AGP Executive Report
Last update: 10 hours agoTransplant Breakthrough: Hansa Biopharma reports strong 1-year outcomes for Idefrix (imlifidase) in highly sensitised kidney transplant patients, with 90% graft failure-free survival and 98% patient survival in a European post-authorisation study—supporting full approval. Cancer Care Update: The EU CHMP issued a positive opinion for perioperative pembrolizumab plus enfortumab vedotin for cisplatin-ineligible resectable muscle-invasive bladder cancer, with a final European Commission decision expected in Q3 2026. Rare Disease Access: Pharming received EU marketing authorization for Joenja (leniolisib) for activated PI3K delta syndrome (APDS), the first approved EU treatment, with launches expected in Germany in Q3 2026. Immunotherapy Approval Path: Merck also secured a positive CHMP recommendation for KEYTRUDA plus Padcev in the same bladder cancer setting, moving to the European Commission review for EU, Iceland, Liechtenstein and Norway. Public Health Watch: STI data shows record highs across Europe, with England highlighted as a major contributor to rising gonorrhoea, chlamydia and syphilis cases. Everyday Health & Safety: UK rules warn travellers about £5,000 fines for bringing banned meat and dairy from the EU into Great Britain.
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