Europe

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

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

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

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

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

Portugal cancer drug delays average 926 days from EU approval, against 655 days across the EU. The figures on the oncology patient journey also show 50.8% of patients have gone without medication at least once, and two of the country's three screening programmes remain below the 90% coverage target. #SyenzaNews #oncology #MarketAccess #healthpolicy

The Bureau of Industry and Security has named nine product classes and 19 jurisdictions that can ship specialty medicines into the United States at a zero tariff, while the 100 percent Section 232 duty reaches most patented pharmaceuticals on 29 September 2026. Companies arguing an urgent U.S. health need now have a defined route to apply. #SyenzaNews #MarketAccess #PharmaceuticalTariffs

Zorginstituut Nederland has ruled that the Inreda AP stays out of the Dutch basic package. The DARE trial found no clinically relevant gain in glucose control or quality of life, serious adverse events were about three times more common, and half of the patients stopped using the device. #SyenzaNews #MedTech #MarketAccess #HealthEconomics

Germany drug pricing policies are now the subject of a US Section 301 investigation. AbbVie's chief counsel, Perry Siatis, has filed written evidence and testified that government price setting, mandatory rebates and reimbursement restrictions undercut the incentives that fund new medicines. He also cites a German-French working group on keeping innovative medicines available. #SyenzaNews #MarketAccess #DrugPricing #HEOR