Syndax Pharmaceuticals Inc. won U.S. FDA approval – the company’s second this year – for menin inhibitor Revuforj (revumenib) with a black box warning for differentiation syndrome. “We’ve long expected that would be the case,” said CEO Michael Metzger. For “the last six years or so” the agency has had a “heightened awareness” of the problem, and he predicted all drugs in the class would bear similar cautionary language. But there’s also a warning about QT prolongation and a requirement for monitoring.
Keymed Biosciences Co. Ltd. is out-licensing global rights, excluding China, for its bispecific antibody, CM-336, to Platina Medicines Ltd. in a deal worth up to $626 million plus sales royalties.
As China rises to second place, next only to the U.S., for innovative new drugs, a new report by Clarivate – A Decade of Innovation, A Decade to Come – outlines key policy reforms and regulatory, R&D and investment trends driving past and future growth of Chinese biopharmaceuticals.
Biopharma deal activity in October totaled $22.31 billion, marking a 72% jump from $13.01 billion in September. Year-to-date deal values have decreased by 2%, from $175.29 billion during the first 10 months of 2023 to $171.77 billion in the same period this year, positioning 2024 as the second-highest year on record, according to BioWorld.
Gender bias in cardiac treatment guidelines is putting women at risk because guidelines are written based on clinical trials conducted mostly in men. As previously reported in BioWorld, nearly 70% of female patients are underdiagnosed for cardiovascular disease as women are grossly under-represented in clinical trials.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvogene, Biogen, BMS, Eisai, Inflarx, Kane, Merck, Regeneron, Samsung Bioepis, Sandoz, Sanofi.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 89bio, Aurinia, Eyenovia, Janssen, Levicept, Lixa, Omega, Osteal , Pacira.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptimmune, Akari, Evotec, Halozyme, Kaken, Numab, Peak, TFF.
RSS
