Thursday, August 14, 2014

Amgen Sees Clinical Trial Failure, Recall

Thousand Oaks-based Amgen reported Wednesday that its Phase 3 clinical trial for its compound Kyprolis--which was being targeted for treatment of multiple myeloma--has failed, and that the study has been discontinued. Separately, in more bad news for the company, it also reported a recall of a number of lots of Aranesp in a number of countries due to a quality control issue. In the Phase 3 clinical trial, which involved 315 patients, Amgen said that its study did not meet its primary endpoint of improving overall survival in patients. The Aranesp recall involved potential presence of cellulose and/or polyester particles in prefilled syringes; the company said it was recalling a number of lots of Aranesp related to those issues, all of which were distributed overseas.

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