Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Genmab, GSK, Halozyme, Sarepta, Terns, Zai Lab.
Vaccine hesitancy could slow the development of herd immunity for COVID-19 in the U.S., but there could be other ways to help reach it. Testifying at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing Sept. 9, Surgeon General Jerome Adams said the numbers needed for herd immunity vary from expert to expert, but it ranges from 60% to 80% of the population.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Apros, Ascendis, Beigene, Biomarin, Canbridge, Moleculin, Nanomab, Peptilogics, Precision, Reneo, Sellas.
The FDA’s approval of Genentech Inc.’s Gavreto (pralsetinib) for treating adults with metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) follows the FDA’s May approval of Eli Lilly and Co.’s Retevmo for patients whose tumors have a RET alteration. Gavreto will be commercialized in the U.S. by Genentech, part of the Roche Group, along with Blueprint Medicines Corp., which developed the once-daily oral therapy. Outside the U.S., Roche will handle commercialization.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascendis, Kite, Lilly.
While the emergency use authorization (EUA) the FDA granted Aug. 23 for convalescent plasma remains a political talking point, the agency moved ahead Sept. 2, issuing an updated, immediately effective guidance on the use of convalescent plasma to treat COVID-19 patients in ongoing clinical trials, on an expanded access basis or under the EUA.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeon, Cytodyn, Innovent, Nippon Shinyaku.
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