New GCP Revision Redefines Vendor Oversight and Digital Accountability
At SCOPE Europe 2025, experts underscored that the revised International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guideline,...
AIM Details New UPMC Trial of Ampligen in Ovarian Cancer
A Phase 2 study in platinum-sensitive recurrent ovarian cancer reported a 50% objective response rate among 24 evaluable patients...
BioCardia, Henry Ford Health Begin Phase 3 Cell Therapy Trial
In BioCardia’s prior CardiAMP-HF study, the composite primary endpoint was achieved with statistical significance in the subgroup of ischemic...
Ernexa Therapeutics Reports Strong Q Performance, Cell Trials
Ernexa reported a 58.2% survival advantage in preclinical models for its ovarian cancer program, ERNA-101, and a 44% year-over-year...
New Data: Rezdiffra Shows Promising MASH Cirrhosis Results
Two-year open-label data from the MAESTRO-NAFLD-1 compensated cirrhosis arm (F4c) reported a mean reduction in liver stiffness by VCTE...
Clearmind Completes First Cohort in Alcohol Use Disorder Trial
Clearmind Medicine has completed dosing in the first cohort of its Phase I/IIa trial of CMND-100 for alcohol use...
SpyGlass Pharma’s Remarkable, Positive 36-Month IOL Results
SpyGlass Pharma reported a 37% mean intraocular pressure reduction at 36 months in its first-in-human study of the bimatoprost...
NEK7 Degrader MRT-8102 Shows Promise in Preclinical Data
Preclinical data presented at AHA 2025 show MRT-8102, an oral NEK7-directed molecular glue degrader, selectively degrades NEK7, suppresses NLRP3...
Telitacicept Hits Endpoint in Phase 3 IgA Nephropathy Trial
Telitacicept reduced the 24-hour urine protein-to-creatinine ratio by 58.9% at Week 39, compared with an 8.8% reduction on placebo...
CRISPR’s CTX310 Shows Positive Phase 1 Lipid-Lowering Data
At the highest dose in a Phase 1 trial of 15 adults with refractory dyslipidemia, a single intravenous course...