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| Updated Sep. 1, 2010 |
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FDA-ODAC Votes To Remove Avastin’s Breast Cancer Indication
POSTED: 7/21/2010 Bevacizumab (Avastin, Genentech) is likely to lose its breast cancer indication, if the FDA follows the advice of its Oncologic Drugs Advisory Committee (ODAC). On Tuesday, the ODAC voted 12 to 1 to remove bevacizumab’s indication as a first-line treatment for metastatic breast cancer. read more | |
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Genetic Warfarin Test Reduces Hospitalizations
POSTED: 7/8/2010 Genotyping patients taking warfarin to determine their sensitivity to the drug resulted in a 30% reduction in all-cause hospitalizations and hospitalizations for bleeding and thromboemboli, according to research presented at the American College of Cardiology 2010 Scientific Sessions. read more | |
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Mylotarg Withdrawn From Market
POSTED: 7/6/2010 Pfizer Inc. has voluntarily withdrawn gemtuzumab ozogamicin (Mylotarg), a drug for patients with acute myeloid leukemia, from the U.S. market. The company took the action at the request of the FDA after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials. read more | |
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Biologic Drug Makers Get 12-Year Marketing Exclusivity in Health Reform Deal
POSTED: 7/6/2010 A provision in the health care reform law gives manufacturers of biologic drugs 12 years of exclusivity before competitors will be able to use their data to produce and sell similar versions of the drugs. read more | |
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Doctor Given Six Months in Prison, Fines, for Fabricating Data
POSTED: 6/25/2010 A doctor has been sentenced to six months in prison for health care fraud stemming from his fabrication of data and related misdeeds in drug trials, federal officials announced Thursday. read more | |
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Cabazitaxel Approved for Advanced Prostate Cancer
POSTED: 6/22/2010 The FDA has approved cabazitaxel (Jevtana, Sanofi-aventis) injection to be used in combination with the steroid prednisone to treat men with advanced, hormone-refractory prostate cancer that has worsened during or after treatment with docetaxel. read more | |
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Promising Lung Cancer Drug Offered Through Clinical Trial
POSTED: 6/9/2010 Three years after the EML4-ALK fusion gene was determined to be a key driver of a subtype of non-small cell lung cancer (NSCLC), a newly developed ALKinhibitor has demonstrated very impressive activity in a Phase II trial. A Phase III trial is currently enrolling patients. read more | |
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Nilotinib Gets First-Line Indication for CML
POSTED: 6/22/2010 The FDA has approved nilotinib (Tasigna, Novartis) for the first-line therapy of adult patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). read more |
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Doctors Sue Over Identity Theft Regulations  1 |
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