A year after Alkermes plc announced it would divide its oncology and neuroscience efforts into two separate businesses, the Dublin-based company spun out Mural Oncology plc with $275 million in funding and the lead solid tumor candidate nemvaleukin alfa. Shares of Mural (NASDAQ:MURA) will begin trading Nov. 16. “We’re very excited,” Mural’s CEO Caroline Loew told BioWorld. “We’ve got two major clinical datapoints in the next 18 months.” Read More
The U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee has a lot to discuss Nov. 17, but only one voting question: Does the evidence demonstrate that Merck & Co. Inc.’s gefapixant provides a clinically meaningful benefit to adults with refractory or unexplained chronic cough? Read More
Reneo Pharmaceuticals Inc.’s last patient visit Oct. 9 in the pivotal study with mavodelpar called Stride – due to yield top-line data in December 2023 – kept interest strong in primary mitochondrial myopathy (PMM), where parties are pursuing development bids by way of assorted strategies. Read More
If there had been any lingering market concerns following the temporary partial clinical hold earlier this year for Arcellx Inc.’s multiple myeloma CAR T-cell therapy, CART-ddBCMA, they were likely put to rest as partner Gilead Sciences Inc.’s Kite unit expanded the scope of the firms’ late 2022 collaboration to include lymphomas. At the same time, Kite exercised an option to negotiate a license for Arcellx’s ARC-Sparx program, ACLX-001, in multiple myeloma. Read More
The U.S. FDA’s Office of Prescription Drug Promotion is calling out Otsuka Pharmaceutical Co. Ltd. for making “false or misleading claims and representations about the efficacy of Rexulti” in a television advertisement. Read More
Senior leaders and investors in the health care sector expect mergers and acquisitions (M&A) activity to continue to pick up next year but this will be corporate led rather than private equity, according to a report by global investment bank Jefferies. Read More
After Cormedix Inc. navigated manufacturing issues that slowed the process, the U.S. FDA approved the antibacterial and antifungal solution Defencath to reduce catheter-related bloodstream infections adults with kidney failure. Read More
New hires and promotions in the biopharma industry, including: Altpep, Biostax, Imidomics, K36, Myricx, Noema, Omass, Pepgen, Pharvaris, Proxygen, Rivus, Tessellate. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Atreca, Genetex, Graphite, Inhalon, Lenz, Lilly, Point. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Astrazeneca, Atsena, Hoth, Intelgenx, Intellia, Jamp, Roche, Tarsier. Read More
