China Filed 3,073 IND Applications in 2024. The West Hasn’t Noticed What That Number Actually Means.
China's CDE accepted 3,073 IND applications in 2024, up from 70 in 2015. For global trial sponsors, that seismic...
One Colonoscopy, Thirteen Years, and a Mortality Signal That Didn’t Arrive: What the NordICC Trial Really Breaks
The NordICC RCT cut colorectal cancer incidence but missed its mortality target — exposing a design flaw that should...
Enpatoran’s Phase 2 Miss Exposes a Protocol Design Flaw That Every SLE Sponsor Needs to Confront
Enpatoran improved BICLA response rates in moderate-to-severe SLE but failed its primary dose-dependent endpoint—a design flaw sponsors can't afford...
When J&J Eliminates the Interim: What the NANORAY-312 Amendment Actually Signals
J&J's FDA-accepted protocol amendment to NANORAY-312 drops the interim analysis for NBTXR3—here's what that move reveals about pivotal trial...
Semaglutide’s Alcohol Data Is Stronger Than Anyone Expected — and the FDA Has No Playbook for It
A landmark Lancet RCT shows once-weekly semaglutide cuts alcohol use in obesity patients with AUD. The FDA's regulatory pathway...
NMN in ITP: A Phase 1/2 Signal That Should Rewrite How We Design Rare Disease Trials
A phase 1/2 NMN trial in immune thrombocytopenia just posted a clean safety signal and platelet response data that...
FDA Real-Time Clinical Trials: Why AI Systems That Update Themselves Are Breaking Clinical Trial Design
FDA's April 2026 real-time clinical trial push exposes a fatal flaw: when AI updates itself mid-study, your protocol is...
The ICU Trial That Should Embarrass Every Sponsor Hiding Behind “Ethical Complexity”
A JAMA RCT on ICU restraint strategies just proved rigorous trial design works even in critically ill patients —...
The MASAI Trial Just Made AI-Augmented Mammography the Standard of Care. The FDA Hasn’t Noticed
The MASAI trial showed AI-plus-one-radiologist outperforms two radiologists in breast cancer screening. FDA's AI device framework still treats this...
The Liver Signal Europe Just Sent About Cenobamate Will Reshape How Sponsors Design Post-Approval Safety Plans
The EMA's PRAC issued a direct communication to healthcare professionals about severe liver injury linked to cenobamate in April...