Swedish Orphan Biovitrum AB: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
Provider: Reuters Investment Profile
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Swedish Orphan Biovitrum AB Publ Files for Kineret Label to Include CAPS
Swedish Orphan Biovitrum AB Publ announced that it has filed an application for an European Union (EU) Marketing Authorization with the European Medicines Agency (EMA) for Kineret (anakinra) for the indication of cryopyrin associated periodic syndromes (CAPS). The filing is based on positive safety and efficacy outcome data from a long-term treatment study in children and adults with neonatal-onset multisystem inflammatory disease (NOMID), the most severe form of CAPS. The EMA filing follows the filing for Kineret for NOMID with the United States Food and Drug Administration (FDA) in July 2012, which has been granted priority review with an expected approval date of December 25, 2012.
Latest Developments for Swedish Orphan Biovitrum publ AB
- Swedish Orphan Biovitrum publ AB and Biogen Idec Inc announce results of phase 3 study of recombinant factor IX and VIII Fc fusion protein candidates
- Swedish Orphan Biovitrum publ AB and Biogen Idec Inc announce results of phase 3 study with ALPROLIX
- Swedish Orphan Biovitrum publ AB Receives Approval for Kineret for Treatment of CAPS
- Swedish Orphan Biovitrum publ AB Maintains FY 2013 Revenue Guidance
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