Onglyza Obtains Positive Opinion From CHMP
CHMP’ positive opinion on Onglyza to be reviewed by the European Commission
AstraZeneca and Bristol-Myers’ marketing authorisation application for Onglyza (saxagliptin) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), for Onglyza. It is intended for the treatment of type 2 diabetes in adults, and can be used as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea.
The positive response was given following the review of CHMP’ comprehensive clinical development program, that included six core phase-III trials assessing the safety and efficacy of saxagliptin as a once daily therapy. They involved 4,148 patients with type 2 diabetes, including 3,021 patients treated with saxagliptin.
CHMP’ positive opinion on Onglyza will now be reviewed by the European Commission. AstraZeneca and Bristol-Myers Squibb expect the European Commission to issue its decision on a marketing authorisation for Onglyza in the EU in coming months.
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GBI Research, the leading business intelligence provider, has released its latest report, “Nanotechnology in Drug Delivery - Technological Improvements and Novel Approaches to Fulfill High Potential” that provides key data, information and analysis of the major trends and issues affecting the global nano-enabled drug delivery market. The report provides a comprehensive insight into the current and future application of nanotechnology in the drug delivery systems. It also provides an insight into the key drivers and barriers for the market growth. The report also provides a detailed analysis of the trends and its effects on the nano-enabled drug delivery market. The report also talks about the key regulations that affect the nanotechnology research and development and issues related to its use in pharmaceutical market. The report also details some case study of the latest technology being exploited in pharmaceutical industry. The report also provides detailed analysis of major deals that have happened in the nano-enabled drug delivery market landscape. At the end, the report looks into the future players. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts. The nano-enabled drug delivery market has been a high growth market and expected to grow at a faster rate in the near future. According to a study conducted by Willi Paul, and Chandra P. Sharma, the nano-enabled drug delivery market was $1.7 billion in 2009 and expected to reach over $4.8 billion in 2012. The market will witness increased competition, high investment from venture capitalist and government. The M&A and Licensing landscape will see significant changes in the coming future. This is because market is expected to become more lucrative in coming future. The major drivers for the market growth are Increasing acceptance of nano-enabled drugs, and a strong pipeline portfolio. The increasing governmental funding and R&D interest will strengthen the market in future. However, lack of consistent policy on technology transfer, poor R&D facility, and tight audit control and lack of centralized system will restrain the market growth. The nano-enabled drug delivery market has strong pipeline. The pipeline is primarily dominated by molecules in early stage of development. This suggests that the there is high level of R&D investment. This will support the future market and will fuel the licensing activity. Reports Buy online from $3500
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