Dutch Court Grants Keytruda SC Injunction in Eight European Markets

BD has agreed a $19 billion partnership with the US Government to expand American manufacturing of essential medical consumables. The deal includes $3 billion for production sites, roughly 5 billion more units a year and Section 232 tariff relief tied to milestones. #SyenzaNews #MedTech #MarketAccess

Lundbeck is trading scale for depth. Michala Fischer-Hansen, EVP for Europe and international markets, explains why 51 affiliates became 22, why a fifth of revenue now goes to R&D, and why US price pressure can decide where a medicine launches. #SyenzaNews #MarketAccess #brainhealth #pharma

Vaxcyte’s VAX-31 met every prespecified primary endpoint in the OPUS-1 Phase 3 trial in adults, including superiority for the three serotypes unique to the vaccine. The 31-valent candidate now heads toward a BLA filing in 2028. #SyenzaNews #vaccines #pneumococcal #MarketAccess

Jaypirca becomes the first non-covalent BTK inhibitor cleared for previously untreated CLL/SLL in the United States. BRUIN CLL-313 showed a hazard ratio of 0.20 against bendamustine plus rituximab, but the comparator is not the drug class that dominates first-line care. #SyenzaNews #MarketAccess #oncology #CLL

US group health plans and issuers must rebuild their public price files under the Transparency in Coverage final rule: quarterly publication, an 11-claim threshold for out-of-network data, a new utilization file and attestation, and consumer phone disclosure from January 2027. #SyenzaNews #MarketAccess #PriceTransparency #HEOR

Clinical trials authorised across the EU and EEA fell 13.5% between the pre-pandemic years and 2022 to 2025, and the drop lands hardest on academic sponsors. Biologics now feature in nearly half of all new trials. #SyenzaNews #clinicaltrials #HTA #MarketAccess

FDA approval of the Autus Size-Adjustable Valve gives children with congenital pulmonary valve disease a pulmonary valve that can be widened as they grow, from 13 millimeters to 22 millimeters. The evidence base is 62 patients and six months of follow-up. #SyenzaNews #medicaldevices #pediatrics #MarketAccess

Rare disease care in Europe is settled in national capitals, not in Brussels. At #EHFG2026, Austria’s Claas Röhl, Czechia’s Markéta Foldyna Hellová, Italy’s Giulia De Ponte and MetabERN’s Maurizio Scarpa set out where national policy delivers and where families still do the coordinating. #SyenzaNews

A once-weekly selective amylin agonist added to tirzepatide cut 23.3% of body weight in 367 adults with obesity and type 2 diabetes, against 14.8% for tirzepatide 15 mg alone. Lilly plans Phase 3 of a co-formulated EloraTZP by the end of 2026. Discontinuation rates that reach 27% in the highest-dose arm will be the detail payers study first.

#SyenzaNews #obesity #type2diabetes #MarketAccess

ADSE’s October table cuts 119 maximum unit prices for hospital chemotherapy and drops prior authorisation from seven cancer medicines, including osimertinib. The workbook and the communiqué do not agree on the count. #SyenzaNews #MarketAccess #oncology