Roche PPAR Development Delayed By FDA-Required Carcinogenicity Tests
This article was originally published in The Pink Sheet Daily
Executive Summary
Phase III studies for Roche's insulin sensitizer R483 will be postponed pending completion of FDA-required two-year carcinogenicity testing
You may also be interested in...
FDA Delays PPAR Development Pending Carcinogenicity Tests, Ligand Says
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.
Lupus Guidance Suggests Broad Use Of Health-Related Quality Of Life Endpoint
FDA’s draft guidance on systemic lupus erythematosus drug development lists four possible claims that the agency “may be willing to approve”: reduction in disease activity; organ-specific lupus treatment; complete clinical response/remission; and reduction in flares.
RiskMAP Guidance Includes Plans For A Website
FDA is planning to develop a Risk Minimization Action Plan website, an agency risk management guidance states