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...
Clinical Trial Operations
Roche’s Englumafusp Plus Glofitamab Combination Shows Why Phase 1 Trial Design Is the Real Competitive Moat in Bispecific Oncology
A Nature Medicine Phase 1 trial combining englumafusp alfa and glofitamab in B-cell NHL reveals how rational dose escalation...
The Bispecific Combination Wave Is Here: What the Englumafusp-Glofitamab Trial Signals for Hematology Trial Design
A Phase 1 trial pairing englumafusp alfa with glofitamab in B-cell NHL reveals a mechanistic shift reshaping how sponsors...
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...
The Trial Without Walls: How Real-World Evidence Is Rewriting the Rules of Drug Approval
Nature Medicine's RWE trial emulation framework is reshaping FDA approval pathways. Here's what sponsors running traditional RCTs need to...
$7 Billion Into AI Drug Discovery and Zero Approved Drugs: The Industry Is Funding the Wrong Race
$7B committed to AI drug discovery, zero approved drugs. The real bottleneck is clinical development—and the capital hasn't caught...
Your AI Scored 92% on the Medical Exam. That Number Is Lying to You.
Health AI acing benchmarks while failing real clinical tasks exposes a validation gap that trial sponsors and the FDA...
When Bad Protocol Design Hits Your Site, AI Won’t Save You
Phesi finds fewer than 1 in 3 trial protocols connect to real patient data — meaning flawed assumptions reach...
Mid-Trial Site Additions Sound Like Progress — The Activation Math Tells a Different Story
NKGen Biotech just added 3 Alzheimer's trial sites across NJ, NY, and FL. Here's what the activation math actually...
The FDA’s One-Day Inspection Pilot Will Catch Sites That Aren’t Ready — Starting Now
FDA's BRIDGE one-day assessment pilot launched April 2026, compressing traditional 3-6 day inspections. Here's what sites must change before...