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Dec 16, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Helixate NexGen regulatory update

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefits of Kogenate Bayer and Helixate NexGen from Bayer outweigh the drugs' risk in previously untreated hemophilia A patients. The PRAC initiated a review following results from the RODIN study evaluating Factor VIII products in 574 treatment-naive children with hemophilia A and preliminary 3-year data...

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