Pediatric Oncology Keeps Getting Treated as an Afterthought. The Biology Disagrees.
Children with cancer wait 6.5 years longer than adults to access new drugs. Adaptive and tumor-agnostic designs can close...
Clinical Trial Design
Neurodegenerative Drug Development Has a 2% Success Rate. Platform Trials Are the Only Honest Response.
With 51% of Alzheimer's disease-modifying compounds failing Phase III, The Lancet's case for MAMS platform trials in neurology isn't...
When Phase 2b Wins and Phase 3 Fails: The Biomarker Stratification Crisis Hidden Inside Astegolimab’s COPD Data
Genentech's astegolimab cut COPD exacerbations in ALIENTO but missed significance in Phase 3 ARNASA—exposing a broken biomarker stratification logic...
Astegolimab’s Split Verdict: What ALIENTO’s Win and ARNASA’s Miss Reveal About COPD Trial Design
Astegolimab cut COPD exacerbations in Phase 2b but missed in Phase 3—a 14.5% gap that exposes critical flaws in...
Intellia’s CRISPR Submission Is a Regulatory Stress Test the FDA Has Never Faced Before
Intellia's nex-z BLA for ATTR amyloidosis is the FDA's first in vivo CRISPR reckoning—and the agency's gene therapy playbook...
The Nacubactam Trials Just Proved Something the FDA Needs to Hear About AMR Drug Development
Integral-1's Phase 3 results for cefepime–nacubactam vs. imipenem show 89% composite cure rates — and a regulatory blueprint AMR...
The TOBRA Trial Just Killed a Widely Used Surgical Assumption — And Most Orthopedic Programs Haven’t Noticed Yet
A 1,660-patient RCT across 39 U.S. trauma centers found tobramycin adds nothing over vancomycin alone for preventing deep SSIs...
Favipiravir Just Beat Ribavirin in Lassa Fever—Now Comes the Hard Part
A Phase 2 RCT published in Nature Medicine shows favipiravir cut Lassa fever mortality with HR 0.50—but the regulatory...
CDR132L’s Phase 2 Miss: What a Well-Run Negative Trial Reveals About Heart Failure Drug Development
Cardior's CDR132L cleared safety hurdles in phase 2 but missed primary cardiac structure endpoints—a rigorous negative result that reshapes...
Digoxin’s Second Chance Just Ran Out: What a Failed Phase 3 RCT Reveals About Cardiovascular Drug Development
Low-dose digoxin cut hospitalizations but missed its primary endpoint in a 1,400-patient RCT—exposing a gap between statistical significance and...