Ebb & Flow

Amgen Inc. (NASDAQ:AMGN) gained $0.90 to $57.38 last week after FDA approved a REMS for the use of erythropoiesis-stimulating agents (ESAs) in cancer patients. Amgen markets Aranesp darbepoetin alfa for cancer and renal indications and Epogen epoetin alfa for chronic renal failure, and Johnson & Johnson (NYSE:JNJ) markets Procrit epoetin alfa for oncology indications (see "APPRISE is Enough," A12).

Separately, after market on Friday, FDA accepted a response to an October complete response letter for Amgen's Prolia denosumab to treat postmenopausal osteoporosis. The agency designated the response a Class 2 resubmission and assigned a July 25 PDUFA date...