Psychedelic Trials Are Producing Stunning Numbers. The Methodology Underneath Them May Not Hold.
Luvesilocin's 70% PPD remission rate and psilocybin-CBT pilot data are turning heads—but sex-specific blind spots and a therapy model...
Zynlonta’s 3-to-1 Death Ratio Is the Accelerated Approval System Grading Its Own Homework
ADC Therapeutics' LOTIS-5 trial shows 13.2% fatal events vs. 4.6% in controls—a 3:1 death imbalance that exposes accelerated approval's...
The EMPHASIS Trial Correspondence Surfaces Three Trial Design Constraints That Will Shape the Next Neuroprotection Protocol
A Lancet correspondence on EMPHASIS identifies patient selection limits, generalisability gaps, and statistical design issues that every stroke trial...
Alkeus Starts Phase 3 Trial of Gildeuretinol for Stargardt Disease
Alkeus starts Phase 3 NORTHSTAR trial of gildeuretinol for Stargardt disease, enrolling 230 patients across 55 sites in 11...
Ambros Starts CRPS-RISE Phase 3 Trial of Neridronate for Complex Regional Pain Syndrome
Ambros launches CRPS-RISE Phase 3 trial of neridronate for complex regional pain syndrome, enrolling 270 patients with warm-phase CRPS-1.
Potravitug Shows Improved Viral Clearance in BKPyV Kidney Transplant Trial
Potravitug shows improved viral clearance in BKPyV kidney transplant trial, with 64% achieving one-log reduction by week 20 versus...
When the Manufacturing Site Fails, Your Enrollment Plan Fails With It
Novo Nordisk's Bloomington facility hit with another FDA 483 — here's how manufacturing findings cascade into site enrollment holds,...
Ecnoglutide Shows Greater Weight Loss Than Semaglutide in Trial
Ecnoglutide shows greater weight loss than semaglutide in interim trial data, with 12.8% versus 9.5% mean body weight reduction...
Reading the SYNCHRONIZE-MASLD Phase 3 Trial Publication Closely
The SYNCHRONIZE-MASLD Phase 3 trial in Nature Medicine shows survodutide cutting liver fat by 64.3% vs placebo — here's...
Survodutide Phase III trial shows 34% visceral fat, 63% liver fat reduction
Survodutide Phase III trial achieves 34% visceral fat and 63% liver fat reduction, positioning the dual agonist as a...