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World's First Cardiac Adult Stem Cell Patient Receives Infusion
Michael (Mike) Jones has become the world"s first recipient of adult cardiac stem cells to treat congestive heart failure. Jones" infusion on July 17 marks the world"s first phase-one FDA-approved clinical trial using adult cardiac stem cells to treat heart disease. The clinical trial is being conducted by a team of University of Louisville physicians at Jewish Hospital.
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Amgen Announces KRAS Safety Update To U.S. Prescribing Information For Vectibix(R) (Panitumumab)
Amgen Inc. (Nasdaq: AMGN) announced the U.S. Food and Drug Administration (FDA) has approved revisions to the U.S. prescribing information for the epidermal growth factor receptor (EGFr) class of antibodies, including Vectibix((R)) (panitumumab). This decision follows the FDA"s December 2008 Oncologics Drugs Advisory Committee (ODAC) meeting where the clinical utility of the KRAS gene as a predictive biomarker in patients with metastatic colorectal cancer (mCRC) treated with anti-EGFr antibody was discussed.
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Vacci-Test Receives U.S. Approval For FoodChekTM-E.Coli Test
The AOAC Research Institute, the approval body for all U.S. food safety tests, has certified Vacci-Test"s FoodChekTM-E.Coli as a Performance Tested(SM) method for detecting E.coli O157 in raw ground beef. This extremely rapid and accurate new test is seen as a technological breakthrough for meat-processors. This approval clears the way for FoodChekTM-E.Coli to be sold as a certified food safety test in the United States and internationally.
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Drug Manufacturer Receives Fast Track Designation From FDA

Pharmaceutical firm Biogen Idec announced that the American drug watchdog the Food and Drug Administration (FDA) has granted Fast Track designation for its multiple sclerosis (MS) drug PEGylated interferon beta-1a (BIIB017). The company is currently enrolling patients in a global Phase III study evaluating the effectiveness and safety of either bi-weekly or once-monthly injections of the therapy in people with relapsing remitting MS. If the trial reports promising results it means that people could inject their medication less often without sacrificing effectiveness. The FDA"s Fast Track program is designed to speed up the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Biogen Idec plans to enrol more than 1,200 patients with relapsing remitting MS in the Phase III, randomized, double-blind, placebo-controlled trial called ADVANCE designed to evaluate the effectiveness and safety of PEGylated interferon beta-1a. Patients interested in finding out more about the ADVANCE trial should speak to their neurologist or email ADVANCEstudy@biogenidec.com Multiple Sclerosis Society


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