Latest News — Page 4

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

WHO and St. Jude, with UNICEF and PAHO, have launched a 2026 to 2030 market-shaping strategy to improve access to childhood cancer medicines in low- and middle-income countries. #SyenzaNews #ChildhoodCancer #MarketAccess #Oncology

Novo Nordisk rebrands to Novo and drops the dual name as obesity shifts to a consumer market. What changes, what is left behind, and what the 21 September Capital Markets Day must deliver. #SyenzaNews #NovoNordisk #MarketAccess #Obesity

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

The FDA’s landmark hearing on psychedelic medicines drew 80 speakers and 1,800 registrants, and the market access message was clear: approval is not access, and reimbursement is the binding constraint. #SyenzaNews #MarketAccess #Psychedelics #HealthPolicy

SAHPRA has opened Phase 2 of its medical device registration feasibility study, with expressions of interest due by 16:30 on Friday 18 September 2026. The test is voluntary and unpaid, but it is a rare chance to shape how South Africa registers devices before the process becomes mandatory. #SAHPRA #MedicalDevices #RegulatoryAffairs #MarketAccess

South Africa’s High Court has kept the semaglutide compounding ban in place, dismissing iDexis’s appeal as an ‘abuse of process’ while SAHPRA and SAPC finish their investigations. #SyenzaNews #MarketAccess #Pharma

A new open-source framework splits medical exam-item writing across specialist AI agents. In a blinded evaluation, multi-agent output won 57.7% of expert preferences against 42.3% for a single model. #SyenzaNews #DigitalHealth #AIinHealthcare

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