NDA
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Dr Reddy’s Laboratories completes first implementation phase of Werum’s standard MES
Dr Reddy’s is the first Indian company to improve its manufacturing processes by installing an electronic PAS-X Manufacturing Execution System (MES). Dr Reddy’s opted for Werum’s MES PAS-X to help enhance the quality and compliance and to optimize the efficiency and productivity of its pharmaceutical shop floor processes.
NDA | 17 January 2012
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Bristol-Myers Squibb Foundation announces collaboration with WHO’s Stop TB Department
To strengthen community based care of tuberculosis including HIV co-infection in five African countries.
NDA | 11 October 2011
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Roche’s investigational medicine T-DM1 shows improvement in progression-free survival compared to standard
First randomised trial of an antibody-drug conjugate (ADC) for metastatic breast cancer highlights importance of personalised approach to cancer care.
NDA | 26 September 2011
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Furiex confirms Takeda's resubmissions of alogliptin NDAs to US FDA
Furiex Pharmaceuticals Inc confirmed that Takeda Pharmaceutical Company Limited has resubmitted two new drug applications (NDAs) for alogliptin to the US Food and Drug Administration (FDA). One application is for marketing approval of alogliptin, and…
NDA | 27 July 2011
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FDA makes recommendation on investigational compound dapagliflozin
Bristol-Myers Squibb company and AstraZeneca reported the outcome of the US Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting on the New Drug Application for the investigational compound dapagliflozin.…
NDA | 20 July 2011
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Gold Standard signs US distribution agreement with Fujirebio
Gold Standard Diagnostics, Corp (GSD) announced the execution of an agreement with Fujirebio Diagnostics to distribute their proprietary Multi-Constituent Tumor Marker Control in the United States. Fujirebio Diagnostics, best known in the US market a…
NDA | 14 July 2011
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The Asia Foundation honors Dr David Ho at Lotus Leadership Awards
The Asia Foundation and The Lotus Circle honor Dr David Ho, Founding Scientific Director and CEO of the Aaron Diamond AIDS Research Center, for his contributions to the health and well-being of Chinese women and children. According to the foundation,…
NDA | 09 June 2011
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Pharmacogenomics becomes standard in over 50 hospitals throughout Taiwan
Pharmigene announced a new milestone in the practice of pharmacogenomics and personalized medicine by partnering with over 50 hospitals across Taiwan. According to the company, healthcare providers at these institutions in Taiwan are utilizing Pharmi…
NDA | 10 March 2011
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Contrave receives positive recommendation from US FDA advisory committee
The US FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 that the available data adequately demonstrate that the potential benefits of Orexigen and Takeda ‘s Contrave (naltrexone sustained release (SR)/bupropion SR) outweigh t…
NDA | 03 March 2011
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Standardized solutions for molecular analysis of FFPE samples
Qiagen has launched several products that assist in the molecular analysis of formalin-fixed, paraffin-embedded (FFPE) tissue samples. The offering provides scientists with a range of dedicated kits over the whole FFPE workflow, from the isolati…
NDA | 21 November 2010
