CIRM Awards Fate Therapeutics $15M for FT819 Lupus Nephritis Trial
CIRM awards Fate Therapeutics $15M to advance FT819 lupus nephritis trial, testing allogeneic CAR T-cell therapy in patients failing...
4D-150 Gene Therapy Enters Phase 3 Trial for Diabetic Macular Edema
4D-150 Gene Therapy enters Phase 3 testing for diabetic macular edema, aiming to replace recurring anti-VEGF injections with a...
FDA Approves Teva’s DEGEVMA Biosimilar to Xgeva for Cancer Bone Complications
FDA approves DEGEVMA biosimilar to Xgeva for cancer bone complications, expanding the competitive denosumab market following Sandoz's earlier approval.
When the Primary Endpoint Moves After 283 Patients Are Already In
A mid-trial primary outcome amendment in a thrombectomy study reveals the operational chain reaction sites and sponsor clinops teams...
Why the First Scan Matters Most: IAG’s Romiesa Hagoug on Keeping Imaging Data Honest Across Multi-Site Trials
Romiesa Hagoug, Head of Project Management at Image Analysis Group (IAG), on what a site's first scan reveals, how...
The WILLOW Trial Didn’t Fail Enpatoran. The Endpoint Did.
WILLOW Cohort B's p=0.14 masked a 58% BICLA response at the lowest dose. The drug worked. The endpoint couldn't...
Inventiva’s Lanifibranor Faces Cash Runway Pressure Before Phase 3 MASH Data
Inventiva's lanifibranor faces cash runway pressure as it awaits Phase 3 MASH data readout. Enrollment pace will determine financing...
Innovent Expands Phase 3 MarsLight-11 Trial of IBI363/TAK-928 to Non-Squamous NSCLC
Innovent and Takeda expand the Phase 3 MarsLight-11 Trial to include non-squamous NSCLC patients, doubling the addressable population for...
Akeso Enrolls First Patient in Phase III Trial of Cadonilimab vs Nivolumab for Gastric Cancer
Akeso launches COMPASSION-37, a global Phase III trial of cadonilimab versus nivolumab for HER2-negative gastric cancer, testing dual checkpoint...
Platform Trials Are Rewriting the Rules of Evidence. Regulators Haven’t Caught Up.
Adaptive platform trials like REMAP-CAP enrolled 4,869 critically ill COVID patients across 300+ sites, but FDA's master protocol guidance...