FDA grants expanded approval to wilate as the first VWF concentrate for prophylaxis in all types of von Willebrand disease – Octapharma

Octapharma USA announced the expansion of the FDA approval for wilate, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection. The approved label now includes routine prophylaxis aimed at reducing the frequency of bleeding episodes in adults and children aged 6 and older with any type of von Willebrand disease (VWD), the most prevalent bleeding […]

Late-breaking efanesoctocog alfa data presented at ISTH demonstrates highly effective bleed protection in children with severe haemophilia A with once-weekly dosing – SOBI + Sanofi

Pivotal data from the Phase III XTEND-Kids study evaluating efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] once-weekly prophylaxis in previously treated patients younger than 12 years of age with severe haemophilia A were presented in a late-breaking session at the Annual Meeting of the International Society on Thrombosis and Haemostasis (ISTH) in Montreal, Canada. The oral presentation detailed results […]

CHMP positive for Mircera to treat paediatric patients with anaemia associated with CKD – Roche

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mircera (methoxypolyethylene glycolepoetin beta). The marketing authorisation holder for this medicinal product is Roche Registration GmbH. The CHMP adopted an extension to an existing indication for use in paediatric patients. For information, the […]

CHMP extends the indication of Refixia to prophylaxis of bleeding in patients 12 years and above with haemophilia B – Novo Nordisk

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FDA approval for SurVeil drug-coated balloon for percutaneous transluminal angioplasty – Abbott

Surmodics, Inc. announced the receipt of FDA approval for the SurVeil drug-coated balloon (DCB). The SurVeil DCB may now be marketed and sold in the U.S. to physicians for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions (less than 180 mm in length) in femoral and popliteal arteries having reference vessel diameters of 4 mm […]

Monthly injections of fitusiran reduces bleeds in patients with haemophilia A and B

Monthly prophylactic injections of fitusiran are effective in reducing bleeds in patients with haemophillia A or B, according to randomised controlled trials publishing simultaneously in The Lancet and The Lancet Haematology journals. Haemophilia is a lifelong, inherited bleeding disorder, which mostly affects men and results in patients with haemophilia A or B missing partially or completely different clotting factor – natural proteins that help […]

Novel AI blood test detects liver cancer

A novel artificial intelligence blood testing technology developed and used by Johns Hopkins Kimmel Cancer Center researchers to successfully detect lung cancer in a 2021 study has now detected more than 80% of liver cancers in a new study of 724 people. The blood test, called DELFI (DNA evaluation of fragments for early interception) detects fragmentation changes among DNA from […]

Researchers find treatment options for patients whose blood cancer relapses after CAR-T

Mount Sinai and Memorial Sloan Kettering Cancer Center (MSK) researchers have identified therapies that can help patients with the blood cancer multiple myeloma who try an immunotherapy known as CAR-T only to find their cancer coming back afterwards. CAR-T, short for chimeric antigen receptor T-cell therapy, enlists immune cells called T cells to fight multiple myeloma by altering them in […]

Tenecteplase outperforms standard stroke treatment

Tenecteplase, a clot buster used off-label for treating ischemic stroke, outperforms alteplase, the standard treatment, in health outcomes and cost, researchers reported on September 23, 2022 in Stroke. Tenecteplase is administered in a single five- to 10-second intravenous injection. Alteplase is injected over a 60-minute period. “When it comes to treating patients with a stroke, every second matters,” said lead […]