Drugs

Former CBER Therapeutics Deputy Anatol Joins Lilly

Former CBER Office of Therapeutic Products (OTP) deputy director Rachael Anatol, who was removed from her post and placed on administrative leave in June, has been hired by Eli Lilly as associate VP, global regulatory policy and strategy — genetic medicine. “In my new role I will be working to advance product development across Lilly’s impressive genetic medicine portfolio,” Anatol said in a LinkedIn post.

OTP is a super office created at CBER in 2023 to improve discipline alignment, increase review capacity, and enhance expertise in cell and gene therapies. It added additional review staff and supervisory positions to address the increased workload and enhance the timeliness and consistency of the office’s interactions with sponsors.

Before joining the agency, Anatol was at the Biotechnology Innovation Organization as vice president of science and regulatory affairs.

In June, Anatol and OTP director Nicole Verdun were pushed out of the Center and placed on administrative leave. At the time, An HHS spokesperson hinted that the move was orchestrated by CBER director Vinay Prasad, telling FDA Webview that “Center directors deserve to be supported by managers that are aligned with aggressive goals to expeditiously advance therapeutics for rare diseases using the gold standard of science.”

In reaction to their ouster, former FDA commissioner Scott Gottlieb said in an X post that this will be a “significant setback for cell gene therapy... These FDA leaders - with their deep subject matter expertise - knew how to make the pathway for these cell and gene therapies more viable. They have been doing hard work to pave the way for safe and effective advances to reach patients who could benefit from them.”

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