Updated June 21: News from Novo Nordisk, Potential Under-filling of Some Vials on the Market

medical supplies

Please read the latest update on this issue and addendum as of June 21, 2024. HFA published the original update on June 18, below: Novo Nordisk provided the following update about NovoSeven® RT, Novoeight®, and Esperoct® [antihemophilic factor (recombinant),glycopegylated-exei]. “Novo Nordisk has identified an issue on a specific production line that is manufacturing NovoSeven® RT, Novoeight®, […]

FDA Approves One-Time Gene Therapy for Adults with Hemophilia B

From Pfizer: Pfizer Inc. announced that the US Food and Drug Administration has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing […]

Novo Nordisk Announces Supply Shortage

medical supplies

Novo Nordisk today announced an important update about the Rebinyn®, Coagulation Factor IX (Recombinant), GlycoPEGylated 3000 IU vial size.  From Novo Nordisk: In May 2023, Novo Nordisk launched the Rebinyn® 3000 IU vial size, and the demand for this vial size has outpaced our expectations. This has resulted in a temporary shortage that will lead […]

Takeda Issues Voluntary Product Withdrawal

medical supplies

Takeda today announced that it is conducting a voluntary market withdrawal for two product lots of 650 IU VONVENDI® [von Willebrand factor] in the U.S. Takeda announced that the withdrawal is being conducted out of an abundance of caution due to misprinted product labels with the incorrect expiration date. The expiration date printed on the […]

Novo Nordisk Issues Supply Notice

medical supplies

Novo Nordisk provided the following update about the NovoSeven® RT (coagulation Factor VIIa, recombinant) 8 mg vial. Due to supply constraints, Novo Nordisk will be unable to provide the 8 mg vial of NovoSeven® RT from January until mid-2024. Importantly, the overall supply of NovoSeven® RT is expected to remain intact as other vial sizes are available […]

Update: Takeda to Voluntarily Replace Certain BAXJECT® II Reconstitution Devices

red blood cells

UPDATE as of 8/28/2023 Takeda, in agreement with the U.S. Food and Drug Administration (FDA), has decided to voluntarily replace BAXJECT® II reconstitution devices produced by Baxter between October 2021 and January 2022 co-packaged for use in conjunction with RECOMBINATE™ [Antihemophilic Factor (Recombinant)] and RIXUBIS® [Coagulation [Factor IX (Recombinant)]. Takeda has received reports of white […]

FDA Approves BioMarin’s Gene Therapy for Adults with Severe Hemophilia A

BioMarin Pharmaceutical Inc. today announced the U.S. Food and Drug Administration approved ROCTAVIAN™ (valoctocogene roxaparvovec-rvox) gene therapy for the treatment of adults with severe hemophilia A (congenital factor VIII (FVIII) deficiency with FVIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test. The one-time, single-dose infusion is […]

Sanofi Announces Data Showing Effective Bleed Protection in Children with Severe Hemophilia A

microscope in lab

Pivotal data from the Phase 3 XTEND-Kids study evaluating ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] once-weekly prophylaxis, a factor VIII replacement therapy, in previously treated patients younger than 12 years of age with severe hemophilia A were presented recently in a late-breaking session at the Annual Meeting of the International Society on Thrombosis and […]

FDA Accepts Pfizer’s Review Application for Hemophilia B Gene Therapy Treatment

Pfizer Inc. announced today that the U.S. Food and Drug Administration has accepted for review Pfizer’s Biologics License Application for fidanacogene elaparvovec for the treatment of adults with hemophilia B. Fidanacogene elaparvovec is a novel, investigational gene therapy that contains a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity variant of human coagulation […]

Pfizer Announces Positive Results from Hemophilia A and B Trial

Pfizer Inc. today announced their Phase 3 BASIS clinical trial evaluating marstacimab has met its primary endpoints, having demonstrated statically significant and clinically meaningful effects. Marstacimab, a novel, investigational anti-tissue factor pathway inhibitor (anti-TFPI) being studied for the treatment of hemophilia A or B for people without inhibitors to Factor VIII (FVIII) or Factor IX […]