Regulatory milestones

Amgen Inc. (NASDAQ:AMGN) gained $0.84 to $57.55 last week after an FDA advisory committee decided against recommending any label changes for anemia drug Aranesp darbepoetin alfa. The committee met after the erythropoiesis stimulating agent (ESA) missed both co-primary endpoints in the Phase III TREAT trial in chronic kidney disease patients with Type II diabetes (see B9).

Amylin Pharmaceuticals Inc. (NASDAQ:AMLN) dropped $9.74 (46%) to $11.30 on Wednesday last week after FDA issued a second complete response letter for an NDA for Bydureon exenatide once weekly to treat Type II diabetes. The agency requested a thorough QT (tQT) study with higher exposures of exenatide (see Cover Story)...