Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascendis, Astrazeneca, Evgen, Kezar.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allarity, Astrazeneca, Bayer, BMS, Curevac, Entos, Gilead, Immunomedics, Innate, Innocan, KBP, Medicago, Nicox, Orphazyme, Precision Nanosystems.
With the lack of public trust and confidence the biggest barrier to SARS-CoV-2 vaccines in the U.S., the risk of granting an emergency use authorization to a vaccine with safety issues or questionable efficacy could destroy confidence in future FDA-approved products. That message was drummed home throughout the Oct. 22 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
Roche Holding AG, already advancing multiple therapies and diagnostics for COVID-19, is adding its support for Boston-based Atea Pharmaceuticals Inc.'s AT-527 to the lineup.
Following a rapid course of development and testing, Gilead Sciences Inc. has secured the first and only FDA approval for a COVID-19 treatment, the antiviral Veklury (remdesivir).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Phage, Adicet, F2G, Gilead, Leo, Nevakar, Reven.
While the FDA’s approach to evaluating safety and efficacy in the development and review of COVID-19 vaccines for the U.S. market will be at the center of its Oct. 22 advisory committee meeting, the panel also will be asked to discuss the practicalities, and ethics, of continuing to conduct trials once a candidate has been granted an emergency use authorization.
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