The 95% Problem: Why Clinical AI Keeps Failing — And What It Takes to Actually Fix It
Medable's Andrew Mackinnon on agentic AI adoption, ontology layers, and why waiting to clean your data may cost you...
The Tolerability Bet: Biohaven’s Irfan Qureshi on Why Being Second in a Drug Class Can Still Win
Opakalim cleared 1,000 patients without the CNS side-effect burden that haunted its predecessors. Now the company is betting that...
Ligufalimab Plus Azacitidine and Venetoclax Shows OS Benefit in AML Phase II
Ligufalimab plus azacitidine and venetoclax achieved 78.7% nine-month OS rate in AML, nearly doubling response duration versus standard care...
The FDA’s Bayesian Guidance Sounds Like Good News for Sponsors. Sites Will Feel It Differently.
FDA's January 2026 Bayesian draft guidance promises flexible trial designs — but adaptive interim triggers, real-time IRB amendments, and...
Closed-Loop DBS Just Validated a New Class of CNS Trial Design. Is Your Protocol Ready?
A UCSF randomized trial of adaptive DBS in Parkinson's gait published in Nature Medicine signals a coming wave of...
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,...
Jazz and PharmaMar Just Ran Out of Runway: Zepzelca’s Confirmatory Failure Is an Accelerated Approval System Under Stress
Zepzelca's Phase 3 LAGOON trial missed overall survival in SCLC—Jazz's second confirmatory failure, six years after a 105-patient single-arm...
Selinexor-Ruxolitinib Combination Meets Primary Endpoint in Myelofibrosis Trial
Selinexor-Ruxolitinib combination achieves 49.8% spleen volume reduction at week 24 in phase 3 myelofibrosis trial, significantly outperforming ruxolitinib mono
Adaptive DBS Just Ran a Randomized Trial on Gait. The Endpoints FDA Needs to Validate Next Are Nowhere in Current Guidance.
A Nature Medicine feasibility trial on adaptive deep brain stimulation for Parkinson's gait signals a regulatory gap: FDA has...
TransCon PTH Maintains Response in 86% of Hypoparathyroidism Patients at 3.5 Years
TransCon PTH maintains response in 86% of hypoparathyroidism patients at 3.5 years, with improved kidney function and sustained biochemical...