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Questions raised over clinical value of Sanofi's semuloparin ahead of US FDA committee meeting

This article was originally published in Scrip

Executive Summary

The staff of the US FDA has presented an extremely negative view of the bid by Sanofi-Aventis to market the experimental blood clot preventative semuloparin sodium. In briefing papers prepared for the 20 June meeting where the agency's independent Oncologic Drugs Advisory Committee will issue its advice on Sanofi's new drug application, it offered a significantly different interpretation of trial results than does the company.



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