FDA commissioners past, present and likely future gathered together for a rare joint discussion Jan. 9, as part of the third annual Innovations in Regulatory Science Summit.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Dynacure, Moderna, Paxmedica.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Biocryst, Biosight, Deinove, Golden, Noxxon, Nuvalent, Oxurion, Recce, Revive.
Within hours of a Jan. 5 vote on COVID-19 boosters for adolescents, U.S. CDC Director Rochelle Walensky endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that all adolescents aged 12-17 years should receive a booster dose five months after their primary series. The recommendation applies to the Pfizer Inc.-Biontech SE COVID-19 vaccine, as it’s the only one authorized in the U.S. for use in adolescents.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, Alphamab, CSPC, Nrx, Oncolyze, Oncotelic, Oncternal, Samsung, Simcere.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 2seventy, Alnylam, Biomea, Biomérieux, Cantabio, Clear Creek, Eisai, Exelixis, Genevant, ICER, Iconic, Liscure, Lqt, Novartis, Novo, Noxxon, Plus, Rain, Roche, Roivant.
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