Drugs

Manufacturing Resumes at Damaged Pfizer Site

Pfizer says it has restarted most manufacturing lines at its Rocky Mount, NC facility following severe tornado damage back in July. “The resumption of production also includes the launch of one line in the site’s new sterile injectable manufacturing area referred to as R3, a state-of-the-art module approved earlier this year by the U.S. Food and Drug Administration (FDA),” the company says.

While manufacturing has resumed, Pfizer notes that some drugs may not be back in full supply until next year. It says that “full supply” means “sufficient inventory available to meet historical demand projections in addition to several weeks of safety stock in distribution centers. The impact of the tornado on the site is expected to affect the supply of medicines from the Rocky Mount facility until at least mid-2024.”

Production is being restarted through a phased approach, Pfizer says, with full production across the site’s three manufacturing suites expected by the end of 2023. “Production restart has been prioritized based on patient need and inventory levels,” it says. “There are approximately 13 medicines in production on the lines that have restarted, including products that are currently available through Pfizer’s emergency ordering process.

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