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.
NHF will update this page as more statements about product supply become available.
XINITY® is currently indicated for the control and prevention of bleeding episodes and for perioperative management in adults and children, 12 years of age or older, with hemophilia B.
On December 23rd, the BioMarin submitted a Biologics License Application for valoctocogene roxaparvovec to the U.S. Food and Drug Administration.
Sangamo transferred the investigational new drug application for their hemophilia A gene therapy candidate to Pfizer, which will now lead its phase 3 clinical development.
Roche is poised to aquire Spark Therapeutics and it's hemophilia A gene therapy portfolio for $4.3 billion.
The FDA first approved Jivi® in August 2018 for the treatment of hemophilia A in adolescents and adults 12 years of age and over, including for prophylactic, on-demand and perioperative management of bleeding.
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