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January 7, 2013
12:46 EDTBAYRY, ONXXOnyx 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.
News For ONXX;BAYRY From The Last 14 Days
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September 28, 2015
07:52 EDTBAYRYIIR Holdings to hold a conference
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September 27, 2015
14:20 EDTBAYRYBayer says receives FDA approval for Betaconnect autoinjector
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September 25, 2015
09:07 EDTBAYRYBayer says Eylea recommended for EU approval in additional indication
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07:22 EDTBAYRYEuropean Society for Medical Oncology to hold a conference
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06:12 EDTBAYRYFDA panel excoriates Bayer for Essure contraceptive device, NY Times reports
A panel of experts collected by the FDA criticized Bayer for manufacturing a contraceptive device, Essure, without collecting data that they say could have helped anticipate risks for women, the New York Times reports. The device has received thousands of complaints from women claiming they were hurt by it, the report says. Reference Link
September 24, 2015
07:45 EDTBAYRYFDA Obstetrics and Gynecology Devices Panel to hold a meeting
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