FDA Extends Review Timeline For Stelara
Centocor Ortho Biotech has announced that FDA has extended the review timeline for its biologic license application (BLA) for Stelara (ustekinumab). The application was filed for approval to market Stelara, for treatment of adult patients with moderate-to-severe plaque psoriasis and who are candidates for phototherapy or systemic therapy.
The amendment contains testing results to establish self-life of the product. FDA has requested no additional clinical trial for Stelara
Earlier in June 2008, FDA's Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) had unanimously recommended Stelara for approval. In December 2008, Centocor Ortho Biotech received complete response letter from FDA requesting additional information, including a proposal for a risk evaluation and mitigation strategy.
Jay P. Siegel, M.D. and Chief Biotechnology Officer, Centocor Ortho Biotech, said: we remain focused on collaborating with the FDA and providing the necessary information to support the review and approval of STELARA for the treatment of adults with moderate to severe plaque psoriasis.
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Nanotechnology in Drug Delivery - Technological Improvements and Novel Approaches to Fulfill High Potential
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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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