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F. Hoffmann-La Roche Ltd: Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19
casirivimab
hospitalised patients
Basel, 20 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Japan s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve(casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of hospitalisation and death. In addition, its ability to retain activity against emerging variants, including the Delta variant, has been demonstrated in preclinical studies, said Levi Garraway, M.D., Ph.D., Roche s Chief Medical Officer and Head of Global Product Development. Today s ap
Press Release: Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19 finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.
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Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A. Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once-weekly, every two weeks or every four weeks (after an initial once-weekly dose for the first four weeks). Hemlibra was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed globally by Chugai, Roche and Genentech. It is marketed in the United States by Genentech as Hemlibra (emicizumab-kxwh), with kxwh as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.
F. Hoffmann-La Roche Ltd: New data for Roche s Hemlibra reinforce safety profile in people with haemophilia A
IIIb
haemophilia
Hemlibra
1
STASEY is one of the largest open-label studies primarily assessing safety and tolerability of a medicine for people with
haemophilia
Hemlibra also continued to demonstrate effective bleed control with a high proportion of participants (82.6%) achieving zero treated bleeds
1
Basel, 19 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the final analysis of the phase IIIb STASEY study, which confirm the favourable safety profile of Hemlibra (emicizumab), consistent with the phase III HAVEN clinical programme.
1,2,3,4 In the analysis, no new safety signals were identified with longer-term Hemlibra treatment in adults and adolescents with haemophilia A with inhibitors to factor VIII, the clotting protein that is missing or defective in people with haemophilia A. The data were presented at the virtual International