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FDA Delays PPAR Development Pending Carcinogenicity Tests, Ligand Says

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency is requiring sponsors of PPAR agents to conduct two-year rodent carcinogenicity studies prior to entering into clinical studies longer than six months in duration. Lilly/Ligand’s naveglitazar development will be postponed between 18 and 24 months.

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