“Disturbing” Proposed Patient Population Trips Up Sanofi’s Semuloparin Before ODAC

This article was originally published in The Pink Sheet Daily

20 Jun 2012
News

Martin Berman-Gorvine m.berman-gorvine@elsevier.com

Executive Summary

FDA’s Oncologic Drugs Advisory Committee recommends by a 14-1 vote, with one abstention, that the agency not approve the low molecular weight heparin for a population of cancer patients that is too broadly defined.

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United States

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Advisory Committees

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Sanofi-Aventis US LLC

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“Disturbing” Proposed Patient Population Trips Up Sanofi’s Semuloparin Before ODAC

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