Drugs

Lilly Covid Drug Pulled in 3 States Due to Variant

FDA acting commissioner Janet Woodcock told an American Medical Association Webinar 3/17 the federal government is no longer distributing Lilly’s monoclonal antibody bamlanivimab in Arizona, California, and Nevada because of the presence of a viral variant that is not susceptible to the drug. Endpoints News reports that Woodcock did not further explain the variant or the decision to stop the distribution.

Overall, she said, FDA remains uniquely positioned to screen monoclonals against different variants, and that’s been predictive of how and where the treatments will work.

The post says Woodcock acknowledged that the initial rollout of the monoclonal antibodies “wasn’t the greatest” because it was centered on a distribution model for Gilead’s remdesivir and hospitals were in no position to give out monoclonals. “We’re getting there,” she said, “but it’s taken quite a long time. Mass vaccination is hard enough but mass infusion is a real challenge for our healthcare system.”

CDER Office of Infectious Diseases director John Farley told the Webinar that the agency expects to soon broaden the definition of who is “high risk” and thus can receive monoclonal antibodies.

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