The EMA’s Virtual Control Group Gambit Could Redraw the Map for Pivotal Trial Design
The EMA has opened consultation on a draft qualification opinion for virtual control groups — a methodology that, if...
The GLP-1 Mood Signal Is Real — But So Is the Psychiatric Worsening Risk
A pattern I’ve been tracking across my dual-diagnosis patient panel this year: the patients who come in asking about...
The Trial That Should Rewrite the Rare Disease Playbook — But Probably Won’t
AstraZeneca's Phase 3 benralizumab trial in hypereosinophilic syndrome just delivered one of the cleanest efficacy signals in rare disease...
The Bone and Muscle Safety Gap That GLP-1 Megastudies Weren’t Designed to Fill
Lilly and Novo have already won the weight-loss efficacy war. The next drug approval battle is being fought on...
The Wearable Gap: Why Sensors Are Outrunning the Trials That Use Them
Wearables are generating physiological data at a scale clinical trials have never seen before. But a March 2026 review...
One Biomarker, Two Diseases: The p-tau Signal That Just Complicated Your Stratification Strategy
A multicenter cross-sectional study in Nature Medicine shows serum p-tau—the cornerstone of Alzheimer's blood-based diagnostics—may also detect systemic amyloidoses....
The 42% Cost Drop That Should Rewrite How We Design OUD Trials
A pattern I’ve been tracking across my patient panel for the past several months: the patients most likely to...
The $30 Million Bet: CNS Investors Are Back — and Registrational Trial Design Hasn’t Kept Up
Serina Therapeutics just closed a $30 million private placement at a 68% premium to fund a registrational trial for...
Triplet Regimen, Biomarker Gate, Phase 3 Signal: What ILUSTRO’s Cohort 4 Actually Proves
Astellas's ILUSTRO trial just published Phase 2 data showing a zolbetuximab-nivolumab-mFOLFOX6 triplet in CLDN18.2-positive gastric cancer produces response rates...
Korea’s Integrated Approach to Clinical Trial Planning: A New Model for Global Sponsors
The sponsor team had expected a slow start in Europe, but they weren’t prepared for how fragmented the process...