The pricier offer by Lundbeck A/S for Avadel Pharmaceuticals plc – which follows last month’s agreement for a takeover by Alkermes plc – had Wall Street buzzing as pundits weighed the odds for each suitor.
Researchers from the Chinese Institute for Brain Research, the Chinese Academy of Medical Sciences, and their collaborators have identified adenosine as the driving force behind the rapid, fast-acting antidepressant effects of ketamine and electroconvulsive therapy (ECT). “Our journey into this area of research began over a decade ago, around 2013, when the clinical world was buzzing with excitement about ketamine's remarkably rapid antidepressant effects,” Minmin Luo, co-senior author of the study, told BioWorld.
The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.
Biopharma happenings, including deals and partnerships, and other news in brief: Aliada, Chiesi, Cypherpunk, Eirgenix, Evotec, Leap, Metagenomi, Sandoz, Tscan.
In an article that reads like informal guidance, U.S. FDA Commissioner Marty Makary and CBER Director Vinay Prasad discussed the criteria for using the agency’s novel plausible mechanism pathway for personalized treatments when a randomized trial isn’t feasible, as well as future uses of the approval path that could expand beyond gene and cell therapies to other biologics and even small molecules.
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