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...
Dyne Therapeutics’ z-rostudirsen Wins Priority Review for Duchenne Muscular Dystrophy
Dyne Therapeutics' z-rostudirsen wins Priority Review for Duchenne muscular dystrophy, compressing FDA evaluation to six months for exon 51...
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...
When the Phase 3 Dies After the Acquisition: The Site-Level Fallout No One Plans For
GSK's Phase 3 termination of camlipixant after its $2B Bellus Health buyout triggers an operational cascade—site deactivation, IRB amendments,...