CSL Behring and Ferring Pharmaceuticals, Inc have responded to the joint NHF-NHF letter of July 22, 2020, regarding a recent recall of Stimate (desmopressin) nasal spray.
The safety data presented at ISTH was based on an analysis of 193 study participants with hemophilia A and factor VIII inhibitors.
Spark's investigational hemophilia A gene therapy, administered via a one-time intravenous infusion, is designed to trigger the production of therapeutic levels of factor VIII via the liver cells.
Pending regulatory clearance, CSL Behring would acquire exclusive global license rights from uniQure to commercialize etranacogene dezaparvovec, otherwise known as AMT-061.
The factor product donation made by the two companies is in support of the World Federation of Hemophilia's Humanitarian Aid Program.
The updated trial data from BioMarin have been submitted as a late-breaking abstract to the upcoming World Federation of Hemophilia (WFH) Virtual Summit to be held June 14-19, 2020.
BD is conducting a voluntary medical device recall for multiple lots of the BD PosiFlush™ SF (Sterile Field) Saline Flush Syringe 10mL.
Hemlibra® is known to interfere with certain laboratory assays used to measure blood coagulation.
Developing such a treatment would necessitate plasma donations from many people who have fully recovered from COVID-19, and whose blood contains antibodies that can fight the coronavirus.
The halted trials were investigating concizumab prophylaxis treatment in hemophilia A and B patients regardless of inhibitor status.
eNewsletter Sign Up
Steps for Living
Victory for Women
Unite for Bleeding Disorders Walk
Donate Your Car