Trials & Filings

Gilead Requests Retraction of Orphan Designation for Remdesivir

Seeks to waive all benefits amid growing concerns the specialty status could impact pricing and availability of competitor products

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By: Kristin Brooks

Managing Editor, Contract Pharma

Gilead Sciences has requested the U.S. FDA rescind orphan drug designation for remdesivir, a potential COVID-19 treatment, waiving all benefits associated with the designation. The request comes amid growing concerns the specialty status could impact pricing and competitor products. Orphan drug designation is given to investigational compounds intended to treat a rare disease, affecting fewer than 200,000 persons in the U.S., or a condition that has limited treatment options. Orphan drug s...

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