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Dendreon Provenge BLA gets rolling

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Dendreon expects to complete its rolling BLA for its prostate cancer vaccine Provenge (sipuleucel-T) "later this year," the firm announces Aug. 24. The biotech initiated a rolling BLA for metastatic, hormone-refractory prostate cancer with the submission of the clinical and non-clinical portions of the package, leaving the chemistry, manufacturing and controls section to be submitted later in 2007...
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