EMA Pre-Submission Pilot Adds Earlier Dialogue to Curb Premature Filings

EMA scientific advice volumes hit a record in the first half of 2026. The agency is planning pre-payment at submission, an agile advice pilot for 2027, and a regulatory sandbox workshop in September. #SyenzaNews #EMA #MarketAccess #DrugDevelopment

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

Portuguese private health insurers cleared €1 billion in six months as premiums climbed 9.1% to €466 a year. #SyenzaNews #HealthInsurance #Portugal #MarketAccess

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

Cipla has licensed Sino Biopharm’s HER2 biparatopic ADC TQB2102 for India, South Africa and five other emerging markets. The deal caps at USD 123 million plus double-digit royalties, with access to HER2-low breast cancer as the core case. #SyenzaNews #Oncology #MarketAccess #DrugDevelopment

Insurers are spending billions on breakthrough medicines, but the tests that decide who gets them are still an afterthought. Kathryn Phillips lays out four reforms to link drug and diagnostic policy pathways. #SyenzaNews #diagnostics #healtheconomics #MarketAccess

A new benchmark in npj Digital Medicine finds frontier AI models at near-perfect accuracy on German medical licensing exams, yet image questions still cut their scores far more than for students. #SyenzaNews #AIinHealthcare #DigitalHealth

South Africa is preparing to register and introduce a new tuberculosis vaccine if late-stage Phase 3 trials succeed. Cabinet confirmed the plans this week and welcomed a Serum Institute of India agreement to manufacture TB vaccines for global distribution.
#SyenzaNews #globalhealth #clinicaltrials #MarketAccess

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

Finland, UNRISD and the WHO asked what the Economics of Health for All strategy means for the next generation, from intergenerational fairness and participatory foresight to dignified access to care. #SyenzaNews #HealthEconomics #WellbeingEconomy