The Two-Fisted Antibody: What the 10E8.4/iMab Phase 1 Trial Teaches Us About Designing for Complexity
A Nature Medicine phase 1 trial of bispecific HIV antibody 10E8.4/iMab shows how partially randomized adaptive design handles dual-mechanism...
$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...
The Patients We’ve Been Afraid to Treat: PTSD, Psychosis, and What the STAR Trial Just Proved
The STAR trial enrolled 305 psychosis-PTSD patients clinicians long excluded from trauma therapy. The safety and efficacy data should...
TG Therapeutics Launches Phase 2 Trial of BRIUMVI in Treatment-Resistant Schizophrenia
TG Therapeutics launches Phase 2 trial of BRIUMVI in treatment-resistant schizophrenia, testing an anti-CD20 therapy approved for MS in...
Genzyme Ireland’s 483 Is Not a Manufacturing Story. It’s a Sponsor Oversight Indictment.
FDA's June 2026 warning letter to Genzyme Ireland over Altuviiio manufacturing exposes how post-approval CGMP oversight collapses at the...
AMO Pharma Aligns With FDA, MHRA, Health Canada on AMO-02 Study Design for cDM1
AMO Pharma aligns with FDA, MHRA, and Health Canada on AMO-02 study design, selecting hospitalization as the primary efficacy...
The Consent Form Doesn’t Cover the Data: A Gap Regulators Can No Longer Ignore
Nature Medicine flags data rights as consent's missing pillar—and three converging signals show the FDA's frameworks haven't caught up...
The Standards Gap Is the Strategy Gap
Veeva's regulatory and policy leads on AI accountability, FDA uncertainty, and why fragmentation is the real competitive threat
When the Manufacturing Site Fails, the Clinical Site Pays the Price
Sanofi's Genzyme Ireland 483 and June 2026 warning letter show how CGMP failures at a manufacturing facility cascade into...
FDA Adopts ICH E6(R3) Guidance Redistributing Trial Accountability
FDA adopts ICH E6(R3) guidance, redistributing trial accountability across sponsors, sites, and vendors with new data governance requirements.