Regulatory milestones

Amgen Inc. (NASDAQ:AMGN) gained $1.78 to $54.53 last week after the U.K.'s NICE terminated an appraisal of Prolia denosumab to treat therapy-induced bone loss in patients with non-metastatic prostate cancer because the company did not provide an evidence submission. Denosumab is a human mAb targeting receptor activator of NF-kappa B ligand (RANKL; TNFSF11) (see B8).

Celgene Corp. (NASDAQ:CELG) gained $2.40 to $55.15 last week after a NICE appeals panel said the U.K. agency should reappraise Vidaza azacitidine because the original appraisal recommending against NHS use of the cancer drug only included one of two possible comparators. The hypomethy-lating agent is approved to treat myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myelogenous leukemia (AML) in patients who are not eligible for hematopoietic stem cell transplantation (see B9). ...