Almost three years of treatment with SerpinPC was associated with a nearly complete resolution of bleeds and a reduction in the number of affected joints among men with severe hemophilia A or B who participated in a Phase 1/2a clinical trial. The…

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Phase 3 trial evaluating SB-525 (giroctocogene fitelparvovec), an investigational gene therapy for hemophilia A. This pause in study recruitment and dosing was taken to give the agency time to review changes to the AFFINE…

SARS-CoV-2, the virus that causes COVID-19, might have triggered acquired hemophilia A (AHA) in a 65-year-old man with a clinical history of autoimmune thyroid disease, a U.S. case study reports. This case suggests that COVID-19 infection should be considered when looking for potential causes of AHA. The study, “…

Light Chain Bioscience, a unit of Swiss biotech Novimmune, has completed the discovery phase of its collaborative program with Takeda for developing bispecific antibodies — protective proteins produced by the immune system — that mimic the activity of blood clotting factor VIII as a treatment for…

Octapharma announced the launch of the PREVAIL clinical study (NCT03344003), which will investigate the use of Wilate for treatment of hemophilia A patients in Canada who recently have developed inhibitors to a factor VIII (FVIII) concentrate, or have had long-term inhibitors against FVIII. Hemophilia A is a…

The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk’s concizumab, which will be sold under the brand name Alhemo, as a daily treatment to prevent or reduce the frequency of bleeding episodes in certain adults and adolescents with hemophilia. Eligible patients are those with hemophilia…

A report describes — for the first time, according to study authors — the case of a girl who has both hemophilia A and C. To date, only 10 such cases had been documented in medical literature, all occurring in men. The case report authors highlight the importance of…

Dr. Reddy’s Laboratories announced the U.S. launch of a generic version of DDAVP (desmopressin acetate), used to control bleeding in people with mild hemophilia A. The generic is available under the name Desmopressin Acetate Injection USP, 4 micrograms/mL, in a carton of 10 single-dose ampules…

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Sigilon Therapeutics’ Phase 1/2 study evaluating the investigational therapy SIG-001 in adults with severe or moderately severe hemophilia A. The move comes after a serious adverse event (SAE) occurred involving one of the three participants…