Biologics

Last Minute Manufacturing Data Delays Novavax Vaccine

Fresh off a positive FDA advisory committee vote (see earlier story) to recommend an emergency use authorization of its Covid-19 vaccine, Novavax now finds its vaccine stalled at the agency because of last minute manufacturing data the company submitted, which have to be reviewed before the agency renders a decision on the EUA. Previous Covid-19 vaccine decisions were made shortly after the advisory committee deliberated.

FDA’s Vaccines and Related Biological Products Advisory Committee 6/7 voted unanimously (21 to 0) to recommend that the agency grant Novavax an emergency use authorization for its Covid-19 vaccine and its use in individuals 18 years of age and older. Data showed that the efficacy against confirmed mild, moderate or severe Covid-19 was 90.4%. Like the currently approved mRNA vaccines, Novavax’s vaccine was also associated with multiple events of myocarditis/pericarditis.

Responding to the late manufacturing data submission, the company said it was part of its routine process improvements, submitted 6/3.

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