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The ODAC recommendation is based on two Phase II studies of Perjeta in high-risk, HER2-positive early-stage breast cancer, while an ongoing Phase III trial will further evaluate Perjeta in the adjuvant setting (after surgery) and compares Perjeta, Herceptin and chemotherapy with Herceptin and chemotherapy in people with HER2-positive early stage breast cancer. The study has completed enrollment with 4,800 people, and the primary endpoint is invasive disease-free survival; data are expected in 2016.
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Amazon is not alone in facing criticism for its tax arrangements. Others including web search leader Google and iPhone maker Apple have come under fire for similar methods to move profits to jurisdictions where they will pay less tax. Both say they follow tax rules wherever they operate.
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