The FDA Just Handed Industry a Rulebook on AI in Trials. Now Comes the Hard Part.
FDA and EMA published coordinated AI frameworks in 2025-2026, but sponsor comment letters reveal the real debate: do these...
Lilly’s $2.8 Billion Bet on Psychedelics Buys Science That Conventional Trial Infrastructure May Not Be Able to Run
Eli Lilly acquires AtaiBeckley for $2.8B, but the FDA's final psychedelic trial guidance reveals an operational crisis Big Pharma...
Compass Has Two Positive Phase 3 Trials. The FDA Has Final Guidance. So Why Does Psilocybin Still Feel Like a Gamble?
Compass Pathways' 39% six-month response rate and the FDA's final psychedelics guidance arrive together. The field looks ready. Look...
$7 Billion Into AI Drug Discovery and Zero Approved Drugs: The Industry Is Funding the Wrong Race
$7B committed to AI drug discovery, zero approved drugs. The real bottleneck is clinical development—and the capital hasn't caught...
Definium’s Phase 3 LSD Win Is Real. The Fracture It Exposed Is Bigger.
Definium's LSD trial hit p<0.0001 and a $700M raise. But credible voices are asking whether FDA's drug model can...
Autonomous AI Agents Can Outperform Physicians. That’s Not the Hard Part.
MIRA beat physicians on diagnostic accuracy. AMIE matched them across 100 cases. Now comes the real test: whether regulated...
The CRO Isn’t Failing Your Trial. Your Governance Model Is.
Sponsors treat CRO contract signing as a handoff. Three independent clinical ops leaders say that abdication, not bad molecules,...
Psychedelic Trials Are Producing Stunning Numbers. The Methodology Underneath Them May Not Hold.
Luvesilocin's 70% PPD remission rate and psilocybin-CBT pilot data are turning heads—but sex-specific blind spots and a therapy model...
Twelve Months, Three Patients: The Enrollment Crisis No Algorithm Can Fix
Sponsors poured $3B into AI to fix trial enrollment and 80% still miss deadlines. Three clinical-ops voices on why...