Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ODE-1 Director Unger, Not Medical Officer, Conducted Epidiolex Safety Review

Executive Summary

Highly unusual move of an ODE director leading clinical review of a drug had nothing to do with public sentiment regarding Epidiolex's derivation from marijuana, US FDA says; Unger instead wanted to use the review as an example for future reviews to rely more on the agency's analyses rather than those of applicants.

You may also be interested in...



US FDA's New Neurology Leadership Likely To Face Two Big Reviews In 2020

Eric Bastings will lead Division of Neurology I, which is expected to handle Biogen’s Alzheimer’s drug aducanumab and Sarepta’s refiling of golodirsen for DMD next year.

Gottlieb: Epidiolex Approval Covers One Specific Cannabidiol Medication, Not Marijuana

The approval for the GW Pharmaceuticals drug covers the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two forms of rare and severe childhood epilepsy – the US agency was quick to clarify what the approval did not cover, chiefly marijuana.

Epidiolex Enjoys Mellow Advisory Cmte. Meeting

GW Pharmaceuticals’ cannabis-derived epilepsy drug gets unanimous panel endorsement, affirming US FDA's belief that there are no obstacles to approval.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL029263

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel