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

A PAHO, RedETSA and HTAi webinar on the EU HTA Regulation: what Latin American agencies can reuse from joint clinical assessments, and which elements may be hard to adapt.

EMA says it is moving artificial intelligence in medicine regulation from concept to practice. Its timeline runs from a 2021 joint workshop to research priorities published in August 2026. #SyenzaNews #MarketAccess #drugregulation

The European Medicines Agency has opened public consultation on its draft guideline on predictive biomarker assays. Comments are accepted from 9 November 2026 until 31 March 2027.

FDA is requiring every GLP-1 receptor agonist label to carry a warning on NAION, a rare eye condition that can cause permanent vision loss. #SyenzaNews #drugsafety #GLP1

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

Law 3563 creates a Neuquén health technology assessment agency. Guadalupe Montero explains how it will weigh safety, benefit, equity and budget impact.

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

Eli Lilly and Hims & Hers Health agreed to widen Zepbound and Foundayo telehealth access, with self-pay prices starting at $149 per month. #SyenzaNews #obesity #telehealth