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).
Keeping you up to date on recent developments in diagnostics, including: Study underscores long-term impact of COVID-19; CT scan enhancement via deep learning; Caution in screening for large fetus size.
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.
The U.S. FDA’s recent decision to pass on any emergency use authorization (EUA) filings for tests for the COVID-19 pandemic is well known, but the agency had a chance to lend some additional information on that question in the Oct. 21 town hall. Despite the opportunity to clarify some of the underlying questions, Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said little more than that the change was made “largely because the FDA cannot require an EUA, according to the HHS statement.”
Abbott Laboratories saw improvement with its medical devices and diagnostics in the third quarter, which featured wins in the areas of COVID-19, diabetes, and structural heart. The company revealed its quarterly results on a Oct. 21 call, during which management said it was increasing its guidance for full-year adjusted earnings per share (EPS) to at least $3.55.
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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