Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Chiesi, Eli Lilly, Johnson & Johnson, Protalix, Sanofi, Ultragenyx, Unicycive.
Biopharma happenings, including deals and partnerships, and other news in brief: Alps, Amgen, Astrazeneca, Bayer, IO Biotech, Kyowa, Moderna, Poxel, Recordati, Regeneron, Samsung Bioepsis.
As the march toward a new therapy continues in metabolic dysfunction-associated steatohepatitis (MASH), new approaches are drawing Wall Street’s attention. Among them is Inventiva SA’s pan-PPAR approach.
The U.S. FDA is now accepting requests from biopharma companies to participate in its new Precheck pilot program, which is intended to make it faster and easier for companies to relocate their prescription drug manufacturing to the U.S.
Sciwind Biosciences Co. Ltd. said Jan. 30 it won Chinese approval for self-developed glucagon-like peptide-1 (GLP-1) receptor agonist, ecnoglutide (Xianyida), to treat adults with type 2 diabetes.