Drugs

AZ Wants EUA for Covid Prophylaxis Drug

AstraZeneca is asking FDA for an emergency use authorization (EUA) for its AZD7442 long-acting antibody (LAAB) combination for prophylaxis of symptomatic Covid-19. The company says that if FDA approves the EUA, it would be the first LAAB to receive an EUA for Covid-19 prevention.

The AZ statement says the filing includes data from the PROVENT Phase 3 trial showing a 77% reduction in risk of developing symptomatic Covid-19 with the LAAB combination. The filing also includes data from the STORM CHASER Phase 3 and Phase 1 trials, it says.

The company says AZD7442 is a combination of tixagevimab and cilgavimab derived from B-cells donated by convalescent patients after the SARS-CoV-2 virus. It was discovered by Vanderbilt University Medical Center and licensed to AZ.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome