FDA’s approval of an antidote to Boehringer Ingelheim GMBH’s Pradaxa should give the company a leg up on the other novel oral anticoagulants – given the continuing concerns about bleeding risks – but with a universal antidote coming soon from Portola Pharmaceuticals Inc., that advantage will be short-lived.
Can Praxbind Push Pradaxa Ahead?
Approval of antidote should give Boehringer Ingelheim’s anticoagulant a needed advantage in a tough market, but it has a short window before Portola’s Factor Xa antidote comes along.
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
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In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.