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...
CNS Gene Therapy Trials Are About to Break Every Monitoring Assumption Your CRO Has
BBM-P002's multicenter Phase 1 Parkinson's data signals a wave of CNS gene therapy trials that will overwhelm standard eClinical...
Single-Cell Spatial Pharmacobiology Just Changed What “Drug Delivery” Means in Solid Tumor Trials
A Nature Biotechnology study using Single-cell Spatial Pharmacobiology exposes heterogeneous antibody delivery in solid tumors—what sponsors assumed about…
Ten Years of EMA Post-Authorization Data Reveal a System Running on Incomplete Evidence
A Nature Reviews Drug Discovery analysis of EMA post-authorization studies exposes systematic gaps in how conditional approvals convert to...
Aleniglipron’s Phase 2b Data Redraws the Oral GLP-1 Efficacy Map — And Raises Hard Questions for Phase 3 Design
Structure Therapeutics' aleniglipron hit 14.7% weight loss in Phase 2b, matching injectable benchmarks. Here's what the trial design signals...
China’s Tenecteplase Trial Just Challenged the Global Stroke Playbook — and the FDA Should Be Paying Attention
A phase 3 RCT from China finds tenecteplase before EVT cuts disability in proximal MCA occlusion strokes 4.5–24 hrs...
The Platform Trial Takeover: Neurology’s Last Best Chance to Stop Failing Patients
Multi-arm multi-stage platform trials could cut neurodegenerative drug timelines in half—but FDA adaptive design rules haven't caught up with...
ADHD Dosing Has Two Failure Modes, and Trials Are Designed to Miss Both
A Lancet Psychiatry network meta-analysis of ADHD pharmacotherapy exposes therapeutic inertia and uncritical dose escalation as twin hazards—with direct…
Platform Trials Are Neurology’s Best Bet — So Why Is the FDA Still Treating Them Like Experiments?
The Lancet calls MAMS platform trials the fix for neurodegenerative drug failure. With 182 Alzheimer's trials active in 2025,...
The Neurodegenerative Trial Problem Has a Design Solution—But Sponsors Keep Ignoring It
MAMS platform trials could slash neurodegenerative drug development timelines—so why are sponsors still running serial Phase 2s for Alzheimer's...