Pharma Pulse: FDA Examines Prenatal Acetaminophen Risks, GSK Files sNDA for Leucovorin, and Celltrion Buys Lilly Plant

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering new FDA safety concerns, an sNDA update from GSK, and a major biomanufacturing acquisition.

• The FDA has released findings alleging a potential association between prenatal acetaminophen use and autism in children. While the agency stresses that more evidence is needed, the report has already prompted renewed debate among clinicians, researchers, and advocacy groups. Acetaminophen remains one of the most widely used medications during pregnancy, so the FDA is encouraging ongoing studies to clarify risks and guide updated recommendations.
• In regulatory news, GSK has filed a supplemental new drug application to update the label for leucovorin. The proposed update seeks to reflect the medication’s new indication for cerebral folate deficiency. The FDA requested GSK to act on the label change as a part of the agency’s plan to investigate opportunities of repurposing older medications as treatment solutions for chronic diseases, along with the agency’s planned approval for the treatment option.
• Lastly, in industry moves, Celltrion has acquired a major Eli Lilly production plant to boost its biologics manufacturing capacity. The facility acquisition strengthens Celltrion’s global supply network and positions the company to better compete in the biosimilars and antibody drug markets. For Lilly, the sale is part of a broader effort to streamline operations and refocus resources on pipeline growth.

From FDA safety reviews to a high-profile manufacturing deal, these stories show how regulation, science, and strategy continue to reshape the pharmaceutical industry.

That’s it for this episode of Pharma Pulse. For more insights on trends transforming pharmaceutical access and care delivery, visit pharmaceuticalcommerce.com.

Thanks for listening—until next time, stay well and stay informed.

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