Remdesivir nears regulatory goal line as Gilead prepares to invest up to $1B into manufacturing

A day after NIAID data pushed remdesivir to the cusp of emergency approval in the U.S., EMA announced its CHMP has begun a rolling review of the antiviral based on the preliminary data from the Phase III ACTT study.

The accelerated process will allow EMA to complete its assessment of the therapy “significantly earlier.” According to the agency’s website, standard review of an MAA takes up to 210 days of active evaluation, or about a year...