Biologics

New Flu Vaccine Framework Needed: Gottlieb

FDA commissioner Scott Gottlieb says FDA needs to develop a science-based framework that includes the regulatory tools and guidances to evaluate cell-based and recombinant technology flu vaccines. “Ultimately, our investment will provide regulatory clarity for this kind of new technology,” Gottlieb said in 3/8 testimony before a House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing on preparedness and response to seasonal influenza.

According to Gottlieb, some studies have found that cell-based and recombinant vaccines are more efficacious, or could be more efficacious, than egg-based vaccines, but more data and analyses are needed. As one step to better understand the differences between egg-based and cell-based technologies, he said, FDA is using Centers for Medicare and Medicaid Services data to compare Medicare patients who received a cell-based vaccine to those who received an egg-based vaccine to determine which vaccine was more effective in that population.

He also said the agency is working to develop more effective cell lines that can be better scaled through continuous manufacturing. “We’re also looking at how we develop a more robust recombinant vaccine manufacturing process to increase yield, while reducing cost,” he added. “Continuous manufacturing holds great promise for both cell-based and recombinant vaccines, because supply could be more easily ramped up on short notice. This would allow us to more rapidly address newly emerging strains or strain drift. Getting all the necessary preparatory work done is one of the limiting steps of egg-based technologies.”

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