Pharma Pulse: A Regulatory Standoff for mRNA Flu Shots and the Dual Power of GLP-1s

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 let’s get into today’s headlines.

• The FDA has issued a Refusal-to-File letter to Moderna regarding its mRNA influenza vaccine application. Despite meeting all primary endpoints in Phase III trials, regulators objected to Moderna’s choice of a standard-dose comparator rather than the "best-available" high-dose shots for seniors. CEO Stéphane Bancel said the refusal “did not identify any safety or efficacy concerns with our product,” and added that the company plans to work with regulators “to understand the path forward as quickly as possible.”
• Meanwhile, according to a meta-analysis featured in PeerJ, GLP-1 receptor agonists significantly lower chronic inflammation markers like CRP and TNF-alpha. The benefit is a dual-threat mechanism: they reduce inflammation indirectly through weight loss and directly by binding to receptors on immune cells. This opens the door for GLP-1s to be used as long-term tools for organ protection and cardiovascular health.

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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