Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Biomarin, Exousia, Merck, Mimetech.
Biopharma happenings, including deals and partnerships, and other news in brief: Biogen, Ferring, GC Cell, Hyloris, Iaso, I-Mab, Kadimastem, NLS, Orion, Relief, Samsung Bioepis.
Lumosa Therapeutics Co. Ltd.’s intravenous odatroltide (LT-3001) met the primary endpoints in a phase IIb trial in China in patients with acute ischemic stroke, paving the way for a pivotal phase III study.
Celltrion Inc. announced Oct. 29 the signing of an $87.75 million joint drug R&D agreement with AI and spatial transcriptome-based biotech Portrai Inc.
The BioWorld Biopharmaceutical Index extended its rebound through August and September, closing the third quarter (Q3) slightly in positive territory after losing ground earlier in the year.
John Crowley doesn’t worry about where his kids’ toys are made, but he told the Senate Health, Education, Labor and Pensions Committee that he does care where their medicines are made. His concerns, as a father and as president/CEO of the Biotechnology Innovation Organization, are becoming more urgent, he testified at an Oct. 29 HELP hearing on the future of biotech in the U.S.