Drugs

Regeneron Seeks EUA Request for Trump’s Covid ‘Cure’

Regeneron says it has submitted to FDA an emergency use authorization (EUA) for its experimental antibody cocktail that president Trump has taken for his coronavirus infection and already the president is applying political pressure on FDA to act fast and calling the therapy a cure. Regeneron’s filing comes on the same day Eli Lilly submitted a EUA for its bamlanivimab neutralizing IgG1 monoclonal antibody as monotherapy in higher-risk patients who have recently been diagnosed with mild-to-moderate Covid-19 (see earlier story).

In a 10/7 White House-released video, Trump said: “I just want to say, we have Regeneron. We have a very similar drug from Eli Lilly and they’re coming out and we’re trying to get them on an emergency basis. We’ve authorized it. I’ve authorized it. If you’re in the hospital and you’re feeling really bad, I think we’re going to work it so that you get them and you’re going to get them free, and especially if you’re a senior, we’re going to get you in there quick. We have hundreds of thousands of doses that are just about ready.”

“I have emergency use authorization, all set, and we got to get it signed now, and you’re going to get better,” Trump continued. “You’re going to get better, really fast... The FDA has acted as quickly as they’ve ever acted in history. There’s never been a time and no president has ever pushed them like I pushed them either, to be honest with you. But the FDA is approving things in a matter of weeks, that used to take a matter of years. So we have these drugs, Eli Lilly, and the others that are so good.”

Trump is presumably still miffed at FDA for requiring longer trials for Covid-19 vaccines before sponsors can seek an EUA. On 10/7, Trump openly admitted he wanted a vaccine available before Election Day, and called FDA’s actions a “political hit job.”

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