Glofitamab Plus Englumafusp Alfa: When Phase 1 Data Rewrites the Combination Therapy Playbook
A Nature Medicine phase 1 trial pairs glofitamab with CD19-4-1BBL co-stimulation in r/r B-NHL, producing efficacy signals that challenge...
SCI-110’s Phase IIb in Tourette Syndrome: What Hannover Tells Us About Cannabinoid Trial Design in CNS
NeuroThera Labs activates Hannover Medical School for SCI-110 Phase IIb in adult Tourette Syndrome, building on a 21% tic...
FDA’s Single-Trial Default: What It Actually Means for Your Protocol Strategy
FDA made a single pivotal trial its default approval standard on Feb. 19, 2026. Here's what clinical ops leaders...
The Geroscience Biomarker Gap: Why Immune Aging Endpoints Are About to Reshape Trial Design
Nature Medicine's immune aging biomarker framework challenges sponsors to redesign geroscience trials around surrogate endpoints the FDA hasn't yet...
The 6-Month RR-TB Trial the FDA Should Be Studying as a Pragmatic Design Blueprint
A NEJM pragmatic trial of a 6-month rifampicin-resistant TB regimen just set a new benchmark for adaptive evidence generation...
GCP Breakdown at King’s College Hospital Just Clouded the Most Promising Parkinson’s Trial in Years
An MHRA inspection at King's College Hospital flagged department-wide GCP failures in the exenatide Phase 3 Parkinson's trial, triggering...
Clinical AI Is Being Deployed Faster Than It Can Be Trusted: Here’s the Network Trying to Fix That
43% of FDA-authorized AI clinical tools lack published validation data. A Columbia-led research network is building the governance framework...
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...
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…
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...