Pharma Pulse: AstraZeneca’s US Setback and Europe’s Medicine Marathon

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.

• First off, the FDA has issued a complete response letter for AstraZeneca’s subcutaneous version of its lupus therapy Saphnelo. While the clinical data showed clear efficacy, the agency is asking for more technical information before patients can self-inject at home. While American patients potentially wait until the first half of 2026, the EU already cleared the same prefilled pen back in December.
• The EMA’s CHMP just crossed the finish line with six new approvals and nine extensions. The headliners? Kayshild—a semaglutide formulation—becomes the first GLP-1 recommended for MASH with liver fibrosis. We also saw a historic "yes" for Kygevvi, the first-ever treatment for an ultra-rare genetic disease called TK2d, and a new hormone therapy for postmenopause called Fylrevy.

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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