Sidebar: Biologics In The Spotlight: Amgen’s Denosumab
This article was originally published in Pharmaceutical Approvals Monthly
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).
You may also be interested in...
In a Jan. 26 interview, Amgen Executive VP for Research and Development Roger Perlmutter talks about denosumab, follow-on biologics and how Amgen is avoiding the size-related innovation drought that many big pharma companies now face.
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011