Diseases

Novartis has won the first FDA approval for symptomatic dermographism. Rhapsido (remibrutinib) is now cleared for adults whose hives and itch stay uncontrolled on H1 antihistamines, with 29.3% of patients achieving complete hive resolution at Week 12 against 14.0% on placebo. #SyenzaNews #dermatology #MarketAccess

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

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

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

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

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

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