AB Science’s “Calendar Update” Is a GCP Inspection Disclosure in Disguise
AB Science buried a five-inspector "for cause" GCP inspection inside a financial calendar update. Masitinib's ALS trial and three...
The AI That Eliminated Cold Chain from mRNA Vaccines Just Changed How You Design a Phase I
AGENT framework achieves 100% mRNA bioactivity after 2+ months at 37°C, forcing a rethink of cold-chain assumptions in vaccine...
FDA Single IRB Rule for Multisite Trials Set for December 2026
FDA Single IRB Rule for multisite trials advances to final rule status in December 2026, ending parallel IRB review...
Novo Nordisk Licenses Oral GLP-1/GIP Dual Agonist HRS-1596 From Hengrui for $300M
Novo Nordisk licenses oral GLP-1/GIP dual agonist HRS-1596 from Hengrui for $300M upfront, with potential $2.6B in milestone payments.
Keros Therapeutics Enrolls First Patient in Phase 2 Rinvatercept DMD Trial
Keros Therapeutics enrolls first patient in Phase 2 rinvatercept DMD trial to evaluate myostatin/activin inhibition for Duchenne muscular dystrophy.
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...