The FDA Created an AI Office. Now Comes the Hard Part.
CDER's new Office of Innovation and Clinical Trial Modernization fuses AI and RWE policy under one roof. That structural...
The Invoiceable Section Is Where Sites Leave Money on the Table
Most sites undercharge on research-paid items because no one reconciles the sponsor budget against the charge master. Here is...
Novo’s Denecimig Got a Green Light From Clinicians and a Red Light From an Inspector: Who Failed?
FDA extended its denecimig BLA review over unnamed facility remediation failures, exposing the manufacturing blind spot that nearly every...
Lancet Psychiatry’s CYP2D6 Venlafaxine Cohort Data Signals a Pre-Emptive Genotyping Inflection Point for CNS Trial Design
A dual-cohort Lancet Psychiatry study links CYP2D6 poor metabolizer status to venlafaxine treatment failure, pressing sponsors to rethink IND...
Headlands Research Portland Site Marks 50 Years in Alzheimer’s Trials
Headlands Research Portland site marks 50 years of continuous Alzheimer's trials, contributing to every FDA-approved medication class since 1993.
Advarra’s IRB Chief Targets Pre-Review Delays as Next Efficiency Frontier
Advarra's IRB chief targets pre-review delays as the next efficiency frontier to reduce waiting time for researchers and trial...
Forward Therapeutics’ FT2109 Advances to Phase 2 After Positive Phase 1 Data
Forward Therapeutics' FT2109 advances to Phase 2 after clearing Phase 1 with once-daily oral dosing and a supportive safety...
Coya Therapeutics Completes Enrollment of 120 Patients in COYA 302 ALS Trial
Coya Therapeutics completes enrollment of 120 patients in COYA 302 ALS trial testing an immunomodulatory approach to slow neuroinflammation.
Lundbeck’s Lu AF28996 gains 2+ hours daily ON-time in Parkinson’s Phase Ib
Lu AF28996 gains over 2 hours of daily ON-time in Parkinson's Phase Ib trial, with meaningful reductions in troublesome...
The Infrastructure Bet That Pays Off Before the First Patient Enrolls
Jon Himoff, Chief Product Officer of Image Analysis Group (IAG), on why purpose-built imaging platforms outperform assembled toolkits in...