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Sidebar: Biologics In The Spotlight: Amgen’s Denosumab

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Denosumab is one of the highest profile products under review, and Amgen is extremely confident in its chances for approval. "It's extremely unlikely that d-mab will not gain registration," Amgen Exec VP-R&D Roger Perlmutter declared during an interview Jan. 26. He described denosumab as "an enormously large clinical program … among the largest ever for registration-enabling trials." Over 11,000 patients were studied in six late-stage trials ("The Pink Sheet," Feb. 2, 2009, p. 19).

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