Drugs

FDA Selecting Fall Covid Vaccine Make-up in June

CBER director Peter Marks says the agency will decide in June what the fall Covid-19 vaccine composition should look like, adding that firms need to focus on broadening the protection of their annual booster vaccines to help public uptake of future annual shots. Speaking at the World Vaccine Congress 4/4, Marks added a caveat: “what we know about SARS-CoV-2 is that it likes to do these funny things,” and a variant could emerge over the summer that may become dominant, according to a report by Bloomberg Law. But he expects the new formulation of the next vaccine booster should prevent severe disease and hospitalization.

“We need to get to something that has a broader breadth of protection, probably first and foremost, and a longer duration of action,” Marks said. “Breadth is probably the most important thing because I think people will get an annual vaccine—if they think it’s going to protect them broadly.” However, Marks doesn’t expect the fall-planned Covid vaccines will be much different from those available now “because we’re just not going to have time to get to a new generation.”

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