Gilead's Letairis Gets Boost Against Actelion's Tracleer With Removal Of Liver Warning
• By The Pink Sheet Daily
REMS helps drive the endothelin receptor antagonist to a cleaner label, as the pulmonary arterial hypertension drug's black box will be modified and liver testing requirements dropped.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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