🔬 Immunology Updates: Drug designations, mergers, new FDA approvals, pivotal clinical trials and more
From regulatory breakthroughs to emerging therapies and strategic partnerships, these updates are shaping the future of immunology and autoimmune disease management. Let’s dive into the most impactful stories in immunology this week.
Here’s what you need to know ⬇️
🇪🇺 Sanofi’s Rilzabrutinib receives orphan drug designation — Rilzabrutinib earns orphan drug status from the European Medicines Agency for IgG4-related disease following promising Phase 2 trial results.
💊 AleraCare and PURE Healthcare merge — A major merger forms one of the largest ambulatory infusion providers across 14 U.S. states, enhancing care for chronic conditions like rheumatoid arthritis and Crohn’s disease.
🧬 Everest Medicines’ VELSIPITY® NDA accepted by Taiwan FDA — VELSIPITY, targeting moderately to severely active ulcerative colitis, moves forward after promising Phase III trial results.
📉 Vedanta Biosciences’ VE202 fails Phase 2 in ulcerative colitis — Despite the setback, Vedanta continues to advance its Phase 3 study of VE303 for recurrent C. difficile infection.
💡 Wegovy FDA approval for MASH with liver fibrosis — Wegovy (semaglutide) is now approved for use in adults with non-cirrhotic MASH and moderate to advanced liver fibrosis, expanding its clinical application beyond obesity.
🤝 Hope Biosciences opens enrollment for Crohn’s disease stem cell trial — The Phase II trial of HB-adMSCs aims to improve clinical outcomes and quality of life for Crohn’s patients.
🤖 Affidea partners with Skin Analytics to improve skin cancer detection — AI-driven skin cancer detection rolls out in multiple European countries, expanding access to cutting-edge technology.
🏆 FDA grants orphan drug designation to Dusquetide for Behçet’s disease — Dusquetide shows promise in early trials, offering a novel approach to treating Behçet’s disease with fewer side effects than current therapies.
🛡️ ASDSA updates SUNucate legislation — New updates to promote sunscreen access and sun protection in schools are now in effect, further protecting public health.
🌍 EAACI launches global antibiotic allergy awareness campaign — Aiming to reduce antibiotic mislabelling, EAACI seeks to fight antimicrobial resistance through improved diagnosis and rational prescribing.
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