Takeda Provides Update On Combination Of Alogliptin And ACTOS
FDA has extended the review of the New Drug Application
Takeda Global Research & Development Center has received notification from the FDA that it has extended the review of the New Drug Application (NDA) for the fixed-dose combination of alogliptin and ACTOS (pioglitazone HCl).
The NDA for alogliptin and ACTOS was submitted in September 2008, following the NDA submission of alogliptin monotherapy in December 2007.
On March 6, 2009, FDA informed Takeda that based on December 2008 FDA Guidance, the amount of existing alogliptin clinical data in the alogliptin monotherapy NDA, was not sufficient to meet certain statistical requirements. On June 26, FDA asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA Guidance for alogliptin.
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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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