Once again, Amgen Inc.’s Tavneos (avacopan) is under U.S. FDA scrutiny, as the agency alerted patients and doctors March 31 about 76 cases of drug-induced liver injury, including eight deaths, with “reasonable evidence of a causal association” with the drug.
Just over a month after emerging from stealth and disclosing a $150 million series A, Korsana Biosciences Inc. is making the leap to the public market via a merger with Cyclerion Therapeutics Inc. The agreement, which is backed by a $370 million private placement from Korsana’s investors, solidly positions the newly merged company as it heads toward the clinic with KRSA-028, a next-generation shuttled antibody targeting amyloid beta for the treatment of Alzheimer’s disease, and builds out a pipeline of neurodegenerative disease candidates.
Eli Lilly and Co. anticipates shipping newly approved Foundayo (orforglipron) within the next week, as the drug becomes the second oral weight-loss glucagon-like peptide-1 (GLP-1) receptor agonist to enter the U.S. market following December’s approval of Novo Nordisk A/S’ Wegovy (semaglutide) pill.
Seeking to increase their understanding of the opportunities and challenges of using digital health technologies (DHTs) in drug trials, the U.S. FDA’s CBER and CDER are requesting public feedback to help inform new guidance as the technologies continue to advance.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: 4DMedical, Anumana, Biogen, Boston Scientific, Bridgebio, Butterfly, Chiesi, Egetis, Eisai,Elevar, GSK, Merck, Nanoscope, Roche, Savara, SS Innovations, Sobi, Teva, Zymeworks.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: AP Biosciences, Aurinia, Biocytogen, Enodia, Everest Medicines, J&J, Kezar, Konica Minolta, Radiant Vision, Royalty Pharma, Taisho, Tasly.
Clinical updates for biopharma and med tech, including data readouts and publications: Alumis, Arcutis, Arrowhead, Biogen, Boston Scientific, BMS, Castle, Cathworks, Connect, Idorsia, Incyte, Inflarx, Innovent, Johnson & Johnson, Kardigan, Kymera, Levicept, Medtronic, Moonlake, Pie Medical, Priovant, Sanofi, Simcere, Takeda, United, Viridian.
Biopharma and med-tech companies raising money in public or private financings, including: 4DMedical, Alamar, Anaptysbio,Arch, Artelo, Centivax, First Tracks, Kailera, Oncomatryx.