Novartis QVA149 Phase III COPD studies meet primary endpoints
The first three Novartis QVA149 Phase III studies in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints. The SHINE, BRIGHT and ENLIGHTEN studies, which are key components of the IGNITE program, demonstrate the potential of QVA149 in the treatment of COPD. The results of SHINE, with an enrollment of more than 2,100 patients, met the primary endpoint by demonstrating the superiority in trough FEV1 (p<0.001) of once-daily QVA149 compared to once-daily indacaterol or once-daily NVA237 in patients with moderate to severe COPD[1]. In addition, QVA149 showed superiority in trough FEV1 (p<0.001) compared to placebo and open-label tiotropium (18 mcg).
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BYETTA® approved for use with basal insulin in Europe
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced that the European Commission has granted marketing authorization to BYETTA® (exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and/or Actos® (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.
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GSK reinforces commitment to youth training
GSK announced the launch of a new multi-disciplinary apprenticeship scheme. The programme, which will sit alongside GSK's established graduate and undergraduate recruitment schemes, is aimed at 16-24 year olds and will offer positions at the company's UK manufacturing, R&D and corporate sites. The scheme will commence in August this year and GSK will take on 40 apprentices in the first intake. The company has historically taken on a number of engineering apprentices, however this new integrated scheme will offer IT, R&D Laboratory Technician, Manufacturing, Supply Chain management and Artwork Design opportunities.
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Boehringer Ingelheim expands capabilities in biopharmaceutical process science
Boehringer Ingelheim has expanded its biopharmaceutical development and manufacturing capabilities at its cell culture and microbial sites in Biberach, Germany and in Vienna, Austria. These expansions will enhance state-of-the art cell line development with the proprietary BI-HEX® high expression system and microbial strain as well as process development services for the contract manufacturing business. The investment of approximately 17 million Euros included the expansion of Boehringer Ingelheim's current GMP (good manufacturing practice) cell banking, process science, cell line development and quality laboratories, all equipped with the latest technologies.
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Shire receives prestigious EURORDIS Company Award for exemplary work in rare diseases
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that it has received the prestigious Company Award from the European Organisation for Rare Diseases (EURORDIS) for its exemplary work in the field of rare diseases. The EURORDIS Company Award, presented last night at the First International Rare Disease Day Gala Dinner in Brussels, is designed to reward outstanding accomplishments of pioneering companies developing treatments for rare disease.
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European Commission approves new label for Novartis drug Glivec®
Novartis announced that the European Commission (EC) has approved an update to the Glivec® (imatinib)* label to include 36 months of treatment after surgery for adults with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) who met the inclusion criteria of the pivotal study. This extended treatment regimen has been shown to improve recurrence-free survival and overall survival for these patients with KIT+ GIST compared to patients who received 12 months of treatment after surgery[3].
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Sanofi and the Institut Pasteur create four prestigious awards
Sanofi (EURONEXT: SAN and NYSE: SNY) and the Institut Pasteur announced the creation of the Sanofi-Institut Pasteur Awards to encourage scientific excellence in the service of health. Four hundred and eighty thousand euro (480,000 €) will support four innovative research projects demonstrating real progress in the life sciences and providing answers to major healthcare problems, more specifically in four fields: neglected tropical diseases, vaccine innovation, drug resistance, and therapeutic approaches to ageing and regenerative medicine.
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