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ImClone Systems And Bristol-Myers Squibb Announce Revisions To ERBITUX(R) (cetuximab) U.S. Product Labeling For Metastatic Colorectal Cancer
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company (NYSE: LLY), and Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved revisions to the U.S. prescribing information for ERBITUX® (cetuximab) concerning the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC). The labeling revisions include a modification to the indication, which now includes a statement that retrospective subset analyses of metastatic or advanced colorectal cancer trials have not shown a treatment benefit for ERBITUX in patients whose tumors had K-ras mutations in codon 12 or 13 and that the use of ERBITUX is not recommended for the treatment of colorectal cancer with these mutations. Revisions concerning the use of ERBITUX in colorectal cancer tumors with K-ras mutations were also made to the clinical studies and clinical pharmacology sections of the product"s prescribing information.
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$20 Million NIH Grant To Transform Clinical Research At UIC
The National Institutes of Health has awarded a five year $20 million grant to the University of Illinois at Chicago"s Center for Clinical and Translational Science.
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Remarriage Does Not Heal The Health Damage Of Divorce And Widowhood, Study
New research from the US suggests that divorce and widowhood damage health in ways that even getting married again doesn"t heal.
Nutrition

Sepracor Pharmaceuticals Ltd Withdraws Its Marketing Authorisation Application For Lunivia (eszopiclone)

The European Medicines Agency has been formally notified by Sepracor Pharmaceuticals Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Lunivia (eszopiclone), 2 and 3 mg tablets. Lunivia was expected to be used for the treatment of insomnia, including difficulty falling asleep, nocturnal awakening or early awakening in adults, usually for short-term duration. The application for the marketing authorisation for Lunivia was submitted to the Agency on 23 July 2007. In October 2008, Lunivia received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending that the medicine be granted a marketing authorisation. However, the CHMP recommended that the medicine should not be granted "new active substance" status. Following a re÷¬examination procedure at the request of the applicant, the CHMP confirmed its previous opinion in February 2009. At the time of withdrawal, the application was pending the adoption of a marketing authorisation decision by the European Commission. In its official letter, the company stated that the withdrawal of the application was based on the CHMP"s recommendation that Lunivia should not be regarded as containing a new active substance, and that the commercial viability of launching the product in the European Union was compromised. More information about Lunivia and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the Agency"s website after the next CHMP meeting of 26-29 May 2009. Notes 1. Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage. 2. The press release from the October 2008 meeting can be found here. 3. The summary of the positive opinion from October 2008 can be found here. EMEA


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