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New data for Roche s Hemlibra reinforce safety profile in people with haemophilia A

) 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.

Glasgow cityUnited kingdomUnited statesNathalie meetzLevi garrawayPatrick barthKarsten kleineChugai pharmaceutical co ltdInternational society on thrombosisDrug administrationHead of global product developmentWorld federation of hemophiliaRoche groupPharmaceuticals industryRoche group media relationsWorld congress

New Data for Genentech s Hemlibra (emicizumab-kxwh) Reinforce Safety Profile in People With Hemophilia A

Press release content from Business Wire. The AP news staff was not involved in its creation. New Data for Genentech’s Hemlibra (emicizumab-kxwh) Reinforce Safety Profile in People With Hemophilia A July 19, 2021 GMT SOUTH SAN FRANCISCO, Calif. (BUSINESS WIRE) Jul 19, 2021 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from the final analysis of the Phase IIIb STASEY study, which confirm the favorable safety profile of Hemlibra ® (emicizumab-kxwh), consistent with the Phase III HAVEN clinical program. In the analysis, no new safety signals were identified with longer-term Hemlibra treatment in adults and adolescents with hemophilia A with inhibitors to factor VIII, the clotting protein that is missing or defective in people with hemophilia A. The data were presented at the virtual International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress, July 17-21.

United statesSouth san franciscoLevi garrawayKarl mahlerLoren kalmGina truslowAdam pryorChugai pharmaceutical co ltdInternational society on thrombosisRoche groupGlobal product developmentInternational societyGlobal productPrescribing informationMedication guideSerious side

F Hoffmann-La Roche Ltd: New data for Roche s Hemlibra reinforce safety profile in people with haemophilia A

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

Glasgow cityUnited kingdomUnited statesNathalie meetzLevi garrawayJon kaspar bayardKarl mahlerMabthera rituxanGazyva gazyvaroSabine borngrGerard tobinBruno eschliVenclexta venclyxtoBirgit masjostLoren kalmPatrick barth

Roche s Actemra/RoActemra receives FDA EUA for the treatment

Roche s Actemra/RoActemra receives FDA EUA for the treatment
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Roche slashing 300 to 400 jobs in its product development unit

Roche slashing 300 to 400 jobs in its product development unit
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United statesUnited kingdomLevi garrawayFelix arellanoஒன்றுபட்டது மாநிலங்களில்ஒன்றுபட்டது கிஂக்டம்லெவி க்யாரவ