Diseases

EMA's safety committee has opened a Deanxit safety review at Belgium's request, after reports of movement disorders and memory problems with the flupentixol/melitracen combination. The Belgian agency also questioned the benefit of combining the two substances. #SyenzaNews #Pharmacovigilance #EMA #MentalHealth

The FDA has granted accelerated approval to Voceryq, the first plasmid DNA-based immunotherapy in the US, for adults with recurrent respiratory papillomatosis.

Infarmed's first Deep Dive looks at migraine medicines in Portugal. In 2025, more than 73,000 people used SNS-reimbursed migraine therapies, 85% of them women. Patients paid about €6 million (61%) of the €9.9 million pharmacy bill, and atogepant, funded only at the end of 2024, already led spending. #SyenzaNews #Migraine #MarketAccess #Portugal

Four authors writing in The Lancet Regional Health - Europe say the Commission's MDR and IVDR simplification proposal keeps the core flaw: notified bodies still decide, one by one, whether innovative devices reach the market. They argue for an EU medical device agency with binding powers over strategy, guidance and advice. #SyenzaNews #MedTech #MedicalDevices #MarketAccess

Lilly's TRANSCEND-T2D-2 trial found retatrutide lowered A1C more than Ozempic 2 mg and produced more than double the weight loss at 80 weeks. #SyenzaNews #clinicaltrials

The FDA's draft guidance lets sponsors add new patient-specific variants to one BLA without new trials, while CMS plans to broaden its gene therapy access model.

The KRAS G12C inhibitor divarasib improved survival versus sotorasib or adagrasib in the phase III Krascendo 1 trial. #SyenzaNews #oncology #NSCLC

Phase 3 PANKU-Breast01 data show izalontamab brengitecan cut the risk of disease progression or death by 59% versus chemotherapy in HR-positive, HER2-negative breast cancer. #SyenzaNews #breastcancer #oncology

Keytruda monotherapy cut the risk of progression or death by 43% against platinum chemotherapy in dMMR endometrial cancer, in the KEYNOTE-C93 Phase 3 trial. #SyenzaNews #oncology #precisionmedicine #endometrialcancer

JNJ-6143, an investigational first-in-class oral molecule, produced a 75% tumor response rate among patients with measurable disease in a Phase 1 study. #SyenzaNews #prostatecancer #oncology

Sone-Ve doubled median overall survival versus investigator's choice in third-line and later gastro-oesophageal cancer; second-line PFS missed significance.

Portaria n.º 464/2026/1 limits state reimbursement for obesity medicines to SNS patients in a hospital obesity pathway. Cover is 15% for 12 months. #SyenzaNews #MarketAccess