Biologics

Makary Says Novavax BLA Decision is Forthcoming

Appearing on MSNBC 5/9, FDA commissioner Marty Makary said discussions are continuing with Novavax on its BLA to convert a 2022 emergency use authorization to a full approval for its Covid-19 vaccine. The agency missed a user fee target date last month, which the company said was related to a post-approval commitment for clinical trial data (see earlier story).

“We’d like to see some clinical trial data, either before or after, and so we are in discussions, and we’re going to see a mutually satisfactory middle ground, and that announcement should be forthcoming,” Makary said in the interview. He said “Americans want to know if they should take a Covid booster. They want to know when they have a comorbid condition, if they should take it. They want to know if their 12-year-old healthy girl should be getting a sixth Covid jab this fall… We have a void of science. It’s been about four years since we’ve had a randomized control trial. So the companies have been creating new vaccines each year and getting a rubber stamp from the FDA.”

Asked whether FDA and the Trump administration still believe in the efficacy of the Covid-19 vaccines, Makary responded: “Show me the data where a young, healthy teenager should be taking a Covid shot right now.” Without the data, opinions have filled that void, Makary said, adding that the administration is committed to gold standard science and common sense.

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