The EMA and the European Center for Disease Control have said COVID-19 vaccine manufacturers should ditch the existing formulations and adapt their products to target the omicron-descendant XBB.1.5, to protect against SARS-CoV-2 in the winter of 2023–2024.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acticor, Aridis, Ascentage, Cocrystal, IGM, Pepgen, Pharmazz, Precigen, Rocket.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Amylyx, Beigene, Bristol Myers Squibb, Inhibrx, Iovance, Janssen, Lexicon, Metriopharm, SK, Valneva.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biophytis, BMS, Curium, Gilead, Hutchmed, Inventiva, Ipsen, Novavax, Novo Nordisk, Sino, Takeda.
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.
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