Icotrokinra’s NEJM Data Reveals the Quiet Shift in How UC Trials Get Designed and Approved
J&J's icotrokinra hit every UC endpoint in NEJM's Oct 2026 data, and the trial design choices behind that success...
Orforglipron’s MACE Data Just Raised the Evidentiary Bar for Every Oral GLP-1 Program Behind It
Orforglipron's ACHIEVE-4 trial showed MACE-4 in 4.2% vs. 5.0% for insulin glargine, now every oral small-molecule GLP-1 program faces...
The CHMP’s October Scorecard: Six Approvals, Five Expansions, and What the Patterns Reveal About EMA’s Evolving Evidence Bar
EMA's CHMP recommended 6 new medicines and 5 label expansions in its Oct 12-15 cycle. Here's what daraxonrasib's pancreatic...
The FDA Just Rewired Alzheimer’s Trial Design, Most Sponsors Haven’t Caught Up Yet
FDA's approval of two blood-based Alzheimer's tests signals regulators now accept plasma biomarkers as primary endpoints, reshaping CNS trial...
Proteomic Aging Clocks Enter Clinical Trials: What Sponsors Need to Know Before the FDA Does
Proteomic aging clocks are moving into clinical trials, but FDA surrogate endpoint standards and assay reproducibility gaps could stall...
Retatrutide’s TRIUMPH-2 Data Forces a Reckoning With How We Design Metabolic Trials
TRIUMPH-2's Phase 3 data on retatrutide in 1,152 T2D patients challenges every assumption sponsors hold about GLP-1 trial design...
Clinical Prediction Models Are Breaking Trials and Nobody Is Requiring a Fix
Only 12% of ~4,000 clinical prediction model studies share code, per Nature Medicine. FDA and NIH mandates exist, but...
The EU Just Made Pre-Submission Advice Permanent. Your CTA Strategy Is Now Out of Date.
EMA's ACT EU advice pilot becomes permanent in January 2027, giving EU sponsors consolidated multi-country feedback before CTA submission....
The Eye as a Biomarker: Why Retinal AI Could Reshape How Trials Screen and Stratify Pregnant Patients
A Nature Biotechnology retinal AI model detects preeclampsia and gestational hypertension risk non-invasively, and its trial implications go far...
Psilocybin Moves the Social Brain in AUD, And Our Trial Endpoints Are Missing It
A pilot RCT links psilocybin's 25 mg dose to reduced egocentric bias in alcohol use disorder, exposing a blind...