The latest global regulatory news, changes and updates affecting biopharma, including: Time needed to develop immunity with Sputnik V; CRS: Rutledge opens door to more PBM reforms.
South San Francsico-based Twist Bioscience Corp. and Biotia Inc., of New York, received the first FDA emergency use authorization (EUA) for a capture-based next-generation sequencing (NGS) assay for the coronavirus that causes COVID-19. The technique reduces the likelihood of misdiagnosing or failing to identify mutations compared to standard sequencing.
TORONTO – A distinguished Canadian health care policy expert said a report from Canada’s COVID-19 Testing and Screening Expert Advisory Panel recommending testing and screening for school-age children and teachers comes “late in the game” now that the focus has shifted to vaccinating the Canadian population.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Airway, Astellas, Biontech, Camurus, Diurnal, Gilead, Glaxosmithkline, Idorsia, J&J, Pfizer, Roche, Seagen, Takeda, Vertex, Vir.
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