Biologics

Pfizer CEO Concerned About FDA Vaccines Chief

Pfizer CEO Albert Bourla on Monday publicly criticized the leadership of FDA’s biologics center, saying the company “has a problem” with the agency’s top vaccines regulator. Speaking at the TD Cowen healthcare conference, Bourla said CBER director Vinay Prasad was dismissing the recommendations of career agency scientists. “I think the current director is not following the recommendations of his staff,” Bourla said in response to a question about Pfizer’s recent communications with the regulator, according to a report by CNBC.

The comments come amid heightened scrutiny of FDA vaccine oversight following the agency’s handling of a filing by Moderna for its mRNA-based seasonal influenza vaccine. Last month, in a letter signed by Prasad, the FDA initially refused to review Moderna’s application. The agency reversed course about a week later after the company amended its submission (see earlier story).

The Moderna episode has fueled concerns in industry circles about potential shifts in U.S. vaccine policy and internal discord within CBER. Despite his criticism of FDA leadership, Bourla emphasized that Pfizer continues to have strong working relationships with agency scientists. “We are having very productive professional collaborations with the scientists at the vaccine department,” he said.

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