Clinical Practice

Merck and Moderna's individualized neoantigen therapy intismeran has cleared its first Phase 3, beating KEYTRUDA alone in resected high-risk melanoma. The open question now is how payers value a medicine made for one patient at a time.

The FDA has opened a public consultation on regulating generative AI medical devices, proposing a two-axis risk framework and a competency-based approach to premarket review. Comments close 19 October 2026.

📉 Why are EMA orphan authorisations set to drop in 2026? Latest statistics reveal a significant decline in orphan medicinal product authorisations by the European Medicines Agency, raising questions about the future pipeline for rare disease therapies. This trend could reshape drug development priorities across Europe. Read the full analysis to understand the implications for patients and industry. #SyenzaNews #pharmaceuticals #regulatoryaffairs #innovation #MarketAccess

The European Medicines Agency’s Management Board met in Amsterdam on 10 and 11 June 2026. The European Commission reported that the first EU joint clinical assessment report appeared on 9 June 2026. Since the Health Technology Assessment Regulation took effect in January 2025, 18 JCAs have started. Seven Joint Scientific Consultations have finished under the Regulation, and the first JCAs for medical devices and in vitro diagnostics will begin in June 2026. Initiative Status Timing First EU joint clinical assessment […]

📱 Are older adults being left behind in the digital health revolution? As populations age, digital exclusion is widening health gaps, limiting access to care, information, and services for seniors who lack the skills or tools to navigate online platforms. This growing divide demands urgent attention from policymakers and innovators alike. Read the full analysis to explore solutions for a more inclusive future. #SyenzaNews #digitalhealth #HealthTech #DigitalTransformation #innovation

🧬 Could your gut microbiota reveal clues about psychopathic traits? New research highlights how distinct microbial profiles may serve as biomarkers, opening fresh paths for mental health diagnostics and targeted interventions in psychiatry. Explore the study’s implications for precision approaches to behavioral health. #SyenzaNews #biotechnology #precisionmedicine #innovation

South Africa's drugmakers and the health department are at odds over lowest-price tenders. Pharmisa says cheaper imports have cost more than 2,500 jobs and eroded local manufacturing capacity.

The NICE Decision Support Unit and EEPRU have released updated Stata, Excel and R commands for mapping EQ-5D-3L data to the new EQ-5D-5L value set, giving UK HTA analysts a validated route to convert legacy three-level utility data ahead of NICE's adoption of the five-level value set.

Why has Portugal's Ordem dos Médicos welcomed the SINACC postponement? The medical association says the surgery access system was still in testing and lacked safeguards, warning that reclassifying minor surgery could hide patients from waiting lists. Read what 278,394 patients on the list means for the rollout. #SyenzaNews #HealthEconomics #digitalhealth #healthcarepolicy

How are cell therapies redefining cancer care through rigorous HTA evaluation? INCA’s latest analysis highlights how CAR-T and other advanced cell therapies are shifting oncology paradigms—balancing innovation with evidence-based access and cost-effectiveness. Explore the full breakdown and its implications for global cancer treatment. #SyenzaNews #oncology #precisionmedicine #innovation #MarketAccess

💊 Is it safe to stop statins in elderly patients for primary prevention? A recent trial shows that deprescribing statins in older adults without established cardiovascular disease does not increase the risk of adverse outcomes, supporting more individualized prescribing decisions. Discover the full trial results and implications for clinical practice. #SyenzaNews #clinicaltrials #pharmaceuticals #costeffectiveness #healthcarepolicy

Is tirzepatide delivering better value than semaglutide for patients and payers? A fresh analysis shows how tirzepatide can drive greater cost savings alongside improved health outcomes in obesity and type 2 diabetes management. Discover the key findings shaping treatment and reimbursement decisions. #SyenzaNews #pharmaceuticals #HealthEconomics #costeffectiveness