Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biophytis, Ferring, Genelux, Oxurion, Profoundbio, Structure, Theseus, TME, Xilio.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accropeutics, Applied Therapeutics, Celltrion, Dyne, Hibio, Janssen, Legend, Pfizer, Sandoz.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adamis, Biontech, DMK, Intercept, Madrigal, Pfizer.
Pfizer Inc.’s Paxlovid (nirmatrelvir/ritonavir) became the first oral antiviral to win full U.S. FDA approval for treating COVID-19, cleared for use in adults who are at high risk for progression to severe disease, including hospitalization or death. The nod follows two months after the agency’s Antimicrobial Drugs Advisory Committee voted 16-1 in favor of Paxlovid’s overall benefit-risk assessment.
Cansino Biologics Inc. reported positive data in a phase IIb trial evaluating the heterologous mRNA vaccine CS-2034 booster compared to an inactivated vaccine to prevent SARS-CoV-2 infections.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alligator, Antengene, Galera, Immupharma, Pepgen, Vifor, Westvac.
China's National Medical Products Administration (NMPA) has given drug clinical trial approval for two new COVID-19 vaccines against the current XBB variants developed by Westvac Biopharma Co. Ltd. and West China Medical Center at Sichuan University.