Akeso Inc. became the fifth company to score an approval for a homegrown PD-1 antibody in China, with penpulimab cleared for relapsed or refractory (r/r) classic Hodgkin’s lymphoma (cHL). The company is seeking more approvals for nasopharyngeal and lung cancers in both China and the U.S. to stand out in the increasingly competitive PD-1 space.
Manufacturing deficiencies were cited in the FDA’s complete response letter (CRL) for Spectrum Pharmaceuticals Inc.’s Rolontis (eflapegrastim), a decision that will further delay to market in the U.S. what could be the *first novel G-CSF drug in more than 15 years to treat chemotherapy-induced neutropenia.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apexigen, China Pharma, Eiger, Everest, Exelixis, Merck, Therapeutic Solutions.
Canada’s Federal Court of Appeal took the Patented Medicine Prices Review Board to task for ordering Alexion Pharmaceuticals Inc. to “forfeit excess revenues” generated by Soliris (eculizumab) between 2009 and 2017.
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.
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