Clinical trials

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

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"

Researchers and Allegheny County plan a $13.3 million trial of weekly semaglutide to reduce opioid and alcohol use and justice involvement.

The EMA has authorised Denosumab Ascend, a biosimilar of Xgeva. Here is what the assessment shows on safety, efficacy and use. #SyenzaNews #biotechnology #MarketAccess

OHE's A Dose of Economics explores why medicines made for one patient challenge regulation, payment and HTA.

The EU's ACT EU advice pilot for clinical trial applications becomes permanent in January 2027, with updated sponsor guidance.

A University of Minnesota model fine-tuned on routine clinical notes separated epileptic from psychogenic seizures with an AUC of up to 0.875, and helped neurologists lift their own accuracy by up to 14.3 percentage points. #SyenzaNews #epilepsy #AI #digitalhealth #MarketAccess

Novartis has won the first FDA approval for symptomatic dermographism. Rhapsido (remibrutinib) is now cleared for adults whose hives and itch stay uncontrolled on H1 antihistamines, with 29.3% of patients achieving complete hive resolution at Week 12 against 14.0% on placebo. #SyenzaNews #dermatology #MarketAccess