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Industry News

Kedrion Announces Voluntary, Temporary Hold on Koate-DVI

Kedrion Biopharma provided the following announcement today: Koate®-DVI Summer Supply Statement Kedrion Biopharma has placed a voluntary, temporary hold on further shipments of Koate-DVI until approximately the September timeframe. The company is working to restore supplies of Koate-DVI as soon as possible so that it can be made available to patients who require it. This is being […]

Industry News

uniQure Announces Data from Phase I/II AMT-060 Clinical Trial

Note: The below is an edited version of a press release by UniQure. The original release can be read in it’s entirety here. On June 11, 2016, uniQure N.V. announced that additional data from its Phase I/II clinical trial of AMT-060 in hemophilia B patients were presented at the 21st Congress of the European Hematology Association (EHA) in Copenhagen, […]

Industry News

Spark Therapeutics Announces Updated Data from Hemophilia B Trial

Note: The below is an edited version of a press release by Spark Therapeutics. The original release can be read in it’s entirety here. PHILADELPHIA, June 13, 2016 – Spark Therapeutics announced today updated results of the first cohort from the ongoing Phase 1/2 clinical trial of SPK-9001, the lead investigational candidate in its SPK-FIX program, which is being studied for the […]

Industry News

Shire Completes Combination with Baxalta

Today, June 3, 2016, Shire completed its previously announced acquisition with Baxalta Incorporated. The combined company is expected to deliver over $20 billion in annual revenues by 2020. The company is focused on serving patients with rare diseases and other highly specialized conditions. Read the press release from Shire in it’s entirety here.   About Shire  […]

Industry News

FDA Approves First Single Chain Product for Hemophilia A

Note: The below is an edited version of a press release by CSL Behring. The original release can be read in it’s entirety here. KING OF PRUSSIA, Pa., May 26, 2016 — CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved AFSTYLA [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor […]

Industry News

Biogen Announces Intent to Spin off Its Hemophilia Business

Note: The below is an edited version of a press release from Biogen Inc. The original release can be read in its entirety here. Biogen Inc. announced on Tuesday, May 3, 2016 that it intends to spin off its hemophilia business as an independent, publicly traded company. The strategic goal of this transaction is to […]

Industry News

FDA Approves Needle-Free Transfer Device for Hemophilia A Product

Note: The following in an edited press release from Kedrion Biopharma. The original release can be read in its entirety here. Kedrion Biopharma has gained approval from the U.S. Food and Drug Administration to package Koāte® Double Viral Inactivation (DVI) Antihemophilic Factor (human) with Mix2Vial™, a needle-free transfer device. The new packaging is designed to offer hemophilia […]

Industry News

FDA Approves New Recombinant Factor Following LEOPOLD Trials

Note: The following is an edited version of a press release from Bayer. The original press release can be found here.  The U.S. Food and Drug Administration (FDA) has approved Bayer’s KOVALTRY® Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. The approval is based […]

Industry News

FDA Approves First 14-Day Hemophilia B Treatment

Note: The following is an edited form of a press release from the FDA . The original form of the release can be read here. The U.S. Food and Drug Administration approved on Friday, March 4, Idelvion, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, for use in children and adults with Hemophilia B. Idelvion is the […]

Industry News

FDA Gives Orphan Drug Designation for Hemophilia A Gene Therapy

Note: The below is an edited version of a press release by BioMarin Pharmaceutical Inc. The original release can be read in its entirety here. BioMarin Pharmaceutical Inc. announced on Tuesday, March 1, that BMN 270, an investigational gene therapy for the treatment of patients with hemophilia A, has been granted orphan drug designation by […]

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