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...
Clinical Trial Design
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...
6.4 Million Patients Can’t Be Wrong — But Can Regulators Read What This Validation Is Actually Saying?
A Nature Medicine validation of PREVENT and SCORE2 across 6.4M individuals offers a blueprint for RWE methodology that FDA...
Semaglutide Just Changed the Math on Alcohol Use Disorder — and Every Addiction Trial Sponsor Should Be Paying Attention
A Lancet RCT shows once-weekly semaglutide cut heavy drinking days in obese AUD patients — targeting a condition where...
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...
Semaglutide Just Passed Its Hardest Test Yet — And the FDA Has No Roadmap for What Comes Next
A landmark Lancet RCT shows once-weekly semaglutide cut heavy drinking days in 108 AUD-plus-obesity patients. The FDA approval path...
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...
Five Approvals, Nine Expansions: What the EMA’s April CHMP Meeting Reveals About Where Global Drug Development Is Heading
EMA's CHMP recommended 5 new medicines and 9 indication expansions in its April 20–23 meeting — here's what the...
Loper Bright Is Rewriting FDA’s Authority Over Synthetic Biology — Before the Industry Knows It
The Supreme Court's Loper Bright ruling is quietly dismantling FDA's deference-based regulatory hold over synthetic biology, and clinical programs...
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 —...