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

MIT’s William Bonvillian opens his innovation systems course with Solow and Romer: technology drives about two-thirds of US growth, and R&D only pays off with trained talent doing it. His prospector theory has a blunt corollary for anyone fencing off talent. #SyenzaNews #InnovationPolicy #HealthEconomics #RandD

The US Department of Labor has finalized its PBM fee disclosure rule. From plan years beginning on or after 1 July 2027, PBMs must disclose rebates, spread compensation, copay claw-backs and per-drug net prices to large self-insured ERISA plans, report twice a year, and accept an annual audit by an auditor the plan chooses. EBSA estimates $818.4 million a year in transfers from PBMs to plans and participants. #SyenzaNews #PBM #DrugPricing #MarketAccess

Four authors writing in The Lancet Regional Health – Europe say the Commission’s MDR and IVDR simplification proposal keeps the core flaw: notified bodies still decide, one by one, whether innovative devices reach the market. They argue for an EU medical device agency with binding powers over strategy, guidance and advice. #SyenzaNews #MedTech #MedicalDevices #MarketAccess

The Santa Maria Local Health Unit and Medtronic have signed a memorandum to create a hybrid care model that pairs in-person care with remote monitoring. Four clinical areas come first. #SyenzaNews #HealthcareInnovation #DigitalHealth

Lilly’s TRANSCEND-T2D-2 trial found retatrutide lowered A1C more than Ozempic 2 mg and produced more than double the weight loss at 80 weeks. #SyenzaNews #clinicaltrials

Portugal’s outpatient medicine bill rose 7.9% in January to August 2026. Antidiabetics drove nearly a third of the increase, and semaglutide spend rose 54.5%. #SyenzaNews #MarketAccess #HealthEconomics

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The FDA’s draft guidance lets sponsors add new patient-specific variants to one BLA without new trials, while CMS plans to broaden its gene therapy access model.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