Margarida Azevedo, MSc,  —

Shire Korea recently received approval from South Korea’s Ministry of Food and Drug Safety for Adynovate (BAX 855), a long-lasting factor VIII gene recombinant therapy for hemophilia A. Adynovate is an injectable form of Shire’s Advate, which is Korea’s most commonly used treatment for the blood disorder. Shire Korea…

Chris Bombardier has just made history by becoming the first person with hemophilia ever to scale the seven summits this January. Bombardier climbed each continent’s highest peak to raise awareness for hemophilia — and to show that with adequate training, medical assistance, preparation and willpower, even someone with a bleeding…

Europe’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion supporting the approval of Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in hemophilia A patients with factor VIII inhibitors. Hemlibra is a humanized monoclonal antibody that binds to activated factor IX and factor X to…

Shire recently received marketing authorization from the European Commission for Adynovi [antihemophilic factor (recombinant) PEGylated], enabling access for adults and adolescents throughout Europe seeking treatment for hemophilia A. Adynovi is an extended half-life recombinant factor VIII for on-demand and prophylactic (preventive) use in patients 12 years and…

A novel clinical study called “The Irish Personalized Approach to the Treatment of Hemophilia (iPATH)” will seek to investigate the potential of new personalized treatment approaches in hemophilia by tailoring care based on the needs of individual patients. The collaborative study will be led by the Irish Hemophilia…

The U.S. Food and Drug Administration (FDA) recently granted orphan drug status to rofecoxib (TRM-201), an non-opioid investigational pain treatment for hemophilic arthropathy (HA, a hemophilia degenerative joint disease) under development by Tremeau Pharmaceuticals. Rofecoxib is a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) with a well-established efficacy profile. It…

Chris Bombardier, who aims to become the first person with severe hemophiliac to climb what are known as the world’s Seven Summits, is about to conquer his last, Mount Vinson in Antarctica, with the help of Octapharma USA. The New Jersey-based company has given an unspecified grant to Bombardier…

The U.S. Food and Drug Administration (FDA) recently granted orphan drug status to SHP654 (BAX 888), an investigational factor VIII (FVIII) gene therapy candidate being developed by Shire for the treatment of hemophilia A. Gene therapy allows the delivery of a functional copy of the defective gene.

Look out, Phoenix, there’s a whole lot of zombies heading your way. The Arizona Hemophilia Association (AHA) is teaming up once again with Lerner and Rowe’s Phoenix personal injury law offices and the radio station 98KUPD to hold Zombie Walk 9 in downtown Phoenix on Oct. 28. The fundraising event…

The U.S. Food and Drug Administration (FDA) has granted orphan drug status (ODD) to Catalyst Biosciences’ highly potent recombinant human factor IX variant CB 2679d (also known as ISU304) to treat hemophilia B. Catalyst is evaluating CB 2679d’s potential for subcutaneous prophylactic treatment in people with hemophilia B. The regulatory…