FDA Ruling On Gepirone Efficacy Data Delayed By One Month
This article was originally published in The Pink Sheet Daily
Executive Summary
Fabre-Kramer responds to Office of New Drugs Director Jenkins' invitation to submit additional information following advisory committee review; Jenkins' decision on the antidepressant now expected by end of January.
You may also be interested in...
Do Negative Trials Count More Than Successful Ones?
Fabre-Kramer, FDA dispute over efficacy of the antidepressant gepirone heads to Psychopharmacologic Drugs Advisory Committee.
Diabetes Drugs: US FDA Proposes Hypoglycemia Efficacy Endpoints, With Limits
Reduction in the risk of hypoglycemia level 2 and 3 events, along with either a reduction or maintenance of an acceptable hemoglobin A1C, is a clinically relevant efficacy endpoint for drug development in Types 1 and 2 diabetes, FDA states in new draft guidance.
Intercept’s Ocaliva: ‘Dangling’ PBC Indication At Risk As Near-Term NASH Approval Looks Unlikely
Accelerated approval for primary biliary cholangitis in 2016 came with three postmarketing requirements, but studies were terminated early; firm working toward sNDA submission in 2023 for regular approval, but US FDA says reports already are overdue and it expects to take PBC indication back to an adcomm.