Chugai's Bispecific Antibody "Emicizumab" Global Phase III Data in Patients with Haemophilia A with Inhibitors Published in The New England Journal of Medicine Online
Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the data from HAVEN 1 study (NCT02622321) was published in the online version of The New England Journal of Medicine (NEJM). This global phase III study examined Chugai’s bispecific antibody emicizumab in adults and adolescents 12 years of age or older with haemophilia A with inhibitors. Results of HAVEN 1 study and the interim analysis of HAVEN 2 study (NCT02795767), a global phase III study of emicizumab in paediatric patients with haemophilia A with inhibitors, are presented today at the 26th International Society on Thrombosis and Haemostasis (ISTH) Meeting in Berlin.
“HAVEN 1 study is the first global phase III study for emicizumab. This important data provides the body of evidence for the upcoming new drug application,” said Chugai’s President & COO, Tatsuro Kosaka. “The interim analysis of HAVEN 2 study showed that emicizumab offers benefit for children as well. Chugai is committed to provide a new treatment option as soon as possible for the disease which may severely affect patients' life.”
Chugai is currently preparing to file the new drug application in Japan for emicizumab based on the data of HAVEN 1 study and the interim analysis of HAVEN 2 study. These data have been filed with the US Food and Drug Administration (FDA) and the European Medicines Agency by Roche. Emicizumab was designated as a Breakthrough Therapy by the FDA for the prophylactic treatment of people who are 12 years or older with haemophilia A with factor VIII inhibitor in September 2015.
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
For US media
Chugai Pharma USA Inc.
For European media
Chugai Pharma France SAS
For Taiwanese media
Chugai Pharma Taiwan Ltd.
Susan Chou, Osamu Kagawa
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Ipsen Receives Approval from European Commission for Xermelo® (Telotristat Ethyl) for the Treatment of Carcinoid Syndrome Diarrhea in Patients Inadequately Controlled by Somatostatin Analogue Therapy19.9.2017 19:00 | Tiedote
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, today announced that the European Commission has approved Xermelo® (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy. This approval allows for the marketing of Xermelo® (telotristat ethyl) in the above indication in all 28 member states of the European Union, Norway and Iceland. David Meek, Chief Executive Officer, Ipsen stated: “We are delighted to provide patients suffering from inadequately controlled carcinoid syndrome with a new treatment option in combination with a somatostatin analogue that demonstrates both efficacy and safety in particularly improving diarrhea, a most debilitating symptom. Xe
6th Annual World Patient Safety, Science & Technology Summit to Be Held in London, England19.9.2017 18:00 | Tiedote
The Patient Safety Movement Foundation (PSMF) announces that the 6th Annual World Patient Safety, Science & Technology Summit will take place in London on February 23-25, 2018. Rt. Hon. Jeremy Hunt MP, the Secretary of State for Health from England’s Department of Health, invited PSMF to hold its 6th annual Summit in London during his speech at the Summit in February of this year. This is the first time the Summit will be held outside of the United States. Over the years, the PSMF has taken an increasingly international scope to reach zero preventable patient deaths by 2020. They currently have over 30 Regional Chapters around the world and partnerships with global organizations such as the World Federation of Societies of Anaesthesiologists (WFSA), European Society of Anaesthesiology (ESA), Global Sepsis Alliance (GSA), the Taiwan Patient Safety Culture Club, Sistema Españo
Vertex Announces Upcoming Presentations of Data at 2017 North American Cystic Fibrosis Conference19.9.2017 17:50 | Tiedote
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 11 abstracts from its cystic fibrosis (CF) research and development program will be presented at the annual North American Cystic Fibrosis Conference (NACFC) in Indianapolis, November 2 to 4, 2017. Previously announced data from the Phase 3 EVOLVE and EXPAND studies of the investigational tezacaftor/ivacaftor combination in people with CF ages 12 and older who have certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene will be presented for the first time. Additionally, data from the Phase 3 extension study of ORKAMBI® (lumacaftor/ivacaftor) in children with CF ages 6 to 11 who have two copies of the F508del mutation and real-world KALYDECO® (ivacaftor) data will be presented. The company also submitted an abstract for the late-breaking poster session with previously announced Phase 1
Biker Summer 2017 campaign: Last Chance to Win Great Prizes from Moto-tyres.co.uk19.9.2017 16:57 | Tiedote
Moto-tyres.co.uk wants to know: For the fifth year in a row, the online motorbike shop is asking bikers from ten European countries about their Biker Summer 2017 travel plans, favourite destinations and longest tours. For survey participants, Moto-tyres.co.uk and its sister shops in other European countries are raffling prizes to get every biker’s heart beating faster, including vouchers for new motorbike tyres, a GARMIN motorbike GPS navigation system, and a GoPro camera with helmet attachment. For more information and a link to the survey, go to: www.moto-tyres.co.uk/promotion-biker-summer-2017.html. The Biker Summer 2017 campaign is running until 30th September 2017 – so you still have time to join in and win top-quality equipment for your next bike tour. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170919006105/en/
Andersen Global Expands into Uruguay19.9.2017 16:30 | Tiedote
Andersen Global announces its expansion into Uruguay through a Collaboration Agreement with Fischer & Schickendantz, one of the country’s leading law firms. The addition of Fischer & Schickendantz continues Andersen Global’s expansion and robust presence within the Latin American region. The team is led by Managing Partner, Juan Federico Fischer. “The addition of Juan Federico and the individuals at Fischer & Schickendantz bring a new depth to our team and our business development efforts in South America, while allowing us to deliver additional services in the region,” said Andersen Tax CEO, Mark Vorsatz. “Uruguay is the next major step in our firm’s growth and is an excellent complement for Andersen Global. The ability to provide a full scope of services in Uruguay offers significant advantages, especially given their large cross border client base and Uruguay’s increase
Horizon Petroleum Enters into Definitive Agreements to Acquire Concessions in Poland19.9.2017 16:05 | Tiedote
Horizon Petroleum Ltd. (the “Company” or “Horizon”) (TSXV:HPL) is pleased to report that further to its press releases dated June 23, 2017, and July 26, 2017, it has entered into a series of definitive agreements (the “Agreements”) with Dublin-based San Leon Energy plc (“SLE”) regarding the purchase from wholly-owned subsidiaries of SLE and other SLE-controlled entities, of 100% interests in 2 oil & gas concessions in the Republic of Poland known as Cieszyn and Bielsko-Biala (the “Primary Concessions”), plus 100% working interests in 2 additional oil & gas concessions in Poland known as Prusice and Kotlarka, and another concession which is under application (together the “Secondary Concessions”). These concessions cover 3,030km2 and lie within the prolific Rotliegendes Basin and Carpathian Foldbelt, where Horizon intends to target undeveloped conventional natural gas discoveries. Gas infr
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme