Clinical Practice

Merck and Moderna report a 42% reduction in recurrence or death for intismeran plus KEYTRUDA in resected stage IIB-IV melanoma, with full data at ESMO 2026. #SyenzaNews #melanoma #MarketAccess

The FDA has launched the Neuroscience Advancement and Innovation Nexus, starting with an Alzheimer's Prevention Accelerator. #SyenzaNews #Alzheimers #MarketAccess

A new npj Digital Medicine article in press from SCPMG proposes the C-TACT clinical AI governance framework, with weighted lifecycle scorecards and its limits stated.

Pfizer has withdrawn its EU application for palbociclib in HER2-positive breast cancer. EMA questioned the open-label PATINA endpoint.

Health economists in clinical trials are most useful when they join early, explain their methods in plain language and plan for the data they will need. That was the central message of a webinar brought together by University College London and the Global Health Network at the University of Oxford. A professor of health policy and systems management in Uganda moderated three panelists with trial experience across Africa and Asia. Why trials need economic questions The moderator framed the session […]

Two post hoc REDEFINE 1 analyses show CagriSema weight loss in women held across premenopausal, perimenopausal and postmenopausal stages. #SyenzaNews #obesity #MarketAccess

Gilead's once-daily oral emvistegrast met the primary endpoint in Phase 2 SWIFT ulcerative colitis data, with 66% clinical response at Week 12 versus 37% on placebo. #SyenzaNews #biotechnology #MarketAccess

FDA grants accelerated approval for Jemperli in locally advanced rectal cancer, based on interim AZUR-1 results. #SyenzaNews #oncology #MarketAccess

Infarmed has logged 695 suspected adverse reactions to GLP-1 drugs in Portugal since 2024, most linked to Mounjaro.

The EMA's CHMP has backed Foundayo, a once-daily orforglipron tablet, for weight management and type 2 diabetes.

"EMA's draft reflection paper sets out how confirmatory platform trials should handle controls, randomisation, blinding and multiplicity. Comments are due 31 January 2027. #SyenzaNews #MarketAccess #ClinicalTrials"

Reinforcement learning rTMS for depression: a new npj Digital Medicine study tests protocol recommendations against clinician choices in 1,609 adults.