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FDA Law Weekly

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Anemia



Amgen to Participate in Oncologic Drugs Advisory Committee in May



March 15th, 2007

Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) has invited the Company to participate at an upcoming meeting of the Oncologic Drugs Advisory Committee (ODAC). The Company's understanding is that the ODAC will review progress made by Amgen and other sponsors in delineating the effects of erythropoiesis-stimulating agents (ESAs) on survival and tumor progression in cancer patients. The ODAC meeting is scheduled for May 10, 2007.

"We look forward to providing an update to the ODAC on the Aranesp(R) (darbepoetin alfa) 103 trial involving cancer patients with anemia not due to chemotherapy. We have recently posted a detailed synopsis of the...


Source: FDA Law Weekly (2007-03-15)

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