Europe

EMA's CHMP September 2026 meeting ended with positive opinions for 12 new medicines and 11 indication extensions. New approvals cover haemophilia A, ALK-positive lung cancer, myasthenia gravis, ovarian cancer, hidradenitis suppurativa and short bowel syndrome, plus the first biosimilar cleared under the tailored clinical pathway. #SyenzaNews #pharmaceuticals #drugdevelopment #innovation #MarketAccess

NICE has reversed its earlier rejection and now recommends Enhertu (trastuzumab deruxtecan) as a routine NHS option for HER2-low metastatic breast cancer after chemotherapy. The change follows an updated commercial deal and new EQ-5D-5L utility values validated in the DESTINY-Breast04 trial. #SyenzaNews #HTA #MarketAccess #BreastCancer

Novo Nordisk and Anthropic have announced a partnership to speed drug discovery. Novo will use Claude Science across R&D and for agentic software engineering, with robust data governance and human oversight built in. #SyenzaNews #DrugDiscovery #AI #MarketAccess

Spain's Real Decreto 415/2026 makes patient involvement in HTA a legal requirement. Speakers from POP, Cancer Patients Europe, BMS and NICE explain how plain-language summaries keep that involvement meaningful.

From 12 September 2026, new connected medical devices on the EU market must be designed for default data access, handing hospitals control of the data their equipment generates. #SyenzaNews #DataAct #MedicalDevices #MarketAccess

Novo Nordisk's STEP Young trial reports 40.4% of children aged 6 to under 12 left the obesity range on semaglutide, the first Phase 3 win in elementary-age obesity. #SyenzaNews #obesity #GLP1 #MarketAccess

Definium Therapeutics' DT120 ODT met its primary endpoint in the Phase 3 Panorama trial, delivering a 5.1-point placebo-adjusted improvement on the HAM-A anxiety scale. #SyenzaNews #GAD #MentalHealth #MarketAccess

Enhertu's DESTINY-Lung04 trial cut the risk of progression versus chemo-immunotherapy in first-line HER2-mutant NSCLC, but an immature overall-survival trend and a 20.8% ILD rate complicate the path to a first-line label. #SyenzaNews #Oncology #NSCLC #MarketAccess

NICE has opened consultation on draft guidance that does not recommend lenacapavir for HIV PrEP, finding the six-monthly injection is not value for money for the NHS in England. #SyenzaNews #HTA #HIV #PrEP #MarketAccess

The European Commission's EU Public Procurement Act would make quality, not price, the default for public tenders. EFPIA supports the shift, with one warning: resilience should not become local-content rules. #SyenzaNews #EUProcurement #Medicines #MarketAccess #HealthPolicy

An independent UK commission has published its recommendations for regulating AI in healthcare. The report calls for staged approvals and continuous real-world monitoring, alongside stronger enforcement powers for the MHRA. #SyenzaNews #AI #Healthcare #MarketAccess

Nova SBE's Saúde em Perspetiva podcast asks what Portugal's National Health Service should want from AI, and where the red lines sit. #SyenzaNews #DigitalHealth #AIinHealthcare