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US Bioservices Working with MedImpact to Offer Select Services to Members with Hemophilia

US Bioservices, a specialty pharmacy, announced that it is working with the pharmacy benefit management company MedImpact to dispense prescriptions and select services through the MedImpact Direct Specialty Program for the hemophilia community. Under the collaboration, US Bioservices will offer hemophilia patients who are MedImpact members the opportunity to…

FDA Grants Priority Review to Hemlibra for Treatment of Hemophilia A Without Factor VIII Inhibitors

Hemlibra (emicizumab-kxwh) was recently granted priority review status by the U.S. Food and Drug Administration following the agency’s acceptance of Genentech’s supplemental biologics license application (sBLA) for the treatment for people with hemophilia A without factor VIII inhibitors. Priority review status is granted to therapies that could…

BIVV001 Extends Lifetime of Hemophilia A Replacement Therapy, Early Trial Data Shows

Preliminary results of a Phase 1/2a trial of the hemophilia A experimental treatment BIVV001 show a significant extension of replacement therapy lifetime in the blood, Bioverativ announced. The ongoing, and still recruiting, open-label, multicenter EXTEN-A study (NCT03205163) is evaluating the safety, tolerability, and pharmacokinetics of a single intravenous injection…

Hemlibra Looks to Reach ‘Ultimate Goal’ of Treating All with Hemophilia A and with Choice in Dosing, Genentech Director Says

Should regulatory authorities agree with favorable results from Genentech’s ongoing Phase 3 studies of Hemlibra (emicizumab-kxwh),  hemophilia A patients may have a treatment they can use regardless of inhibitor status, with a choice of three dosing schedules that might better match their lifestyle and preferences. “The ultimate goal for…