Regulatory milestones

Amgen Inc. (NASDAQ:AMGN) gained $1.10 to $55.20 last week after the U.K.'s NICE issued a preliminary appraisal recommending the use of Prolia denosumab for the primary and secondary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures for whom oral bisphosphonates are unsuitable. Prolia is approved in the EU to treat osteoporosis in postmenopausal women at increased risk of fractures(see Online Links, A24).

Human Genome Sciences Inc. (NASDAQ:HGSI) was up $0.93 to $27.44 last week on a pair of announcements. First, the company said approval of a BLA for Zalbin albinterferon alfa-2b to treat chronic HCV is "unlikely" after FDA expressed concerns regarding the product's risk-benefit profile. The PDUFA date for the fusion protein of interferon alpha and albumin is Oct. 4 (see "A Narrowing Window," A11)...