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January 7, 2013
12:46 EDTONXX, BAYRYOnyx Pharmaceuticals expects to initiate Phase 3 carfilzomib trial in 2013
As part of the global commercialization strategy for Kyprolis, Onyx (ONXX) is exploring opportunities in countries outside of the U.S. that consider marketing authorization based on U.S. approval. Onyx expects to pursue agreements with established distributors for regulatory and commercialization activities in those markets. Last week, Onyx and Bayer (BAYRY) announced top-line results from the DECISION trial in patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer. The study met its primary endpoint of improving progression-free survival. Full results are expected to be presented at an upcoming medical meeting. The companies anticipate that this data will form the basis for regulatory submission of Nexavar in the treatment of RAI-refractory differentiated thyroid cancer.In the first half of 2013, enrollment is expected to complete in the RESILIENCE trial, a Phase 3 study comparing capecitabine in combination with sorafenib or placebo for treatment of locally advanced or metastatic HER2-negative breast cancer.
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August 29, 2014
08:18 EDTBAYRYPerrigo among companies showing interest in Omega Pharma, Bloomberg says
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August 26, 2014
08:04 EDTONXXOnyx treatment of Waldenstrom's macroglobulinemia granted orphan status
Oprozomib was granted FDA orphan drug designation as a treatment of Waldenstrom's macroglobulinemia, the agency stated. Reference Link

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