Diversity Planning Belongs in Protocol Design, Not the Enrollment Crisis Meeting
A new pilot shows early diversity planning cuts mid-trial amendments, here's what that means for site selection, IRT setup,...
MASH Trials Are Screening Out the Patients They Were Designed to Treat
MASH trial NIT thresholds misalign with clinical practice, creating screen failure crises that delay approvals and exclude the patients...
Clinical Research Sites Report Growing Trial Complexity Strain
Clinical research sites report trial complexity as their top operational problem, with 41% naming it their biggest challenge as...
CLN-049 achieves 53% response rate with reduced cytokine release toxicity
CLN-049 achieves 53% response rate in AML/MDS trials while reducing cytokine release toxicity through adjusted two-step dosing regimen.
Acepodia Doses First Patient With ACE723 Dual-Payload ADC in HCC Trial
Acepodia doses first patient with ACE723 dual-payload ADC in hepatocellular carcinoma trial, targeting GPC3 with two distinct cytotoxic mechanisms.
SynKIR-310 Shows 80% Response Rate With No Severe Toxicity in Lymphoma Trial
SynKIR-310 achieves 80% response rate with no severe toxicity in early lymphoma trial, challenging established CAR-T safety profiles.
The 36-Month Retention Problem Nobody Puts in the Protocol Risk Register
uniQure's 200-patient, 36-month HD gene therapy confirmatory trial exposes the operational gap between regulatory-compliant design and site-level execution…
The Libre Duo Authorization Signals a New FDA Posture on Dual-Biomarker Wearables: Who Benefits and Who Gets Left Behind
FDA's Libre Duo authorization on Aug 25 marks the first continuous ketone+glucose wearable cleared globally. Here's what it means...
FDA Clears PANDA Phase 3 Protocol for Pentixapharm’s PentixaFor PET/CT Study
FDA clears Phase 3 PANDA study protocol for PentixaFor PET/CT imaging in primary aldosteronism subtyping, targeting Q1 2027 enrollment.
AI Is Making Drug Pipelines Bigger. It Might Also Be Making Them Worse.
Daphne Koller agrees with Bruce Booth: AI molecular design will worsen pharma R&D productivity before improving it. Here's what...