rFIXFc regulatory update

Biogen Idec said FDA accepted for review a BLA for rFIXFc to treat hemophilia B. Biogen Idec said the application was submitted during 4Q12; a standard review would place the PDUFA date in 4Q13, though a specific date is not disclosed. In 2007, Swedish Orphan exercised an option to co-develop and commercialize the product obtained in a 2006 deal with Syntonix Pharmaceuticals Inc., which Biogen Idec acquired (see BioCentury, Nov. 12, 2007). ...