North America

Novartis and Bristol Myers Squibb have paused autoimmune CAR-T trials after inflammatory events and three deaths, putting the immune-reset thesis to its first real safety test. #SyenzaNews #CellTherapy #AutoimmuneDisease #MarketAccess

CTS's Global Horizon panel brought four US operators to Montréal to explain why the US healthcare market rewards commercial readiness over good technology, and what founders can do about it. #SyenzaNews #MarketAccess #HealthTech

The RECOVER-VITAL trial found nirmatrelvir-ritonavir offered no benefit for long COVID across cognitive, autonomic, or exercise symptoms. The study also shows why placebo controls matter: a large share of the placebo group improved on their own. #SyenzaNews #LongCOVID #ClinicalTrials #MarketAccess

FDA has authorized Stryker SportSuite Vision, the first surgical application built for Apple Vision Pro. The De Novo clearance is narrow: hip arthroscopy display, used alongside standard monitors. #SyenzaNews #DigitalHealth #MedTech #FDA #AppleVisionPro

Novartis' oral BTK inhibitor remibrutinib met its primary endpoint in the Phase III REMODEL-1 and REMODEL-2 trials, cutting annualized relapse rates versus teriflunomide in relapsing multiple sclerosis. #SyenzaNews #MultipleSclerosis #MarketAccess #Neurology

The United States has added nine more manufacturers to its most-favored-nation drug pricing program, taking the total to 26 companies that now cover 89% of the branded drug market. #MarketAccess #DrugPricing #Pharma

The Fifth Circuit affirmed the constitutionality of the Medicare drug price negotiation program, rejecting claims from NICA, the Global Colon Cancer Association, and PhRMA. #SyenzaNews #DrugPricing #MarketAccess #Pharma

In Alberta, patients of fee-for-service heart specialists receive roughly three times the cardiac testing, with no measurable difference in outcomes. #HealthEconomics #PhysicianPayment #SyenzaNews

A real-world study from Eli Lilly finds sustained Zepbound use lowers healthcare costs in adults over 55, with savings exceeding the Medicare GLP-1 Bridge price within 12 months. #SyenzaNews #MarketAccess #Obesity #HealthEconomics

The FDA has cleared Abbott's Libre Duo 10 Day, the first continuous glucose ketone monitor that tracks ketones and glucose every minute to flag diabetic ketoacidosis risk before it becomes an emergency. #SyenzaNews #Diabetes #MedicalDevices #MarketAccess

Hanmi Pharm has signed a licensing deal with Genentech for its novel obesity candidate HM17321, worth up to $2.3 billion. The UCN2 analog is designed to cut weight while preserving lean muscle mass, a gap GLP-1 therapies have not filled. #SyenzaNews #biotechnology #drugdevelopment #MarketAccess

Weill Cornell researchers have proposed ASTRA, a multi-agent system that would delegate routine clinical trial work to AI agents while human experts keep the final say on clinical and regulatory decisions.