The 2024 McDonald Criteria’s Lancet Neurology Publication Signals a Mandatory Protocol Audit for Active MS Trials
The 2024 McDonald MS criteria raised diagnosis rates 28% and cut median time to diagnosis from 84 to 40...
The FDA’s Psychedelic Guidance Is Really a Study-Design Reckoning
The FDA's July 2026 psychedelic guidance is nonbinding on paper. In practice it tells psilocybin, LSD, and MDMA developers...
When Your CRO Merges Mid-Study, the Site Pays the Price
Caidya and Simbec-Orion's merger creates a 6-month operational danger zone for sites running active studies. Here's what sponsor clinops...
Digital Twins Are Rewriting Clinical Trial Math. The Validation Problem Could Erase the Gains.
Biotech's digital twin rush is outpacing regulatory frameworks. Without standardized qualification, sponsors risk building trial strategies on unvalidated…
Lecanemab Subcutaneous Autoinjector Shows Bioequivalent Exposure to IV Form
Lecanemab subcutaneous autoinjector achieves bioequivalent exposure to IV form with 104% ratio, supporting fixed-dose initiation without weight adjustments.
Denecimig shows consistent safety and efficacy across age groups in hemophilia A trial
Denecimig demonstrates consistent safety and efficacy across age groups in hemophilia A trial, with 89% of children achieving zero...
Checkpoint Inhibitors Are Failing Recurrent GBM. This Phase 1 Trial Design May Explain Why They Keep Trying.
A 46-patient LAG-3/PD-1 phase 1 trial in recurrent GBM reveals the protocol innovations sponsors need before scaling immunotherapy in...
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 Serotonin Signal Hiding in Plain Sight Across Two Rapid-Acting Depression Treatments
A Bayesian PET re-analysis finds ketamine and ECT both upregulate 5-HT1B receptors, pointing to a shared biomarker that TRD...
INmune Bio’s XPro Shows Significant Brain Imaging Changes in Early Alzheimer’s Trial
INmune Bio's XPro demonstrates statistically significant changes in white matter and gray matter microstructure at 24 weeks in early...