Dabigatran Etexilate Recommended For Approval In Atrial Fibrillation For Stroke Prevention In Europe

04/15/11 Boehringer Ingelheim's novel oral anticoagulant dabigatran etexilate (to be marketed under the trademark Pradaxa®), 1 received a positive opinion from the European Medicines Agency's (EMA) medicinal committee today. This positive opinion is a decisive step in making the breakthrough therapy available to millions of patients with atrial fibrillation (AF) at risk of stroke in the European Union...

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Biogen Idec and Swedish Orphan Biovitrum Receive Opinion From EMA on Pediatric Plan for Long-Lasting Hemophilia B ...

05/09/11 WESTON, MA and STOCKHOLM, SWEDEN--(Marketwire - May 9, 2011) - Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (STO: SOBI) today announced that the European Medicines Agency's (EMA) Pediatric Committee (PDCO) has adopted an opinion agreeing to the pediatric investigational plan for the companies' long- lasting, fully-recombinant Factor IX Fc fusion protein (rFIXFc).

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European regulators OK Shire manufacturing site

06/24/11 Irish drugmaker Shire Plc said Friday the European Medicines Agency has approved a new manufacturing site in Massachusetts that will be used to make the Fabry disease treatment Replagal.

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