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.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquestive, Bayer, Glaxosmithkline, Medicure, Merus, Moderna, Neoleukin.

The latest global regulatory news, changes and updates affecting biopharma, including: Health care bills become U.S. law; MHRA releases safety review of epilepsy drugs.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apollomics, Bluerock, Gemini, Glycomimetics, Inversago, Praxis Precision, Union, Visen.

LONDON – The EMA has recommended approval of Moderna Inc.’s COVID-19 vaccine, becoming the fourth western regulator to do so, after Israel approved the product on Jan. 5 and the FDA and Health Canada in December.

The latest global regulatory news, changes and updates affecting biopharma, including: Fed Circuit: Nonsensical claims indefinite; USPTO seeks more uniformity between PTAB, courts; EC investing in startups.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amolyt, Astellas, Astrazeneca, Everest, Inventiva, Moderna, RDIF, Redhill, Stealth.