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Bristol Expects FDA Advisory Committee Review Of Muraglitazar

This article was originally published in The Pink Sheet Daily

Executive Summary

Bristol-Myers Squibb expects FDA will hold an advisory committee meeting to discuss the application for its dual PPAR agonist muraglitazar

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Bristol's Abatacept Launch Supply Limited Until FDA Clears Contract Facility

Company faces the possibility of nearly 12 months of limited supply of the rheumatoid arthritis therapy until third-party manufacturer Lonza is approved by FDA, which could occur in mid-2006. Bristol completed the abatacept rolling BLA at the end of March and has requested a priority review.

Drug Safety Issues Will Raise Regulatory Expectations, Bristol Says

Bristol expects a more critical regulatory environment for its recently submitted muraglitazar NDA. Greater scrutiny by FDA could translate into more focused labeling, CEO Dolan says.

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