Syenza News — health technology assessment, market access and health economics

The EMA orphan medical devices pilot ran from August 2024 to March 2026. All 13 finalised procedures gave positive orphan status advice, and the service is now established. #SyenzaNews #MedTech #MarketAccess

EMA’s expert panel advice pilot for high-risk medical devices closed in February 2026 with 27 advice procedures finalised. Average advice time fell from 112 days in phase one to 86 in phase two, and a 60-day procedure followed. #SyenzaNews #MedicalDevices #HTA #MarketAccess

The FDA’s draft guidance lets sponsors add new patient-specific variants to one BLA without new trials, while CMS plans to broaden its gene therapy access model.

The KRAS G12C inhibitor divarasib improved survival versus sotorasib or adagrasib in the phase III Krascendo 1 trial. #SyenzaNews #oncology #NSCLC

Novartis core operating income rose 10% at constant exchange rates in Q3 2026, and 2026 guidance for the measure was raised. #SyenzaNews #MarketAccess

Phase 3 PANKU-Breast01 data show izalontamab brengitecan cut the risk of disease progression or death by 59% versus chemotherapy in HR-positive, HER2-negative breast cancer. #SyenzaNews #breastcancer #oncology

Keytruda monotherapy cut the risk of progression or death by 43% against platinum chemotherapy in dMMR endometrial cancer, in the KEYNOTE-C93 Phase 3 trial. #SyenzaNews #oncology #precisionmedicine #endometrialcancer

NHS use of NICE-recommended endometriosis and fibroid tablets in England more than tripled in a year, from 1.2 million to 3.7 million tablets. #SyenzaNews #MarketAccess

JNJ-6143, an investigational first-in-class oral molecule, produced a 75% tumor response rate among patients with measurable disease in a Phase 1 study. #SyenzaNews #prostatecancer #oncology

Sone-Ve doubled median overall survival versus investigator’s choice in third-line and later gastro-oesophageal cancer; second-line PFS missed significance.