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Can Praxbind Push Pradaxa Ahead?

 
• By Mary Jo Laffler

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.

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.

Boehringer’s Praxbind (idarucizumab) was granted accelerated approval Oct. 16 to reverse the anticoagulant effects of Pradaxa (dabigatran) for emergency surgery/urgent procedures or in cases of life-threatening or uncontrolled bleeding.

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

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.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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