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FDA Advisory Committee Recommends Randomized Trial to Support Proposed Indication for Clolar in Adult AML
Genzyme, 09/02/09

Genzyme Corporation announced that the FDA's Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar in adult myeloid leukemia. The committee found that the single–arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessary to better interpret Clolar's efficacy and safety in the proposed patient population.

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Data Presented at San Antonio Breast Cancer Symposium Demonstrate Treatment with Denosumab is Superior to the Standard of Care
Amgen, 12/11/09

A phase I dose-escalation and bioavailability study of oral and intravenous formulations of erlotinib (Tarceva, OSI-774) in patients with advanced solid tumors of epithelial origin
Cancer Chemotherapy and Pharmacology, 12/11/09

Repligen Reports Phase 3 Clinical Trial Results of RG1068 in Pancreatic Imaging
Repligen, 12/10/09

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