Month-to-month Spherical-Up of What to Learn on Pharma Regulation and Coverage

By Ameet Sarpatwari, Aviva Wang, Liam Bendicksen, and Aaron S. Kesselheim

Every month, members of the Program On Regulation, Therapeutics, And Regulation (PORTAL) assessment the peer-reviewed medical literature to determine fascinating empirical research, coverage analyses, and editorials on well being regulation and coverage points related to present or potential future work within the Division.

Under are the abstracts/summaries for papers recognized from the month of October. The picks function matters starting from newly enacted incentives for growing variety in scientific trials, to an evaluation of how sufferers’ out of pocket prices modified after biosimilar variations of infliximab entered the US market, to an analysis of how producers have navigated postmarket necessities for medication not too long ago accredited by the FDA. A full posting of abstracts/summaries of those articles could also be discovered on our web site.

1. Brown BL, Mitra-Majumdar M, Darrow JJ, Moneer O, Pham C, Avorn J, Kesselheim AS. Achievement of Postmarket Commitments and Necessities for New Medicine Authorised by the FDA, 2013-2016. JAMA Intern Med. 2022 Oct 3:e224226. Epub forward of print.
2. Califf RM, Cavazzoni P, Woodcock J. Advantages of Streamlined Level-of-CareTrial Designs: Classes Discovered From the UK RECOVERY Research. JAMA Intern Med. 2022 Oct 24. Epub forward of print.
3. Dhodapkar MM, Shi X, Ramachandran R, Chen EM, Wallach JD, Ross JS. Characterization and corroboration of security indicators recognized from the US Meals and Drug Administration Hostile Occasion Reporting System, 2008-19: cross sectional examine. 2022 Oct 5;379:e071752.
4. Dhruva SS, Ramachandran R, Ross JS. Medicare’s Nationwide Protection Willpower for Aducanumab – A One-Off or a Pragmatic Path Ahead? N Engl J Med. 2022 Oct 27;387(17):1539-1541. Epub 2022 Oct 22.
5. Feng Okay, Kesselheim AS, Russo M, Rome BN. Affected person Out-of-Pocket Prices Following the Availability of Biosimilar Variations of Infliximab. Clin Pharmacol Ther. 2022 Oct 13. Epub forward of print.
6. Hwang TJ, Brawley OW. New Federal Incentives for Variety in Scientific Trials. N Engl J Med. 2022 Oct 13;387(15):1347-1349. Epub 2022 Oct 8.
7. Hwang TJ, Kesselheim AS, Vokinger KN. Reforming the World Well being Group’s Important Medicines Record: Important however Unaffordable. 2022 Oct 24. Epub forward of print.
8. Miljkovic MD, Tuia JE, Olivier T, Haslam A, Prasad V. Affiliation Between US Drug Value and Measures of Efficacy for Oncology Medicine Authorised by the US Meals and Drug Administration From 2015 to 2020. JAMA Intern Med. 2022 Oct 31. Epub forward of print.
9. Rand LZ, Kesselheim AS. Limitations on the Functionality of the FDA to Advise. Am J Bioeth. 2022 Oct;22(10):15-17.
10. Rome BN, Egilman AC, Patel NG, Kesselheim AS. Utilizing A number of Approved Generics to Preserve Excessive Costs: The Instance of Entacapone. Worth Well being. 2022 Oct 17:S1098-3015(22)02181-7. Epub forward of print.
11. Walsh BS, Kesselheim AS, Rome BN. Medicaid Spending on Antiretrovirals from 2007-2019. Clin Infect Dis. 2022 Oct 21:ciac833. Epub forward of print.

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