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...
The Patient Tearing Up My Waiting Room Is Why Cebranopadol Matters
Tris Pharma presents cebranopadol (TRN-228) dual NOP/MOP data at CPDD 2026. For patients with comorbid chronic pain and OUD,...
Lilly’s Bet on Abridge Exposes the Recruitment Handoff Nobody Wants to Own
Eli Lilly invested in Abridge's AI recruitment tool — but the real question is whether sites can operationalize patient...
Gene Therapy Just Delivered Dopamine Directly Into the Brain. Now Comes the Hard Part.
BBM-P002's Phase 1 data in 10 Parkinson's patients shows dual-target AAV gene therapy can restore dopamine synthesis. The FDA...
Selinexor Plus Ruxolitinib Meets Primary Endpoint in Myelofibrosis Trial
Selinexor plus ruxolitinib met its primary spleen response endpoint in myelofibrosis, with 49.8% achieving SVR35 versus 28% on ruxolitinib...
Atumelnant cuts androgen levels 67% while reducing glucocorticoid doses in CAH trial
Atumelnant cuts androgen levels 67% while reducing glucocorticoid doses to physiologic levels in CAH trial, advancing toward Phase 3.