Once-daily Lyxumia® (lixisenatide) approved for treatment of type 2 diabetes
Sanofi (EURONEXT : SAN and NYSE : SNY) announced that the European Commission has granted Marketing Authorisation in Europe for Lyxumia® (lixisenatide). Lyxumia®, the first once-daily prandial GLP-1 receptor agonist, is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.
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Boehringer Ingelheim and the EFSD call for grant applications in diabetes research
The Boehringer Ingelheim and EFSD diabetes partnership has opened submissions for diabetes research grant applications from across Europe. In a collaboration which aims to stimulate and accelerate European research in diabetes, the EFSD/Boehringer Ingelheim European Diabetes Research Programmes have dedicated more than 2.5 million euros over three years to support research projects targeting specific areas of interest.
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GSK and Theravance announce regulatory submission for ANORO™ (UMEC/VI)
GlaxoSmithKline plc (LSE:GSK) and Theravance, Inc. (NASDAQ: THRX) announced the submission of a regulatory application in the European Union for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD). On 18th December 2012, GSK and Theravance announced the submission of a regulatory application in the United States (US) for UMEC/VI, for patients with COPD.
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Roche to invest 240 million Swiss francs in diagnostics production in Germany
Roche announced plans to invest over 240 million Swiss francs (more than 200 million euros) in its Penzberg biotechnology centre, near Munich, Germany. The plans call for construction of a new production facility, to be known as Diagnostics Operations Complex II (DOCII). The facility is scheduled to be operational in December 2014 and will create 50 new jobs. This further investment in the Penzberg site is a response to sustained global demand for the reagents used in immunoassay testing in laboratories and hospitals.
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Bayer supports pharmaceutical research in Europe
Bayer HealthCare and Leiden University of The Netherlands will coordinate a newly founded international consortium, dubbed "K4DD" (Kinetics for Drug Discovery), which has been launched to explore a novel concept in modern drug discovery and to tackle a big problem in the development of new drugs. Although successful in early phases of development, many drug candidates fail in clinical studies due to lack of efficacy. The new five-year project will focus on 'optimizing binding kinetics' for drug candidates with the goal of improving drug design. The consortium is financially supported with 20 million Euro by Europe's Innovative Medicines Initiative (IMI).
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Abbott's HUMIRA® (Adalimumab) approved for severe active pediatric Crohn's disease
Abbott announced today that the European Commission has approved HUMIRA® (adalimumab) for the treatment of pediatric patients aged 6 to 17 years with severe active Crohn's disease (CD) who failed, are intolerant to, or have contraindications to conventional therapy. With this approval, HUMIRA becomes the first biologic treatment approved for these patients in more than five years. Pediatric CD is a chronic, debilitating condition of the gastrointestinal (GI) tract that affects up to 200,000 children worldwide.
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Bayer's Xarelto® (Rivaroxaban) approved for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE
Bayer HealthCare's oral anticoagulant Xarelto® (rivaroxaban) has been approved by the European Commission (EC) for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults. This approval makes rivaroxaban the only novel oral anticoagulant approved in this indication in the EU. "Approximately 1 in 10 patients who suffer a pulmonary embolism dies, and concerningly, PE remains a leading cause of hospital death," said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development.
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