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.
The update reported on a Phase 1/2 clinical trial for the company’s investigational therapy for the treatment of patients with severe hemophilia B/factor IX (FIX) deficiency.
The new web portal for patients and caregivers is intended to provide timely and accurate information on targeted serious adverse events of interest for HEMLIBRA.
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