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Bayer Issues Voluntary Recall of Kogenate FS

October 18, 2017

Note: The following is the full text of an email communication received by HFA from Bayer HealthCare Pharmaceuticals: Bayer in consultation with the FDA has voluntarily recalled approximately 300 vials (part of one lot) of Kogenate® FS, Antihemophilic Factor (Recombinant) in the U.S. as an excipient, used to stabilize the product during manufacturing, may not conform […]

Prescription Benefit Program Changes for Recombinant Clotting Factor Product

October 18, 2016

  It has come to our attention that Helixate FS, a recombinant clotting factor product sold and distributed by CSL Behring, is being removed from prescription benefit programs for a limited number of patients using CVS/Caremark effective January 1, 2017. Patients currently using Helixate FS who have the “Advanced Control Formulary” plan with CVS/Caremark will have the […]

FDA Approves New Recombinant Factor Following LEOPOLD Trials

March 17, 2016

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 […]

Update #3: NHF’s MASAC Assessment on Inhibitor Studies

December 3, 2014

On September 24, 2014, the medical journal, Blood, came out with a study called, Recombinant Factor VIII Products and Inhibitor Development in Previously Untreated Boys with Severe Hemophilia A.  This study suggests that inhibitor incidence is higher in previously untreated patients (PUPs) with severe hemophilia A that are using Kogenate/Helixate.  The World Hemophilia Federation (WHF) issued a statement on October 6, and another […]

Update #2: FDA will Review Study Suggesting Higher Inhibitor Incidence in PUPS

November 20, 2014

On September 24, 2014, the medical journal, Blood, came out with a study called, Recombinant Factor VIII Products and Inhibitor Development in Previously Untreated Boys with Severe Hemophilia A.  This study suggests that inhibitor incidence is higher in previously untreated patients (PUPs) with severe hemophilia A that are using Kogenate/Helixate. The Food and Drug Administration (FDA) and European Medicines Agency (EMA) have […]

Update #1: Study Suggests Higher Inhibitor Incidence in PUPS Using Kogenate/Helixate

October 6, 2014

On September 24, 2014, the medical journal, Blood, came out with a study called, Recombinant Factor VIII Products and Inhibitor Development in Previously Untreated Boys with Severe Hemophilia A.  This study suggests that inhibitor incidence is higher in previously untreated patients (PUPs) with severe Hemophilia A that are using Kogenate/Helixate (Bayer/Nexgen). Click here to read the […]

Bayer to Develop Hemophilia Gene Therapy Treatment

June 23, 2014

Dimension Therapeutics, a Cambridge biotechnology startup, has struck a deal worth up to $252 million with the pharmaceutical giant Bayer HealthCare to develop a gene therapy to treat hemophilia, a rare disease that prevents blood from clotting. The goal of the prospective treatment, which is not yet in clinical trials, is to repair a faulty […]

Bayer Hemophilia Awards Program (BHAP) Recipients

May 19, 2014

Harvard Stem Cell Institute Affiliated Faculty member Juan Melero-Martin, PhD, at Boston Children’s Hospital is one of the 2014 grant recipients of the Bayer Hemophilia Awards Program (BHAP), a unique initiative dedicated to supporting innovative research and educational initiatives that benefit people with hemophilia. This year, Bayer Healthcare awarded more than $2 million in funding […]

FDA Approves Bayer’s Kogenate® FS for Adult Prophylaxis

May 13, 2014

Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Bayer’s Kogenate® FS antihemophilic factor VIII (recombinant), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A. The approval is based on data from the SPINART study, in which 84 patients […]


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