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

EMA Begins Rolling Review Of Remdesivir For COVID-19

Data To Be Reviewed As They Become Available

Executive Summary

Results from the US ACCT study have led both the EMA and the FDA to accelerate the review of Gilead’s remdesivir for use in coronavirus patients. The EMA says it will also take account of the results of a Chinese study that found the antiviral was “not associated with statistically significant clinical benefits.”

You may also be interested in...



Pandemic Expected To Drive Rolling Review Upsurge At EMA

The European Medicines Agency is anticipating greater use of its rolling review process during the coronavirus pandemic. Companies who use it will be asked to pay upfront half of what they would pay for a full marketing application. 

EMA’s Rasi: Approval Decision For Remdesivir May Come ‘Very Soon’

Speaking at a high-level European Parliament committee meeting today about COVID-19, the European Medicines Agency’s executive director indicated that Gilead would be submitting a conditional marketing authorization application for remdesivir in the EU.

Coronavirus Update: More EU R&D Projects, A Potential New Vaccine & Making Sense Of The Data Deluge

In addition to our daily in-depth coverage of key events relating to the coronavirus, we’re bringing you a periodic round-up of other pandemic developments. This edition covers events at the national and EU level. 

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS142123

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