US FDA Accepts Review for CSL Behring's BLA for rIX-FP for Hemophilia B
The FDA has accepted for review the Biologics License Application (BLA) for the marketing authorization of CSL Behring's long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). Approval would provide hemophilia B patients a long-acting treatment option. See full story at newswire.ca
OPKO Submits to Initiate Phase 2a Trial for Long-Acting Coagulation Factor VIIa-CTP to Treat Hemophilia
OPKO health, Inc. announced the submission of an Investigational New Drug Application to the FDA to conduct a Phase 2a study of OPKO's long-acting version of coagulation Factor VIIa for the treatment of hemophilia A and B patients with inhibitors to Factor VIII or Factor IX. See full story at businesswire.com.
Biogen Idec, Fondazione Telethon and Ospedale San Raffaele Announce Collaboration to Develop Gene Therapies for Hemophilia
Fondazione Telethon and Ospedale San Raffaele have entered into a collaboration with Biogen Idec to develop gene therapies for the treatment of both hemophilia A and B. Research into gene therapy strategies is hoped to provide new approaches for lasting therapy for hemophilia. See full story at pipelinereview.com
Baxter seeks FDA approval for BAX111 to treat Von Willebrand disease
Baxter International has submitted to the FDA for the approval of BAX111, the first highly-purified recombinant von Willebrand Factor (rVWF), that is currently in development as a treatment for patients with Von Willebrand disease, the most common type of inherited bleeding disorder. See full story at pharmabiz.com
FDA Approves Obizur for Treatment of Acquired Hemophilia A
The US Food and Drug Administration approved the use of Obizur for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency. See full story at fda.gov.
NSAIDs Linked to Increased Venous Thromboembolism Risk
Nonsteroidal anti-inflammatory drugs (NSAIDs) may almost double the risk for venous thromboembolism (VTE), including deep venous thrombosis and pulmonary embolism, according to an article published online September 24 in Rheumatology. See full story at Medscape.com (free registration may be required)
The HTC Has Also Joined Twitter! Follow Us and Get Involved!
The HTC has joined Twitter and created a profile here: https://twitter.com/HTCColorado
. Any of our patients, families, fellow providers and other interested parties are welcome to follow us and keep up with the latest news, events and information about our center and the disorders we treat.
See our Social Media page for more.
The HTC Has Joined Facebook. Like Our Page and Connect With Us Today!
The HTC has joined Facebook by creating a page here: https://www.facebook.com/ColoradoHTC If Facebook is a social media tool our patients and families use, we hope they will connect with us and keep up with the latest news, events and information about our center, hemophilia, bleeding and clotting disorders and pediatric stroke. See our Social Media page here.