COVID-19 undoubtedly will be the top U.S. health care priority for the 117th Congress and the incoming Biden administration, but that doesn’t mean prescription drug prices are no longer an issue. A raft of new-year price increases, many for already costly drugs, is ensuring drug pricing remains high on the congressional agenda.
The latest global regulatory news, changes and updates affecting biopharma, including: HHS posts rule for agency enforcement action; Guidance to help with COVID-19 Mabs; Chinese pharma exec sentenced on U.S. drug charges.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Innovation, Lexicon, Novartis, Orchard, Theratechnologies, Vor.
As expected, pharmacy benefit managers are challenging a final rule that would end Medicare’s antitrust safe harbor for the rebates drug companies pay to the PBMs for formulary placement.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Gracell, Harpoon, Hoth, Incyte, Inhibrx, Innovent, Leading, Marinus, Morphosys, Qilu, Sesen, Timber, Travere.
With so much ire in Congress directed toward U.S. prescription drug prices in 2019, it’s not surprising that prices remained relatively stable that year. That’s not to say there weren’t price hikes. In its second report on unsupported price increases, the Institute for Clinical and Economic Review (ICER) identified nine of the 100 top-selling drugs that had list price increases more than double the rate of medical inflation in 2019 and that accounted for the largest increases in U.S. spending on drugs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Creative Medical, Diurnal, Innovent, Lantheus, Merck, Moderna, Neurosense, Veralox.
Despite a circuit split on the issue, the U.S. Supreme Court Dec. 11 rejected an appeal by Bristol Myers Squibb Co. (BMS) and Sanofi SA over giving states a “second bite at the apple” in whistleblower cases.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerie, Amydis, Axcella, Boehringer, Chipscreen, Cytokinetics, Editas, Eli Lilly, Ideaya, Istari, Exicure, Lysogene, Neuren, Obseva, Organogenesis, RDIF, Receptor Life Sciences, Roche.
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