Pharma Pulse: FDA’s Moderna Reversal and Eli Lilly’s $100 Million IL-6 Bet

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 agreed to review Moderna’s seasonal mRNA influenza vaccine, setting a decision date for Aug. 5, 2026. This follows a rare refusal-to-file letter issued earlier this month over concerns that Moderna’s trial didn’t use high-dose comparators for seniors. Under a newly agreed-upon pathway, Moderna is now seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older.
• Turning to market access, Eli Lilly has entered a $100 million licensing agreement with CSL Limited for clazakizumab. While CSL maintains the rights for kidney-related cardiovascular trials, Lilly will now spearhead the development of this anti-IL-6 antibody for a wide range of additional immuno-inflammatory conditions.

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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