FDA Warns of Serious Drug Interaction with Hepatitis C Drugs Harvoni & Sovaldi
The FDA warned that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. See full announcement at FDA.gov.
One-Time Dose of Gene Therapy in Animal Testing Treats Hemophilia B
An ongoing study suggests a new type of gene therapy can safely treat hemophilia B by using a virus to swap out faulty genes with new clotting (factor IX) genes. The research was done at the University of North Carolina. See full article at futurity.org.
Study Uses Gene Therapy to Produce Mutated Protein as Tool for Hemophilia
Using gene therapy to produce a mutant human protein with unusually high blood clotting power, scientists have successfully treated dogs with the bleeding disorder hemophilia, without triggering an unwanted immune response. See full story at medicalxpress.com.
FDA Accepts Bayer's Biologics License Application for BAY 81-8973 to treat hemophilia A in Children and Adults
Bayer Healthcare announced that the FDA has accepted the company's Biologics License Application (BLA) for BAY 81-8973, a recombinant Factor VIII compound. Bayer is seeking approval of the investigational compound, proposed trade name KovaltryTM, for the treatment of hemophilia A in children and adults. See full story at news-medical.net.
Biogen Idec & Sobi Report Positive Results from Phase III Alprolix Pediatric Study
Biogen Idec and Swedish Orphan Biovitrum AB (Sobi) announced positive top-line results of the Kids B-LONG Phase 3 clinical study that evaluated safety, efficacy and pharmacokinetics of Alprolix for treatment of children under age 12 with severe hemophilia B. See full story at marketwatch.com.
Acquired Hemophilia A Successfully Treated with Rituximab
The Mediterranean Journal of Hematology and Infectious Diseases reports on a case where Hemophilia A was successfully treated with the drug Rituximab. The research case confirms Rituximab may be a safe and useful tool to treat AHA. See synopsis at HFA.com and full story at mjhid.org.
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