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.
While data on functional endpoints are still to come, Avidity Biosciences Inc. executives said the firm is moving ahead with plans for a BLA filing by the end of 2025 for del-zota, an antibody-oligonucleotide conjugate, in Duchenne muscular dystrophy with mutations amenable to exon 44 skipping (DMD44), based on positive top-line data that analysts say bode well for Avidity’s other late-stage programs targeting rare neuromuscular diseases.
Artificial intelligence (AI) drug developer Insilico Medicine raised $110 million in a series E round led by an Asian private equity fund, Value Partners Group, that will see Insilico advance its pipeline and AI platform developments.
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