BIOMEDE Missed Its Primary Endpoint — And Still Changed Pediatric CNS Trial Design Forever
The BIOMEDE Phase 2 trial in DIPG missed OS superiority but exposed a biomarker-survival link that should rewrite how...
When the Vendor Consolidates, Sites Feel It First
WCG's acquisition of The Contract Network promises faster trial startup—but site coordinators know vendor mergers rarely simplify the contracts...
Altimmune’s Remarkable $225M Offering Sees Surging Demand
Altimmune priced a $225 million underwritten offering built around 64.25 million common shares paired one-for-one with immediately exercisable $3.00...
Oral Semaglutide: A Breakthrough for Kids with Diabetes?
In the Phase 3a PIONEER TEENS study (n=132), oral semaglutide delivered a statistically significant 0.83% greater reduction in HbA1c...
Clinuvel Gets EMA Advice for Pivotal Phase III Vitiligo Study
EMA has issued final scientific advice clearing Clinuvel’s pivotal vitiligo trial to use a “totality of evidence” assessment anchored...
Nectero Reports 2-Year Safety and Efficacy Data for AAA
In a 46-patient first-in-human study of small- to medium-sized abdominal aortic aneurysms (AAA), Nectero’s investigational Nectero EAST System delivered...
KOL Event Spotlights Lasofoxifene for Resistant Cancer
Phase 2 signals continue to support lasofoxifene’s pursuit of ESR1‑mutated, ER+/HER2‑ metastatic breast cancer. In ELAINE‑1, lasofoxifene outperformed fulvestrant...
Psyence Biomed Doses First Patient in Adjustment Disorder Trial
Psyence Biomedical has dosed the first patient in its Phase IIb study of NPX-5, a GMP-compliant, nature-derived psilocybin candidate,...
Epitopea Announces New Ovarian Cancer Clinical Trial Approval
Epitopea has secured UK MHRA and Regional Ethics Committee clearance to initiate OVACT, a first‑in‑human Phase 1/1b study of...
When the Trial Says No but the Site Was Never Ready
The THEIA trial's negative alteplase result may reflect site execution failures more than drug biology—a CAPA lesson every ops...