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Genzyme Drug Fails to Win FDA Nod

The FDA turned down Genzyme’s application to market clofarabine (Clolar) for patients over age 60 with acute myeloid leukemia, saying the Cambridge, MA-based company should conduct another randomized, controlled clinical trial. The agency’s decision comes about a month after one of its advisory panels recommended the drug not be cleared for the new group of patients, saying Genzyme (NASDAQ: GENZ) lacked data. The product is already approved for a smaller population of children with leukemia.

Luke Timmerman is the National Biotechnology Editor for Xconomy. You can e-mail him at ltimmerman@xconomy.com, call 206-624-2374, or follow him on Twitter at http://twitter.com/ldtimmerman.

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