Clinical Practice

Weill Cornell researchers have proposed ASTRA, a multi-agent system that would delegate routine clinical trial work to AI agents while human experts keep the final say on clinical and regulatory decisions.

The European Commission has approved Trodelvy plus Keytruda for first-line metastatic triple-negative breast cancer, making Trodelvy the first ADC-based backbone across PD-L1 status.

A new consensus framework grades dehiscence, infection, seroma, and haematoma in a single score, with strong agreement across 60 specialists.

Portugal medicinal cannabis exports reached 66,305 kg in the first half of 2026, according to INFARMED, already 83% of the 79,883 kg shipped across all of 2025. The country’s medicines regulator published the figures in its mid-year report on the sector, which also shows cultivation and manufacturing licences easing back after several years of rapid expansion. Portugal began regulating medicinal cannabis in 2018, when the Assembly of the Republic approved a law covering marketing authorisations, prescribing and pharmacy dispensing. A […]

💊 Can generic medicines deliver €300 million in savings for Portugal? Portugal is targeting major cost reductions in its healthcare system by accelerating the uptake of generic medicines, aiming to improve affordability and sustainability. This move highlights strategic efforts in market access and cost-effectiveness within the pharmaceutical sector. Read the full analysis to see what it means for stakeholders. #SyenzaNews #pharmaceuticals #MarketAccess #costeffectiveness

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.