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Industry News

FDA Approves Revised Wilate Product Labeling For Surgery

Note: This is an edited form of a press release from Octapharma. To read the original release in its entirety, click here. Octapharma USA announced on August 13, 2015 that the U.S. Food and Drug Administration (FDA) has approved revised product labeling for WILATE® [von Willebrand Factor/Coagulation Factor VIII Complex (Human)] to include prevention of excessive […]

Industry News

New Data Supports Safety & Efficacy Claims of ALPROLIX

Note: This is an edited form of a press release from Biogen. To read the original release in its entirety, click here.  New clinical data support the long-term safety and efficacy of ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] in people with severe hemophilia B treated for up to two years, Biogen announced on […]

Industry News

New Data Supports Safety & Efficacy of ELOCTATE

Note: This is an edited version of a press release from Biogen. To read the original release, click here. _____________________________________ Newly published clinical data demonstrate that people on extended-interval prophylaxis regimens with ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] experienced low bleeding rates, Biogen and Swedish Orphan Biovitrum AB (Sobi) announced on Monday, August 10, […]

Industry News

vWD Recombinant Clotting Protein Shown To Be Effective

Note: This is an edited version of a release originally published in Blood, the Journal of the American Society of Hematology (ASH).  On August 3, 2015, the journal Blood published study data indicating that the first protein engineered to help control bleeding episodes in patients with severe von Willebrand disease (vWD) had been shown to be safe and effective, […]

Industry News

FDA Accepts CSL Behring’s Application for New Hemophilia Treatment

Note: The below is an edited press release from CSL Behring. To read the full release, click here. CSL Behring announced that the U.S. Food and Drug Administration has accepted for review the company’s Biologics License Application (BLA) for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment of hemophilia A. In the […]

Industry News

Baxalta Releases Findings of Potential Extended Half-Life Product

Note: This is an edited form of a press release from Baxalta, Inc., originally published on July 16, 2015. To read the full press release, click here. Baxalta Incorporated announced the publication of the complete data from the Phase II/III pivotal study and Phase I trial of BAX 855 in Blood, the journal of the […]

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FDA Grants Orphan Status for New Inhibitor Treatment

Below is from a press release Apitope sent out on June 9, 2015. To read it in its entirety, click here. Apitope, the drug discovery and development company focused on disease-modifying treatments that reinstate immune tolerance, announced today that pre-clinical product candidate ATX-F8-117 has been granted Orphan Drug Status by the US Food and Drug […]

Industry News

FDA Approves New Hemophilia B Treatment

  Note: This is an edited version of a Emergent BioSolutions Inc. press release. To read the full release, click here. Emergent BioSolutions Inc. announced on Thursday, April 29 the U.S. Food and Drug Administration (FDA) has approved IXINITY®, an intravenous recombinant human coagulation factor IX therapeutic for the control and prevention of bleeding episodes and for perioperative management […]

Industry News

CSL Behring Renews Pledge to World Federation of Hemophilia

  In recognition of World Hemophilia Day April 17, the World Federation of Hemophilia (WFH) and CSL Behring announced today that CSL Behring has once again committed to donating bleeding disorder protein therapy international units (IUs) to the WFH Global Alliance for Progress (GAP) Program and other WFH programs, as well as making significant financial […]

Industry News

Kedrion Announces Safer Manufacture Process for Koate Antihemophilic Factor

Note: This is an edited version of a Kedrion press release. To read the full release, click here.  ____________________ Kedrion Biopharma proudly announced that Koate® Double Viral Inactivation (DVI) Antihemophilic Factor (human) is now being manufactured using a process that further enhances the safety and purity of that product. Koate-DVI is used in the treatment […]

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