EMA Begins Rolling Review Of Remdesivir For COVID-19
Data To Be Reviewed As They Become Available
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.”
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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.
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.
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.