SAHPRA Annual Report: Clean Audit and WHO ML3 Vaccine Milestone

Portugal pharmaceutical exports climbed 42.9% in 2025 to €5.0 billion. Without that increase, national goods exports would have contracted. #SyenzaNews #MarketAccess #Pharma

Infarmed has launched INOV@INFARMED, a new network connecting Portugal’s medicines regulator with 26 universities and research institutes to advance regulation and health technology assessment. #SyenzaNews #HTA #RegulatoryScience #HealthInnovation

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

FDA approved finerenone (Kerendia) for CKD associated with type 1 diabetes, the first new treatment for this population in 30 years. The label rests on a six-month UACR reduction, not hard kidney outcomes, so payers and HTA agencies will each have to decide how much credit the surrogate deserves. #SyenzaNews #MarketAccess #CKD #Type1Diabetes

EMEA and GBEI brought China, Malaysia, Japan and India together to map an Asian brain economy strategy, framing brain capital as core economic infrastructure and introducing the Asian Brain Economy Index. #BrainEconomy #BrainCapital #Asia #BrainHealth

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