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Items: 1 to 50 of 417

1.

Insulin access and affordability in the USA: anticipating the first interchangeable insulin product.

Luo J, Kesselheim AS, Sarpatwari A.

Lancet Diabetes Endocrinol. 2020 Mar 20. pii: S2213-8587(20)30105-4. doi: 10.1016/S2213-8587(20)30105-4. [Epub ahead of print] No abstract available.

PMID:
32203681
2.

Generating comparative evidence on new drugs and devices before approval.

Naci H, Salcher-Konrad M, Kesselheim AS, Wieseler B, Rochaix L, Redberg RF, Salanti G, Jackson E, Garner S, Stroup TS, Cipriani A.

Lancet. 2020 Mar 21;395(10228):986-997. doi: 10.1016/S0140-6736(19)33178-2. Review.

PMID:
32199486
3.

Using real-world safety data in regulatory approval decisions: Sotagliflozin and the risk of diabetic ketoacidosis.

Fralick M, Kesselheim AS.

Pharmacoepidemiol Drug Saf. 2020 Mar 18. doi: 10.1002/pds.4994. [Epub ahead of print] No abstract available.

PMID:
32189390
4.

Rates and Costs of Dispensing Naloxone to Patients at High Risk for Opioid Overdose in the United States, 2014-2018.

Barenie RE, Gagne JJ, Kesselheim AS, Pawar A, Tong A, Luo J, Bateman BT.

Drug Saf. 2020 Mar 16. doi: 10.1007/s40264-020-00923-6. [Epub ahead of print]

PMID:
32180134
5.

Federal Spending on Off-Patent Drugs That Lack Generic Competition.

Rome BN, Kesselheim AS.

J Gen Intern Med. 2020 Mar 6. doi: 10.1007/s11606-020-05752-y. [Epub ahead of print] No abstract available.

PMID:
32144695
6.

Reply to Boucher, et al.

Rome BN, Kesselheim AS.

Clin Infect Dis. 2020 Jan 30. pii: ciaa095. doi: 10.1093/cid/ciaa095. [Epub ahead of print] No abstract available.

PMID:
32022228
7.

New drug approvals in oncology.

Kurzrock R, Kantarjian HM, Kesselheim AS, Sigal EV.

Nat Rev Clin Oncol. 2020 Mar;17(3):140-146. doi: 10.1038/s41571-019-0313-2. Epub 2020 Feb 4. Review.

PMID:
32020042
8.

Incentivizing Antibiotic Development: Why Isn't the Generating Antibiotic Incentives Now (GAIN) Act Working?

Darrow JJ, Kesselheim AS.

Open Forum Infect Dis. 2020 Jan 28;7(1):ofaa001. doi: 10.1093/ofid/ofaa001. eCollection 2020 Jan.

9.

Estimation of Medicare Part D Spending on Insulin for Patients With Diabetes Using Negotiated Prices and a Defined Formulary.

Feldman WB, Rome BN, Lehmann LS, Kesselheim AS.

JAMA Intern Med. 2020 Feb 3. doi: 10.1001/jamainternmed.2019.7018. [Epub ahead of print] No abstract available.

PMID:
32011624
10.

Revisiting the National Institutes of Health Fair Pricing Condition: Promoting the Affordability of Drugs Developed With Government Support.

Sarpatwari A, LaPidus AK, Kesselheim AS.

Ann Intern Med. 2020 Jan 28. doi: 10.7326/M19-2576. [Epub ahead of print] No abstract available.

PMID:
31986528
11.

The Supreme Court's Latest Ruling on Drug Liability and its Implications for Future Failure-to-Warn Litigation.

Morten CJ, Kesselheim AS, Ross JS.

J Law Med Ethics. 2019 Dec;47(4):783-787. doi: 10.1177/1073110519897793. No abstract available.

PMID:
31957583
12.

FDA Approval and Regulation of Pharmaceuticals, 1983-2018.

Darrow JJ, Avorn J, Kesselheim AS.

JAMA. 2020 Jan 14;323(2):164-176. doi: 10.1001/jama.2019.20288.

PMID:
31935033
13.

Response Rates and Durations of Response for Biomarker-Based Cancer Drugs in Nonrandomized Versus Randomized Trials.

Gyawali B, D'Andrea E, Franklin JM, Kesselheim AS.

J Natl Compr Canc Netw. 2020 Jan;18(1):36-43. doi: 10.6004/jnccn.2019.7345.

PMID:
31910385
14.

Novelty of Active Ingredients in High-Cost Brand-Name Drugs.

Jung EH, Sarpatwari A, Kesselheim AS.

J Gen Intern Med. 2020 Jan 2. doi: 10.1007/s11606-019-05565-8. [Epub ahead of print] No abstract available.

PMID:
31898115
15.

Correction to: FDA and EMA Biosimilar Approvals.

Jung EH, Sarpatwari A, Kesselheim AS, Sinha MS.

J Gen Intern Med. 2019 Dec 5. doi: 10.1007/s11606-019-05558-7. [Epub ahead of print]

PMID:
31808127
16.

Potential Medicare Savings on Inhaler Prescriptions Through the Use of Negotiated Prices and a Defined Formulary.

Feldman WB, Avorn J, Kesselheim AS.

JAMA Intern Med. 2019 Dec 2. doi: 10.1001/jamainternmed.2019.5337. [Epub ahead of print] No abstract available.

PMID:
31790541
17.

Lifecycle Regulation of Artificial Intelligence- and Machine Learning-Based Software Devices in Medicine.

Hwang TJ, Kesselheim AS, Vokinger KN.

JAMA. 2019 Nov 22. doi: 10.1001/jama.2019.16842. [Epub ahead of print] No abstract available.

PMID:
31755907
18.

US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals.

Hey SP, Kesselheim AS, Patel P, Mehrotra P, Powers JH 3rd.

JAMA Intern Med. 2019 Nov 11. doi: 10.1001/jamainternmed.2019.5451. [Epub ahead of print]

PMID:
31710344
19.

Randomized Study of Providing Evidence Context to Mitigate Physician Misinterpretation Arising From Off-Label Drug Promotion.

Schwartz LM, Woloshin S, Lu Z, Ross KM, Tessema FA, Peter D, Kesselheim AS.

Circ Cardiovasc Qual Outcomes. 2019 Nov;12(11):e006073. doi: 10.1161/CIRCOUTCOMES.119.006073. Epub 2019 Nov 11.

PMID:
31707825
20.

The U.S. Insulin Crisis - Rationing a Lifesaving Medication Discovered in the 1920s.

Fralick M, Kesselheim AS.

N Engl J Med. 2019 Nov 7;381(19):1793-1795. doi: 10.1056/NEJMp1909402. No abstract available.

PMID:
31693804
21.

Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications.

Hwang TJ, Sinha MS, Dave CV, Kesselheim AS.

Mayo Clin Proc. 2019 Dec;94(12):2437-2443. doi: 10.1016/j.mayocp.2019.05.015. Epub 2019 Nov 2.

PMID:
31685265
22.

Physician Perceptions of Step Therapy Prescribing Requirements.

Fischer MA, Kesselheim AS, Lu Z, Ross KM, Tessema FA, Avorn J.

J Manag Care Spec Pharm. 2019 Nov;25(11):1210-1224. doi: 10.18553/jmcp.2019.25.11.1210.

23.

Confidentiality Orders and Public Interest in Drug and Medical Device Litigation.

Egilman AC, Kesselheim AS, Krumholz HM, Ross JS, Kim J, Kapczynski A.

JAMA Intern Med. 2019 Oct 28:1-8. doi: 10.1001/jamainternmed.2019.5161. [Epub ahead of print]

PMID:
31657836
24.

A Systematic Review and Meta-analysis of Bevacizumab in First-line Metastatic Breast Cancer: Lessons for the Research and Regulatory Enterprises.

Hey SP, Gyawali B, D'Andrea E, Kanagaraj M, Franklin JM, Kesselheim AS.

J Natl Cancer Inst. 2019 Oct 25. pii: djz211. doi: 10.1093/jnci/djz211. [Epub ahead of print]

PMID:
31651981
25.

Public sector financial support for late stage discovery of new drugs in the United States: cohort study.

Nayak RK, Avorn J, Kesselheim AS.

BMJ. 2019 Oct 23;367:l5766. doi: 10.1136/bmj.l5766.

26.

FDA and EMA Biosimilar Approvals.

Jung EH, Sarpatwari A, Kesselheim AS, Sinha MS.

J Gen Intern Med. 2019 Dec 2. doi: 10.1007/s11606-019-05408-6. [Epub ahead of print] No abstract available. Erratum in: J Gen Intern Med. 2019 Dec 5;:.

PMID:
31637641
27.

Desmopressin and the risk of hyponatremia: A population-based cohort study.

Fralick M, Schneeweiss S, Wallis CJD, Jung EH, Kesselheim AS.

PLoS Med. 2019 Oct 21;16(10):e1002930. doi: 10.1371/journal.pmed.1002930. eCollection 2019 Oct.

28.

Transferrable Market Exclusivity Extensions to Promote Antibiotic Development: An Economic Analysis.

Rome BN, Kesselheim AS.

Clin Infect Dis. 2019 Oct 20. pii: ciz1039. doi: 10.1093/cid/ciz1039. [Epub ahead of print]

PMID:
31630159
29.

Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU.

Vokinger KN, Kesselheim AS.

BMJ Open. 2019 Oct 10;9(10):e028634. doi: 10.1136/bmjopen-2018-028634.

30.

Variation in Prescription Drug Prices by Retail Pharmacy Type: A National Cross-sectional Study.

Luo J, Kulldorff M, Sarpatwari A, Pawar A, Kesselheim AS.

Ann Intern Med. 2019 Oct 1. doi: 10.7326/M18-1138. [Epub ahead of print]

PMID:
31569218
31.

Fool Me Twice? The Reemergence of Rofecoxib and the Orphan Drug Act.

Lee TT, Solomon DH, Kesselheim AS.

Ann Intern Med. 2019 Oct 1. doi: 10.7326/M19-1218. [Epub ahead of print] No abstract available.

PMID:
31569216
32.

Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey.

Kesselheim AS, Sinha MS, Rausch P, Lu Z, Tessema FA, Lappin BM, Zhou EH, Dal Pan GJ, Zwanziger L, Ramanadham A, Loughlin A, Enger C, Avorn J, Campbell EG.

J Law Med Ethics. 2019 Sep;47(3):430-441. doi: 10.1177/1073110519876176.

PMID:
31560634
33.

Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence.

Hey SP, Feldman WB, Jung EH, D'Andrea E, Kesselheim AS.

J Law Med Ethics. 2019 Sep;47(3):381-387. doi: 10.1177/1073110519876167.

PMID:
31560631
34.

Lung Cancer Survival Gains: Contributions of Academia and Industry.

Gyawali B, Bouche G, Pantziarka P, Kesselheim AS, Sarpatwari A.

J Law Med Ethics. 2019 Sep;47(3):465-467. doi: 10.1177/1073110519876182. No abstract available.

PMID:
31560624
35.

Challenges and Opportunities for Biomarker Validation.

Hey SP, D'Andrea E, Jung EH, Tessema F, Luo J, Gyawali B, Kesselheim AS.

J Law Med Ethics. 2019 Sep;47(3):357-361. doi: 10.1177/1073110519876162.

PMID:
31560620
36.

Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis.

Gyawali B, Tessema FA, Jung EH, Kesselheim AS.

JAMA Netw Open. 2019 Aug 2;2(8):e199570. doi: 10.1001/jamanetworkopen.2019.9570.

37.

Promoting Pediatric Drug Research and Labeling - Outcomes of Legislation.

Bourgeois FT, Kesselheim AS.

N Engl J Med. 2019 Aug 29;381(9):875-881. doi: 10.1056/NEJMhle1901265. No abstract available.

PMID:
31461599
38.

Landscape of Cardiovascular Device Registries in the United States.

Rajan PV, Holtzman JN, Kesselheim AS, Yeh RW, Kramer DB.

J Am Heart Assoc. 2019 Jun 4;8(11):e012756. doi: 10.1161/JAHA.119.012756. Epub 2019 Jun 1.

39.

Why Are Biosimilars Not Living up to Their Promise in the US?

Zhai MZ, Sarpatwari A, Kesselheim AS.

AMA J Ethics. 2019 Aug 1;21(8):E668-678. doi: 10.1001/amajethics.2019.668.

40.

Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers.

Growdon ME, Sacks CA, Kesselheim AS, Avorn J.

JAMA Intern Med. 2019 Aug 5. doi: 10.1001/jamainternmed.2019.3107. [Epub ahead of print] No abstract available.

PMID:
31380893
41.

Competition and price among brand-name drugs in the same class: A systematic review of the evidence.

Sarpatwari A, DiBello J, Zakarian M, Najafzadeh M, Kesselheim AS.

PLoS Med. 2019 Jul 30;16(7):e1002872. doi: 10.1371/journal.pmed.1002872. eCollection 2019 Jul.

42.

Affordability and Price Increases of New Cancer Drugs in Clinical Guidelines, 2007-2016.

Hwang TJ, Kesselheim AS, Gyawali B.

JNCI Cancer Spectr. 2018 Jun 1;2(2):pky016. doi: 10.1093/jncics/pky016. eCollection 2018 Apr.

43.

Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys.

Feldman WB, Hey SP, Franklin JM, Kesselheim AS.

JAMA Netw Open. 2019 Jul 3;2(7):e197591. doi: 10.1001/jamanetworkopen.2019.7591.

44.

Spending on World Health Organization essential medicines in Medicare Part D, 2011-15: retrospective cost analysis.

Li DG, Najafzadeh M, Kesselheim AS, Mostaghimi A.

BMJ. 2019 Jul 17;366:l4257. doi: 10.1136/bmj.l4257.

45.

Price Increases of Protected-Class Drugs in Medicare Part D, Relative to Inflation, 2012-2017.

Hwang TJ, Dusetzina SB, Feng J, Maini L, Kesselheim AS.

JAMA. 2019 Jul 16;322(3):267-269. doi: 10.1001/jama.2019.7521. No abstract available.

46.

Impact of State Laws Restricting Opioid Duration on Characteristics of New Opioid Prescriptions.

Dave CV, Patorno E, Franklin JM, Huybrechts K, Sarpatwari A, Kesselheim AS, Bateman BT.

J Gen Intern Med. 2019 Nov;34(11):2339-2341. doi: 10.1007/s11606-019-05150-z. No abstract available.

PMID:
31309407
47.

Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem.

Kesselheim AS, Sinha MS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Avorn J, Dal Pan GJ.

Drug Saf. 2019 Nov;42(11):1287-1295. doi: 10.1007/s40264-019-00849-8.

PMID:
31302895
48.

Orphan Drug Designation and Exclusivity for "Same Drugs".

Hong P, Sarpatwari A, Kesselheim AS.

J Law Med Ethics. 2019 Jun;47(2):347-349. doi: 10.1177/1073110519857293. No abstract available.

PMID:
31298092
49.

Reforming the Orphan Drug Act for the 21st Century.

Sarpatwari A, Kesselheim AS.

N Engl J Med. 2019 Jul 11;381(2):106-108. doi: 10.1056/NEJMp1902943. No abstract available.

PMID:
31291512
50.

The Impact Of Price Regulation On The Availability Of New Drugs In Germany.

Stern AD, Pietrulla F, Herr A, Kesselheim AS, Sarpatwari A.

Health Aff (Millwood). 2019 Jul;38(7):1182-1187. doi: 10.1377/hlthaff.2018.05142.

PMID:
31260362

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