Two days after US FDA granted remdesivir orphan status for treatment of COVID-19, Gilead told the agency it is unnecessary. EMA says it would not grant orphan drug designation to a COVID-19 treatment.
In a surprising reversal, Gilead Sciences Inc. announced on 25 March that it has asked the US Food and Drug Administration to rescind the orphan drug designation for remdesivir for treatment of COVID-19, which the agency granted two days earlier. By the end of the day, the agency had processed the request and withdrawn the designation.
Several groups had issued calls for the FDA to revoke the designation after it became public, arguing that the number...
Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.
The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.
