UniQure recently announced initial clinical data from patients treated in an open-label phase IIb dose-confirmation study of AMT-061, the company’s investigational gene therapy treatment for patients with severe and moderately severe hemophilia B.
CSL Behring is experiencing intermittent supply delays of Mononine®, the company’s human plasma derived factor IX product for treatment of patients with hemophilia B.
Bayer received FDA approval for new extended half-life hemophilia A product for patients 12 yrs and older.
The new vial size will reduce the reconstitution time that was needed to prepare multiple vials for a similar dose.
The therapy is for people with severe and moderately severe hemophilia B.
The therapy in trial is for the prophylactic treatment of individuals with hemophilia A or B with inhibitors.
The company reported on preliminary data from the Phase 1/2 clinical trial designed to evaluate SB-525, the company’s gene therapy program for people with hemophilia A.
The therapy is administered via a one-time intravenous infusion, which is designed to elicit the production of therapeutic levels of factor VIII.
The preliminary injunction was part of an ongoing patent lawsuit.
The first stage will collect data that will be eventually used to evaluate the efficacy and safety of the investigational hemophilia B therapy.
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