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F. Hoffmann-La Roche Ltd: FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes need for new treatment options 1 Ib This is the 11th Breakthrough Therapy Designation for Roche s haematology Venclexta demonstrating its potential across multiple blood cancers Basel, 21 July 2021 - Roche] study is a phase Ib, open-label, non-randomised, multicentre, dose-finding study evaluating Venclexta/Venclyxto (venetoclax) in combination with azacitidine in treatment-naïve patients with higher-risk myelodysplastic syndromes (MDS) comprising a dose-escalation portion and a safety expansion portion. The primary objectives of the study are to assess the safety profile and pharmacokinetics and determine the recommended phase II dose and dosing schedule of Venclexta/Venclyxto in combination with azacitidine. The response criteria specified in the M15-531 study are based ....
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 pr ....
F. Hoffmann-La Roche Ltd: Roche to present new data at the ISTH 2021 Congress highlighting long-standing commitment to advancing haemophilia A standard of care 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.
Global Rare Disease Market worth US$623.73 Billion by 2031: globenewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from globenewswire.com Daily Mail and Mail on Sunday newspapers.
Roche presents latest advances with immunotherapies in non-Hodgkin lymphoma Data for investigational CD20xCD3 bispecific antibodies and new combination regimens with Polivy showed enhanced clinical benefits for people with non-Hodgkin lymphoma in early studies Basel, 4 June 2021 ‒ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data on its investigational CD20xCD3 T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, and its first-in-class anti-CD79b antibody-drug conjugate, Polivy® (polatuzumab vedotin), in non-Hodgkin lymphoma (NHL) will be presented at the 2021 ASCO Annual Meeting from 4-8 June 2021. “People with difficult-to-treat blood cancers such as non-Hodgkin lymphoma still need more options to help improve outcomes,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are encouraged by promising data from our emerging T-cell engaging bispecific antibodies, m ....