Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amplia, Apellis, Biocon, Biotech, Ipsen, Janssen, Johnson & Johnson, Merck, Novo Nordisk, Pfizer, Samsung Bioepis, Sanofi.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acadia, Axcelead, Biosyent, Centenara, Mithra, Novalon, Rejuveron.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Innovative, Neuraptive, Novo Nordisk, Passage, Quralis, Sanofi, Sensorion, Tectonic.
August saw the U.S. FDA approve 22 drugs, an increase from July's 17 but fewer than the 28 approved in June. This brings the 2024 monthly average to just over 19 approvals, outpacing last year's average of 16 per month, as well as the 12.5 per month seen in 2022 and 17 per month in both 2021 and 2020.
Vicebio Ltd. is funded to take two of its molecular clamp respiratory infection vaccines through phase II development, after raising $100 million in a series B.
Both the biotech industry and Hong Kong have become strategic points for China as the People’s Republic of China works to lay a biotech “belt and road” through Asia to expand global influence.
The U.S. Court of Appeals for the Fifth Circuit revived the Pharmaceutical Research and Manufacturers of America’s (PhRMA) constitutional challenge to the Medicare price negotiations, sending it back to a federal court in Texas for a do-over.
For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S. PDUFA date is set for the fourth quarter of the year.
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