The 2-Week Window: What a Phase 1 iPSC Trial Teaches Us About Designing Cell Therapy Studies That Can Actually Win Approval
A Nature Medicine phase 1 iPSC neural progenitor trial in subacute spinal cord injury shows how to build the...
Armata Submits Phase 3 Protocol for AP-SA02 Bacteriophage in S. aureus Bacteremia
Armata Pharmaceuticals submits Phase 3 protocol for AP-SA02 bacteriophage targeting S. aureus bacteremia, with trial launch planned for late...
The Informed Consent Warning Letter Every Site Director Should Read Twice
FDA's July 2026 warning letter to Alembic's bioequivalence site exposes informed consent failures that can ground any trial. Here's...
Healx Doses First Patient in HLX-4310 Trial for Metastatic Osteosarcoma
Healx doses first patient in HLX-4310 trial for metastatic osteosarcoma, targeting micro-metastatic dormancy in relapsed and refractory cases.
Agios Discontinues Tebapivat Development in Sickle Cell Disease
Agios discontinues tebapivat development in sickle cell disease after Phase 2 showed no meaningful separation from placebo.
AI-Designed Drugs Are Reaching Human Trials. Now Comes the Hard Part.
Healx's HLX-4310 Phase 1/2 trial in osteosarcoma shows AI drug discovery maturing—but adaptive dose-escalation in adolescent oncology exposes trial...
IMUNON’s IMNN-001 Shows Lower Residual Disease in Phase 2 Ovarian Cancer Study
IMNN-001 demonstrated lower residual disease rates versus control in Phase 2 ovarian cancer study, with 44% showing disease at...
GLP-1 Agonists Are Quietly Reducing Addiction Hospitalizations, But Only While Patients Take Them
A Lancet Psychiatry study shows GLP-1 agonists cut AUD and SUD hospitalizations, but the protection fades after stopping —...
Lilly’s $2.8 Billion Bet on Psychedelics Buys Science That Conventional Trial Infrastructure May Not Be Able to Run
Eli Lilly acquires AtaiBeckley for $2.8B, but the FDA's final psychedelic trial guidance reveals an operational crisis Big Pharma...
Veeva’s eSource Isn’t Another Digital Layer. It’s the Last One.
Manny Vazquez and Denali Rose on why the industry's oldest data-entry problem is finally solvable and why sites have...