Bristol Antidiabetic Carcinogenicity Data Look Clean; NDA Filing By Year-End?
This article was originally published in The Pink Sheet Daily
Executive Summary
With 80% of data reported, Bristol has "not seen anything that would concern us" about muraglitazar. NDA would be the first in the dual PPAR class after repeated development failures for similar compounds.
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Long-term patient follow-up is extended to two years in light of regulatory concerns about PPAR class safety, firm tells analysts. News is setback for AstraZeneca's near-term cardiovascular pipeline and a boost for Bristol/Merck's muraglitazar.
AstraZeneca's Galida Filing Delayed Until 2007 Due To PPAR Safety Concerns
Long-term patient follow-up is extended to two years in light of regulatory concerns about PPAR class safety, firm tells analysts. News is setback for AstraZeneca's near-term cardiovascular pipeline and a boost for Bristol/Merck's muraglitazar.
Merck Gets Second Chance On Dual PPAR: Will Co-Develop Bristol's Muraglitazar
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