An interim analysis after a median of 12 weeks of prophylaxis with emicizumab showed a “clinically meaningful” reduction in the number of bleeds over time.
The company will donate a minimum of 140 million international units (IU) of factor VIII to the WFH Humanitarian Aid Program over the next five years.
Spark reports that all participants have experienced “consistent and sustained increases in factor IX activity” following administration of SPK-9001.
Shire has announced a phase 3 clinical trial for ADYNOVATE®, the company’s recombinant factor VIII (FVIII) therapy designed using pegylation technology to extend FVIII time in circulation and increase FVIII exposure to enhance bleed prevention.
The trial is Spark's investigational gene transfer candidate for hemophilia A.
A statement from Genentech/Roche regarding the death of a participant in the HAVEN 1 clinical trial.
AbbVie recently announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for glecaprevir/pibrentasvir (G/P).
As of February 1, 2017, the new company, known as Bioverativ, became an independent global biotechnology company focused on hemophilia and other rare blood disorders.
This Breakthrough designated therapy is put on a fast-track approval program from the FDA and could dramatically reduce the frequency of bleeding episodes in people with hemophilia B.
Collaboration will enhance the development of gene therapy tools for people with hemophilia A and B.
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