Fibrocaps regulatory update

The Medicines Co. said EMA accepted for review an MAA for Fibrocaps as an adjunct to hemostasis during surgery when control of mild or moderate bleeding by conventional surgical techniques is ineffective or impractical. The company plans to submit a BLA to FDA for the product next quarter. The Medicines Co. gained the dry powder topical fibrin sealant composed of fibrinogen and thrombin through its August acquisition of ProFibrix B.V. (see BioCentury, Aug. 12). ...