Innovative medicines and medical devices

The FDA approved Sunharbo (asundexian), the first factor XIa inhibitor for stroke prevention, for adults after a recent ischemic stroke or high-risk TIA. #SyenzaNews #MarketAccess

The Enzutrix patent dispute goes to South Africa's Constitutional Court on 23 November 2026. UC and Astellas are pursuing damages over the generic prostate cancer drug, while Eurolab argues the patent was never validly obtained. #SyenzaNews #MarketAccess

CMS finalizes the GLOBE Model drug pricing rule, benchmarking Medicare Part B drug rebates against international prices from April 2027. #SyenzaNews #MarketAccess

The final rule also covers a temporary price floor for small biotech drugs and Part D plan payments to dispensing entities. #SyenzaNews #DrugPricing #MarketAccess

The G-BA has found no proven added benefit for dupilumab in chronic spontaneous urticaria, compared with omalizumab plus second-generation H1 antihistamines.

FDA has finalized its potency assurance guidance for cell and gene therapy products. It covers lot-release testing, potency assays, acceptance criteria and how sponsors should build a strategy from the IND stage onward. #SyenzaNews #CellAndGeneTherapy #FDA

The FDA has granted accelerated approval to Voceryq, the first plasmid DNA-based immunotherapy in the US, for adults with recurrent respiratory papillomatosis.

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

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 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

EMA has updated its business process for expert panel consultations on high-risk medical devices. The revision, effective 12 October 2026, adds orphan device advice as a new sub-process. #SyenzaNews #MedicalDevices #MarketAccess #HTA