GenEng News  Jul 17  Comment 
Amgen and UCB have acknowledged that their Biologics License Application (BLA) for Evenity™ (romosozumab) has been rejected by the FDA. The companies said yesterday that they received a Complete Response Letter asking them to include in...
Financial Times  May 22  Comment 
Drugmaker’s shares plunge on fears osteoporosis medication will not win approval
MarketWatch  May 22  Comment 
Amgen Inc. shares dropped 1.9% in morning trade Monday after the company said that it has observed new cardiovascular risks for its Evenity drug, which is intended to reduce risk of fractures in patients with osteoporosis, and that it does not...
FierceBiotech  May 22  Comment 
Amgen and UCB's romosozumab trounced a comparator drug in a trial in osteoporosis, but there's a big catch: The therapy seems to cause side effects that will delay and could scupper its chances of reaching the market.
GenEng News  May 22  Comment 
Amgen and UCB’s bone-forming antibody drug candidate Evenity™ (romosozumab) met primary and secondary endpoints in the Phase III ARCH study in postmenopausal women with osteoporosis at high risk of fracture. However, women treated using the...
MedPage Today  Mar 6  Comment 
(MedPage Today) -- Met primary efficacy goals versus placebo; third trial still to come

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