The 82x ROI Claim Looks Great on a Slide Deck — But Who’s Paying for the Infrastructure at the Site?
Tufts CSDD says AI monitoring agents deliver 82x ROI in Phase 3 oncology. But that number assumes sites can...
What JAMA’s Causal Language Guidance Actually Says About Difference-in-Differences Studies
JAMA's new guidance on causal language in DiD studies draws a sharp line between association and causation—with direct consequences...
Atea’s Bemnifosbuvir/Ruzasvir Meets Phase 3 Endpoints in Hepatitis C Trial
Atea's bemnifosbuvir/ruzasvir met Phase 3 endpoints in the C-BEYOND hepatitis C trial, advancing toward NDA submission and regulatory review.
ArkBio’s AK0406 Influenza Drug Advances to China Clinical Trials
ArkBio's AK0406 influenza drug advances to China clinical trials after completing Phase 1 dosing in Australia, targeting both flu...
Talphera’s nafamostat gains KDIGO endorsement as NEPHRO CRRT trial nears completion
Talphera's NEPHRO CRRT trial nears completion at 75% enrollment while nafamostat gains KDIGO guideline endorsement for acute kidney injury...
Definium’s DT120 Meets Primary Endpoint in Phase 3 Anxiety Trial
Definium's DT120 meets primary endpoint in Phase 3 anxiety trial with 5.4-point HAM-A separation from placebo at week 12.
When Your CMO Fails an FDA Inspection, Your Sites Pay the Price
Scholar Rock's BLA refiling for SMA drug apitegromab after Catalent Indiana's OAI classification shows how CMO inspection failures translate...
Daraxonrasib’s Resistance Map Is a Blueprint for How Oncology Trials Should Be Designed
Daraxonrasib's Phase 3 data in pancreatic cancer reveals how ctDNA-guided resistance profiling can reshape adaptive trial design—before acquired resistance…
TherapeuticsMD Q2 2026 License Revenue Drops 8.7% Year Over Year
TherapeuticsMD's license revenue drops 8.7% year-over-year in Q2 2026, with net income falling 70% as the company relies solely...
AbCellera’s ABCL635 Meets Primary Endpoints in Phase 2 for Menopause Symptoms
AbCellera's ABCL635 Phase 2 trial met primary endpoints for menopause vasomotor symptoms, showing statistically significant reductions in frequency and...