Hemophilia Federation of America is a national nonprofit organization that assists, educates and advocates for the bleeding disorders community.
The following is a press release from Bayer regarding a voluntary recall. PATIENTS SHOULD NOT USE THIS PRODUCT! Bayer is voluntarily recalling two lots of Kogenate庐 FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain […]
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聽Ko膩te庐 Double Viral Inactivation (DVI) Antihemophilic Factor (human)聽with Mix2Vial鈩, a needle-free transfer device. The new packaging is designed to offer hemophilia […]
Note: The following is an edited version of a press release from Bayer. The original press release can be found here.聽 The U.S. Food and Drug Administration (FDA) has approved Bayer鈥檚 KOVALTRY庐 Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. The approval is based […]
Note: The below is an edited press release from Alnylam Pharmaceuticals, Inc. The original release can be read in its entirety聽here.聽 Alnylam Pharmaceuticals, Inc. announced on Monday, March 14, 2016, that it has initiated dosing of hemophilia patients with inhibitors in Part D of an ongoing Phase 1 clinical trial evaluating a once-monthly subcutaneous dose […]
Note: This is an edited form of a press release from Octapharma. To read the original release in its entirety,聽click here. Octapharma USA announced on September 15, 2015, that the U.S. Food and Drug Administration (FDA) has approved NUWIQ庐, Antihemophilic Factor (Recombinant), an intravenous therapy for adults and children living with Hemophilia A. The NUWIQ庐 […]
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庐 [Antihemophilic Factor (Recombinant), Fc Fusion Protein] experienced low bleeding rates, Biogen and Swedish Orphan Biovitrum AB (Sobi) announced on Monday, August 10, […]
Note: The following is taken from a press release from the Korean-based Institute for Basic Science. To read the original release, click here. Sufferers of hemophilia live in a perpetual state of stress and anxiety: their joints wear down prematurely and they have bleeding episodes that feel like they will never end. Their bodies lack […]
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 […]
Note: This press release was originally published by Children’s Hospital Los Angeles. To read the original post, please click here. ____________________ Children with hemophilia A require three to four infusions each week to prevent bleeding episodes, chronic pain and joint damage. The effect on quality of life can be significant, due to time and discomfort […]
Note: This is an edited version of a Kedrion press release. To read the full release, click here.聽 ____________________ Kedrion Biopharma proudly announced that Koate庐 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 […]
Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for BAY 81-8973, a recombinant Factor VIII compound. Bayer is seeking FDA approval of the investigational compound, proposed trade name Kovaltry鈩, for the treatment of hemophilia A in children and adults. “Bayer is committed to continually […]
Baxter International Inc. presented additional efficacy and safety data from the Phase III pivotal study of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)] at the 8th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) in Helsinki, Finland. The […]
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