The 36-Month Retention Problem Nobody Puts in the Protocol Risk Register
uniQure's 200-patient, 36-month HD gene therapy confirmatory trial exposes the operational gap between regulatory-compliant design and site-level execution…
The Libre Duo Authorization Signals a New FDA Posture on Dual-Biomarker Wearables: Who Benefits and Who Gets Left Behind
FDA's Libre Duo authorization on Aug 25 marks the first continuous ketone+glucose wearable cleared globally. Here's what it means...
FDA Clears PANDA Phase 3 Protocol for Pentixapharm’s PentixaFor PET/CT Study
FDA clears Phase 3 PANDA study protocol for PentixaFor PET/CT imaging in primary aldosteronism subtyping, targeting Q1 2027 enrollment.
AI Is Making Drug Pipelines Bigger. It Might Also Be Making Them Worse.
Daphne Koller agrees with Bruce Booth: AI molecular design will worsen pharma R&D productivity before improving it. Here's what...
Bright Minds’ BMB-101 Hold Exposes a Recurring Failure in Preclinical-to-IND Translation
FDA's partial hold on Bright Minds' BMB-101 for pediatric epilepsy, citing mouse toxicity and inadequate data, reveals a preclinical...
The LITMUS Data Just Made Liver Biopsy Optional in MASH Trials, Regulators Need to Catch Up
LITMUS prospective data shows proteomic panels outperform single-marker tests vs. histology in MASH, reshaping trial design and FDA's NIT...
78% of Moderate Aortic Stenosis Patients Have High-Risk Features, Study Finds
78% of moderate aortic stenosis patients have high-risk features that double mortality and heart failure hospitalization risk within two...
Eton Pharma Tests Mecasermin for Refractory Infantile Spasms in 2027 Trial
Eton Pharma's ET-900 program tests mecasermin injection for refractory infantile spasms, with first patient dosing planned for Q1 2027.
PROSpect’s Negative Findings Should Change How We Design Pediatric Critical Care Trials Forever
PROSpect enrolled 424 children across 75 PICUs in 18 countries to test prone positioning and HFOV in PARDS, and...
PROSpect Proved Two Treatments Don’t Work. The Real Story Is What That Took.
PROSpect's phase 3 RCT enrolled 424 children with PARDS and found neither prone positioning nor HFOV improves ventilator-free days....