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...
When Privacy Is the Product: How Albus Health Is Redefining What Clinical Trials Can Measure at Home
A contactless device, 40 countries, and a design philosophy that starts with patients — not compliance checklists The question...
Mabwell’s Bulumtatug Fuvedotin Shows Promise in Topo I-Pretreated TNBC
Mabwell's bulumtatug fuvedotin shows clinical promise in triple-negative breast cancer patients with prior topoisomerase I inhibitor exposure.
OMEICOS’ OMT-28 Advances to Phase 3 Trial in Mitochondrial Disease
OMT-28 Phase 3 trial advances for mitochondrial disease after FDA end-of-phase 2 meeting, with composite functional endpoints and adaptive...
4D Molecular Therapeutics Reports 2-Year Durability Data for 4D-150 in Wet AMD
4D-150 shows sustained efficacy in wet AMD patients at two years post-injection, supporting the Phase 3 program's durability foundation...
CMS Just Declared War on RPM Vendors. Clinical Trial Sponsors Should Be Paying Attention.
CMS's proposed 2027 fee schedule would ban Medicare payments for third-party RPM vendors after OIG flagged $536M in billing...