CHMP September 2026 Recommends 12 New Medicines

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