Optimism rose for what could be the first CAR T therapy in autoimmune disease as Kyverna Therapeutics Inc. made public a positive primary analysis from its registrational trial, KYSA-8, of mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome. Kyverna plans to submit a BLA to the U.S. FDA in the first half of this year.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Astellas, Bracco, Conavi, Debiopharma, GSK, Orion, Pasithea, Specialised.
Researchers in the U.K. have developed an AI-driven method of identifying viruses in wild animals with the potential to spillover into humans. The technique makes it possible to use the genome sequences of the spike proteins by which viruses enter host cells to assess the potential to infect humans without having to isolate an individual virus and tests its infectivity in the lab.
Clinical updates for biopharma and med tech, including data readouts and publications: Abbott, Agenus, Astrazeneca, Briacell, Clearmind, Greenwich, Intodna, Kyverna, Mink, Nektar, Nested, Novo Nordisk, Passage Bio, Revolution, Salubris, Sanofi, Sapience, Taurx, Xenon.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Abbvie, Aicuris, Anaptys, Asahi Kasei, Cathworks, First Tracks, GSK, H. Lundbeck, Insphero, Lex, Medtronic, Novartis, Nxera, Quidelortho, Vanda.
Arriving a week ahead of April 28 PDUFA date, the U.S. FDA approval of Merck & Co. Inc.’s Idvynso (doravirine/islatravir) brings a new treatment option to adults with HIV-1 infection who are virologically suppressed. The approval is for those with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.
Another biopharma acquisition is at the heart of one of the U.S. SEC’s latest insider trading settlements. This time, the trading centered on Jazz Pharmaceuticals plc’s $935 million purchase of Chimerix Inc. last year.
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