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The amendment, including two bedaquiline-containing treatment arms, will be known as Stream 2. It is part of the post-approval requirements for bedaquiline from both US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and is accepted as an alternative to the initially planned Phase III trial of Sirturo.As clinical trials continue to grow in size and complexity, more and more companies are adopting software-as-a-service applications as an effective means of data management, without the hassle of bu2014/11/10
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Janssen and The Union collaborate to evaluate bedaquiline in MDR-TBJanssen Research & Development has partnered with the International Union Against Tuberculosis and Lung Disease (The Union) to include Sirturo (bedaquiline) in the Stream study. The Stream study2014/11/10
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GSK seeks regulatory approvals for eosinophilic asthma drug in US and EuropeBritish drug-maker GlaxoSmithKline (GSK) has submitted regulatory applications in the US and Europe for approval of its to treat patients with severe eosinophilic asthma. Mepolizumab is an investigat2014/11/7
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Abide Therapeutics and University of Oxford to explore new drug targetsAbide Therapeutics has partnered with the University of Oxford and the Oxford University Hospitals NHS Trust to examine the therapeutic potential of serine hydrolases, the enzyme classes with validate2014/11/7
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A New Formulation Line for Insulin VialsThe Danish pharmaceutical group Novo Nordisk has chosen Bürkert, the fluid control specialists, to equip its latest production line for the formulation of insulin vials at its site in Chartres, France2014/11/7
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Roche’s Basel Site Expansion, Basel, SwitzerlandRoche, the world's fourthbiggest pharmaceutical companyof 2014, announced its investment plans on a major infrastructure development project at its Basel site in Switzerland in October 2014. The deve2014/11/6
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BMS signs exclusive option deal to buy Danish Galecto BiotechBristol-Myers Squibb (BMS) has entered into an exclusive option agreement to acquire Denmark-based Galecto Biotech and receive worldwide rights to its inhaled inhibitor of galectin-3, TD139. Galectin2014/11/6
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Astellas and Proteostasis partner to develop therapeutic candidates for UPRJapan-based Astellas Pharma has partnered with Proteostasis Therapeutics for research, development and commercialisation of therapies, which modulate the unfolded protein response (UPR). Under the de2014/11/6
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Bayer acquires Chinese Dihon Pharmaceutical for €460mGermany-based Bayer has completed the acquisition of China-based Dihon Pharmaceutical Group, for CNY3.6bn (€460m). Dihon produces over-the-counter (OTC) dermatology products and herbal traditional Ch2014/11/5
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Pharming and Salix introduce acute angioedema treatment Ruconest in USPharming Group and Salix Pharmaceuticals have introduced Ruconest (C1 esterase inhibitor [recombinant]) 50IU/kg in the US, a treatment developed to treat acute angioedema attacks in adult and adolesce2014/11/5