Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atsena, Beigene, Bridgebio, Camp4, GSK, Papillon, Sonoma.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AC Immune, Anew, Athira, Charles River, Cebina, Enzian, Janssen, Klotho, Orbis, Rakovina, Variational, Vivtex.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alkeus, Asieris, Daiichi Sankyo, Dizal, Eisai, Inmune Bio, Karolinska, Merck, Ossium, Revalesio.
How do exercise and insulin collaborate in metabolism? The European Association for the Study of Diabetes (EASD) and the Novo Nordisk Foundation recognized the work of Juleen Zierath in this topic with the Diabetes Prize for Excellence at their recent annual meeting.
Two tales of one law were told Sept. 17 as the U.S. Senate Finance Committee discussed the successes and failures of the health care provisions included in the Inflation Reduction Act (IRA) as members looked toward different sequels.
Capricor Therapeutics Inc. has expanded its commercialization and distribution deal with Nippon Shinyaku Co. Ltd. to include the EU and the U.K. for deramiocel, Capricor’s lead asset, in treating Duchenne muscular dystrophy (DMD). In the new agreement, Capricor will receive an up-front payment of $20 million. Capricor will handle development and manufacturing duties for deramiocel while Nippon Shinyaku will be responsible for the sales and distribution.
Scattered investor qualms about Nuvalent Inc.’s largely upbeat data during the European Society for Medical Oncology (ESMO) meeting in Barcelona didn’t stop the firm from pricing an upsized $500 million public offering. The Cambridge, Mass.-based firm is selling 5 million shares of class A common stock at $100 each. The offering is expected to close on Sept. 18, with underwriters holding a 30-day option to purchase up to 750,000 more shares.
Instil Bio Inc. and Immuneonco Biopharmaceuticals Inc. laid out their global registrational strategy for the PD-L1xVEGF bispecific antibody SYN-2510 (IMM-2510) in front-line non-small-cell lung cancer and front-line triple-negative breast cancer amid a wild stock ride for the former over the past week and a half.
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