The American Journal of Managed Care

Comparing Factor Use and Bleed Rates in US Hemophilia A Patients Receiving Prophylaxis With 3 Different Long-Acting Recombinant Factor VIII Products

AFSTYLA ®, Antihemophilic Factor (Recombinant), Single Chain, is contraindicated in patients who have had life-threatening hypersensitivity reactions to AFSTYLA or its excipients, or to hamster ...
The New England Journal of Medicine

BIVV001 Fusion Protein as Factor VIII Replacement Therapy for Hemophilia A

Factor VIII replacement products have improved the care of patients with hemophilia A, but the short half-life of these products affects the patients’ quality of life. The half-life of recombinant ...
Monthly Prescribing Reference

Altuviiio Approved as Once-Weekly Factor VIII Therapy for Hemophilia A

Altuviiio temporarily replaces the missing coagulation factor VIII needed for effective hemostasis. The Food and Drug Administration (FDA) has approved Altuviiio ™ (antihemophilic factor [recombinant] ...
FiercePharma

FDA Approves Bayer's Kogenate® FS Antihemophilic Factor VIII (recombinant) for Routine Prophylaxis in Adults with Hemophilia A

Kogenate® FS antihemophilic factor (recombinant) approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A- Bayer's SPINART study met its ...
FierceBiotech

Baxter Announces Positive Top-Line Results from Its Phase 3 Study of BAX 855, Extended Half-Life Recombinant FVIII for Hemophilia A Patients

DEERFIELD, Ill., August 21, 2014 - Baxter International Inc. (NYSE:BAX) today announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life ...
EurekAlert!

FDA approves Baxter’s ADVATE for the treatment of hemophilia A

Deerfield, Ill., July 25, 2003 -- Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved ADVATE (Antihemophilic Factor (Recombinant), ...
The American Journal of Managed Care

The Benefits of Sustaining High Factor VIII Levels in People With Hemophilia A

Hemophilia A is characterized by FVIII deficiency, leading to joint bleeds and chronic pain despite prophylactic therapy. Treatment options vary in sustaining FVIII levels, with gene therapy and ...
FierceBiotech

Biogen Idec and Swedish Orphan Biovitrum Announce First Patient Dosed in Global Registrational Trial of Long-Lasting Recom

WESTON, Mass. & STOCKHOLM--(BUSINESS WIRE)-- Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (STO: SOBI) today announced that the first patient has been dosed with the companies’ long-lasting ...
Business Wire

Takeda Announces Results from First-of-Its-Kind Phase IIIb/IV Trial PROPEL – a Randomized PK-Guided Prophylaxis Study Evaluating Higher Factor VIII Levels in Hemophilia A ...

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”), the global biotechnology leader in rare diseases, has today announced results ...
WebMD

Altuviiio for Hemophilia A

People with severe hemophilia A are at risk for prolonged bleeding events that can cause serious complications. To prevent these bleeding events, most people with this condition get injections of a ...
RAPS

EMA Finds No Difference in Inhibitor Risk Between Factor VIII Classes

The European Medicines Agency (EMA) on Friday said it could find "no clear and consistent" evidence of a difference in the risk of inhibitor development between recombinant and plasma-derived factor ...