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Top 3 PBMs Contribute to Over 1500% Increase in Formulary Exclusions Since 2014

Drug Topics

For biosimilar, generic, and branded medications, Cencora researchers conducted a report detailing growth in formulary exclusions among the 3 largest pharmacy benefit managers in the US.

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PBMs, not patents, are blocking access to lower-cost medicines

PhRMA

Since 2014, the three largest pharmacy benefit managers (PBMs) have excluded 1,584% more medicines from commercial formularies, according to a new report from Cencora. Formularies are the lists of medicines covered in commercial health plans, often organized into tiers.

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

The FDA Law Blog

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Publishing virtually every GDUFA guidance and MAPP since 2014 to fulfill FDAs GDUFA commitments.

FDA
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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

Guideline On Similar Biological Medicinal Products, CHMP/437/04 Rev 1. European Medicines Agency. Guideline On Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins As Active Substance: Non-Clinical and Clinical Issues, EMEA/CHMP/BMWP/42832/2005 Rev1. Guillen E, Ekman N, Barry S, et al.

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2024 IDstewardship Year End Review

IDStewardship

Steven Smoke, Pharm.D., BCIDP, BCPT Five Things To Know: How To Use Artificial Intelligence To Be A Better Clinical Pharmacist Katarzyna Wojcik, PMP, PhD,Andrea Prinzi, PhD, MPH, CPH, SM(ASCP),Amanda Suchanek, Ph.D., Jessica Blavignac Microbiology Laboratory Strategies to Advance Antimicrobial Stewardship Timothy Gauthier, Pharm.D.,

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How and why pharmacists should get involved in clinical research

Hospital Pharmacy Europe

of NIHR Doctoral Fellowship applications between 2014 and 2021 came from pharmacy professionals. According to Professor Debi Bhattacharya, professor of behavioural medicines at the University of Leicesters School of Allied Health Professions, who is leading the Incubator project, only 2.7%

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The Issue with Reissue: PTE Edition

The FDA Law Blog

In the generic filers view, the regulatory review period should have started in January 2014 when the patent was reissued rather than in April 2004, when the IND was opened, because the reissued patent did not exist in April 2004. The plain text of 35 U.S.C.