Diseases

A Mayo Clinic cardiologist's TV-set question makes the case for a home blood pressure monitor, with a caution on device reliability and home data in the chart.

The Dutch health institute Zorginstituut Nederland has concluded that a second cochlear implant for adults with severe hearing loss in both ears belongs in the basic health package. #SyenzaNews #MarketAccess

FDA has finalized its potency assurance guidance for cell and gene therapy products. It covers lot-release testing, potency assays, acceptance criteria and how sponsors should build a strategy from the IND stage onward. #SyenzaNews #CellAndGeneTherapy #FDA

Dr. Reddy's has FDA tentative approval for generic lenacapavir HIV prevention, priced at US$40 per person per year across 120 countries. #SyenzaNews #HIVprevention #MarketAccess

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The FDA's draft guidance lets sponsors add new patient-specific variants to one BLA without new trials, while CMS plans to broaden its gene therapy access model.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