Drugs

Trump Given Investigational Regeneron Covid-19 Cocktail

After being confirmed to be infected with Covid-19 late 10/1, President Trump 10/2 was given an investigational drug cocktail from Regeneron that is still undergoing clinical trials. Trump presumably was granted access under an expanded (compassionate use) access protocol. Late in the day, the press pool was told he would also be heading to Walter Reed hospital for further treatment and observation.

The Regeneron cocktail was touted as promising earlier this week by CDER director Janet Woodcock during a Friends of Cancer Research program (see story). Woodcock is on detail to Operation Warp Speed, where she says she has been focused on therapeutics, particularly antiviral compounds and monoclonal antibody therapies. She pointed to a recent Regeneron announcement on data from a seamless Phase 1/2/3 trial of its investigational antibody cocktail REGN-COV2. The data showed that the therapy “reduced viral load and the time to alleviate symptoms in non-hospitalized patients with Covid-19,” according to the company. It also showed “positive trends” in reducing medical visits, and the “greatest improvements” were in patients “who had not mounted their own effective immune response prior to treatment,” Regeneron said.

President Trump’s physician also said Trump is taking zinc, vitamin D, famotidine, melatonin and a daily aspirin.

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