Tempest Unveils Promising Dual-Targeting CAR-T Platform
Interim data from the REDEEM-1 Phase 1/2a study reported earlier this year showed a 100% complete response rate among...
The Process Is the Point: Why One Enterprise Leader Says Pharma Keeps Automating the Wrong Thing
Poonam Rihel Senior Enterprise Leader, R&D Poonam Rihel has watched a decade of digital transformation initiatives in pharma produce...
The 35% Problem: Why Isolate-Based AST Is Systematically Under-Detecting Resistance in Complicated Urinary Tract Infection
The 35% Problem — The Clinical Trial Vanguard The clinician prescribed empirically. The lab report said susceptible. Three weeks...
FDA Real-Time Clinical Trials: Why AI Systems That Update Themselves Are Breaking Clinical Trial Design
FDA's April 2026 real-time clinical trial push exposes a fatal flaw: when AI updates itself mid-study, your protocol is...
Hope for Back Pain: Mesoblast’s Phase 3 Trial Fully Enrolled
Mesoblast has completed enrollment in its 300-patient, sham-controlled Phase 3 trial (MSB-DR004) of rexlemestrocel-L for chronic low back pain...
Coultreon Biopharma Raises $125M for Immunology Pipeline
Coultreon Biopharma closed an oversubscribed $125 million Series A to push its lead oral SIK3 inhibitor, COL-5671, from Phase...
Promising New KRAS Inhibitor Trial Doses Its First Patient
Kestrel Therapeutics dosed the first patient in FALCON, its Phase 1, open-label dose-escalation and expansion study of KST-6051, an...
First Patient Dosed in Orelabrutinib Phase III SLE Trial
Orelabrutinib posted a 57.1% SRI-4 response at Week 48 in Phase IIb versus 34.4% on placebo (p
Noted Annovis Alzheimer’s Trial Results Published in Nature
A 12-week Phase 2/3 study in 351 patients with mild to moderate Alzheimer’s disease reported statistically significant, dose-dependent improvements...
Five Approvals, Nine Expansions: What the EMA’s April CHMP Meeting Reveals About Where Global Drug Development Is Heading
EMA's CHMP recommended 5 new medicines and 9 indication expansions in its April 20–23 meeting — here's what the...