The U.K.’s Competition and Markets Authority (CMA) has accused Pfizer Inc., together with a smaller U.K. player, of illegally overcharging the National Health Service (NHS) for the anti-epilepsy drug branded Epanutin (phenytoin sodium) before it went off patent in 2012.
Citing a surge in merger filings, the U.S. Federal Trade Commission (FTC) said it is adjusting its process for reviewing mergers, which means more mergers may be reviewed retroactively.
For the first time ever, Canada will be granting patent term adjustments beginning in January. That’s welcome news for the biopharmaceutical and med-tech industries, and it’s long overdue, Jeffrey Morton, a partner at Snell & Wilmer LLP, told BioWorld.
The U.K.’s National Institute for Health and Care Excellence (NICE) is playing catch-up after seeing its workflow disrupted by the COVID-19 pandemic and has made the first funding approval using a new fast track appraisal process.
PERTH, Australia – In a possible world-first decision, an Australian court has ruled that artificial intelligence can be named as the inventor of a patent. Federal Court Justice Jonathan Beach ruled in Thaler v. Commissioner of Patents that under Australian patent law, inventors don’t necessarily have to be human.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abl, Advita, Aldeyra, Arcturus, Bausch, BMS, CSL, Cytodyn, Marinus, Medexus, Moderna, Monopar, Novartis, Panther, Pharmather, Relief, Roche, UCB.
Despite prior marketing approvals in Europe and Canada, an effort to win FDA support for the bifunctional alkylating agent treosulfan has drawn a complete response letter (CRL) from the agency, the company's U.S. rights holder, Medexus Pharmaceuticals Inc., said.
Statements Cytodyn Inc. made about the potential for its investigational monoclonal antibody, leronlimab, to treat COVID-19 continue to reverberate with U.S. authorities.
After a long and tortuous development Astrazeneca plc’s anifrolumab has been approved by the FDA for the autoimmune disease systemic lupus erythematosus (SLE), setting up a rivalry with its U.K.-based counterpart Glaxosmithkline plc. The first-in-class type 1 interferon receptor antibody, the first new drug for the disease in a decade, will be marketed under the brand name Saphnelo for adults with moderate to severe disease who are receiving standard therapy.
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