Summary Information for: SPOT-Light® HER2 CISH Kit

Published in July 30th, 2008

Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health

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Second-Line Doxorubicin/ketoconazole an Option in Hard-To-Treat Prostate Cancer

Published in July 30th, 2008

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A biweekly regimen of doxorubicin plus ketoconazole is a “reasonable” second-line therapy for men with docetaxel-resistant, hormone-refractory prostate cancer, clinicians from Greece report.
Reuters Health Information

Statin Use May Improve Survival in Kidney Transplant Recipients

Published in July 30th, 2008

Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News

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Although statin use does not significantly improve graft survival after kidney transplantation, it may improve patient survival, according to a report in the July 23rd online issue of the Journal of the American Society of Nephrology.
Reuters Health Information

A counter to counterfeit drugs

Published in July 30th, 2008

Posted by Pharmaceutical News Feed in Drugs and Food Information, Pharmaceutical Industry News

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The counterfeiting of medicines has been known of since around 1990 and is a growing problem-in both developing and developed countries. Counterfeit medicines are estimated as more than 10% of the global medicines market and in some developing countries it is thought to be as high as 50%. One prediction is that global counterfeit drug sales will reach $75 billion by 2010.

FDA seizes more than $24 Million in unapproved new drugs

Published in July 30th, 2008

Posted by Pharmaceutical News Feed in Drugs and Food Information, Pharmaceutical Industry News

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Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

Rize 2 The Occasion Capsules, Rose 4 Her Capsules

Published in July 30th, 2008

Posted by FDA MedWatch in Safety Information

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UPDATE - Voluntary nationwide recall of all lot numbers. FDA lab analysis found the products contained a potentially harmful, undeclared ingredient, thiomethisosildenafil.

FDA Extends Consumer Warning on Serrano Peppers from Mexico

Published in July 30th, 2008

Posted by Food and Drug Administration Press Releases in Drugs and Food Information

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Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States.

FDA issues Complete Response letters ordering Safety Labeling Changes under FDAAA for Aranesp, Epogen, and Procrit

Published in July 30th, 2008

Posted by FDA Center for Drug Evaluation and Research - What's New in Drug Evaluation and Research

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FDA issues Complete Response letters ordering Safety Labeling Changes under FDAAA for Aranesp, Epogen, and Procrit

FDA Safety Changes: Reyataz and Invanz

Published in July 30th, 2008

Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News

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The FDA has approved revisions to the safety labeling for atazanavir sulfate capsules (Reyataz) and ertapenem sodium injection (Invanz).
Medscape Medical News

Biomarkers May Predict Response to B Cell Depletion Therapy in Patients With Lupus

Published in July 30th, 2008

Posted by Medscape Pharmacists Headlines in Drugs and Food Information, Health Information, Pharmaceutical Industry News

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Among patients with active, refractory systemic lupus erythematosus, clinical responses to B cell depletion therapy (BCDT) were shorter in those had an expanded autoantibody profile and elevated B lymphocyte stimulator (BLyS) levels at baseline, researchers from the US and UK report in the July issue of the Annals of the Rheumatic Diseases.
Reuters Health Information

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