the United Kingdom With Incident Atrial Fibrillation.

Durham TA, Hassmiller Lich K, Viera AJ, Fine JP, Mukherjee J, Weinberger M, Dusetzina SB.

Am J Cardiol. 2017 Nov 15;120(10):1820-1829. doi: 10.1016/j.amjcard.2017.07.091. Epub 2017 Aug 12.

PMID: 28867127

Imaged capillary isoelectric focusing in native condition: A novel and successful example.

Zhang X, Chemmalil L, Ding J, Mussa N, Li Z.

Anal Biochem. 2017 Nov 15;537:13-19. doi: 10.1016/j.ab.2017.08.014. Epub 2017 Aug 24.

PMID: 28844814

Design and synthesis of a novel series of (1'S,2R,4'S)-3H-4'-azaspiro[benzo[4,5]imidazo[2,1-b]oxazole-2,2'-bicyclo[2.2.2]octanes] with high affinity for the α7 neuronal nicotinic receptor.

Cook J, Zusi FC, Hill MD, Fang H, Pearce B, Park H, Gallagher L, McDonald IM, Bristow L, Macor JE, Olson RE.

Bioorg Med Chem Lett. 2017 Nov 15;27(22):5002-5005. doi: 10.1016/j.bmcl.2017.10.009. Epub 2017 Oct 10.

PMID: 29050783

Identification and quantification of signal peptide variants in an IgG1 monoclonal antibody produced in mammalian cell lines.

Huang Y, Fu J, Ludwig R, Tao L, Bongers J, Ma L, Yao M, Zhu M, Das T, Russell R.

J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Nov 15;1068-1069:193-200. doi: 10.1016/j.jchromb.2017.08.046. Epub 2017 Oct 12.

PMID: 29078145

Enablement of the direct analysis of excipients in monoclonal antibody formulations through the incorporation of a wide pore C18 protein trap with hydrophilic interaction liquid chromatography.

Huang JZ, Lin S, Huang Z, Bolgar MS.

J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Nov 15;1068-1069:131-135. doi: 10.1016/j.jchromb.2017.10.034. Epub 2017 Oct 16.

PMID: 29059588 

Modelling the effect of beliefs 博彩app软件下载app软件 asthma medication and treatment intrusiveness on adherence and preference for once-daily vs. twice-daily medication.

Chapman S, Dale P, Svedsater H, Stynes G, Vyas N, Price D, Horne R.

NPJ Prim Care Respir Med. 2017 Nov 14;27(1):61. doi: 10.1038/s41533-017-0061-7.

PMID: 29138431

Racial differences in calculated bioavailable vitamin D with vitamin D/calcium supplementation.

Yin MT, Chan ES, Brown TT, Tebas P, McComsey GA, Melbourne KM, Napoli A, Hardin WR, Ribaudo HJ, Overton ET; A5280 Study Team.

AIDS. 2017 Nov 13;31(17):2337-2344. doi: 10.1097/QAD.0000000000001621.

PMID: 28832406

Conformation Preservation of α-Helical Peptides within Supramolecular Filamentous Assemblies.

Li Y, Wang Y, Ou SH, Lock LL, Xu X, Ghose S, Li ZJ, Cui H.

Biomacromolecules. 2017 Nov 13;18(11):3611-3620. doi: 10.1021/acs.biomac.7b00992. Epub 2017 Sep 27.

PMID: 28891286

Catabolic Effects of Human PTH (1-34) on Bone: Requirement of Monocyte Chemoattractant Protein-1 in Murine Model of Hyperparathyroidism.

Siddiqui JA, Johnson J, Le Henaff C, Bitel CL, Tamasi JA, Partridge NC.

Sci Rep. 2017 Nov 10;7(1):15300. doi: 10.1038/s41598-017-15563-7.

PMID:29127344

Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma.

Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbé C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA; CheckMate 238 Collaborators.

N Engl J Med. 2017 Nov 9;377(19):1824-1835. doi: 10.1056/NEJMoa1709030. Epub 2017 Sep 10.

PMID: 28891423

Novel lung imaging biomarkers and skin gene expression subsetting in dasatinib treatment of systemic sclerosis-associated interstitial lung disease.

Martyanov V, Kim GJ, Hayes W, Du S, Ganguly BJ, Sy O, Lee SK, Bogatkevich GS, Schieven GL, Schiopu E, Marangoni RG, Goldin J, Whitfield ML, Varga J.

PLoS One. 2017 Nov 9;12(11):e0187580. doi: 10.1371/journal.pone.0187580. eCollection 2017.

PMID: 29121645

 

Real-world evidence for nucleoside/nucleotide analogues in a 5-year multicentre study of antiviral-naive chronic hepatitis B patients in China: 52-week results.

Jia J, Tang H, Ning Q, Jiang J, Dou X, Zhang M, Zhang S, Shang J, Lu W, Ye Y, Wang X, Li M, Liu J, Bo Q, Tan W; EVOLVE Study Group.

Antivir Ther. 2017 Nov 8. doi: 10.3851/IMP. [Epub ahead of print]

PMID: 29116050

Transcriptome alterations of prefrontal cortical parvalbumin neurons in schizophrenia.

Enwright Iii JF, Huo Z, Arion D, Corradi JP, Tseng G, Lewis DA.

Mol Psychiatry. 2017 Nov 7. doi: 10.1038/mp.2017.216. [Epub ahead of print]

PMID: 29112193

Tumor and Microenvironment Evolution during Immunotherapy with Nivolumab.

Riaz N, Havel JJ, Makarov V, Desrichard A, Urba WJ, Sims JS, Hodi FS, Martín-Algarra S, Mandal R, Sharfman WH, Bhatia S, Hwu WJ, Gajewski TF, Slingluff CL Jr, Chowell D, Kendall SM, Chang H, Shah R, Kuo F, Morris LGT, Sidhom JW, Schneck JP, Horak CE, Weinhold N, Chan TA.

Cell. 2017 Nov 2;171(4):934-949.e15. doi: 10.1016/j.cell.2017.09.028. Epub 2017 Oct 12.

PMID: 29033130

Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development.

Xue L, Clements-Egan A, Amaravadi L, Birchler M, Gorovits B, Liang M, Myler H, Purushothama S, Manning MS, Sung C.

AAPS J. 2017 Nov;19(6):1576-1586. doi: 10.1208/s12248-017-0153-x. Epub 2017 Nov 6.

PMID: 29110222

Physiologically Based Pharmacokinetic Modeling of Transporter-Mediated Hepatic Clearance and Liver Partitioning of OATP and OCT Substrates in Cynomolgus Monkeys.

Morse BL, MacGuire JG, Marino AM, Zhao Y, Fox M, Zhang Y, Shen H, Griffith Humphreys W, Marathe P, Lai Y.

AAPS J. 2017 Nov;19(6):1878-1889. doi: 10.1208/s12248-017-0151-z. Epub 2017 Oct 10.

PMID: 29019117

Recommendations for Selection and Characterization of Protein Biomarker Assay Calibrator Material.

Cowan KJ, Amaravadi L, Cameron MJ, Fink D, Jani D, Kamat M, King L, Neely RJ, Ni Y, Rhyne P, Riffon R, Zhu Y.

AAPS J. 2017 Nov;19(6):1550-1563. doi: 10.1208/s12248-017-0146-9. Epub 2017 Oct 2.

PMID: 28971363

How Close Are We to Profiling Immunogenicity Risk Using In Silico Algorithms and In Vitro Methods?: an Industry Perspective.

Gokemeijer J, Jawa V, Mitra-Kaushik S.

AAPS J. 2017 Nov;19(6):1587-1592. doi: 10.1208/s12248-017-0143-z. Epub 2017 Oct 2.

PMID: 28971356

Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms.

Hermans A, Abend AM, Kesisoglou F, Flanagan T, Cohen MJ, Diaz DA, Mao Y, Zhang L, Webster GK, Lin Y, Hahn DA, Coutant CA, Grady H.

AAPS J. 2017 Nov;19(6):1537-1549. doi: 10.1208/s12248-017-0117-1. Epub 2017 Aug 22.

PMID: 28831727

Prevalence of Co-existing Autoimmune Disease in Rheumatoid Arthritis: A Cross-Sectional Study.

Simon TA, Kawabata H, Ray N, Baheti A, Suissa S, Esdaile JM.

Adv Ther. 2017 Nov;34(11):2481-2490. doi: 10.1007/s12325-017-0627-3. Epub 2017 Oct 24.

PMID: 29067557

First-line treatment selection and early monitoring patterns in chronic phase-chronic myeloid leukemia in routine clinical practice: SIMPLICITY.

Goldberg SL, Cortes JE, Gambacorti-Passerini C, Hehlmann R, Khoury HJ, Michallet M, Paquette RL, Simonsson B, Zyczynski T, Foreman A, Abruzzese E, Andorsky D, Beeker A, Cony-Makhoul P, Hansen R, Lomaia E, Olavarria E, Mauro MJ.

Am J Hematol. 2017 Nov;92(11):1214-1223. doi: 10.1002/ajh.24887. Epub 2017 Sep 25.

PMID:  28815757

2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).

Welink J, Yang E, Hughes N, Rago B, Woolf E, Sydor J, Coppola L, Ackermann B, Li W, Alley SC, Arnold M, Berger I, Briscoe C, Buonarati M, Bustard M, Cancilla M, Cho SJ, Duggan J, Fraier D, Garofolo F, Green R, Haidar S, Hittle L, Ishii-Watabe A, Islam R, Jenkins R, Jones B, Kadavil J, Kassim S, Kavetska O, Blaye OL, Lee A, Liu H, Mehl J, Lima Santos GM, Musuku A, Ramanathan R, Saito Y, Savoie N, Summerfield S, Surapaneni S, Szapacs M, Tampal N, Verhaeghe T, Vinter S, Whale E.

Bioanalysis. 2017 Nov;9(22):1807-1825. doi: 10.4155/bio-2017-4975. Epub 2017 Nov 17.

PMID: 29148835

 

Enantioselective supercritical fluid chromatography-tandem mass spectrometry method for simultaneous estimation of risperidone and its 9-hydroxyl metabolites in rat plasma.

Prasad TR, Joseph S, Kole P, Kumar A, Subramanian M, Rajagopalan S, Kr P.

Bioanalysis. 2017 Nov;9(22):1739-1750. doi: 10.4155/bio-2017-0168. Epub 2017 Nov 9.

PMID: 29120220

The future of immunocapture-capillary electrophoresis-high resolution mass spectrometry.

Wang L, Dodge RW, Ji QC.

Bioanalysis. 2017 Nov;9(21):1627-1631. doi: 10.4155/bio-2017-4977. Epub 2017 Nov 2. No abstract available.

PMID: 29095042

Discovery and structure-based design of 4,6-diaminonicotinamides as potent and selective IRAK4 inhibitors.

Bhide RS, Keon A, Weigelt C, Sack JS, Schmidt RJ, Lin S, Xiao HY, Spergel SH, Kempson J, Pitts WJ, Carman J, Poss MA.

Bioorg Med Chem Lett. 2017 Nov 1;27(21):4908-4913. doi: 10.1016/j.bmcl.2017.09.029. Epub 2017 Sep 18.

PMID: 28947151

pH variations during diafiltration due to buffer nonidealities.

Baek Y, Yang D, Singh N, Arunkumar A, Ghose S, Li ZJ, Zydney AL.

Biotechnol Prog. 2017 Nov;33(6):1555-1560. doi: 10.1002/btpr.2544. Epub 2017 Sep 4.

PMID: 28840650

Comparative study of therapeutic antibody candidates derived from mini-pool and clonal cell lines.

Fan L, Rizzi G, Bierilo K, Tian J, Yee JC, Russell R, Das TK.

Biotechnol Prog. 2017 Nov;33(6):1456-1462. doi: 10.1002/btpr.2477. Epub 2017 May 2.

PMID: 28393481

A Blueprint to Advance Colorectal Cancer Immunotherapies.

Le DT, Hubbard-Lucey VM, Morse MA, Heery CR, Dwyer A, Marsilje TH, Brodsky AN, Chan E, Deming DA, Diaz LA Jr, Fridman WH, Goldberg RM, Hamilton SR, Housseau F, Jaffee EM, Kang SP, Krishnamurthi SS, Lieu CH, Messersmith W, Sears CL, Segal NH, Yang A, Moss RA, Cha E, O'Donnell-Tormey J, Roach N, Davis AQ, McAbee K, Worrall S, Benson AB.

Cancer Immunol Res. 2017 Nov;5(11):942-949. doi: 10.1158/2326-6066.CIR-17-0375. Epub 2017 Oct 16.

PMID: 29038296

PDX-MI: Minimal Information for Patient-Derived Tumor Xenograft Models.

Meehan TF, Conte N, Goldstein T, Inghirami G, Murakami MA, Brabetz S, Gu Z, Wiser JA, Dunn P, Begley DA, Krupke DM, Bertotti A, Bruna A, Brush MH, Byrne AT, Caldas C, Christie AL, Clark DA, Dowst H, Dry JR, Doroshow JH, Duchamp O, Evrard YA, Ferretti S, Frese KK, Goodwin NC, Greenawalt D, Haendel MA, Hermans E, Houghton PJ, Jonkers J, Kemper K, Khor TO, Lewis MT, Lloyd KCK, Mason J, Medico E, Neuhauser SB, Olson JM, Peeper DS, Rueda OM, Seong JK, Trusolino L, Vinolo E, Wechsler-Reya RJ, Weinstock DM, Welm A, Weroha SJ, Amant F, Pfister SM, Kool M, Parkinson H, Butte AJ, Bult CJ.

Cancer Res. 2017 Nov 1;77(21):e62-e66. doi: 10.1158/0008-5472.CAN-17-0582.

PMID: 29092942

Bleeding risk of apixaban, dabigatran, and low-dose rivaroxaban compared with warfarin in Japanese patients with non-valvular atrial fibrillation: a propensity matched analysis of administrative claims data.

Kohsaka S, Murata T, Izumi N, Katada J, Wang F, Terayama Y.

Curr Med Res Opin. 2017 Nov;33(11):1955-1963. doi: 10.1080/03007995.2017.1374935. Epub 2017 Sep 12.

PMID: 28857611

Phase II study of ipilimumab in adolescents with unresectable stage III or IV malignant melanoma.

Geoerger B, Bergeron C, Gore L, Sender L, Dunkel IJ, Herzog C, Brochez L, Cruz O, Nysom K, Berghorn E, Simsek B, Shen J, Pappo A.

Eur J Cancer. 2017 Nov;86:358-363. doi: 10.1016/j.ejca.2017.09.032. Epub 2017 Nov 5.

PMID: 29100190

Hepatitis C disease transmission and treatment uptake: impact on the cost-effectiveness of new direct-acting antiviral therapies.

Bennett H, Gordon J, Jones B, Ward T, Webster S, Kalsekar A, Yuan Y, Brenner M, McEwan P.

Eur J Health Econ. 2017 Nov;18(8):1001-1011. doi: 10.1007/s10198-016-0844-8. Epub 2016 Nov 1.

PMID:  27803989

A photochemical kinetic model for solid dosage forms.

Carvalho TC, La Cruz TE, Tábora JE.

Eur J Pharm Biopharm. 2017 Nov;120:63-72. doi: 10.1016/j.ejpb.2017.08.010. Epub 2017 Aug 20.

PMID: 28834735

Lysophosphatidic Acid Receptor Antagonism Protects against Diabetic Nephropathy in a Type 2 Diabetic Model.

Zhang MZ, Wang X, Yang H, Fogo AB, Murphy BJ, Kaltenbach R, Cheng P, Zinker B, Harris RC.

J Am Soc Nephrol. 2017 Nov;28(11):3300-3311. doi: 10.1681/ASN.2017010107. Epub 2017 Jul 24.

PMID: 28739650

Incidence of dose escalation and impact on biologic costs among patients with rheumatoid arthritis treated with three intravenous agents.

Nadkarni A, McMorrow D, Patel C, Fowler R, Smith D.

J Comp Eff Res. 2017 Nov;6(8):671-682. doi: 10.2217/cer-2016-0090. Epub 2017 Aug 9.

PMID: 28791875

Comparing biologic persistence and healthcare costs in rheumatoid arthritis patients initiating subcutaneous biologics.

Nadkarni A, McMorrow D, Fowler R, Smith D.

J Comp Eff Res. 2017 Nov;6(8):659-669. doi: 10.2217/cer-2017-0010. Epub 2017 Aug 9.

PMID: 28791873

A novel function of CXCL10 in mediating monocyte production of proinflammatory cytokines.

Zhao Q, Kim T, Pang J, Sun W, Yang X, Wang J, Song Y, Zhang H, Sun H, Rangan V, Deshpande S, Tang H, Cvijic ME, Westhouse R, Olah T, Xie J, Struthers M, Salter-Cid L.

J Leukoc Biol. 2017 Nov;102(5):1271-1280. doi: 10.1189/jlb.5A0717-302. Epub 2017 Sep 12.

PMID: 28899907

Effect of Apixaban Versus Warfarin Use on Health Care Resource Utilization and Costs Among Elderly Patients with Nonvalvular Atrial Fibrillation.

Deitelzweig S, Luo X, Gupta K, Trocio J, Mardekian J, Curtice T, Lingohr-Smith M, Menges B, Lin J.

J Manag Care Spec Pharm. 2017 Nov;23(11):1191-1201. doi: 10.18553/jmcp.2017.17060. Epub 2017 Aug 11.

PMID: 29083968

Reply: Cost-effectiveness of combination daclatasvir-sofosbuvir for treatment of genotype 3 chronic hepatitis C infection in the United States.

Saint-Laurent Thibault C, Moorjaney D, Ganz ML, Sill B, Hede S, Yuan Y, Gorsh B.

J Med Econ. 2017 Nov;20(11):1123-1125. doi: 10.1080/13696998.2017.1360313. Epub 2017 Aug 11. No abstract available.

PMID: 28745536

Understanding the Delamination Risk of a Trilayer Tablet Using Minipiloting Tools.

Tao J, Robertson-Lavalle S, Pandey P, Badawy S.

J Pharm Sci. 2017 Nov;106(11):3346-3352. doi: 10.1016/j.xphs.2017.07.005. Epub 2017 Jul 16.

PMID: 28720384

Mapping the Binding Interface in a Noncovalent Size Variant of a Monoclonal Antibody Using Native Mass Spectrometry, Hydrogen-Deuterium Exchange Mass Spectrometry, and Computational Analysis.

Yan Y, Wei H, Jusuf S, Krystek SR Jr, Chen J, Chen G, Ludwig RT, Tao L, Das TK.

J Pharm Sci. 2017 Nov;106(11):3222-3229. doi: 10.1016/j.xphs.2017.06.009. Epub 2017 Jun 17.

PMID: 28634122

Reversal of apixaban anticoagulation by four-factor prothrombin complex concentrates in healthy subjects: a randomized three-period crossover study.

Song Y, Wang Z, Perlstein I, Wang J, LaCreta F, Frost RJA, Frost C.

J Thromb Haemost. 2017 Nov;15(11):2125-2137. doi: 10.1111/jth.13815. Epub 2017 Oct 9.

PMID: 28846831

Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial.

Dandona P, Mathieu C, Phillip M, Hansen L, Griffen SC, Tschöpe D, Thorén F, Xu J, Langkilde AM; DEPICT-1 Investigators.

Lancet Diabetes Endocrinol. 2017 Nov;5(11):864-876. doi: 10.1016/S2213-8587(17)30308-X. Epub 2017 Sep 14. Erratum in: Lancet Diabetes Endocrinol. 2017 Dec;5(12 ):e8.

PMID: 28919061

Forced degradation of recombinant monoclonal antibodies: A practical guide.

Nowak C, K Cheung J, M Dellatore S, Katiyar A, Bhat R, Sun J, Ponniah G, Neill A, Mason B, Beck A, Liu H.

MAbs. 2017 Nov/Dec;9(8):1217-1230. doi: 10.1080/19420862.2017.1368602. Epub 2017 Aug 30.

PMID: 28853987 

Determination of process variables affecting drug particle attrition withinmulti-component blends during powder feed transmission.

Gamble JF, Dennis AB, Hutchins P, Jones JW, Musembi P, Tobyn M.

Pharm Dev Technol. 2017 Nov;22(7):904-909. doi: 10.1080/10837450.2016.1200616. Epub 2016 Jun 27.

PMID: 27344924

RAF inhibitors promote RAS-RAF interaction by allosterically disrupting RAF autoinhibition.

Jin T, Lavoie H, Sahmi M, David M, Hilt C, Hammell A, Therrien M.

Nat Commun. 2017 Oct 31;8(1):1211. doi: 10.1038/s41467-017-01274-0.

PMID: 29084939

Lack of data sharing in observational studies.

McDonald L, Schultze A, Simpson A, Graham S, Wasiak R, Ramagopalan SV.

BMJ. 2017 Oct 24;359:j4866. doi: 10.1136/bmj.j4866. No abstract available.

PMID: 29066583 

Design strategies in the prodrugs of HIV-1 protease inhibitors to improve the pharmaceutical properties.

Subbaiah MAM, Meanwell NA, Kadow JF.

Eur J Med Chem. 2017 Oct 20;139:865-883. doi: 10.1016/j.ejmech.2017.07.044. Epub 2017 Jul 22. Review.

PMID: 28865281

Phase III Trial of Ipilimumab Combined With Paclitaxel and Carboplatin in Advanced Squamous Non-Small-Cell Lung Cancer.

Govindan R, Szczesna A, Ahn MJ, Schneider CP, Gonzalez Mella PF, Barlesi F, Han B, Ganea DE, Von Pawel J, Vladimirov V, Fadeeva N, Lee KH, Kurata T, Zhang L, Tamura T, Postmus PE, Jassem J, O'Byrne K, Kopit J, Li M, Tschaika M, Reck M.

J Clin Oncol. 2017 Oct 20;35(30):3449-3457. doi: 10.1200/JCO.2016.71.7629. Epub 2017 Aug 30.

PMID: 28854067

Societal preferences for adjuvant melanoma health states: UK and Australia.

Middleton MR, Atkins MB, Amos K, Wang PF, Kotapati S, Sabater J, Beusterien K.

BMC Cancer. 2017 Oct 17;17(1):689. doi: 10.1186/s12885-017-3673-y.

PMID: 29041898

Rapid reversal of innate immune dysregulation in blood of patients and livers of humanized mice with HCV following DAA therapy.

Burchill MA, Roby JA, Crochet N, Wind-Rotolo M, Stone AE, Edwards MG, Dran RJ, Kriss MS, Gale M Jr, Rosen HR.

PLoS One. 2017 Oct 17;12(10):e0186213. doi: 10.1371/journal.pone.0186213. eCollection 2017.

PMID: 29040318

Real-world data really matter.

McDonald L, Ramagopalan SV, Lees M.

CMAJ. 2017 Oct 16;189(41):E1293. doi: 10.1503/cmaj.733383. No abstract available.

PMID: 29038323

Endogenous Biomarkers to Assess Drug-Drug Interactions by Drug Transporters and Enzymes.

Mariappan TT, Shen H, Marathe P.

Curr Drug Metab. 2017 Oct 16;18(8):757-768. doi: 10.2174/1389200218666170724110818.

PMID: 28738769

Discovery of non-zwitterionic aryl sulfonamides as Na_v1.7 inhibitors with efficacy in preclinical behavioral models and translational measures of nociceptive neuron activation.

Wu YJ, Guernon J, McClure A, Luo G, Rajamani R, Ng A, Easton A, Newton A, Bourin C, Parker D, Mosure K, Barnaby O, Soars MG, Knox RJ, Matchett M, Pieschl R, Herrington J, Chen P, Sivarao DV, Bristow LJ, Meanwell NA, Bronson J, Olson R, Thompson LA, Dzierba C.

Bioorg Med Chem. 2017 Oct 15;25(20):5490-5505. doi: 10.1016/j.bmc.2017.08.012. Epub 2017 Aug 9

PMID: 28818462

Radiosynthesis and preclinical PET evaluation of ₈₉Zr-nivolumab (BMS-936558) in healthy non-human primates.

Cole EL, Kim J, Donnelly DJ, Smith RA, Cohen D, Lafont V, Morin PE, Huang RY, Chow PL, Hayes W, Bonacorsi S Jr..

Bioorg Med Chem. 2017 Oct 15;25(20):5407-5414. doi: 10.1016/j.bmc.2017.07.066. Epub 2017 Aug 4.

PMID: 28803798

Discovery of highly potent, selective, covalent inhibitors of JAK3.

Kempson J, Ovalle D, Guo J, Wrobleski ST, Lin S, Spergel SH, Duan JJ, Jiang B, Lu Z, Das J, Yang BV, Hynes J Jr, Wu H, Tokarski J, Sack JS, Khan J, Schieven G, Blatt Y, Chaudhry C, Salter-Cid LM, Fura A, Barrish JC, Carter PH, Pitts WJ.

Bioorg Med Chem Lett. 2017 Oct 15;27(20):4622-4625. doi: 10.1016/j.bmcl.2017.09.023. Epub 2017 Sep 11.

PMID: 28927786

Setting priorities in the health care sector - the case of oral anticoagulants in nonvalvular atrial fibrillation in Denmark.

Poulsen PB, Johnsen SP, Hansen ML, Brandes A, Husted S, Harboe L, Dybro L.

Clinicoecon Outcomes Res. 2017 Oct 13;9:617-627. doi: 10.2147/CEOR.S145813. eCollection 2017.

PMID: 29066923

Characteristic rotational behaviors of rod-shaped cargo revealed by automated five-dimensional single particle tracking.

Chen K, Gu Y, Sun W, Bin Dong, Wang G, Fan X, Xia T, Fang N.

Nat Commun. 2017 Oct 12;8(1):887. doi: 10.1038/s41467-017-01001-9.

PMID: 29026088

Epidemiology, patient profile, and health care resource use for hepatitis C in Italy.

Sangiorgi D, Perrone V, Buda S, Boglione L, Cariti G, Lefevre C, Nappi C, Degli Esposti L.

Clinicoecon Outcomes Res. 2017 Oct 10;9:609-616. doi: 10.2147/CEOR.S136456. eCollection 2017.

PMID:  29066922

Oral anticoagulant persistence in patients with non-valvular atrial fibrillation: A cohort study using primary care data in Germany.

Collings SL, Lefèvre C, Johnson ME, Evans D, Hack G, Stynes G, Maguire A.

PLoS One. 2017 Oct 10;12(10):e0185642. doi: 10.1371/journal.pone.0185642. eCollection 2017.

PMID: 29016695

IRAK2 directs stimulus-dependent nuclear export of inflammatory mRNAs.

Zhou H, Bulek K, Li X, Herjan T, Yu M, Qian W, Wang H, Zhou G, Chen X, Yang H, Hong L, Zhao J, Qin L, Fukuda K, Flotho A, Gao J, Dongre A, Carman JA, Kang Z, Su B, Kern TS, Smith JD, Hamilton TA, Melchior F, Fox PL, Li X.

Elife. 2017 Oct 9;6. pii: e29630. doi: 10.7554/eLife.29630.

PMID: 28990926

Treatment patterns and costs of care for patients with relapsed and refractory Hodgkin lymphoma treated with brentuximab vedotin in the United States: A retrospective cohort study.

Szabo SM, Hirji I, Johnston KM, Juarez-Garcia A, Connors JM.

PLoS One. 2017 Oct 9;12(10):e0180261. doi: 10.1371/journal.pone.0180261. eCollection 2017.

PMID: 28991893

Development of the Large-Scale Synthesis of Tetrahydropyran Glycine, a Precursor to the HCV NS5A Inhibitor BMS-986097.

Mathur A, Wang B, Smith D, Li J, Pawluczyk J, Sun JH, Wong MK, Krishnananthan S, Wu DR, Sun D, Li P, Yip S, Chen BC, Baran PS, Chen Q, Lopez OD, Yong Z, Bender JA, Nguyen VN, Romine JL, Laurent DRS, Wang G, Kadow JF, Meanwell NA, Belema M, Zhao R.

J Org Chem. 2017 Oct 6;82(19):10376-10387. doi: 10.1021/acs.joc.7b01852. Epub 2017 Sep 14.

PMID: 28877441

A Mild, Functional Group Tolerant Addition of Organozinc Nucleophiles to N-Activated Quinolines and Isoquinolines.

Luzung MR, Dixon DD, Ortiz A, Guerrero CA, Ayers S, Ho J, Schmidt MA, Strotman NA, Eastgate MD.

J Org Chem. 2017 Oct 6;82(19):10715-10721. doi: 10.1021/acs.joc.7b01882. Epub 2017 Sep 7.

PMID: 28809492

Synergistic inhibition of Aβ production by combinations of γ-secretase modulators.

Robertson AS, Iben LG, Wei C, Meredith JE Jr, Drexler DM, Banks M, Vite GD, Olson RE, Thompson LA, Albright CF, Ahlijanian MK, Toyn JH.

Eur J Pharmacol. 2017 Oct 5;812:104-112. doi: 10.1016/j.ejphar.2017.07.019. Epub 2017 Jul 8.

PMID: 28690193

A polychromatic turbidity microplate assay to distinguish discovery stage drug molecules with beneficial precipitation properties.

Morrison J, Nophsker M, Elzinga P, Donoso M, Park H, Haskell R.

Int J Pharm. 2017 Oct 5;531(1):24-34. doi: 10.1016/j.ijpharm.2017.07.086. Epub 2017 Aug 7.

PMID: 28797968

Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.

Wolchok JD, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao CD, Wagstaff J, Schadendorf D, Ferrucci PF, Smylie M, Dummer R, Hill A, Hogg D, Haanen J, Carlino MS, Bechter O, Maio M, Marquez-Rodas I, Guidoboni M, McArthur G, Lebbé C, Ascierto PA, Long GV, Cebon J, Sosman J, Postow MA, Callahan MK, Walker D, Rollin L, Bhore R, Hodi FS, Larkin J.

N Engl J Med. 2017 Oct 5;377(14):1345-1356. doi: 10.1056/NEJMoa1709684. Epub 2017 Sep 11.

PMID: 28889792

Interleukin-21 combined with PD-1 or CTLA-4 blockade enhances antitumor immunity in mouse tumor models.

Lewis KE, Selby MJ, Masters G, Valle J, Dito G, Curtis WR, Garcia R, Mink KA, Waggie KS, Holdren MS, Grosso JF, Korman AJ, Jure-Kunkel M, Dillon SR.

Oncoimmunology. 2017 Oct 4;7(1):e1377873. doi: 10.1080/2162402X.2017.1377873. eCollection 2017.

PMID: 29296539

Standard Curves Are Necessary to Determine Pharmacological Properties for Ligands in Functional Assays Using Competition Binding Technologies.

Burford NT, Watson J, Alt A.

Assay Drug Dev Technol. 2017 Oct/Nov;15(7):320-329. doi: 10.1089/adt.2017.811.

PMID: 29120673

Immunoaffinity LC-MS/MS for quantitative determination of a free and total protein target as a target engagement biomarker.

Zhang H, Gu H, Shipkova P, Ciccimaro E, Sun H, Zhao Q, Olah TV.

Bioanalysis. 2017 Oct;9(20):1573-1588. doi: 10.4155/bio-2017-0152. Epub 2017 Oct 26.

PMID: 29072496

Spotting of external calibration standards on blank dried blood spots as a resource-sparing protocol.

Nigam A, Kole P, Kurawattimath V, Mandlekar S, Subramanian M.

Bioanalysis. 2017 Oct;9(19):1441-1450. doi: 10.4155/bio-2017-0143. Epub 2017 Oct 21.

PMID: 29056076

Efficacy of Sequential Ipilimumab Monotherapy versus Best Supportive Care for Unresectable Locally Advanced/Metastatic Gastric or Gastroesophageal Junction Cancer.

Bang YJ, Cho JY, Kim YH, Kim JW, Di Bartolomeo M, Ajani JA, Yamaguchi K, Balogh A, Sanchez T, Moehler M.

Clin Cancer Res. 2017 Oct 1;23(19):5671-5678. doi: 10.1158/1078-0432.CCR-17-0025. Epub 2017 Jun 27.

PMID: 28655793

Elevated Cardiovascular Disease Risk in Patients With Chronic Myelogenous Leukemia Seen in Community-based Oncology Practices in the United States.

Coutinho AD, Makenbaeva D, Farrelly E, Landsman-Blumberg PB, Lenihan D.

Clin Lymphoma Myeloma Leuk. 2017 Oct;17(10):676-683. doi: 10.1016/j.clml.2017.06.011. Epub 2017 Jun 17.

PMID: 28729178

Population Pharmacokinetic Analysis of Daclatasvir in Subjects with Chronic Hepatitis C Virus Infection.

Chan P, Li H, Zhu L, Bifano M, Eley T, Osawa M, Ueno T, Hughes E, Bertz R, Garimella T, AbuTarif M.

Clin Pharmacokinet. 2017 Oct;56(10):1173-1183. doi: 10.1007/s40262-016-0504-2.

PMID: 28066880

Coccidioidomycosis in an Indoor-housed Rhesus Macaque (Macaca mulatta).

Kundu MC, Ringenberg MA, d'Epagnier DL, Haag HL, Maguire S.

Comp Med. 2017 Oct 1;67(5):452-455.

PMID: 28935008

Model-based Meta-Analysis on the Efficacy of Pharmacological Treatments for Idiopathic Pulmonary Fibrosis.

Chan P, Bax L, Chen C, Zhang N, Huang SP, Soares H, Rosen G, AbuTarif M.

CPT Pharmacometrics Syst Pharmacol. 2017 Oct;6(10):695-704. doi: 10.1002/psp4.12227. Epub 2017 Sep 7.

PMID: 28699195

Comparison of effectiveness and safety of treatment with apixaban vs. other oral anticoagulants among elderly nonvalvular atrial fibrillation patients.

Deitelzweig S, Luo X, Gupta K, Trocio J, Mardekian J, Curtice T, Lingohr-Smith M, Menges B, Lin J.

Curr Med Res Opin. 2017 Oct;33(10):1745-1754. doi: 10.1080/03007995.2017.1334638. Epub 2017 Aug 29.

PMID: 28849676

Translational pharmacokinetic-pharmacodynamic analysis in the pharmaceutical industry: an IQ Consortium PK-PD Discussion Group perspective.

Wong H, Bohnert T, Damian-Iordache V, Gibson C, Hsu CP, Krishnatry AS, Liederer BM, Lin J, Lu Q, Mettetal JT, Mudra DR, Nijsen MJMA, Schroeder P, Schuck E, Suryawanshi S, Trapa P, Tsai A, Wang H, Wu F.

Drug Discov Today. 2017 Oct;22(10):1447-1459. doi: 10.1016/j.drudis.2017.04.015. Epub 2017 May 2.

PMID: 28476536

Considerations from the IQ Induction Working Group in Response to Drug-Drug Interaction Guidance from Regulatory Agencies: Focus on Downregulation, CYP2C Induction, and CYP2B6 Positive Control.

Hariparsad N, Ramsden D, Palamanda J, Dekeyser JG, Fahmi OA, Kenny JR, Einolf H, Mohutsky M, Pardon M, Siu YA, Chen L, Sinz M, Jones B, Walsky R, Dallas S, Balani SK, Zhang G, Buckley D, Tweedie D.

Drug Metab Dispos. 2017 Oct;45(10):1049-1059. doi: 10.1124/dmd.116.074567. Epub 2017 Jun 23.

PMID: 28646080

Navigating tissue chips from development to dissemination: A pharmaceutical industry perspective.

Ewart L, Fabre K, Chakilam A, Dragan Y, Duignan DB, Eswaraka J, Gan J, Guzzie-Peck P, Otieno M, Jeong CG, Keller DA, de Morais SM, Phillips JA, Proctor W, Sura R, Van Vleet T, Watson D, Will Y, Tagle D, Berridge B.

Exp Biol Med (Maywood). 2017 Oct;242(16):1579-1585. doi: 10.1177/1535370217715441. Epub 2017 Jun 16.

PMID: 28622731

Antibody-Drug Conjugates as Cancer Therapeutics: Past, Present, and Future.

Vezina HE, Cotreau M, Han TH, Gupta M.

J Clin Pharmacol. 2017 Oct;57 Suppl 10:S11-S25. doi: 10.1002/jcph.981.

PMID: 28921650

Clinical Pharmacology Considerations for the Development of Immune Checkpoint Inhibitors.

Sheng J, Srivastava S, Sanghavi K, Lu Z, Schmidt BJ, Bello A, Gupta M.

J Clin Pharmacol. 2017 Oct;57 Suppl 10:S26-S42. doi: 10.1002/jcph.990.

PMID: 28921644

The Utility of a Population Approach in Drug-Drug Interaction Assessments: A Simulation Evaluation.

Wang DD, Yu Y, Kassir N, Zhu M, Hanley WD, Earp JC, Chow AT, Gupta M, Hu C.

J Clin Pharmacol. 2017 Oct;57(10):1268-1278. doi: 10.1002/jcph.921. Epub 2017 May 17.

PMID: 28513856

Perspectives on Subcutaneous Route of Administration as an Immunogenicity Risk Factor for Therapeutic Proteins.

Hamuro L, Kijanka G, Kinderman F, Kropshofer H, Bu DX, Zepeda M, Jawa V.

J Pharm Sci. 2017 Oct;106(10):2946-2954. doi: 10.1016/j.xphs.2017.05.030. Epub 2017 May 31. Review.

PMID: 28576695

Suboptimal Anticoagulant Management in Japanese Patients with Nonvalvular Atrial Fibrillation Receiving Warfarin for Stroke Prevention.

Hirano T, Kaneko H, Mishina S, Wang F, Morita S.

J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2102-2110. doi: 10.1016/j.jstrokecerebrovasdis.2017.04.030. Epub 2017 May 19.

PMID: 28532651

The effect of body mass index on clinical response to abatacept as a first-line biologic for rheumatoid arthritis: 6-month results from the 2-year, observational, prospective ACTION study.

Mariette X, Alten R, Nüßlein HG, Galeazzi M, Lorenz HM, Cantagrel A, Chartier M, Poncet C, Rauch C, Le Bars M.

Joint Bone Spine. 2017 Oct;84(5):571-576. doi: 10.1016/j.jbspin.2016.10.011. Epub 2016 Dec 30.

PMID: 28043761

Crystal structures of trimeric HIV envelope with entry inhibitors BMS-378806 and BMS-626529.

Pancera M, Lai YT, Bylund T, Druz A, Narpala S, O'Dell S, Schön A, Bailer RT, Chuang GY, Geng H, Louder MK, Rawi R, Soumana DI, Finzi A, Herschhorn A, Madani N, Sodroski J, Freire E, Langley DR, Mascola JR, McDermott AB, Kwong PD.

Nat Chem Biol. 2017 Oct;13(10):1115-1122. doi: 10.1038/nchembio.2460. Epub 2017 Aug 21.

PMID: 28825711

A functional genomics predictive network model identifies regulators of inflammatory bowel disease.

Peters LA, Perrigoue J, Mortha A, Iuga A, Song WM, Neiman EM, Llewellyn SR, Di Narzo A, Kidd BA, Telesco SE, Zhao Y, Stojmirovic A, Sendecki J, Shameer K, Miotto R, Losic B, Shah H, Lee E, Wang M, Faith JJ, Kasarskis A, Brodmerkel C, Curran M, Das A, Friedman JR, Fukui Y, Humphrey MB, Iritani BM, Sibinga N, Tarrant TK, Argmann C, Hao K, Roussos P, Zhu J, Zhang B, Dobrin R, Mayer LF, Schadt EE.

Nat Genet. 2017 Oct;49(10):1437-1449. doi: 10.1038/ng.3947. Epub 2017 Sep 11.

PMID: 28892060

A randomized, open-label, Phase III clinical trial of nivolumab vs. therapy of investigator's choice in recurrent squamous cell carcinoma of the head and neck: A subanalysis of Asian patients versus the global population in checkmate 141.

Kiyota N, Hasegawa Y, Takahashi S, Yokota T, Yen CJ, Iwae S, Shimizu Y, Hong RL, Goto M, Kang JH, Sum Kenneth Li W, Ferris RL, Gillison M, Namba Y, Monga M, Lynch M, Tahara M.

Oral Oncol. 2017 Oct;73:138-146. doi: 10.1016/j.oraloncology.2017.07.023. Epub 2017 Sep 1.

PMID: 28939066

Characterization of the adrenocorticotrophic hormone - induced mouse model of resistance to antidepressant drug treatment.

Srikumar BN, Paschapur M, Kalidindi N, Adepu B, Das ML, Sreedhara MV, Kuchibhotla VK, Pieschl RL, Li YW, Ega DSP, Louis JV, Murugesan S, Naidu PS, Ramarao M, Bristow LJ, Vikramadithyan RK.

Pharmacol Biochem Behav. 2017 Oct;161:53-61. doi: 10.1016/j.pbb.2017.09.003. Epub 2017 Sep 11.

PMID: 28911960

Update of the budget impact analysis of the simplification to atazanavir + ritonavir + lamivudine dual therapy of HIV-positive patients receiving atazanavir-based triple therapies in Italy starting from data of the Atlas-M trial.

Restelli U, Fabbiani M, Di Giambenedetto S, Nappi C, Croce D.

Clinicoecon Outcomes Res. 2017 Sep 27;9:569-571. doi: 10.2147/CEOR.S143377. eCollection 2017. No abstract available.

PMID: 29026324

Cardiovascular outcomes among HIV-infected veterans receiving atazanavir.

LaFleur J, Bress AP, Rosenblatt L, Crook J, Sax PE, Myers J, Ritchings C.

AIDS. 2017 Sep 24;31(15):2095-2106. doi: 10.1097/QAD.0000000000001594.

PMID: 28692532

Deubiquitinases A20 and CYLD modulate costimulatory signaling via CD137 (4-1BB).

Azpilikueta A, Bolaños E, Lang V, Labiano S, Aznar MA, Etxeberria I, Teijeira A, Rodriguez-Ruiz ME, Perez-Gracia JL, Jure-Kunkel M, Zapata JM, Rodriguez MS, Melero I.

Oncoimmunology. 2017 Sep 21;7(1):e1368605. doi: 10.1080/2162402X.2017.1368605. eCollection 2017.

PMID: 29296520

Unintended consequences of machine learning in medicine?

McDonald L, Ramagopalan SV, Cox AP, Oguz M.

F1000Res. 2017 Sep 19;6:1707. doi: 10.12688/f1000research.12693.1. eCollection 2017.

PMID: 29250316

A review of data sharing statements in observational studies published in the BMJ: A cross-sectional study.

McDonald L, Schultze A, Simpson A, Graham S, Wasiak R, Ramagopalan SV.

Version 2. F1000Res. 2017 Sep 19 [revised 2017 Jan 1];6:1708. doi: 10.12688/f1000research.12673.2. eCollection 2017.

PMID: 29167735

Decarboxylative Alkynylation.

Smith JM, Qin T, Merchant RR, Edwards JT, Malins LR, Liu Z, Che G, Shen Z, Shaw SA, Eastgate MD, Baran PS.

Angew Chem Int Ed Engl. 2017 Sep 18;56(39):11906-11910. doi: 10.1002/anie.201705107. Epub 2017 Aug 1.

PMID: 28636185

Human leukocyte antigen variants and risk of hepatocellular carcinoma modified by hepatitis C virus genotypes: A genome-wide association study.

Lee MH, Huang YH, Chen HY, Khor SS, Chang YH, Lin YJ, Jen CL, Lu SN, Yang HI, Nishida N, Sugiyama M, Mizokami M, Yuan Y, L'Italien G, Tokunaga K, Chen CJ; REVEAL-HCV Cohort Study Group.

Hepatology. 2017 Sep 16. doi: 10.1002/hep.29531. [Epub ahead of print]

PMID: 28921602

Nivolumab Exposure-Response Analyses of Efficacy and Safety in Previously Treated Squamous or Nonsquamous Non-Small Cell Lung Cancer.

Feng Y, Wang X, Bajaj G, Agrawal S, Bello A, Lestini B, Finckenstein FG, Park JS, Roy A.

Clin Cancer Res. 2017 Sep 15;23(18):5394-5405. doi: 10.1158/1078-0432.CCR-16-2842.

PMID: 28916617

Nonclinical and clinical pharmacology evidence for cardiovascular safety of saxagliptin.

Pollack PS, Chadwick KD, Smith DM, Billger M, Hirshberg B, Iqbal N, Boulton DW.

Cardiovasc Diabetol. 2017 Sep 13;16(1):113. doi: 10.1186/s12933-017-0595-6. Review.

PMID: 28903775 

Functional differences between PD-1+ and PD-1- CD4+ effector T cells in healthy donors and patients with glioblastoma multiforme.

Goods BA, Hernandez AL, Lowther DE, Lucca LE, Lerner BA, Gunel M, Raddassi K, Coric V, Hafler DA, Love JC.

PLoS One. 2017 Sep 7;12(9):e0181538. doi: 10.1371/journal.pone.0181538. eCollection 2017.

PMID: 28880903

Biopharmaceutical Evaluation and CMC Aspects of Oral Modified Release Formulations.

Chang RK, Mathias N, Hussain MA.

AAPS J. 2017 Sep;19(5):1348-1358. doi: 10.1208/s12248-017-0112-6. Epub 2017 Jul 5.

PMID: 28681160

The Impact of Disintegrant Type, Surfactant, and API Properties on the Processability and Performance of Roller Compacted Formulations of Acetaminophen and Aspirin.

Zhao J, Koo O, Pan D, Wu Y, Morkhade D, Rana S, Saha P, Marin A.

AAPS J. 2017 Sep;19(5):1387-1395. doi: 10.1208/s12248-017-0104-6. Epub 2017 Jun 12.

PMID: 28608238

Singlicate Ligand Binding Assay Using an Automated Microfluidic System: a Clinical Case Study.

Jiang H, Kozhich A, Cummings J, Gambardella J, Zambito F, Titsch C, Haulenbeek J, Phillips K, Fergus R, Myler H.

AAPS J. 2017 Sep;19(5):1461-1468. doi: 10.1208/s12248-017-0105-5. Epub 2017 Jun 6.

PMID: 28589510

Belatacept-Resistant Rejection Is Associated With CD28₊ Memory CD8 T Cells.

Mathews DV, Wakwe WC, Kim SC, Lowe MC, Breeden C, Roberts ME, Farris AB, Strobert EA, Jenkins JB, Larsen CP, Ford ML, Townsend R, Adams AB.

Am J Transplant. 2017 Sep;17(9):2285-2299. doi: 10.1111/ajt.14349. Epub 2017 Jul 11.

PMID: 28502128

Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis.

Mease PJ, Gottlieb AB, van der Heijde D, FitzGerald O, Johnsen A, Nys M, Banerjee S, Gladman DD.

Ann Rheum Dis. 2017 Sep;76(9):1550-1558. doi: 10.1136/annrheumdis-2016-210724. Epub 2017 May 4.

PMID: 28473423

Technologies and strategies for bioanalysis of biopharmaceuticals.

Zhang YJ, An HJ.

Bioanalysis. 2017 Sep;9(18):1343-1347. doi: 10.4155/bio-2017-4981. No abstract available.

PMID: 28956635

Challenges and opportunities in bioanalytical support for gene therapy medicinal product development.

Ma M, Balasubramanian N, Dodge R, Zhang Y.

Bioanalysis. 2017 Sep;9(18):1423-1430. doi: 10.4155/bio-2017-0116. Epub 2017 Sep 18.

PMID: 28920452

Macrocyclic factor XIa inhibitors.

Wang C, Corte JR, Rossi KA, Bozarth JM, Wu Y, Sheriff S, Myers JE Jr, Luettgen JM, Seiffert DA, Wexler RR, Quan ML.

Bioorg Med Chem Lett. 2017 Sep 1;27(17):4056-4060. doi: 10.1016/j.bmcl.2017.07.048. Epub 2017 Jul 25.

PMID: 28780160

Ultrafiltration behavior of monoclonal antibodies and Fc-fusion proteins: Effects of physical properties.

Baek Y, Singh N, Arunkumar A, Borys M, Li ZJ, Zydney AL.

Biotechnol Bioeng. 2017 Sep;114(9):2057-2065. doi: 10.1002/bit.26326. Epub 2017 May 18.

PMID: 28464237

Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT-2 follow-up and post-hoc analyses on progression-free survival and tumour growth.

Dimopoulos MA, Lonial S, White D, Moreau P, Palumbo A, San-Miguel J, Shpilberg O, Anderson K, Grosicki S, Spicka I, Walter-Croneck A, Magen H, Mateos MV, Belch A, Reece D, Beksac M, Bleickardt E, Poulart V, Sheng J, Sy O, Katz J, Singhal A, Richardson P.

Br J Haematol. 2017 Sep;178(6):896-905. doi: 10.1111/bjh.14787. Epub 2017 Jul 5.

PMID: 28677826

Focused microwave irradiation-assisted immunohistochemistry to study effects of ketamine on phospho-ERK expression in the mouse brain.

Fernandes A, Li YW.

Brain Res. 2017 Sep 1;1670:86-95. doi: 10.1016/j.brainres.2017.05.008. Epub 2017 May 10.

PMID: 28501494

Adenoma Prevalence in Blacks and Whites Having Equal Adherence To Screening Colonoscopy: The National Colonoscopy Study.

Mendelsohn RB, Winawer SJ, Jammula A, Mills G, Jordan P, O'Brien MJ, Close GM, Dorfman M, Church TR, Mandelson MT, Allen J, Feld A, Kauff ND, Morgan GA, Kumar JMR, Serrano V, Bayuga-Miller S, Fischer SE, Kuk D, Zauber AG.

Clin Gastroenterol Hepatol. 2017 Sep;15(9):1469-1470. doi: 10.1016/j.cgh.2017.04.014. Epub 2017 Apr 15.

PMID: 28419856

Developing a Natural History Progression Model for Duchenne Muscular Dystrophy Using the Six-Minute Walk Test.

Hamuro L, Chan P, Tirucherai G, AbuTarif M.

CPT Pharmacometrics Syst Pharmacol. 2017 Sep;6(9):596-603. doi: 10.1002/psp4.12220. Epub 2017 Aug 29.

PMID: 28643370

Risk of major bleeding in patients with non-valvular atrial fibrillation treated with oral anticoagulants: a systematic review of real-world observational studies.

Deitelzweig S, Farmer C, Luo X, Vo L, Li X, Hamilton M, Horblyuk R, Ashaye A.

Curr Med Res Opin. 2017 Sep;33(9):1583-1594. doi: 10.1080/03007995.2017.1347090. Epub 2017 Jul 6. Review.

PMID: 28644048

Risk of stroke/systemic embolism, major bleeding and associated costs in non-valvular atrial fibrillation patients who initiated apixaban, dabigatran or rivaroxaban compared with warfarin in the United States Medicare population.

Amin A, Keshishian A, Trocio J, Dina O, Le H, Rosenblatt L, Liu X, Mardekian J, Zhang Q, Baser O, Vo L.

Curr Med Res Opin. 2017 Sep;33(9):1595-1604. doi: 10.1080/03007995.2017.1345729. Epub 2017 Jul 11.

PMID: 28635338

Health-related quality of life results from the phase III CheckMate 067 study.

Schadendorf D, Larkin J, Wolchok J, Hodi FS, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao C, Wagstaff J, Callahan MK, Postow MA, Smylie M, Ferrucci PF, Dummer R, Hill A, Taylor F, Sabater J, Walker D, Kotapati S, Abernethy A, Long GV.

Eur J Cancer. 2017 Sep;82:80-91. doi: 10.1016/j.ejca.2017.05.031. Epub 2017 Jun 23.

PMID: 28651159

Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025.

Escudier B, Motzer RJ, Sharma P, Wagstaff J, Plimack ER, Hammers HJ, Donskov F, Gurney H, Sosman JA, Zalewski PG, Harmenberg U, McDermott DF, Choueiri TK, Richardet M, Tomita Y, Ravaud A, Doan J, Zhao H, Hardy H, George S.

Eur Urol. 2017 Sep;72(3):368-376. doi: 10.1016/j.eururo.2017.03.037. Epub 2017 Apr 12.

PMID:28410865

Hepatitis C viral load, genotype, and increased risk of developing end-stage renal disease: REVEAL-HCV study.

Lai TS, Lee MH, Yang HI, You SL, Lu SN, Wang LY, Yuan Y, L'Italien G, Chien KL, Chen CJ; REVEAL-HCV Study Group.

Hepatology. 2017 Sep;66(3):784-793. doi: 10.1002/hep.29192. Epub 2017 Jul 18.

PMID: 28370058

A Systematic Review and Pooled Analysis of Select Safety Parameters Among Normal Healthy Volunteers Taking Placebo in Phase 1 Clinical Trials.

Young TC, Srinivasan S, Vetter ML, Sethuraman V, Bhagwagar Z, Zwirtes R, Narasimhan P, Chuang T, Smyth BJ.

J Clin Pharmacol. 2017 Sep;57(9):1079-1087. doi: 10.1002/jcph.913. Epub 2017 May 16.

PMID: 28510323

Practical implications of using real-world evidence (RWE) in comparative effectiveness research: learnings from IMI-GetReal.

Makady A, Stegenga H, Ciaglia A, Debray TP, Lees M, Happich M, Ryll B, Abrams K, Thwaites R, Garner S, Jonsson P, Goettsch W.

J Comp Eff Res. 2017 Sep;6(6):485-490. doi: 10.2217/cer-2017-0044. Epub 2017 Aug 31.

PMID: 28857631

A systematic study of the effect of low pH acid treatment on anti-drug antibodies specific for a domain antibody therapeutic: Impact on drug tolerance, assay sensitivity and post-validation method assessment of ADA in clinical serum samples.

Kavita U, Duo J, Crawford SM, Liu R, Valcin J, Gleason C, Dong H, Gadkari S, Dodge RW, Pillutla RC, DeSilva BS.

J Immunol Methods. 2017 Sep;448:91-104. doi: 10.1016/j.jim.2017.06.002. Epub 2017 Jun 16.

PMID: 28625864

Evaluation of healthcare resource utilization and incremental economic burden of patients with chronic myeloid leukemia after disease progression to blast phase.

Jabbour EJ, Lin J, Siegartel LR, Lingohr-Smith M, Menges B, Makenbaeva D.

J Med Econ. 2017 Sep;20(9):1007-1012. doi: 10.1080/13696998.2017.1345750. Epub 2017 Jul 6.

PMID: 28681664

Major bleeding risk and healthcare economic outcomes of non-valvular atrial fibrillation patients newly-initiated with oral anticoagulant therapy in the real-world setting.

Lin J, Trocio J, Gupta K, Mardekian J, Lingohr-Smith M, Menges B, You M, Nadkarni A.

J Med Econ. 2017 Sep;20(9):952-961. doi: 10.1080/13696998.2017.1341902. Epub 2017 Jun 22.

PMID: 28604139

Radiation-agent combinations for glioblastoma: challenges in drug development and future considerations.

Kunos CA, Galanis E, Buchsbaum J, Shi Q, Strauss LC, Coleman CN, Ahmed MM.

J Neurooncol. 2017 Sep;134(3):551-557. doi: 10.1007/s11060-017-2458-0. Epub 2017 May 30. Review.

PMID: 28560665

Bile Salt Homeostasis in Normal and Bsep Gene Knockout Rats with Single and Repeated Doses of Troglitazone.

Cheng Y, Chen S, Freeden C, Chen W, Zhang Y, Abraham P, Nelson DM, Humphreys WG, Gan J, Lai Y.

J Pharmacol Exp Ther. 2017 Sep;362(3):385-394. doi: 10.1124/jpet.117.242370. Epub 2017 Jun 23.

PMID: 28645914

High hepatitis C viral load and genotype 2 are strong predictors of chronic kidney disease.

Lai TS, Lee MH, Yang HI, You SL, Lu SN, Wang LY, Yuan Y, L'Italien G, Chien KL, Chen CJ; REVEAL-HCV Study Group.

Kidney Int. 2017 Sep;92(3):703-709. doi: 10.1016/j.kint.2017.03.021. Epub 2017 May 20.

PMID: 28532708

Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study.

Overman MJ, McDermott R, Leach JL, Lonardi S, Lenz HJ, Morse MA, Desai J, Hill A, Axelson M, Moss RA, Goldberg MV, Cao ZA, Ledeine JM, Maglinte GA, Kopetz S, André T.

Lancet Oncol. 2017 Sep;18(9):1182-1191. doi: 10.1016/S1470-2045(17)30422-9. Epub 2017 Jul 19.

PMID: 28734759

Daclatasvir plus sofosbuvir, with or without ribavirin, for hepatitis C virus genotype 3 in a French early access programme.

Hézode C, Lebray P, De Ledinghen V, Zoulim F, Di Martino V, Boyer N, Larrey D, Botta-Fridlund D, Silvain C, Fontaine H, D'Alteroche L, Leroy V, Bourliere M, Hubert-Fouchard I, Guyader D, Rosa I, Nguyen-Khac E, Fedchuk L, Akremi R, Bennai Y, Filipovics A, Zhao Y, Bronowicki JP.

Liver Int. 2017 Sep;37(9):1314-1324. doi: 10.1111/liv.13383. Epub 2017 Mar 8.

PMID: 28177199

A Functional Na_V1.7-Na_VAb Chimera with a Reconstituted High-Affinity ProTx-II Binding Site.

Rajamani R, Wu S, Rodrigo I, Gao M, Low S, Megson L, Wensel D, Pieschl RL, Post-Munson DJ, Watson J, Langley DR, Ahlijanian MK, Bristow LJ, Herrington J.

Mol Pharmacol. 2017 Sep;92(3):310-317. doi: 10.1124/mol.117.108712. Epub 2017 Jun 23.

PMID: 28645932

Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective.

Bawa A, Asefi S, Ramsey S, Arbesser-Rastburg C, Paul M, Leira F, Landeryou T, Reddy B, Murphy M, Daddis B, Bain D.

PDA J Pharm Sci Technol. 2017 Sep-Oct;71(5):413-420. doi: 10.5731/pdajpst.2016.007351. Epub 2017 Jun 16.

PMID: 28624776

Small Molecule PET Tracers in Drug Discovery.

Donnelly DJ.

Semin Nucl Med. 2017 Sep;47(5):454-460. doi: 10.1053/j.semnuclmed.2017.05.006. Review.

PMID: 28826520

Randomized Clinical Trial Design to Assess Abatacept in Resistant Nephrotic Syndrome.

Trachtman H, Gipson DS, Somers M, Spino C, Adler S, Holzman L, Kopp JB, Sedor J, Overfield S, Elegbe A, Maldonado M, Greka A.

Kidney Int Rep. 2017 Aug 31;3(1):115-121. doi: 10.1016/j.ekir.2017.08.013. eCollection 2018 Jan.

PMID: 29340321

 

Discrete particle modeling and micromechanical characterization of bilayer tablet compaction.

Yohannes B, Gonzalez M, Abebe A, Sprockel O, Nikfar F, Kiang S, Cuitiño AM.

Int J Pharm. 2017 Aug 30;529(1-2):597-607. doi: 10.1016/j.ijpharm.2017.07.032. Epub 2017 Jul 13.

PMID: 28713000

Palladium(II)-Catalyzed Site-Selective C(sp₃ )-H Alkynylation of Oligopeptides: A Linchpin Approach for Oligopeptide-Drug

Conjugation.

Liu T, Qiao JX, Poss MA, Yu JQ.

Angew Chem Int Ed Engl. 2017 Aug 28;56(36):10924-10927. doi: 10.1002/anie.201706367. Epub 2017 Aug 7.

PMID: 28714148

Improving Accuracy, Diversity, and Speed with Prime Macrocycle Conformational Sampling.

Sindhikara D, Spronk SA, Day T, Borrelli K, Cheney DL, Posy SL.

J Chem Inf Model. 2017 Aug 28;57(8):1881-1894. doi: 10.1021/acs.jcim.7b00052. Epub 2017 Aug 8.

PMID: 28727915

Survival inequalities in patients with lung cancer in France: A nationwide cohort study (the TERRITOIRE Study).

Chouaïd C, Debieuvre D, Durand-Zaleski I, Fernandes J, Scherpereel A, Westeel V, Blein C, Gaudin AF, Ozan N, Leblanc S, Vainchtock A, Chauvin P, Cotté FE, Souquet PJ.

PLoS One. 2017 Aug 25;12(8):e0182798. doi: 10.1371/journal.pone.0182798. eCollection 2017.

PMID: 28841679

The Economic Burden of Small Cell Lung Cancer: A Systematic Review of the Literature.

Enstone A, Greaney M, Povsic M, Wyn R, Penrod JR, Yuan Y.

Pharmacoecon Open. 2017 Aug 18. doi: 10.1007/s41669-017-0045-0. [Epub ahead of print] Review.

PMID: 29623624

An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register.

Carroll R, Ramagopalan SV, Cid-Ruzafa J, Lambrelli D, McDonald L.

Version 2. F1000Res. 2017 Aug 14 [revised 2017 Jan 1];6:1447. doi: 10.12688/f1000research.12198.2. eCollection 2017.

PMID: 29188016

Downstream Processing Technologies/Capturing and Final Purification : Opportunities for Innovation, Change, and Improvement. A Review of Downstream Processing Developments in Protein Purification.

Singh N, Herzer S.

Adv Biochem Eng Biotechnol. 2017 Aug 10. doi: 10.1007/10_2017_12. [Epub ahead of print]

PMID: 28795201

 

Hospitalisation costs of metastatic melanoma in France; the MELISSA study (MELanoma In hoSpital coSts Assessment).

Fernandes J, Bregman B, Combemale P, Amaz C, de Léotoing L, Vainchtock A, Gaudin AF.

BMC Health Serv Res. 2017 Aug 8;17(1):542. doi: 10.1186/s12913-017-2472-0.

PMID: 28789648

 

Characterization of Naturally Occurring NS5A and NS5B Polymorphisms in Patients Infected with HCV Genotype 3a Treated with Direct-Acting Antiviral Agents.

Bartolini B, Giombini E, Taibi C, Lionetti R, Montalbano M, Visco-Comandini U, D'Offizi G, Capobianchi MR, McPhee F, Garbuglia AR.

Viruses. 2017 Aug 7;9(8). pii: E212. doi: 10.3390/v9080212.

PMID: 28783119

 

Health-related quality-of-life implications of cardiovascular events in individuals with type 2 diabetes mellitus: A subanalysis from the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)-TIMI 53 trial.

Briggs AH, Bhatt DL, Scirica BM, Raz I, Johnston KM, Szabo SM, Bergenheim K, Mukherjee J, Hirshberg B, Mosenzon O.

Diabetes Res Clin Pract. 2017 Aug;130:24-33. doi: 10.1016/j.diabres.2016.12.019. Epub 2017 Jan 23.

PMID: 28554140

An improved protocol for amino acid type-selective isotope labeling in insect cells.

Zhang Y, Wei H, Xie D, Calambur D, Douglas A, Gao M, Marsilio F, Metzler WJ, Szapiel N, Zhang P, Witmer MR, Mueller L, Hedin D.

J Biomol NMR. 2017 Aug;68(4):237-247. doi: 10.1007/s10858-017-0117-6. Epub 2017 Jul 15.

PMID: 28711957

Chromatoprobe as a sample-sparing technique for residual solvent analysis of drug discovery candidates by gas chromatography.

Poronsky CJ, Cutrone JQ.

J Pharm Anal. 2017 Aug;7(4):265-269. doi: 10.1016/j.jpha.2017.03.009. Epub 2017 Apr 3.

PMID: 29404048

Identification of biomarkers of response to abatacept in patients with SLE using deconvolution of whole blood transcriptomic data from a phase IIb clinical trial.

Bandyopadhyay S, Connolly SE, Jabado O, Ye J, Kelly S, Maldonado MA, Westhovens R, Nash P, Merrill JT, Townsend RM.

Lupus Sci Med. 2017 Jul 28;4(1):e000206. doi: 10.1136/lupus-2017-000206. eCollection 2017.

PMID: 29214034

Genome-wide association analysis identifies genetic correlates of immune infiltrates in solid tumors.

Siemers NO, Holloway JL, Chang H, Chasalow SD, Ross-MacDonald PB, Voliva CF, Szustakowski JD.

PLoS One. 2017 Jul 27;12(7):e0179726. doi: 10.1371/journal.pone.0179726. eCollection 2017.

PMID: 28749946

Bruton's tyrosine kinase inhibitor BMS-986142 in experimental models of rheumatoid arthritis enhances efficacy of agents representing clinical standard-of-care.

Gillooly KM, Pulicicchio C, Pattoli MA, Cheng L, Skala S, Heimrich EM, McIntyre KW, Taylor TL, Kukral DW, Dudhgaonkar S, Nagar J, Banas D, Watterson SH, Tino JA, Fura A, Burke JR.

PLoS One. 2017 Jul 24;12(7):e0181782. doi: 10.1371/journal.pone.0181782. eCollection 2017.

PMID: 28742141

Patient-derived xenografts of low-grade B-cell lymphomas demonstrate roles of the tumor microenvironment.

Burack WR, Spence JM, Spence JP, Spence SA, Rock PJ, Shenoy GN, Shultz LD, Bankert RB, Bernstein SH.

Blood Adv. 2017 Jul 7;1(16):1263-1273. doi: 10.1182/bloodadvances.2017005892. eCollection 2017 Jul 11.

PMID: 29296768

Improving Metabolic Stability with Deuterium: The Discovery of BMT-052, a Pan-genotypic HCV NS5B Polymerase Inhibitor.

Parcella K, Eastman K, Yeung KS, Grant-Young KA, Zhu J, Wang T, Zhang Z, Yin Z, Parker D, Mosure K, Fang H, Wang YK, Lemm J, Zhuo X, Hanumegowda U, Liu M, Rigat K, Donoso M, Tuttle M, Zvyaga T, Haarhoff Z, Meanwell NA, Soars MG, Roberts SB, Kadow JF.

ACS Med Chem Lett. 2017 Jun 29;8(7):771-774. doi: 10.1021/acsmedchemlett.7b00211. eCollection 2017 Jul 13.

PMID: 28740615

The anti-SLAMF7 antibody elotuzumab mediates NK cell activation through both CD16-dependent and -independent mechanisms.

Pazina T, James AM, MacFarlane AW 4th, Bezman NA, Henning KA, Bee C, Graziano RF, Robbins MD, Cohen AD, Campbell KS.

Oncoimmunology. 2017 Jun 16;6(9):e1339853. doi: 10.1080/2162402X.2017.1339853. eCollection 2017.

PMID: 28932638

 

The effect of body mass index on clinical response to abatacept as a first-line biologic for rheumatoid arthritis: 6-month results from the 2-year, observational, prospective ACTION study.

Mariette X, Alten R, Nüßlein HG, Galeazzi M, Lorenz HM, Cantagrel A, Chartier M, Poncet C, Rauch C, Le Bars M.

Joint Bone Spine. 2016 Dec 30. pii: S1297-319X(16)30210-X. doi: 10.1016/j.jbspin.2016.10.011. [Epub ahead of print]

PMID: 28043761

 

Designer vaccine nanodiscs for personalized cancer immunotherapy.

Kuai R, Ochyl LJ, Bahjat KS, Schwendeman A, Moon JJ.

Nat Mater. 2016 Dec 26. doi: 10.1038/nmat4822. [Epub ahead of print]

PMID: 28024156

 

Real-World Experience With Daclatasvir Plus Sofosbuvir ± Ribavirin for Post-Liver Transplant HCV Recurrence and Severe Liver Disease.

Herzer K, Welzel TM, Spengler U, Hinrichsen H, Klinker H, Berg T, Ferenci P, Peck-Radosavljevic M, Inderson A, Zhao Y, Jimenez-Exposito MJ, Zeuzem S.

Transpl Int. 2016 Dec 24. doi: 10.1111/tri.12910. [Epub ahead of print]

PMID: 28012215

 

Effect of minor populations of NS5A and NS5B resistance-associated variants on HCV genotype-3 response to daclatasvir plus sofosbuvir, with or without ribavirin.

McPhee F, Hernandez D, Zhou N.

Antivir Ther. 2016 Dec 23. doi: 10.3851/IMP3120. [Epub ahead of print]

PMID: 28008868

 

Effects of aripiprazole and haloperidol on neural activation during a simple motor task in healthy individuals: A functional MRI study.

Goozee R, O'Daly O, Handley R, Reis Marques T, Taylor H, McQueen G, Hubbard K, Pariante C, Mondelli V, Reinders AA, Dazzan P.

Hum Brain Mapp. 2016 Dec 23. doi: 10.1002/hbm.23485. [Epub ahead of print]

PMID: 28009070

 

Cost-effectiveness analysis of the use of daclatasvir + sofosbuvir + ribavirin (16 weeks and 12 weeks) vs sofosbuvir + ribavirin (16 weeks and 24 weeks) for the treatment of cirrhotic patients affected with hepatitis C virus genotype 3 in Italy.

Restelli U, Alberti A, Lazzarin A, Bonfanti M, Nappi C, Croce D.

Eur J Health Econ. 2016 Dec 22. doi: 10.1007/s10198-016-0865-3. [Epub ahead of print]

PMID: 28008546

 

Asymmetric Hydroboration Approach to the Scalable Synthesis of ((1R,3S)-1-Amino-3-((R)-6-hexyl-5,6,7,8-tetrahydronaphthalen-2-yl)cyclopentyl)methanol (BMS-986104) as a Potent S1P₁ Receptor Modulator.

Yang MG, Xiao Z, Dhar TG, Xiao HY, Gilmore JL, Marcoux D, Xie JH, McIntyre KW, Taylor TL, Borowski V, Heimrich E, Li YW, Feng J, Fernandes A, Yang Z, Balimane P, Marino AM, Cornelius G, Warrack BM, Mathur A, Wu DR, Li P, Gupta A, Pragalathan B, Shen DR, Cvijic ME, Lehman-McKeeman LD, Salter-Cid L, Barrish JC, Carter PH, Dyckman AJ.

J Med Chem. 2016 Dec 22;59(24):11138-11147. doi: 10.1021/acs.jmedchem.6b01433.

PMID: 28002964

 

Design and Synthesis of a New Series of 4-Heteroarylamino-1'-azaspiro[oxazole-5,3'-bicyclo[2.2.2]octanes as α7 Nicotinic Receptor Agonists. 1. Development of Pharmacophore and Early Structure-Activity Relationship.

Cook J, Zusi FC, McDonald IM, King D, Hill MD, Iwuagwu C, Mate RA, Fang H, Zhao R, Wang B, Cutrone J, Ma B, Gao Q, Knox RJ, Matchett M, Gallagher L, Ferrante M, Post-Munson D, Molski T, Easton A, Miller R, Jones K, Digavalli S, Healy F, Lentz K, Benitex Y, Clarke W, Natale J, Siuciak JA, Lodge N, Zaczek R, Denton R, Morgan D, Bristow LJ, Macor JE, Olson RE.

J Med Chem. 2016 Dec 22;59(24):11171-11181. doi: 10.1021/acs.jmedchem.6b01506.

PMID: 27958732

 

Discovery of Indazoles as Potent, Orally Active Dual Neurokinin 1 Receptor Antagonists and Serotonin Transporter Inhibitors for the Treatment of Depression.

Degnan AP, Tora GO, Huang H, Conlon DA, Davis CD, Hanumegowda UM, Hou X, Hsiao Y, Hu J, Krause R, Li YW, Newton AE, Pieschl RL, Raybon J, Rosner T, Sun JH, Taber MT, Taylor SJ, Wong MK, Zhang H, Lodge NJ, Bronson JJ, Macor JE, Gillman KW.

ACS Chem Neurosci. 2016 Dec 21;7(12):1635-1640. doi: 10.1021/acschemneuro.6b00337.

PMID: 27744678

 

Evaluation of automated Wes system as an analytical and characterization tool to support monoclonal antibody drug product development.

Wang J, Valdez A, Chen Y.

J Pharm Biomed Anal. 2016 Dec 21. pii: S0731-7085(16)30669-0. doi: 10.1016/j.jpba.2016.12.024. [Epub ahead of print]

PMID: 28069351

 

Phase 2 Placebo-Controlled, Double-Blind Trial of Dasatinib Added to Gemcitabine for Patients with Locally-Advanced Pancreatic Cancer.

Evans TR, Van Cutsem E, Moore MJ, Bazin IS, Rosemurgy A, Bodoky G, Deplanque G, Harrison M, Melichar B, Pezet D, Elekes A, Rock E, Lin C, Strauss L, O'Dwyer PJ.

Ann Oncol. 2016 Dec 19. pii: mdw607. doi: 10.1093/annonc/mdw607. [Epub ahead of print]

PMID: 27998964

 

Revised Reply to Letter to the Editor with regards to manuscript AR-15-1750.R1.

Fleischmann R, Connolly SE, Maldonado MA, Schiff M.

Arthritis Rheumatol. 2016 Dec 19. doi: 10.1002/art.40021. [Epub ahead of print] No abstract available.

PMID: 27992708

 

Systematic interpolation method predicts protein chromatographic elution with salt gradients, pH gradients and combined salt/pH gradients.

Creasy A, Barker G, Carta G.

Biotechnol J. 2016 Dec 19. doi: 10.1002/biot.201600636. [Epub ahead of print]

PMID: 27992113

 

Drug-Protein Adducts: Chemistry, Mechanisms of Toxicity, and Methods of Characterization.

Gan J, Zhang H, Humphreys WG.

Chem Res Toxicol. 2016 Dec 19;29(12):2040-2057.

PMID: 27989144

 

Functionalized triazines as potent HCV entry inhibitors.

Mull ES, Sun LQ, Zhao Q, Eggers B, Pokornowski K, Zhai G, Rajamani R, Jenkins S, Kramer M, Wang YK, Fang H, Tenney D, Baldick CJ, Cockett MI, Meanwell NA, Scola PM.

Bioorg Med Chem Lett. 2016 Dec 18. pii: S0960-894X(16)31304-X. doi: 10.1016/j.bmcl.2016.12.038. [Epub ahead of print]

PMID: 28089701

 

Difluorocyclobutylacetylenes as positive allosteric modulators of mGluR5 with reduced bioactivation potential.

Degnan AP, Maxwell D, Balakrishnan A, Brown JM, Easton A, Gulianello M, Hanumegowda U, Hill-Drzewi M, Miller R, Santone KS, Senapati A, Shields EE, Sivarao DV, Westphal R, Whiterock VJ, Zhuo X, Bronson JJ, Macor JE.

Bioorg Med Chem Lett. 2016 Dec 15;26(24):5871-5876. doi: 10.1016/j.bmcl.2016.11.014.

PMID: 27856084

 

Characterization of TAP Ambr 250 disposable bioreactors, as a reliable scale-down model for biologics process development.

Xu P, Clark C, Ryder T, Sparks C, Zhou J, Wang M, Russell R, Scott C.

Biotechnol Prog. 2016 Dec 15. doi: 10.1002/btpr.2417. [Epub ahead of print]

PMID: 27977912

 

Structure of CC chemokine receptor 2 with orthosteric and allosteric antagonists.

Zheng Y, Qin L, Zacarías NV, de Vries H, Han GW, Gustavsson M, Dabros M, Zhao C, Cherney RJ, Carter P, Stamos D, Abagyan R, Cherezov V, Stevens RC, IJzerman AP, Heitman LH, Tebben A, Kufareva I, Handel TM.

Nature. 2016 Dec 15;540(7633):458-461. doi: 10.1038/nature20605.

PMID: 27926736

 

Enhancing tablet disintegration characteristics of a highly water-soluble high-drug-loading formulation by granulation process.

Pandey P, Levins C, Pafiakis S, Zacour B, Bindra DS, Trinh J, Buckley D, Gour S, Sharif S, Stamato H.

Pharm Dev Technol. 2016 Dec 15:1-9. [Epub ahead of print]

PMID: 27879156

 

Microbiota metabolite short-chain fatty acid acetate promotes intestinal IgA response to microbiota which is mediated by GPR43.

Wu W, Sun M, Chen F, Cao AT, Liu H, Zhao Y, Huang X, Xiao Y, Yao S, Zhao Q, Liu Z, Cong Y.

Mucosal Immunol. 2016 Dec 14. doi: 10.1038/mi.2016.114. [Epub ahead of print]

PMID: 27966553

 

Real-World Assessment of Renal and Bone Safety among Patients with HIV Infection Exposed to Tenofovir Disoproxil Fumarate-Containing Single-Tablet Regimens.

Nkhoma ET, Rosenblatt L, Myers J, Villasis-Keever A, Coumbis J.

PLoS One. 2016 Dec 12;11(12):e0166982. doi: 10.1371/journal.pone.0166982.

PMID: 27941989

  

Short-duration treatment for chronic hepatitis C virus with daclatasvir, asunaprevir, beclabuvir and sofosbuvir (FOURward study).

Sulkowski MS, Flamm S, Kayali Z, Lawitz EJ, Kwo P, McPhee F, Torbeyns A, Hughes EA, Swenson ES, Yin PD, Linaberry M.

Liver Int. 2016 Dec 10. doi: 10.1111/liv.13335. [Epub ahead of print]

PMID: 27943563

 

The cellular kinetics of lung alveolar epithelial cells and its relationship with lung tissue repair after acute lung injury.

Zeng L, Yang XT, Li HS, Li Y, Yang C, Gu W, Zhou YH, Du J, Wang HY, Sun JH, Wen DL, Jiang JX.

Respir Res. 2016 Dec 7;17(1):164.

PMID: 27923370

 

 Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial.

Thompson M, Lalezari JP, Kaplan R, Pinedo Y, Pena OA, Cahn P, Stock DA, Joshi SR, Hanna GJ, Lataillade M; AI.; study team..

Antivir Ther. 2016 Dec 6. doi: 10.3851/IMP3112. [Epub ahead of print]

PMID: 27922453

 

A carbon dioxide stripping model for mammalian cell culture in manufacturing scale bioreactors.

Xing Z, Lewis AM, Borys MC, Li ZJ.

Biotechnol Bioeng. 2016 Dec 6. doi: 10.1002/bit.26232. [Epub ahead of print]

PMID: 27922179

 

John Staniforth-An appreciation: The non-conformist nonconformist.

Tobyn M, Price R.

Int J Pharm. 2016 Dec 5;514(2):333-334. doi: 10.1016/j.ijpharm.2016.10.028. No abstract available.

PMID: 27780744

 

Development of aqueous dispersions of Coenzyme Q₁₀ for pulmonary delivery and the dynamics of active vibrating-mesh aerosolization.

Carvalho TC, McCook JP, Narain NR, McConville JT.

Int J Pharm. 2016 Dec 5;514(2):407-419. doi: 10.1016/j.ijpharm.2016.10.011.

PMID: 27732894

 

Pre-absorption physicochemical compatibility assessment of 8-drug metabolic cocktail.

Tye CK, Wang Z, Dockens RC, Vakkalagadda B, Wang C, Zhang Y, Su CC, Hageman MJ.

Int J Pharm. 2016 Dec 5;514(2):364-373. doi: 10.1016/j.ijpharm.2016.06.028.

PMID: 27291974

 

Use of similarity scoring in the development of oral solid dosage forms.

Ferreira AP, Olusanmi D, Sprockel O, Abebe A, Nikfar F, Tobyn M.

Int J Pharm. 2016 Dec 5;514(2):335-340. doi: 10.1016/j.ijpharm.2015.09.046.

PMID: 26423176

 

Discrepancies in column parameters presented in hydrophobic subtraction model manuscripts.

Shackman JG.

J Chromatogr A. 2016 Dec 2;1475:116-118. doi: 10.1016/j.chroma.2016.11.006. No abstract available.

PMID: 27842900

 

Development of 4-Heteroarylamino-1'-azaspiro[oxazole-5,3'-bicyclo[2.2.2]octanes] as α7 Nicotinic Receptor Agonists.

Hill MD, Fang H, King HD, Iwuagwu CI, McDonald IM, Cook J, Zusi FC, Mate RA, Knox RJ, Post-Munson D, Easton A, Miller R, Lentz K, Clarke W, Benitex Y, Lodge N, Zaczek R, Denton R, Morgan D, Bristow L, Macor JE, Olson R.

ACS Med Chem Lett. 2016 Dec 1;8(1):133-137. doi: 10.1021/acsmedchemlett.6b00471.

PMID: 28105289

 

Reasons for non-intensification of treatment in people with type 2 diabetes receiving oral monotherapy: Outcomes from the prospective DIAttitude study.

Balkau B, Halimi S, Blickle JF, Vergès B, Avignon A, Attali C, Chartier I, Amelineau E.

Ann Endocrinol (Paris). 2016 Dec;77(6):649-657. doi: 10.1016/j.ando.2016.03.001.

PMID: 27646493

 

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).

Richards S, Amaravadi L, Pillutla R, Birnboeck H, Torri A, Cowan KJ, Papadimitriou A, Garofolo F, Satterwhite C, Piccoli S, Wu B, Krinos-Fiorotti C, Allinson J, Berisha F, Cocea L, Croft S, Fraser S, Galliccia F, Gorovits B, Gupta S, Gupta V, Haidar S, Hottenstein C, Ishii-Watabe A, Jani D, Kadavil J, Kamerud J, Kramer D, Litwin V, Lima Santos GM, Nelson R, Ni Y, Pedras-Vasconcelos J, Qiu Y, Rhyne P, Safavi A, Saito Y, Savoie N, Scheibner K, Schick E, Siguenza PY, Smeraglia J, Staack RF, Subramanyam M, Sumner G, Thway T, Uhlinger D, Ullmann M, Vitaliti A, Welink J, Whiting CC, Xue L, Zeng R.

Bioanalysis. 2016 Dec;8(23):2475-2496.

PMID: 27855512

 

UHPLC-MS/MS bioanalysis of urinary DHEA, cortisone and their hydroxylated metabolites as potential biomarkers for CYP3A-mediated drug-drug interactions.

Zheng N, Christopher LJ, Ma X, Ji QC, Buzescu A, Kandoussi H, Garonzik SM, LaCreta F, Aubry AF, Arnold ME, Zeng J.

Bioanalysis. 2016 Dec;8(23):2429-2443.

PMID: 27855510

 

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).

Song A, Lee A, Garofolo F, Kaur S, Duggan J, Evans C, Palandra J, Donato LD, Xu K, Bauer R, Bustard M, Chen L, Cocea L, Croft S, Galliccia F, Haidar S, Hughes N, Ishii-Watabe A, Islam R, Jones B, Kadavil J, Krantz C, Lima Santos GM, Olah T, Pedras-Vasconcelos J, Staelens L, Saito Y, Savoie N, Scheibner K, Spitz S, Tampal N, Thomas E, Vinter S, Wakelin-Smith J, Welink J, Zeng J, Zhou S.

Bioanalysis. 2016 Dec;8(23):2457-2474.

PMID: 27855509

 

A simple, fast, sensitive and robust LC-MS/MS bioanalytical assay for evaluating 7α-hydroxy-4-cholesten-3-one biomarker in a clinical program.

Yuan L, Luo Y, Kandoussi H, Ji QC.

Bioanalysis. 2016 Dec;8(23):2445-2455.

PMID: 27855505

 

Robust Ki67 detection in human blood by flow cytometry for clinical studies.

Sun Y, Yang K, Bridal T, Ehrhardt AG.

Bioanalysis. 2016 Dec;8(23):2399-2413.

PMID: 27807982

 

Allosteric activation of midazolam CYP3A5 hydroxylase activity by icotinib - Enhancement by ketoconazole.

Zhuang X, Zhang T, Yue S, Wang J, Luo H, Zhang Y, Li Z, Che J, Yang H, Li H, Zhu M, Lu C.

Biochem Pharmacol. 2016 Dec 1;121:67-77. doi: 10.1016/j.bcp.2016.09.012.

PMID: 27666601

 

[2.2.1]-Bicyclic sultams as potent androgen receptor antagonists.

Shan W, Balog A, Nation A, Zhu X, Chen J, Cvijic ME, Geng J, Rizzo CA, Spires T Jr, Attar RM, Obermeier M, Traeger S, Dai J, Zhang Y, Galella M, Trainor G, Vite GD, Gavai AV.

Bioorg Med Chem Lett. 2016 Dec 1;26(23):5707-5711. doi: 10.1016/j.bmcl.2016.10.059.

PMID: 27836399

 

Discovery of furo[2,3-d][1,3]thiazinamines as beta amyloid cleaving enzyme-1 (BACE1) inhibitors.

Wu YJ, Guernon J, Rajamani R, Toyn JH, Ahlijanian MK, Albright CF, Muckelbauer J, Chang C, Camac D, Macor JE, Thompson LA.

Bioorg Med Chem Lett. 2016 Dec 1;26(23):5729-5731. doi: 10.1016/j.bmcl.2016.10.055.

PMID: 27816517

 

Effects of elotuzumab on QT interval and cardiac safety in patients with multiple myeloma.

Passey C, Darbenzio R, Jou YM, Lynch M, Gupta M.

Cancer Chemother Pharmacol. 2016 Dec;78(6):1237-1244.

PMID: 27796540

 

A Systematic Literature Review on the Cost-Effectiveness of Apixaban for Stroke Prevention in Non-valvular Atrial Fibrillation.

Pinyol C, Cepeda JM, Roldan I, Roldan V, Jimenez S, Gonzalez P, Soto J.

Cardiol Ther. 2016 Dec;5(2):171-186.

PMID: 27457613

 

Using Population Pharmacokinetic and Pharmacodynamic Analyses of Entecavir in Pediatric Subjects to Simplify Dosing Recommendations.

Chan P, Mould DR, Tarif MA, Reynolds L, LaCreta F, Bertz R, Bifano M.

Clin Pharmacokinet. 2016 Dec;55(12):1559-1572.

PMID: 27319000

 

Atazanavir and Cardiovascular Risk Among Human Immunodeficiency Virus-Infected Patients: A Systematic Review.

Chow D, Shikuma C, Ritchings C, Guo M, Rosenblatt L.

Infect Dis Ther. 2016 Dec;5(4):473-489. Review.

PMID: 27677263

 

Characterization of NS5A polymorphisms and their impact on response rates in patients with HCV genotype 2 treated with daclatasvir-based regimens.

Zhou N, Han Z, Hartman-Neumann S, DeGray B, Ueland J, Vellucci V, Hernandez D, McPhee F.

J Antimicrob Chemother. 2016 Dec;71(12):3495-3505.

PMID: 27605597

 

Collaborating to improve the use of free-energy and other quantitative methods in drug discovery.

Sherborne B, Shanmugasundaram V, Cheng AC, Christ CD, DesJarlais RL, Duca JS, Lewis RA, Loughney DA, Manas ES, McGaughey GB, Peishoff CE, van Vlijmen H.

J Comput Aided Mol Des. 2016 Dec;30(12):1139-1141. doi: 10.1007/s10822-016-9996-y.

PMID: 28013427

 

Nationwide survey of specialist knowledge on current standard of care (Peg-IFN/RBV) and barriers of care in chronic hepatitis C patients in China.

Wei L, Li J, Yang X, Wang G, Feng B, Hou J, Duan Z, Jia J, Ren H, Niu J, Chen X, Wang FS, Shang J, Bo Q, Li R, Liu Y, Zhuang H.

J Gastroenterol Hepatol. 2016 Dec;31(12):1995-2003. doi: 10.1111/jgh.13399.

PMID: 27043040

 

The syntheses of isotopically labelled CB-1 antagonists for the treatment of obesity.

Tran SB, Maxwell BD, Burrell R, Bonacorsi SJ Jr.

J Labelled Comp Radiopharm. 2016 Dec;59(14):665-672. doi: 10.1002/jlcr.3433.

PMID: 27624665

 

The synthesis and analysis of [phenyl-₁₄ C(U)]BMS-770767 and [₁₃ C₆ ]BMS-770767 for use in discovery biotransformation, human ADME and bioanalytical studies.

Maxwell BD, Bonacorsi SJ Jr.

J Labelled Comp Radiopharm. 2016 Dec;59(14):657-664. doi: 10.1002/jlcr.3428.

PMID: 27460954

 

Literature review of the distribution of hepatitis C virus genotypes across Europe.

Alberti A, Lacoin L, Morais E, Lefevre C, Abogunrin S, Iheanacho I.

J Med Virol. 2016 Dec;88(12):2157-2169. doi: 10.1002/jmv.24573.

PMID: 27171396

 

Resolution and Sensitivity of Inline Focused Beam Reflectance Measurement During Wet Granulation in Pharmaceutically Relevant Particle Size Ranges.

Narang AS, Stevens T, Hubert M, Paruchuri S, Macias K, Bindra D, Gao Z, Badawy S.

J Pharm Sci. 2016 Dec;105(12):3594-3602. doi: 10.1016/j.xphs.2016.09.001.

PMID: 27745886

 

Technical Decision Making With Higher Order Structure Data: Perspectives on Higher Order Structure Characterization From the Biopharmaceutical Industry.

Weiss WF 4th, Gabrielson JP, Al-Azzam W, Chen G, Davis DL, Das TK, Hayes DB, Houde D, Singh SK.

J Pharm Sci. 2016 Dec;105(12):3465-3470. doi: 10.1016/j.xphs.2016.09.003.

PMID: 27743675

 

Autoxidation of betulonaldehyde.

Ayers S, Benkovics T, Marshall J, Tan Y.

Planta Med. 2016 Dec;81(S 01):S1-S381. No abstract available.

PMID: 27975757

 

Tackling the burden of the hepatitis C virus in the UK: characterizing and assessing the clinical and economic consequences.

Ward T, Gordon J, Bennett H, Webster S, Sugrue D, Jones B, Brenner M, McEwan P.

Public Health. 2016 Dec;141:42-51. doi: 10.1016/j.puhe.2016.08.002.

PMID: 27932014

 

Progression-free survival, overall survival and quality of life: What is their medicoeconomic importance in oncology?

Pavlovic M, Garnier J, Durand-Zaleski I; participants of Round Table n(o) 3 of Giens XXXI., Bilbault P, Gaudin AF, Le Jeunne C, Lalaude O, Roze S, de Sahb R, Sapède C.

Therapie. 2016 Dec;71(6):625-632. doi: 10.1016/j.therap.2016.03.004.

PMID: 27639631

 

Evaluation of microRNAs-208 and 133a/b as differential biomarkers of acute cardiac and skeletal muscle toxicity in rats.

Calvano J, Achanzar W, Murphy B, DiPiero J, Hixson C, Parrula C, Burr H, Mangipudy R, Tirmenstein M.

Toxicol Appl Pharmacol. 2016 Dec 1;312:53-60. doi: 10.1016/j.taap.2015.11.015.

PMID: 26627004

 

MicroRNA as biomarkers of mitochondrial toxicity.

Baumgart BR, Gray KL, Woicke J, Bunch RT, Sanderson TP, Van Vleet TR.

Toxicol Appl Pharmacol. 2016 Dec 1;312:26-33. doi: 10.1016/j.taap.2015.10.007.

PMID: 26476301

 

The Cost of Costing Treatments Incorrectly: Errors in the Application of Drug Prices in Economic Evaluation Due to Failing to Account for the Distribution of Patient Weight.

Hatswell AJ, Porter J, Lee D, Hertel N, Latimer NR.

Value Health. 2016 Dec;19(8):1055-1058. doi: 10.1016/j.jval.2016.04.013.

PMID: 27987632

 

A Cost-Effectiveness Analysis of Nivolumab Compared with Ipilimumab for the Treatment of BRAF Wild-Type Advanced Melanoma in Australia.

Bohensky MA, Pasupathi K, Gorelik A, Kim H, Harrison JP, Liew D.

Value Health. 2016 Dec;19(8):1009-1015. doi: 10.1016/j.jval.2016.05.013.

PMID: 27987627

 

Reducing blood volume requirements for clinical pathology testing in toxicologic studies-points to consider.

Poitout-Belissent F, Aulbach A, Tripathi N, Ramaiah L.

Vet Clin Pathol. 2016 Dec;45(4):534-551. doi: 10.1111/vcp.12429.

PMID: 27935623

 

Additive free preparative chiral SFC separations of 2,2-dimethyl-3-aryl-propanoic acids.

Wu DR, Yip SH, Li P, Sun D, Kempson J, Mathur A.

J Pharm Biomed Anal. 2016 Nov 30;131:54-63. doi: 10.1016/j.jpba.2016.08.009.

PMID: 27522108

 

Use of Spray-Dried Dispersions in Early Pharmaceutical Development: Theoretical and Practical Challenges.

Li J, Patel D, Wang G.

AAPS J. 2016 Nov 28. [Epub ahead of print]

PMID: 27896684

 

Population Pharmacokinetics of an Extended-Release Formulation of Exenatide Following Single- and Multiple-Dose Administration.

Cirincione B, Edwards J, Mager DE.

AAPS J. 2016 Nov 28. [Epub ahead of print]

PMID: 27896683

 

Mechanistic Studies and Modeling Reveal the Origin of Differential Inhibition of Gag Polymorphic Viruses by HIV-1 Maturation Inhibitors.

Lin Z, Cantone J, Lu H, Nowicka-Sans B, Protack T, Yuan T, Yang H, Liu Z, Drexler D, Regueiro-Ren A, Meanwell NA, Cockett M, Krystal M, Lataillade M, Dicker IB.

PLoS Pathog. 2016 Nov 28;12(11):e1005990. doi: 10.1371/journal.ppat.1005990.

PMID: 27893830

 

Surface induced three-peak elution behavior of a monoclonal antibody during cation exchange chromatography.

Guo J, Creasy AD, Barker G, Carta G.

J Chromatogr A. 2016 Nov 25;1474:85-94. doi: 10.1016/j.chroma.2016.10.061.

PMID: 27802880

 

Allogeneic human mesenchymal stem cells in patients with idiopathic pulmonary fibrosis via intravenous delivery (AETHER): a phase I, safety, clinical trial.

Glassberg MK, Minkiewicz J, Toonkel RL, Simonet ES, Rubio GA, Difede D, Shafazand S, Khan A, Pujol MV, LaRussa VF, Lancaster LH, Rosen GD, Fishman J, Mageto YN, Mendizabal A, Hare JM.

Chest. 2016 Nov 24. pii: S0012-3692(16)62462-5. doi: 10.1016/j.chest.2016.10.061. [Epub ahead of print]

PMID: 27890713

 

A novel liquid chromatography tandem mass spectrometry method for the estimation of bilirubin glucuronides and its application to in vitro enzyme assays.

Putluru SP, Matta MK, Ahire D, Subramanian M, Sinz M, Mandlekar S.

Drug Metab Lett. 2016 Nov 24. [Epub ahead of print]

PMID: 27908259

 

Safety and Efficacy Outcomes 3 Years After Switching to Belatacept From a Calcineurin Inhibitor in Kidney Transplant Recipients: Results From a Phase 2 Randomized Trial.

Grinyó JM, Del Carmen Rial M, Alberu J, Steinberg SM, Manfro RC, Nainan G, Vincenti F, Jones-Burton C, Kamar N.

Am J Kidney Dis. 2016 Nov 23. pii: S0272-6386(16)30572-8. doi: 10.1053/j.ajkd.2016.09.021. [Epub ahead of print]

PMID: 27889299

Synthesis of unlabelled and stable-isotope-labelled glucuronide metabolites of dapagliflozin and synthesis of stable-isotope-labelled dapagliflozin.

Cao K, Brailsford JA, Yao M, Caceres-Cortes J, Espina R, Bonacorsi SJ Jr.

J Labelled Comp Radiopharm. 2016 Nov 21. doi: 10.1002/jlcr.3484. [Epub ahead of print]

PMID: 27868223

 

A comparison of the variance estimation methods for heteroscedastic nonlinear models.

Sidik K, Jonkman JN.

Stat Med. 2016 Nov 20;35(26):4856-4874. doi: 10.1002/sim.7024.

PMID: 27383279

 

Readmission Risk in Chronic Obstructive Pulmonary Disease Patients: Comparative Study of Nebulized β₂-Agonists.

Bollu V, Guérin A, Gauthier G, Hiscock R, Wu EQ.

Drugs Real World Outcomes. 2016 Nov 18. [Epub ahead of print]

PMID: 27864792

 

Investigation of the "true" extraction recovery of analytes from multiple types of tissues and its impact on tissue bioanalysis using two model compounds.

Yuan L, Ma L, Dillon L, Fancher RM, Sun H, Zhu M, Lehman-McKeeman L, Aubry AF, Ji QC.

Anal Chim Acta. 2016 Nov 16;945:57-66. doi: 10.1016/j.aca.2016.09.039.

PMID: 27968716

 

COMBINED TREATMENT WITH SAXAGLIPTIN PLUS DAPAGLIFLOZIN REDUCES INSULIN LEVELS BY INCREASED INSULIN CLEARANCE AND IMPROVES β-CELL FUNCTION.

Ekholm E, Hansen L, Johnsson E, Iqbal N, Carlsson B, Chen H, Hirshberg B.

Endocr Pract. 2016 Nov 16. [Epub ahead of print]

PMID: 27849380

 

Daclatasvir plus sofosbuvir, with or without ribavirin, in real-world patients with HIV-HCV coinfection and advanced liver disease.

Rockstroh JK, Ingiliz P, Petersen J, Peck-Radosavljevic M, Welzel TM, Van der Valk M, Zhao Y, Exposito MJ, Zeuzem S.

Antivir Ther. 2016 Nov 15. doi: 10.3851/IMP3108. [Epub ahead of print]

PMID: 27845298

 

Immunomodulatory Activity of Nivolumab in Metastatic Renal Cell Carcinoma.

Choueiri TK, Fishman MN, Escudier B, McDermott DF, Drake CG, Kluger H, Stadler WM, Perez-Gracia JL, McNeel DG, Curti B, Harrison MR, Plimack ER, Appleman L, Fong L, Albiges L, Cohen L, Young TC, Chasalow SD, Ross-Macdonald P, Srivastava S, Jure-Kunkel M, Kurland JF, Simon JS, Sznol M.

Clin Cancer Res. 2016 Nov 15;22(22):5461-5471. doi: 10.1158/1078-0432.CCR-15-2839.

PMID: 27169994

 

 Elotuzumab with lenalidomide and dexamethasone for Japanese patients with relapsed/refractory multiple myeloma: phase 1 study.

Iida S, Nagai H, Kinoshita G, Miyoshi M, Robbins M, Pandya D, Bleickardt E, Chou T.

Int J Hematol. 2016 Nov 15. [Epub ahead of print]

PMID: 27848182

 

Nivolumab dose selection: challenges, opportunities, and lessons learned for cancer immunotherapy.

Agrawal S, Feng Y, Roy A, Kollia G, Lestini B.

J Immunother Cancer. 2016 Nov 15;4:72.

PMID: 27879974

 

Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma.

Weber JS, Hodi FS, Wolchok JD, Topalian SL, Schadendorf D, Larkin J, Sznol M, Long GV, Li H, Waxman IM, Jiang J, Robert C.

J Clin Oncol. 2016 Nov 14:JCO2015661389. [Epub ahead of print]

PMID: 28068177

 

Identification of Tricyclic Agonists of Sphingosine-1-phosphate Receptor 1 (S1P₁) Employing Ligand-Based Drug Design.

Xiao HY, Watterson SH, Langevine CM, Srivastava AS, Ko SS, Zhang Y, Cherney RJ, Guo WW, Gilmore JL, Sheppeck JE 2nd, Wu DR, Li P, Ramasamy D, Arunachalam P, Mathur A, Taylor TL, Shuster DJ, McIntyre KW, Shen DR, Yarde M, Cvijic ME, Marino AM, Balimane PV, Yang Z, Banas DM, Cornelius G, D'Arienzo CJ, Warrack BM, Lehman-McKeeman L, Salter-Cid LM, Xie J, Barrish JC, Carter PH, Dyckman AJ, Dhar TG.

J Med Chem. 2016 Nov 10;59(21):9837-9854.

PMID: 27726358

 

Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck.

Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, Harrington K, Kasper S, Vokes EE, Even C, Worden F, Saba NF, Iglesias Docampo LC, Haddad R, Rordorf T, Kiyota N, Tahara M, Monga M, Lynch M, Geese WJ, Kopit J, Shaw JW, Gillison ML.

N Engl J Med. 2016 Nov 10;375(19):1856-1867.

PMID: 27718784

 

Prolonged Survival in Stage III Melanoma with Ipilimumab Adjuvant Therapy.

Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, Hamid O, Robert C, Ascierto PA, Richards JM, Lebbé C, Ferraresi V, Smylie M, Weber JS, Maio M, Bastholt L, Mortier L, Thomas L, Tahir S, Hauschild A, Hassel JC, Hodi FS, Taitt C, de Pril V, de Schaetzen G, Suciu S, Testori A.

N Engl J Med. 2016 Nov 10;375(19):1845-1855.

PMID: 27717298

 

Untargeted screening of unknown xenobiotics and potential toxins in plasma of poisoned patients using high-resolution mass spectrometry: Generation of xenobiotic fingerprint using background subtraction.

Chen C, Wohlfarth A, Xu H, Su D, Wang X, Jiang H, Feng Y, Zhu M.

Anal Chim Acta. 2016 Nov 9;944:37-43. doi: 10.1016/j.aca.2016.09.034.

PMID: 27776637

 

Pd-Catalyzed γ-C(sp₃)-H Arylation of Free Amines Using a Transient Directing Group.

Wu Y, Chen YQ, Liu T, Eastgate MD, Yu JQ.

J Am Chem Soc. 2016 Nov 9;138(44):14554-14557.

PMID: 27786439

 

Development of an HTS-Compatible Assay for Discovery of Melanoma-Related Microphthalmia Transcription Factor Disruptors Using AlphaScreen Technology.

Wang J, Fang P, Chase P, Tshori S, Razin E, Spicer TP, Scampavia L, Hodder P, Guo M.

J Biomol Screen. 2016 Nov 8. pii: 1087057116675274. [Epub ahead of print]

PMID: 27827304

 

Advances in analytical methodologies to guide bioprocess engineering for bio-therapeutics.

Saldova R, Kilcoyne M, Stöckmann H, Millán Martín S, Lewis AM, Tuite CM, Gerlach JQ, Le Berre M, Borys MC, Li ZJ, Abu-Absi NR, Leister K, Joshi L, Rudd PM.

Methods. 2016 Nov 8. pii: S1046-2023(16)30434-0. doi: 10.1016/j.ymeth.2016.11.002. [Epub ahead of print]

PMID: 27832969

 

A Phase I/II Multicenter Study of Single-Agent Foretinib as First-Line Therapy in Patients with Advanced Hepatocellular Carcinoma.

Yau TC, Lencioni R, Sukeepaisarnjaroen W, Chao Y, Yen CJ, Lausoontornsiri W, Chen PJ, Sanpajit T, Camp A, Cox DS, Gagnon RC, Liu Y, Raffensperger KE, Kulkarni DA, Kallender H, Ottesen LH, Poon RT, Bottaro DP.

Clin Cancer Res. 2016 Nov 7. pii: clincanres.1789.2016. [Epub ahead of print]

PMID: 27821605

 

Understanding the Impact of Chemical Variability and Calibration Algorithms on Prediction of Solid Fraction of Roller Compacted Ribbons Using Near-Infrared (NIR) Spectroscopy.

Talwar S, Nunes C, Stevens T, Nesarikar V, Timmins P, Anderson CA, Drennen JK 3rd.

Appl Spectrosc. 2016 Nov 4. pii: 0003702816671960. [Epub ahead of print]

PMID: 27815436

 

Erratum to: Agonist anti-GITR monoclonal antibody and stereotactic radiation induce immune-mediated survival advantage in murine intracranial glioma.

Patel MA, Kim JE, Theodros D, Tam A, Velarde E, Kochel CM, Francica B, Nirschl TR, Ghasemzadeh A, Mathios D, Harris-Bookman S, Jackson CC, Jackson C, Ye X, Tran PT, Tyler B, Coric V, Selby M, Brem H, Drake CG, Pardoll DM, Lim M.

J Immunother Cancer. 2016 Nov 4;4:74.

PMID: 27822377

 

Reply to Letter to the Editor.

Fleischmann R, Connolly SE, Maldonado MA, Schiff M.

Arthritis Rheumatol. 2016 Nov 3. doi: 10.1002/art.39978. [Epub ahead of print] Review. No abstract available.

PMID: 27813366

 

Fulminant Myocarditis with Combination Immune Checkpoint Blockade.

Johnson DB, Balko JM, Compton ML, Chalkias S, Gorham J, Xu Y, Hicks M, Puzanov I, Alexander MR, Bloomer TL, Becker JR, Slosky DA, Phillips EJ, Pilkinton MA, Craig-Owens L, Kola N, Plautz G, Reshef DS, Deutsch JS, Deering RP, Olenchock BA, Lichtman AH, Roden DM, Seidman CE, Koralnik IJ, Seidman JG, Hoffman RD, Taube JM, Diaz LA Jr, Anders RA, Sosman JA, Moslehi JJ.

N Engl J Med. 2016 Nov 3;375(18):1749-1755.

PMID: 27806233

 

Strategies to Determine Assay Format for the Assessment of Neutralizing Antibody Responses to Biotherapeutics.

Wu B, Chung S, Jiang XR, McNally J, Pedras-Vasconcelos J, Pillutla R, White JT, Xu Y, Gupta S.

AAPS J. 2016 Nov;18(6):1335-1350.

PMID: 27495119

 

Challenges and Opportunities with Non-CYP Enzymes Aldehyde Oxidase, Carboxylesterase, and UDP-Glucuronosyltransferase: Focus on Reaction Phenotyping and Prediction of Human Clearance.

Argikar UA, Potter PM, Hutzler JM, Marathe PH.

AAPS J. 2016 Nov;18(6):1391-1405. Review.

PMID: 27495117

 

Design and Synthesis of Novel Meta-Linked Phenylglycine Macrocyclic FVIIa Inhibitors.

Richter JM, Cheney DL, Bates JA, Wei A, Luettgen JM, Rendina AR, Harper TM, Narayanan R, Wong PC, Seiffert D, Wexler RR, Priestley ES.

ACS Med Chem Lett. 2016 Nov 1;8(1):67-72. doi: 10.1021/acsmedchemlett.6b00375.

PMID: 28105277

 

A Review of Daclatasvir Drug-Drug Interactions.

Garimella T, You X, Wang R, Huang SP, Kandoussi H, Bifano M, Bertz R, Eley T.

Adv Ther. 2016 Nov;33(11):1867-1884. Review.

PMID: 27664109

 

 Long-Term Outcomes in Belatacept- Versus Cyclosporine-Treated Recipients of Extended Criteria Donor Kidneys: Final Results From BENEFIT-EXT, a Phase III Randomized Study.

Durrbach A, Pestana JM, Florman S, Del Carmen Rial M, Rostaing L, Kuypers D, Matas A, Wekerle T, Polinsky M, Meier-Kriesche HU, Munier S, Grinyó JM.

Am J Transplant. 2016 Nov;16(11):3192-3201. doi: 10.1111/ajt.13830.

PMID: 27130868

 

Daclatasvir and Peginterferon/Ribavirin for Black/African-American and Latino Patients with HCV infection.

Rodriguez-Torres M, Lawitz E, Yangco B, Jeffers L, Han SH, Thuluvath PJ, Rustgi V, Harrison S, Ghalib R, Vierling JM, Luketic V, Zamor PJ, Ravendhran N, Morgan TR, Pearlman B, O'Brien C, Khallafi H, Pyrsopoulos N, Kong G, McPhee F, Yin PD, Hughes E, Treitel M.

Ann Hepatol. 2016 Nov-Dec 2016;15(6):834-845.

PMID: 27740516

 

Elotuzumab in combination with thalidomide and low-dose dexamethasone: a phase 2 single-arm safety study in patients with relapsed/refractory multiple myeloma.

Mateos MV, Granell M, Oriol A, Martinez-Lopez J, Blade J, Hernandez MT, Martín J, Gironella M, Lynch M, Bleickardt E, Paliwal P, Singhal A, San-Miguel J.

Br J Haematol. 2016 Nov;175(3):448-456. doi: 10.1111/bjh.14263.

PMID: 27434748

 

Agonistic CD40 mAb-Driven IL12 Reverses Resistance to Anti-PD1 in a T-cell-Rich Tumor.

Ngiow SF, Young A, Blake SJ, Hill GR, Yagita H, Teng MW, Korman AJ, Smyth MJ.

Cancer Res. 2016 Nov 1;76(21):6266-6277.

PMID: 27634762

 

Highlights From the American Association of Pharmaceutical Scientists/ International Transporter Consortium Joint Workshop on Drug Transporters in Absorption, Distribution, Metabolism, and Excretion: From the Bench to the Bedside - Clinical Pharmacology Considerations.

Ronaldson PT, Bauer B, El-Kattan AF, Shen H, Salphati L, Louie SW.

Clin Pharmacol Ther. 2016 Nov;100(5):419-422. doi: 10.1002/cpt.439.

PMID: 27500791

 

Comparison of rat and rabbit embryo-fetal developmental toxicity data for 379 pharmaceuticals: on the nature and severity of developmental effects.

Theunissen PT, Beken S, Beyer BK, Breslin WJ, Cappon GD, Chen CL, Chmielewski G, De Schaepdrijver L, Enright B, Foreman JE, Harrouk W, Hew KW, Hoberman AM, Hui JY, Knudsen TB, Laffan SB, Makris SL, Martin M, McNerney ME, Siezen CL, Stanislaus DJ, Stewart J, Thompson KE, Tornesi B, Van der Laan JW, Weinbauer GF, Wood S, Piersma AH.

Crit Rev Toxicol. 2016 Nov;46(10):900-910.

PMID: 27848393

 

One-year efficacy and safety of saxagliptin add-on in patients receiving dapagliflozin and metformin.

Matthaei S, Aggarwal N, Garcia-Hernandez P, Iqbal N, Chen H, Johnsson E, Chin A, Hansen L.

Diabetes Obes Metab. 2016 Nov;18(11):1128-1133. doi: 10.1111/dom.12741.

PMID: 27403645

 

Efficacy and safety of triple therapy with dapagliflozin add-on to saxagliptin plus metformin over 52 weeks in patients with type 2 diabetes.

Mathieu C, Herrera Marmolejo M, González González JG, Hansen L, Chen H, Johnsson E, Garcia-Sanchez R, Iqbal N.

Diabetes Obes Metab. 2016 Nov;18(11):1134-1137. doi: 10.1111/dom.12737.

PMID: 27385192

 

Transporter Expression in Liver Tissue from Subjects with Alcoholic or Hepatitis C Cirrhosis Quantified by Targeted Quantitative Proteomics.

Wang L, Collins C, Kelly EJ, Chu X, Ray AS, Salphati L, Xiao G, Lee C, Lai Y, Liao M, Mathias A, Evers R, Humphreys W, Hop CE, Kumer SC, Unadkat JD.

Drug Metab Dispos. 2016 Nov;44(11):1752-1758.

PMID: 27543206

 

Non-cytochrome P450-mediated bioactivation and its toxicological relevance.

Gan J, Ma S, Zhang D.

Drug Metab Rev. 2016 Nov;48(4):473-501.

PMID: 27533622

 

Hepatitis C disease transmission and treatment uptake: impact on the cost-effectiveness of new direct-acting antiviral therapies.

Bennett H, Gordon J, Jones B, Ward T, Webster S, Kalsekar A, Yuan Y, Brenner M, McEwan P.

Eur J Health Econ. 2016 Nov 1. [Epub ahead of print]

PMID: 27803989

 

Systematic review of renal and bone safety of the antiretroviral regimen efavirenz, emtricitabine, and tenofovir disoproxil fumarate in patients with HIV infection.

Bedimo R, Rosenblatt L, Myers J.

HIV Clin Trials. 2016 Nov;17(6):246-266.

PMID: 27809711

 

Efficacy and safety of dapagliflozin in Asian patients with type 2 diabetes after metformin failure: A randomized controlled trial.

Yang W, Han P, Min KW, Wang B, Mansfield T, T'Joen C, Iqbal N, Johnsson E, Ptaszynska A.

J Diabetes. 2016 Nov;8(6):796-808. doi: 10.1111/1753-0407.12357.

PMID: 26589253

 

A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin.

Wei L, Zhang M, Xu M, Chuang WL, Lu W, Xie W, Jia Z, Gong G, Li Y, Bae SH, Yang YF, Xie Q, Lin S, Chen X, Niu J, Jia J, Garimella T, Torbeyns A, McPhee F, Treitel M, Yin PD, Mo L.

J Gastroenterol Hepatol. 2016 Nov;31(11):1860-1867. doi: 10.1111/jgh.13379.

PMID: 27003037

 

Mechanisms of Hyperbilirubinemia During Peginterferon Lambda-1a Therapy for Chronic Hepatitis C Infection: A Retrospective Investigation.

Zwirtes R, Narasimhan P, Wind-Rotolo MM, Xu D, Hruska MW, Kishnani N, Colston EM, Srinivasan S.

J Interferon Cytokine Res. 2016 Nov;36(11):644-651.

PMID: 27710263

 

Peginterferon Lambda-1a/Ribavirin with Daclatasvir or Peginterferon Alfa-2a/Ribavirin with Telaprevir for Chronic Hepatitis C Genotype 1b.

Flisiak R, Kawazoe S, Znoyko O, Assy N, Gadano A, Kao JH, Lee KS, Zwirtes R, Portsmouth S, Dong Y, Xu D, Kumada H, Srinivasan S.

J Interferon Cytokine Res. 2016 Nov;36(11):635-643.

PMID: 27327078

 

Cardiovascular Outcomes Associated with Lowering Low-density Lipoprotein Cholesterol in Rheumatoid Arthritis and Matched Nonrheumatoid Arthritis.

An J, Alemao E, Reynolds K, Kawabata H, Solomon DH, Liao KP, Niu F, Cheetham TC.

J Rheumatol. 2016 Nov;43(11):1989-1996.

PMID: 27585690

  

PS01.74: Systemic Treatment Sequencing in US Medicare Patients with Extensive Disease (ED)-Small Cell Lung Cancer (SCLC): Topic: Medical Oncology.

Danese M, Gleeson M, Lubeck D, Korytowsky B, Bobiak S.

J Thorac Oncol. 2016 Nov;11(11S):S317-S318. doi: 10.1016/j.jtho.2016.09.109. No abstract available.

PMID: 27969541

 

PS01.73: Have We Shifted the Therapeutic Innovation Frontier? A US Assessment of Advanced Non-Small Cell Lung Cancer (advNSCLC): Topic: Medical Oncology.

Korytowsky B, Justo N, Nilsson J, Madison T, Dalen J, McGuire A.

J Thorac Oncol. 2016 Nov;11(11S):S316-S317. doi: 10.1016/j.jtho.2016.09.108. No abstract available.

PMID: 27969540

 

PS01.59: CheckMate 370: A Master Protocol of Phase 1/2 Studies of Nivolumab as Maintenance or First-Line ± Standard-of-Care Therapies in Advanced NSCLC: Topic: Medical Oncology.

Blumenschein G Jr, Chandler J, Garon EB, Waterhouse D, Goldman JW, Gunuganti VK, Boccia R, Spigel D, Glaspy J, Berry DA, Korytowsky B, Zhu J, Lin WH, Bennett K, Reynolds C.

J Thorac Oncol. 2016 Nov;11(11S):S307. doi: 10.1016/j.jtho.2016.09.094. No abstract available.

PMID: 27969526

 

PS01.58: A Phase 3 Trial of Nivolumab, Nivolumab Plus Ipilimumab, or Placebo Maintenance for Extensive-Stage SCLC After First-Line Chemotherapy: Topic: Medical Oncology.

Owonikoko T, Ready N, Postmus P, Reck M, Peters S, Pieters A, Selvaggi G, Fairchild J, Govindan R.

J Thorac Oncol. 2016 Nov;11(11S):S306-S307. doi: 10.1016/j.jtho.2016.09.093. No abstract available.

PMID: 27969525

 

ORAL01.03: CheckMate 012: Safety and Efficacy of First-Line Nivolumab and Ipilimumab in Advanced NSCLC: Topic: Medical Oncology.

Antonia SJ, Gettinger SN, Goldman J, Brahmer J, Borghaei H, Chow LQ, Ready NE, Gerber DE, Juergens R, Shepherd F, Laurie SA, Young T, Geese WJ, Agrawal S, Li X, Hellmann MD.

J Thorac Oncol. 2016 Nov;11(11S):S250-S251. doi: 10.1016/j.jtho.2016.09.008. No abstract available.

PMID: 27969442

 

ORAL01.02: Biopsies in Initial Diagnosis of Non-Small Cell Lung Cancer in US Community Oncology Practices: Implications for First-Line Immunotherapy: Topic: Medical Oncology.

Hussein M, Richards DA, Ulrich B, Korytowsky B, Pandya D, Cogswell J, Batenchuk C, Burns V.

J Thorac Oncol. 2016 Nov;11(11S):S249-S250. doi: 10.1016/j.jtho.2016.09.007. No abstract available.

PMID: 27969441

 

Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial.

Sharma P, Callahan MK, Bono P, Kim J, Spiliopoulou P, Calvo E, Pillai RN, Ott PA, de Braud F, Morse M, Le DT, Jaeger D, Chan E, Harbison C, Lin CS, Tschaika M, Azrilevich A, Rosenberg JE.

Lancet Oncol. 2016 Nov;17(11):1590-1598. doi: 10.1016/S1470-2045(16)30496-X.

PMID: 27733243

 

Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial.

Hodi FS, Chesney J, Pavlick AC, Robert C, Grossmann KF, McDermott DF, Linette GP, Meyer N, Giguere JK, Agarwala SS, Shaheen M, Ernstoff MS, Minor DR, Salama AK, Taylor MH, Ott PA, Horak C, Gagnier P, Jiang J, Wolchok JD, Postow MA.

Lancet Oncol. 2016 Nov;17(11):1558-1568. doi: 10.1016/S1470-2045(16)30366-7.

PMID: 27622997

 

On-treatment HCV RNA as a predictor of sustained virological response in HCV genotype 3-infected patients treated with daclatasvir and sofosbuvir.

Kowdley KV, Nelson DR, Lalezari JP, Box T, Gitlin N, Poleynard G, Rabinovitz M, Ravendhran N, Sheikh AM, Siddique A, Bhore R, Noviello S, Rana K.

Liver Int. 2016 Nov;36(11):1611-1618. doi: 10.1111/liv.13165.

PMID: 27188960

 

Some practical considerations in three-arm non-inferiority trial design.

Zhou M, Kundu S.

Pharm Stat. 2016 Nov;15(6):550-559. doi: 10.1002/pst.1779.

PMID: 27681603

 

Autoxidation Products of Betulonaldehyde.

Ayers S, Benkovics T, Marshall J, Tan Y, Strotman NA, Kiau S.

J Nat Prod. 2016 Oct 28;79(10):2758-2761.

PMID: 27684353

 

Treatment Design and Rationale for a Randomized Trial of Cisplatin and Etoposide Plus Thoracic Radiotherapy Followed by Nivolumab or Placebo for Locally Advanced Non-Small-Cell Lung Cancer (RTOG 3505).

Gerber DE, Urbanic JJ, Langer C, Hu C, Chang IF, Lu B, Movsas B, Jeraj R, Curran WJ, Bradley JD.

Clin Lung Cancer. 2016 Oct 26. pii: S1525-7304(16)30352-7. doi: 10.1016/j.cllc.2016.10.009. [Epub ahead of print]

PMID: 27923550

 

Non-major bleeding with apixaban versus warfarin in patients with atrial fibrillation.

Bahit MC, Lopes RD, Wojdyla DM, Held C, Hanna M, Vinereanu D, Hylek EM, Verheugt F, Goto S, Alexander JH, Wallentin L, Granger CB.

Heart. 2016 Oct 24. pii: heartjnl-2016-309901. doi: 10.1136/heartjnl-2016-309901. [Epub ahead of print]

PMID: 27798052

 

Discovery of Highly Potent Liver X Receptor β Agonists.

Kick EK, Busch BB, Martin R, Stevens WC, Bollu V, Xie Y, Boren BC, Nyman MC, Nanao MH, Nguyen L, Plonowski A, Schulman IG, Yan G, Zhang H, Hou X, Valente MN, Narayanan R, Behnia K, Rodrigues AD, Brock B, Smalley J, Cantor GH, Lupisella J, Sleph P, Grimm D, Ostrowski J, Wexler RR, Kirchgessner T, Mohan R.

ACS Med Chem Lett. 2016 Oct 23;7(12):1207-1212.

PMID: 27994765

 

Comparing rat and rabbit embryo-fetal developmental toxicity data for 379 pharmaceuticals: on systemic dose and developmental effects.

Theunissen PT, Beken S, Beyer B, Breslin WJ, Cappon GD, Chen CL, Chmielewski G, de Schaepdrijver L, Enright B, Foreman JE, Harrouk W, Hew KW, Hoberman AM, Y Hui J, Knudsen TB, Laffan SB, Makris SL, Martin M, McNerney ME, Siezen CL, Stanislaus DJ, Stewart J, Thompson KE, Tornesi B, Van der Laan JW, Weinbauer GF, Wood S, Piersma AH.

Crit Rev Toxicol. 2016 Oct 21:1-13. [Epub ahead of print]

PMID: 27766926

 

Dual roles for regulatory T cell depletion and co-stimulatory signaling in agonistic GITR targeting for tumor immunotherapy.

Mahne A, Mauze S, Joyce-Shaikh B, Xia J, Bowman E, Beebe A, Cua D, Jain R.

Cancer Res. 2016 Oct 20. pii: canres.0797.2016. doi: 10.1158/0008-5472.CAN-16-0797. [Epub ahead of print]

PMID: 28122327

 

Results From an Integrated Safety Analysis of Urelumab, an Agonist Anti-CD137 Monoclonal Antibody.

Segal NH, Logan TF, Hodi FS, McDermott DF, Melero I, Hamid O, Schmidt H, Robert C, Chiarion-Sileni V, Ascierto PA, Maio M, Urba WJ, Gangadhar TC, Suryawanshi S, Neely J, Jure-Kunkel M, Krishnan S, Kohrt HE, Sznol M, Levy R.

Clin Cancer Res. 2016 Oct 18. pii: clincanres.1272.2016. [Epub ahead of print]

PMID: 27756788

 

A Randomized Study of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a in Combination with Ribavirin and Telaprevir in Patients with Genotype-1 Chronic Hepatitis C.

Flisiak R, Shiffman M, Arenas J, Cheinquer H, Nikitin I, Dong Y, Rana K, Srinivasan S.

PLoS One. 2016 Oct 17;11(10):e0164563. doi: 10.1371/journal.pone.0164563.

PMID: 27749900

 

Regulatory Forum*: Progress toward ICH S1 Revision.

Peden WM.

Toxicol Pathol. 2016 Oct 17. pii: 0192623316673201. [Epub ahead of print]

PMID: 27753636

 

Synthesis and P1' SAR exploration of potent macrocyclic tissue factor-factor VIIa inhibitors.

Ladziata VU, Glunz PW, Zou Y, Zhang X, Jiang W, Jacutin-Porte S, Cheney DL, Wei A, Luettgen JM, Harper TM, Wong PC, Seiffert D, Wexler RR, Priestley ES.

Bioorg Med Chem Lett. 2016 Oct 15;26(20):5051-5057. doi: 10.1016/j.bmcl.2016.08.088.

PMID: 27612545

 

Abscopal Effects of Radiotherapy Are Enhanced by Combined Immunostimulatory mAbs and Are Dependent on CD8 T Cells and Crosspriming.

Rodriguez-Ruiz ME, Rodriguez I, Garasa S, Barbes B, Solorzano JL, Perez-Gracia JL, Labiano S, Sanmamed MF, Azpilikueta A, Bolaños E, Sanchez-Paulete AR, Aznar MA, Rouzaut A, Schalper KA, Jure-Kunkel M, Melero I.

Cancer Res. 2016 Oct 15;76(20):5994-6005.

PMID: 27550452

 

Discovery of 6-Fluoro-5-(R)-(3-(S)-(8-fluoro-1-methyl-2,4-dioxo-1,2-dihydroquinazolin-3(4H)-yl)-2-methylphenyl)-2-(S)-(2-hydroxypropan-2-yl)-2,3,4,9-tetrahydro-1H-carbazole-8-carboxamide (BMS-986142): A Reversible Inhibitor of Bruton's Tyrosine Kinase (BTK) Conformationally Constrained by Two Locked Atropisomers.

Watterson SH, De Lucca GV, Shi Q, Langevine CM, Liu Q, Batt DG, Beaudoin Bertrand M, Gong H, Dai J, Yip S, Li P, Sun D, Wu DR, Wang C, Zhang Y, Traeger SC, Pattoli MA, Skala S, Cheng L, Obermeier MT, Vickery R, Discenza LN, D'Arienzo CJ, Zhang Y, Heimrich E, Gillooly KM, Taylor TL, Pulicicchio C, McIntyre KW, Galella MA, Tebben AJ, Muckelbauer JK, Chang C, Rampulla R, Mathur A, Salter-Cid L, Barrish JC, Carter PH, Fura A, Burke JR, Tino JA.

J Med Chem. 2016 Oct 13;59(19):9173-9200.

PMID: 27583770

 

Synthesis and Antiobesity Properties of 6-(4-Chlorophenyl)-3-(4-((3,3-difluoro-1-hydroxycyclobutyl)methoxy)-3-methoxyphenyl)thieno[3,2-d]pyrimidin-4(3H)-one (BMS-814580): A Highly Efficacious Melanin Concentrating Hormone Receptor 1 (MCHR1) Inhibitor.

Ahmad S, Washburn WN, Hernandez AS, Bisaha S, Ngu K, Wang W, Pelleymounter MA, Longhi D, Flynn N, Azzara AV, Rohrbach K, Devenny J, Rooney S, Thomas M, Glick S, Godonis H, Harvey S, Zhang H, Gemzik B, Janovitz EB, Huang C, Zhang L, Robl JA, Murphy BJ.

J Med Chem. 2016 Oct 13;59(19):8848-8858.

PMID: 27564419

 

Evaluation and selection of a non-PCR based technology for improved gene expression profiling from clinical formalin-fixed, paraffin-embedded samples.

Qi Z, Wang L, He A, Ma-Edmonds M, Cogswell J.

Bioanalysis. 2016 Oct 7. [Epub ahead of print]

PMID: 27712086

 

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 - small molecules, peptides and small molecule biomarkers by LCMS).

Yang E, Welink J, Cape S, Woolf E, Sydor J, James C, Goykhman D, Arnold M, Addock N, Bauer R, Buonarati M, Ciccimaro E, Dodda R, Evans C, Garofolo F, Hughes N, Islam R, Nehls C, Wilson A, Briscoe C, Bustard M, Coppola L, Croft S, Drexler D, Ferrari L, Fraier D, Jenkins R, Kadavil J, King L, Li W, Lima Santos GM, Musuku A, Ramanathan R, Saito Y, Savoie N, Summerfield S, Sun R, Tampal N, Vinter S, Wakelin-Smith J, Yue Q.

Bioanalysis. 2016 Oct 7. [Epub ahead of print]

PMID: 27712081

 

Erratum to: Risk of cardiovascular events among patients with HIV treated with atazanavircontaining regimens: a retrospective cohort study.

Rosenblatt L, Farr AM, Nkhoma ET, Nelson JK, Ritchings C, Johnston SS.

BMC Infect Dis. 2016 Oct 7;16(1):547. No abstract available.

PMID: 27717332

 

The 'obesity paradox' in atrial fibrillation: observations from the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial.

Sandhu RK, Ezekowitz J, Andersson U, Alexander JH, Granger CB, Halvorsen S, Hanna M, Hijazi Z, Jansky P, Lopes RD, Wallentin L.

Eur Heart J. 2016 Oct 7;37(38):2869-2878.

PMID: 27071819

 

Synthesis of Fmoc-Protected Arylphenylalanines (Bip Derivatives) via Nonaqueous Suzuki-Miyaura Cross-Coupling Reactions.

Qiao JX, Fraunhoffer KJ, Hsiao Y, Li YX, Wang C, Wang TC, Poss MA.

J Org Chem. 2016 Oct 7;81(19):9499-9506.

PMID: 27615449

 

Novel platens to measure the hardness of a pentagonal shaped tablet.

Malladi J, Sidik K, Wu S, McCann R, Dougherty J, Parab P, Carragher T.

Pharm Dev Technol. 2016 Oct 4:1-10. [Epub ahead of print]

PMID: 27607150

 

Development of 1H-Pyrazolo[3,4-b]pyridines as Metabotropic Glutamate Receptor 5 Positive Allosteric Modulators.

Hill MD, Fang H, Brown JM, Molski T, Easton A, Han X, Miller R, Hill-Drzewi M, Gallagher L, Matchett M, Gulianello M, Balakrishnan A, Bertekap RL, Santone KS, Whiterock VJ, Zhuo X, Bronson JJ, Macor JE, Degnan AP.

ACS Med Chem Lett. 2016 Oct 3;7(12):1082-1086.

PMID: 27994742

 

Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective.

Lineberry N, Berlin JA, Mansi B, Glasser S, Berkwits M, Klem C, Bhattacharya A, Citrome L, Enck R, Fletcher J, Haller D, Chen TT, Laine C.

BMJ. 2016 Oct 3;355:i5078. doi: 10.1136/bmj.i5078. No abstract available.

PMID: 27697753

 

In-line ATR-UV and Raman Spectroscopy for Monitoring API Dissolution Process During Liquid-Filled Soft-Gelatin Capsule Manufacturing.

Wan B, Zordan CA, Lu X, McGeorge G.

AAPS PharmSciTech. 2016 Oct;17(5):1173-81. doi: 10.1208/s12249-015-0456-0.

PMID: 26604007

 

Establishing a complementary diagnostic for anti-PD-1 immune checkpoint inhibitor therapy.

Novotny JF Jr, Cogswell J, Inzunza H, Harbison C, Horak C, Averbuch S.

Ann Oncol. 2016 Oct;27(10):1966-9. doi: 10.1093/annonc/mdw288. No abstract available.

PMID: 27502705

 

Effect of nivolumab on health-related quality of life in patients with treatment-naïve advanced melanoma: results from the phase III CheckMate 066 study.

Long GV, Atkinson V, Ascierto PA, Robert C, Hassel JC, Rutkowski P, Savage KJ, Taylor F, Coon C, Gilloteau I, Dastani HB, Waxman IM, Abernethy AP.

Ann Oncol. 2016 Oct;27(10):1940-6. doi: 10.1093/annonc/mdw265.

PMID: 27405322

 

Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results from the APPRAISE study.

D'Agostino MA, Wakefield RJ, Berner-Hammer H, Vittecoq O, Filippou G, Balint P, Möller I, Iagnocco A, Naredo E, Østergaard M, Boers M, Gaillez C, Van Holder K, Le Bars M; OMERACT-EULAR-Ultrasound Task Force..

Ann Rheum Dis. 2016 Oct;75(10):1763-9. doi: 10.1136/annrheumdis-2015-207709.

PMID: 26590174

 

A validated LC-MS/MS method for the quantitative measurement of creatinine as an endogenous biomarker in human plasma.

Zhao Y, Liu G, Angeles A, Christopher LJ, Wang Z, Arnold ME, Shen JX.

Bioanalysis. 2016 Oct;8(19):1997-2005. doi: 10.4155/bio-2016-0086.

PMID: 27611058

 

HCV NS5A replication complex inhibitors.

Gao M, O'Boyle DR 2nd, Roberts S.

Curr Opin Pharmacol. 2016 Oct;30:151-157. doi: 10.1016/j.coph.2016.07.014. Review.

PMID: 27643675

 

Efficacy and Safety of Multiple Doses of Exenatide Once-Monthly Suspension in Patients With Type 2 Diabetes: A Phase II Randomized Clinical Trial.

Wysham CH, MacConell L, Hardy E.

Diabetes Care. 2016 Oct;39(10):1768-76. doi: 10.2337/dc16-0238.

PMID: 27436275

 

Evaluation of CYP2B6 Induction and Prediction of Clinical Drug-Drug Interactions: Considerations from the IQ Consortium Induction Working Group-An Industry Perspective.

Fahmi OA, Shebley M, Palamanda J, Sinz MW, Ramsden D, Einolf HJ, Chen L, Wang H.

Drug Metab Dispos. 2016 Oct;44(10):1720-30. doi: 10.1124/dmd.116.071076.

PMID: 27422672

 

Oxygen-dependent regulation of c-di-GMP synthesis by SadC controls alginate production in Pseudomonas aeruginosa.

Schmidt A, Hammerbacher AS, Bastian M, Nieken KJ, Klockgether J, Merighi M, Lapouge K, Poschgan C, Kölle J, Acharya KR, Ulrich M, Tümmler B, Unden G, Kaever V, Lory S, Haas D, Schwarz S, Döring G.

Environ Microbiol. 2016 Oct;18(10):3390-3402. doi: 10.1111/1462-2920.13208.

PMID: 26743546

 

Novel statistical approach for evaluating flow cytometric in vitro micronucleus data.

Wojciechowski JP, Gleason CR, Roberts DJ, Custer LL.

Environ Mol Mutagen. 2016 Oct;57(8):623-629. doi: 10.1002/em.22038.

PMID: 27545269

 

P2.46 (also presented as PD1.01): LCSS as a Marker of Treatment Benefit With Nivolumab vs Docetaxel in Pts With Advanced Non-Squamous NSCLC From Checkmate 057: Track: Immunotherapy.

Gralla RJ, Spigel D, Bennett B, Taylor F, Penrod JR, Derosa M, Dastani H, Orsini L, Mathias C, Reck M.

J Thorac Oncol. 2016 Oct;11(10S):S247. doi: 10.1016/j.jtho.2016.08.117. No abstract available.

PMID: 27676580

 

P2.36: Nivolumab (nivo) in Patients (pts) With Advanced (adv) NSCLC and Central Nervous System (CNS) Metastases (mets): Track: Immunotherapy.

Goldman JW, Crino L, Vokes EE, Holgado E, Reckamp K, Pluzanski A, Spigel D, Kohlhaeufl M, Garassino M, Chow LQ, Gettinger S, Gerber DE, Havel L, Ramalingam SS, Dy GK, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Lopes G.

J Thorac Oncol. 2016 Oct;11(10S):S238-S239. doi: 10.1016/j.jtho.2016.08.107. No abstract available.

PMID: 27676570

 

P2.35: Nivolumab vs Docetaxel in Advanced NSCLC: CheckMate 017/057 2-Y Update and Exploratory Cytokine Profile Analysis: Track: Immunotherapy.

Borghaei H, Brahmer J, Horn L, Ready N, Steins M, Felip E, Paz-Ares L, Xx X, Barlesi F, Antonia S, Fayette J, Rizvi N, Crino L, Reck M, Erich Eberhardt WE, Hellmann M, Desai K, Li A, Healey D, Spigel D, Mathias C.

J Thorac Oncol. 2016 Oct;11(10S):S237-S238. doi: 10.1016/j.jtho.2016.08.106. No abstract available.

PMID: 27676569

 

P2.33: Safety Profile of Nivolumab Administered as 30-Minute (MIN) Infusion: Analysis of Data From Checkmate 153: Track: Immunotherapy.

Waterhouse D, Horn L, Reynolds C, Spigel D, Chandler J, Mekhail T, Mohamed M, Creelan B, Blankstein KB, Nikolinakos P, Mccleod MJ, Li A, Waxman IM, Aanur N, Agrawal S, Richardet E.

J Thorac Oncol. 2016 Oct;11(10S):S236. doi: 10.1016/j.jtho.2016.08.104. No abstract available.

PMID: 27676567

 

PD1.01 (also presented as P2.46): LCSS as a Marker of Treatment Benefit With Nivolumab vs Docetaxel in Pts With Advanced Non-Squamous NSCLC From Checkmate 057.

Gralla RJ, Spigel D, Bennett B, Taylor F, Penrod JR, Derosa M, Dastani H, Orsini L, Mathias C, Reck M.

J Thorac Oncol. 2016 Oct;11(10S):S171. doi: 10.1016/j.jtho.2016.08.009. No abstract available.

PMID: 27676476

  

All-oral daclatasvir plus asunaprevir for chronic hepatitis C virus (HCV) genotype 1b infection: a sub-analysis in Asian patients from the HALLMARK DUAL study.

Kao JH, Lee YJ, Heo J, Ahn SH, Lim YS, Peng CY, Chang TT, Torbeyns A, Hughes E, Bhore R, Noviello S.

Liver Int. 2016 Oct;36(10):1433-41. doi: 10.1111/liv.13128.

PMID: 27009831

 

Investigating investment in biopharmaceutical R&D.

Carter PH, Berndt ER, DiMasi JA, Trusheim M.

Nat Rev Drug Discov. 2016 Oct;15(10):673-4. doi: 10.1038/nrd.2016.104. No abstract available.

PMID: 27616295

 

Initial Drug Dissolution from Amorphous Solid Dispersions Controlled by Polymer Dissolution and Drug-Polymer Interaction.

Chen Y, Wang S, Wang S, Liu C, Su C, Hageman M, Hussain M, Haskell R, Stefanski K, Qian F.

Pharm Res. 2016 Oct;33(10):2445-58. doi: 10.1007/s11095-016-1969-2.

PMID: 27283830

 

Effects of BMS-986094, a Guanosine Nucleotide Analogue, on Mitochondrial DNA Synthesis and Function.

Baumgart BR, Wang F, Kwagh J, Storck C, Euler C, Fuller M, Simic D, Sharma S, Arnold JJ, Cameron CE, Van Vleet TR, Flint O, Bunch RT, Davies MH, Graziano MJ, Sanderson TP.

Toxicol Sci. 2016 Oct;153(2):396-408. doi: 10.1093/toxsci/kfw135.

PMID: 27466212

 

Mixtures, Metabolites, and Mechanisms: Understanding Toxicology Using Zebrafish.

Gamse JT, Gorelick DA.

Zebrafish. 2016 Oct;13(5):377-8. doi: 10.1089/zeb.2016.1370.

PMID: 27618129

 

Early real-world evidence of persistence on oral anticoagulants for stroke prevention in non-valvular atrial fibrillation: a cohort study in UK primary care.

Johnson ME, Lefèvre C, Collings SL, Evans D, Kloss S, Ridha E, Maguire A.

BMJ Open. 2016 Sep 26;6(9):e011471. doi: 10.1136/bmjopen-2016-011471.

PMID: 27678530

 

 Discovery of S3-Truncated, C-6 Heteroaryl Substituted Aminothiazine β-Site APP Cleaving Enzyme-1 (BACE1) Inhibitors.

Wu YJ, Guernon J, Shi J, Marcin L, Higgins M, Rajamani R, Muckelbauer J, Lewis H, Chang C, Camac D, Toyn JH, Ahlijanian MK, Albright CF, Macor JE, Thompson LA.

J Med Chem. 2016 Sep 22;59(18):8593-600. doi: 10.1021/acs.jmedchem.6b01012.

PMID: 27559936

 

Discovery, Synthesis, and Preclinical Characterization of N-(3-Chloro-4-fluorophenyl)-1H-pyrazolo[4,3-b]pyridin-3-amine (VU0418506), a Novel Positive Allosteric Modulator of the Metabotropic Glutamate Receptor 4 (mGlu4).

Engers DW, Blobaum AL, Gogliotti RD, Cheung YY, Salovich JM, Garcia-Barrantes PM, Daniels JS, Morrison R, Jones CK, Soars MG, Zhuo X, Hurley J, Macor JE, Bronson JJ, Conn PJ, Lindsley CW, Niswender CM, Hopkins CR.

ACS Chem Neurosci. 2016 Sep 21;7(9):1192-200. doi: 10.1021/acschemneuro.6b00035.

PMID: 27075300

 

Population pharmacokinetics of exenatide.

Cirincione B, Mager DE.

Br J Clin Pharmacol. 2016 Sep 21. doi: 10.1111/bcp.13135. [Epub ahead of print]

PMID: 27650681

 

Risk of cardiovascular events among patients with HIV treated with atazanavir-containing regimens: a retrospective cohort study.

Rosenblatt L, Farr AM, Nkhoma ET, Nelson JK, Ritchings C, Johnston SS.

BMC Infect Dis. 2016 Sep 19;16:492. doi: 10.1186/s12879-016-1827-1. Erratum in: BMC Infect Dis. 2016 Oct 7;16(1):547.

PMID: 27643691

 

 Discovery of Phenylglycine Lactams as Potent Neutral Factor VIIa Inhibitors.

Wurtz NR, Parkhurst BL, Jiang W, DeLucca I, Zhang X, Ladziata V, Cheney DL, Bozarth JR, Rendina AR, Wei A, Luettgen JM, Wu Y, Wong PC, Seiffert DA, Wexler RR, Priestley ES.

ACS Med Chem Lett. 2016 Sep 17;7(12):1077-1081.

PMID: 27994741

 

Overview of Critical Parameters for the Design and Execution of a High-Throughput Screen for Allosteric Ligands.

Alt A.

Curr Protoc Pharmacol. 2016 Sep 16;74:9.20.1-9.20.23. doi: 10.1002/cpph.12.

PMID: 27636112

 

Bioequivalence and food effect of heat-stressed and non-heat-stressed dapagliflozin 2.5- and 10-mg tablets.

LaCreta F, Griffen SC, Liu X, Smith C, Hines C, Volk K, Tejwani R, Boulton DW.

Int J Pharm. 2016 Sep 10;511(1):288-95. doi: 10.1016/j.ijpharm.2016.07.017.

PMID: 27418571

 

An integrated approach for profiling oxidative metabolites and glutathione adducts using liquid chromatography coupled with ultraviolet detection and triple quadrupole-linear ion trap mass spectrometry.

Chen G, Cheng Z, Zhang K, Jiang H, Zhu M.

J Pharm Biomed Anal. 2016 Sep 10;129:482-91. doi: 10.1016/j.jpba.2016.07.048.

PMID: 27497649

 

Definitive Upfront Stereotactic Ablative Radiotherapy Combined with Image-Guided, Intensity Modulated Radiotherapy (IG-IMRT) or IG-IMRT Alone for Locally Advanced Non-Small Cell Lung Cancer.

Chi A, Wen S, Monga M, Almubarak M, He X, Rojanasakul Y, Tse W, Remick SC.

PLoS One. 2016 Sep 9;11(9):e0162453. doi: 10.1371/journal.pone.0162453.

PMID: 27611833

 

Preclinical Development of Ipilimumab and Nivolumab Combination Immunotherapy: Mouse Tumor Models, In Vitro Functional Studies, and Cynomolgus Macaque Toxicology.

Selby MJ, Engelhardt JJ, Johnston RJ, Lu LS, Han M, Thudium K, Yao D, Quigley M, Valle J, Wang C, Chen B, Cardarelli PM, Blanset D, Korman AJ.

PLoS One. 2016 Sep 9;11(9):e0161779. doi: 10.1371/journal.pone.0161779. Erratum in: PLoS One. 2016 Nov 18;11(11):e0167251.

PMID: 27610613

 

Discovery of a Potent Acyclic, Tripeptidic, Acyl Sulfonamide Inhibitor of Hepatitis C Virus NS3 Protease as a Back-up to Asunaprevir with the Potential for Once-Daily Dosing.

Sun LQ, Mull E, Zheng B, D'Andrea S, Zhao Q, Wang AX, Sin N, Venables BL, Sit SY, Chen Y, Chen J, Cocuzza A, Bilder DM, Mathur A, Rampulla R, Chen BC, Palani T, Ganesan S, Arunachalam PN, Falk P, Levine S, Chen C, Friborg J, Yu F, Hernandez D, Sheaffer AK, Knipe JO, Han YH, Schartman R, Donoso M, Mosure K, Sinz MW, Zvyaga T, Rajamani R, Kish K, Tredup J, Klei HE, Gao Q, Ng A, Mueller L, Grasela DM, Adams S, Loy J, Levesque PC, Sun H, Shi H, Sun L, Warner W, Li D, Zhu J, Wang YK, Fang H, Cockett MI, Meanwell NA, McPhee F, Scola PM.

J Med Chem. 2016 Sep 8;59(17):8042-60. doi: 10.1021/acs.jmedchem.6b00821.

PMID: 27564532

 

Small Molecule Reversible Inhibitors of Bruton's Tyrosine Kinase (BTK): Structure-Activity Relationships Leading to the Identification of 7-(2-Hydroxypropan-2-yl)-4-[2-methyl-3-(4-oxo-3,4-dihydroquinazolin-3-yl)phenyl]-9H-carbazole-1-carboxamide (BMS-935177).

De Lucca GV, Shi Q, Liu Q, Batt DG, Beaudoin Bertrand M, Rampulla R, Mathur A, Discenza L, D'Arienzo C, Dai J, Obermeier M, Vickery R, Zhang Y, Yang Z, Marathe P, Tebben AJ, Muckelbauer JK, Chang CJ, Zhang H, Gillooly K, Taylor T, Pattoli MA, Skala S, Kukral DW, McIntyre KW, Salter-Cid L, Fura A, Burke JR, Barrish JC, Carter PH, Tino JA.

J Med Chem. 2016 Sep 8;59(17):7915-35. doi: 10.1021/acs.jmedchem.6b00722.

PMID: 27531604

 

Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort.

Welzel TM, Petersen J, Herzer K, Ferenci P, Gschwantler M, Wedemeyer H, Berg T, Spengler U, Weiland O, van der Valk M, Rockstroh J, Peck-Radosavljevic M, Zhao Y, Jimenez-Exposito MJ, Zeuzem S.

Gut. 2016 Sep 7. pii: gutjnl-2016-312444. doi: 10.1136/gutjnl-2016-312444. [Epub ahead of print] Erratum in: Gut. 2016 Dec;65(12 ):2060.

PMID: 27605539

 

Redox-Active Esters in Fe-Catalyzed C-C Coupling.

Toriyama F, Cornella J, Wimmer L, Chen TG, Dixon DD, Creech G, Baran PS.

J Am Chem Soc. 2016 Sep 7;138(35):11132-5. doi: 10.1021/jacs.6b07172.

PMID: 27548696

 

Implementation of USP antibody standard for system suitability in capillary electrophoresis sodium dodecyl sulfate (CE-SDS) for release and stability methods.

Esterman AL, Katiyar A, Krishnamurthy G.

J Pharm Biomed Anal. 2016 Sep 5;128:447-54. doi: 10.1016/j.jpba.2016.06.006.

PMID: 27344634

 

Characterization of human metabolism and disposition of levo-tetrahydropalmatine: Qualitative and quantitative determination of oxidative and conjugated metabolites.

Xiao W, Shen G, Zhuang X, Ran X, Zhu M, Li H.

J Pharm Biomed Anal. 2016 Sep 5;128:371-81. doi: 10.1016/j.jpba.2016.06.015.

PMID: 27343900

 

Recommendations on the Development of a Bioanalytical Assay for 4β-Hydroxycholesterol, an Emerging Endogenous Biomarker of CYP3A Activity.

Aubry AF, Dean B, Diczfalusy U, Goodenough A, Iffland A, McLeod J, Weng N, Yang Z.

AAPS J. 2016 Sep;18(5):1056-66. doi: 10.1208/s12248-016-9949-3. Review.

PMID: 27350147

 

Preclinical to Clinical Translation of Antibody-Drug Conjugates Using PK/PD Modeling: a Retrospective Analysis of Inotuzumab Ozogamicin.

Betts AM, Haddish-Berhane N, Tolsma J, Jasper P, King LE, Sun Y, Chakrapani S, Shor B, Boni J, Johnson TR.

AAPS J. 2016 Sep;18(5):1101-16. doi: 10.1208/s12248-016-9929-7.

PMID: 27198897

 

Tissue distribution and tumor uptake of folate receptor-targeted epothilone folate conjugate, BMS-753493, in CD2F1 mice after systemic administration.

Shen H, Wang L, Chen W, Menard K, Hong Y, Tian Y, Bonacorsi SJ, Humphreys WG, Lee FY, Gan J.

Acta Pharm Sin B. 2016 Sep;6(5):460-467.

PMID: 27709015

 

Apixaban compared with parenteral heparin and/or vitamin K antagonist in patients with nonvalvular atrial fibrillation undergoing cardioversion: Rationale and design of the EMANATE trial.

Ezekowitz MD, Pollack CV, Sanders P, Halperin JL, Spahr J, Cater N, Petkun W, Breazna A, Kirchhof P, Oldgren J.

Am Heart J. 2016 Sep;179:59-68. doi: 10.1016/j.ahj.2016.06.008.

PMID: 27595680

 

Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients: 7-year follow-up of study CA180-034.

Shah NP, Rousselot P, Schiffer C, Rea D, Cortes JE, Milone J, Mohamed H, Healey D, Kantarjian H, Hochhaus A, Saglio G.

Am J Hematol. 2016 Sep;91(9):869-74. doi: 10.1002/ajh.24423.

PMID: 27192969

 

Brief Report: Estimating Disease Activity Using Multi-Biomarker Disease Activity Scores in Rheumatoid Arthritis Patients Treated With Abatacept or Adalimumab.

Fleischmann R, Connolly SE, Maldonado MA, Schiff M.

Arthritis Rheumatol. 2016 Sep;68(9):2083-9. doi: 10.1002/art.39714.

PMID: 27111089

 

The Efficacy and Safety of Clazakizumab, an Anti-Interleukin-6 Monoclonal Antibody, in a Phase IIb Study of Adults With Active Psoriatic Arthritis.

Mease PJ, Gottlieb AB, Berman A, Drescher E, Xing J, Wong R, Banerjee S.

Arthritis Rheumatol. 2016 Sep;68(9):2163-73. doi: 10.1002/art.39700.

PMID: 27059799

 

A simple, effective approach for rapid development of high-throughput and reliable LC-MS/MS bioanalytical assays.

Yuan L, Aubry AF, Ji QC.

Bioanalysis. 2016 Sep;8(17):1809-22. doi: 10.4155/bio-2016-0100.

PMID: 27491843

 

Oxazolidinone-based allosteric modulators of mGluR5: Defining molecular switches to create a pharmacological tool box.

Huang H, Degnan AP, Balakrishnan A, Easton A, Gulianello M, Huang Y, Matchett M, Mattson G, Miller R, Santone KS, Senapati A, Shields EE, Sivarao DV, Snyder LB, Westphal R, Whiterock VJ, Yang F, Bronson JJ, Macor JE.

Bioorg Med Chem Lett. 2016 Sep 1;26(17):4165-9. doi: 10.1016/j.bmcl.2016.07.065.

PMID: 27496211

 

Discovery and SAR of pyrrolo[2,1-f][1,2,4]triazin-4-amines as potent and selective PI3Kδ inhibitors.

Bhide RS, Neels J, Qin LY, Ruan Z, Stachura S, Weigelt C, Sack JS, Stefanski K, Gu X, Xie JH, Goldstine CB, Skala S, Pedicord DL, Ruepp S, Dhar TG, Carter PH, Salter-Cid LM, Poss MA, Davies P.

Bioorg Med Chem Lett. 2016 Sep 1;26(17):4256-60. doi: 10.1016/j.bmcl.2016.07.047.

PMID: 27476421

 

CHO cells knocked out for TSC2 display an improved productivity of antibodies under fed batch conditions.

McVey D, Aronov M, Rizzi G, Cowan A, Scott C, Megill J, Russell R, Tirosh B.

Biotechnol Bioeng. 2016 Sep;113(9):1942-52. doi: 10.1002/bit.25951.

PMID: 26888596

 

Combined metabolomics and proteomics reveals hypoxia as a cause of lower productivity on scale-up to a 5000-liter CHO bioprocess.

Gao Y, Ray S, Dai S, Ivanov AR, Abu-Absi NR, Lewis AM, Huang Z, Xing Z, Borys MC, Li ZJ, Karger BL.

Biotechnol J. 2016 Sep;11(9):1190-200. doi: 10.1002/biot.201600030.

PMID: 27213298

 

Large Cell Neuroendocrine Carcinoma of the Lung: Clinico-Pathologic Features, Treatment, and Outcomes.

Naidoo J, Santos-Zabala ML, Iyriboz T, Woo KM, Sima CS, Fiore JJ, Kris MG, Riely GJ, Lito P, Iqbal A, Veach S, Smith-Marrone S, Sarkaria IS, Krug LM, Rudin CM, Travis WD, Rekhtman N, Pietanza MC.

Clin Lung Cancer. 2016 Sep;17(5):e121-e129. doi: 10.1016/j.cllc.2016.01.003.

PMID: 26898325

 

A practical approach for the scale-up of roller compaction process.

Shi W, Sprockel OL.

Eur J Pharm Biopharm. 2016 Sep;106:15-9. doi: 10.1016/j.ejpb.2016.02.005.

PMID: 26883853

 

 Daclatasvir/peginterferon lambda-1a/ribavirin in patients with chronic HCV infection and haemophilia who are treatment naïve or prior relapsers to peginterferon alfa-2a/ribavirin.

Santagostino E, Pol S, Olveira A, Reesink HW, van Erpecum K, Bogomolov P, Xu D, Critelli L, Srinivasan S, Cooney E.

Haemophilia. 2016 Sep;22(5):692-9. doi: 10.1111/hae.12947.

PMID: 27339614

 

Entecavir plus tenofovir combination therapy for chronic hepatitis B in patients with previous nucleos(t)ide treatment failure.

Zoulim F, Białkowska-Warzecha J, Diculescu MM, Goldis AE, Heyne R, Mach T, Marcellin P, Petersen J, Simon K, Bendahmane S, Klauck I, Wasiak W, Janssen HL.

Hepatol Int. 2016 Sep;10(5):779-88. doi: 10.1007/s12072-016-9737-2.

PMID: 27206517

 

Major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban or warfarin: a "real-world" observational study in the United States.

Lip GY, Pan X, Kamble S, Kawabata H, Mardekian J, Masseria C, Bruno A, Phatak H.

Int J Clin Pract. 2016 Sep;70(9):752-63. doi: 10.1111/ijcp.12863.

PMID: 27550177

 

 Effect of rate of pyrolysis on the textural properties of naturally-templated porous carbons from alginic acid.

Marriott AS, Hunt AJ, Bergström E, Thomas-Oates J, Clark JH.

J Anal Appl Pyrolysis. 2016 Sep;121:62-66.

PMID: 27695151

 

Development of a Human Whole Blood Screening Platform to Monitor JAK/STAT Signaling Using High-Throughput Flow Cytometry.

Fereshteh MP, Li X, Li S, Fan Y, Zhang R, Farr GA, Kolodin G, Lippy J, Naglich JG, Schieven G, Schweizer L, Zhang L.

J Biomol Screen. 2016 Sep;21(8):866-74. doi: 10.1177/1087057116645095.

PMID: 27142718

 

Nivolumab Monotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer.

Gettinger S, Rizvi NA, Chow LQ, Borghaei H, Brahmer J, Ready N, Gerber DE, Shepherd FA, Antonia S, Goldman JW, Juergens RA, Laurie SA, Nathan FE, Shen Y, Harbison CT, Hellmann MD.

J Clin Oncol. 2016 Sep 1;34(25):2980-7. doi: 10.1200/JCO.2016.66.9929.

PMID: 27354485

 

Nivolumab in Combination With Platinum-Based Doublet Chemotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer.

Rizvi NA, Hellmann MD, Brahmer JR, Juergens RA, Borghaei H, Gettinger S, Chow LQ, Gerber DE, Laurie SA, Goldman JW, Shepherd FA, Chen AC, Shen Y, Nathan FE, Harbison CT, Antonia S.

J Clin Oncol. 2016 Sep 1;34(25):2969-79. doi: 10.1200/JCO.2016.66.9861.

PMID: 27354481

 

Current Challenges and Potential Opportunities for the Pharmaceutical Sciences to Make Global Impact: An FIP Perspective.

Tucker G, DeSilva B, Dressman J, Ito M, Kumamoto T, Mager D, Mahler HC, Maitland-van der Zee AH, Pauletti GM, Sasaki H, Shah V, Tang D, Ward M.

J Pharm Sci. 2016 Sep;105(9):2489-97. doi: 10.1016/j.xphs.2015.12.001.

PMID: 26886325

 

Inhibition of AAK1 Kinase as a Novel Therapeutic Approach to Treat Neuropathic Pain.

Kostich W, Hamman BD, Li YW, Naidu S, Dandapani K, Feng J, Easton A, Bourin C, Baker K, Allen J, Savelieva K, Louis JV, Dokania M, Elavazhagan S, Vattikundala P, Sharma V, Das ML, Shankar G, Kumar A, Holenarsipur VK, Gulianello M, Molski T, Brown JM, Lewis M, Huang Y, Lu Y, Pieschl R, O'Malley K, Lippy J, Nouraldeen A, Lanthorn TH, Ye G, Wilson A, Balakrishnan A, Denton R, Grace JE, Lentz KA, Santone KS, Bi Y, Main A, Swaffield J, Carson K, Mandlekar S, Vikramadithyan RK, Nara SJ, Dzierba C, Bronson J, Macor JE, Zaczek R, Westphal R, Kiss L, Bristow L, Conway CM, Zambrowicz B, Albright CF.

J Pharmacol Exp Ther. 2016 Sep;358(3):371-86. doi: 10.1124/jpet.116.235333.

PMID: 27411717

 

Coproporphyrins in Plasma and Urine Can Be Appropriate Clinical Biomarkers to Recapitulate Drug-Drug Interactions Mediated by Organic Anion Transporting Polypeptide Inhibition.

Lai Y, Mandlekar S, Shen H, Holenarsipur VK, Langish R, Rajanna P, Murugesan S, Gaud N, Selvam S, Date O, Cheng Y, Shipkova P, Dai J, Humphreys WG, Marathe P.

J Pharmacol Exp Ther. 2016 Sep;358(3):397-404. doi: 10.1124/jpet.116.234914.

PMID: 27317801

 

Apixaban 5 mg Twice Daily and Clinical Outcomes in Patients With Atrial Fibrillation and Advanced Age, Low Body Weight, or High Creatinine: A Secondary Analysis of a Randomized Clinical Trial.

Alexander JH, Andersson U, Lopes RD, Hijazi Z, Hohnloser SH, Ezekowitz JA, Halvorsen S, Hanna M, Commerford P, Ruzyllo W, Huber K, Al-Khatib SM, Granger CB, Wallentin L; Apixaban for Reduction of Stroke and Other Thromboembolic Complications in Atrial Fibrillation (ARISTOTLE) Investigators..

JAMA Cardiol. 2016 Sep 1;1(6):673-81. doi: 10.1001/jamacardio.2016.1829.

PMID: 27463942

 

Safety and Efficacy of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Treated Beyond Progression: A Subgroup Analysis of a Randomized Clinical Trial.

George S, Motzer RJ, Hammers HJ, Redman BG, Kuzel TM, Tykodi SS, Plimack ER, Jiang J, Waxman IM, Rini BI.

JAMA Oncol. 2016 Sep 1;2(9):1179-86. doi: 10.1001/jamaoncol.2016.0775.

PMID: 27243803

 

Nivolumab for classical Hodgkin's lymphoma after failure of both autologous stem-cell transplantation and brentuximab vedotin: a multicentre, multicohort, single-arm phase 2 trial.

Younes A, Santoro A, Shipp M, Zinzani PL, Timmerman JM, Ansell S, Armand P, Fanale M, Ratanatharathorn V, Kuruvilla J, Cohen JB, Collins G, Savage KJ, Trneny M, Kato K, Farsaci B, Parker SM, Rodig S, Roemer MG, Ligon AH, Engert A.

Lancet Oncol. 2016 Sep;17(9):1283-94. doi: 10.1016/S1470-2045(16)30167-X.

PMID: 27451390