Clinical trial applications advice becomes permanent from 2027

Halozyme has won a Keytruda SC injunction in the Netherlands, ordering MSD to stop supplying the subcutaneous form of pembrolizumab in eight European markets. The case turned on how the patent’s stability test is measured, and the injunction lapses country by country if a national court invalidates its part of EP 2 797 622. #SyenzaNews #oncology #patentlitigation #MarketAccess

A national study projects the liver cancer burden in Portugal will reach 4,851 cases and about 6,600 deaths by 2027, at a cost near 370 million euros. #SyenzaNews #oncology #hepatology

A new European Observatory toolkit says biosimilar uptake policies only work as a mix. Denmark pushed adalimumab biosimilars past 90%, Ireland shared €10 million of savings with clinical teams, and Finland cut reimbursement spending by €42 million. #SyenzaNews #Biosimilars #MarketAccess #HealthPolicy

MedTech Europe’s Facts & Figures 2026 lands a split verdict on the European medtech industry 2026: record employment, near-record patent filings and a 77.4% EPO grant rate on one side; 1.8% market growth, a world market share down to 25.6% and the first fall in company numbers on the other. Digital reimbursement keeps expanding, led by Germany’s 59 DiGA. #SyenzaNews #medtech #MarketAccess #digitalhealth

Genmab and AbbVie report topline Phase 3 results in which epcoritamab plus R-CHOP cut the risk of progression or death by 51% in newly diagnosed diffuse large B-cell lymphoma, the first positive readout for a bispecific combination in the first-line setting. #SyenzaNews #DLBCL #bispecifics #oncology #MarketAccess

The CDRH FY 2027 guidance list is out. AI-enabled device software and change control plans top the A-list, 510(k) reform sits Under Construction, and comments close on November 30, 2026. #SyenzaNews #medicaldevices #FDA #MarketAccess

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