Wall Street was weighing the gravity of the death from acute liver failure of a patient who was treated for Duchenne muscular dystrophy (DMD) with Sarepta Therapeutics Inc.’s gene therapy, Elevidys (delandistrogene moxeparvovec). Liver injury is a known possible side effect of the product, first approved by the U.S. FDA in June 2023 for DMD, as well as other AAV-mediated gene therapies, and the potential problem is highlighted in Elevidys’ prescribing information.
Maxion Therapeutics Ltd. is poised to extend the therapeutic reach of antibodies into the vast field of G-protein coupled receptors and ion channel targets, after raising $72 million in a series A round.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ani, BMS, Innovent, Korro.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelyrin, Alumis, Azurity, Basilea, Eton, Covis, Medexus, NX Development, Pfizer, Sutro.
Breaking with a 30-year tradition, the U.S. FDA selected the strains for the next flu vaccine March 13 without convening its independent vaccine advisory committee. Instead, the agency brought together 15 scientific and public health experts from within the FDA, the CDC and the Department of Defense to make the recommendations for the next flu season. That group met the same day that the agency’s Vaccines and Related Biological Products Advisory Committee had been scheduled to make the selection.
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