Germany’s final depemokimab decision highlights the evidentiary cost of an active-biologic comparator gap in severe nasal polyposis. https://www.mattheneus.com/editorial/g-ba-depemokimab-crswnp-final-resolution-active-biologic-comparator-gap-2026-10-01 #HTA #Pharma #RegulatoryAffairs
#regulatoryaffairs — Public Fediverse posts
Live and recent posts from across the Fediverse tagged #regulatoryaffairs, aggregated by home.social.
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The EMA's human medicines committee has backed Frehemgo for haemophilia A bleeding prophylaxis, adding a new factor VIII-mimetic option to the European landscape. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/ema-frehemgo-denecimig-haemophilia-a-positive-opinion-fviii-mimetic-2026-09-17
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France’s HAS grants durvalumab a minor added-benefit rating in resectable gastric and gastro-oesophageal junction cancer, translating MATTERHORN evidence into a measured access signal. https://www.mattheneus.com/editorial/has-imfinzi-durvalumab-resectable-gastric-gej-matterhorn-asmr-iv-2026-09-11 #HTA #Pharma #RegulatoryAffairs
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Australia’s PBAC recommends subcutaneous amivantamab at intravenous price parity, highlighting how formulation convenience can shape reimbursement decisions. https://www.mattheneus.com/editorial/pbac-amivantamab-subcutaneous-exon20-lung-cancer-formulation-bridge-2026-07 #HTA #Pharma #RegulatoryAffairs