Archive for October, 2006
FDA Warns About Decorative Contacts
Closed Published by FDA - Topix.net October 31st, 2006 in UncategorizedWearing decorative contact lenses without talking to an eye-care professional carries serious risks, the U.S. Food and Drug Administration warned on a day when many people may be considering going for an evil …
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Earnings Preview: Cephalon
Closed Published by Live Search News: "Food and Drug Administration" October 31st, 2006 in Regulatory AffairsMSN MoneyCentral - In August, the Food and Drug Administration rejected an application for the company’s attention deficit hyperactivity disorder drug candidate Sparlon, which was a formulation of Provigil. The FDA rejected the application on safety grounds. Cephalon …
Sara Lee recalls hamburger buns
Closed Published by FDA - Topix.net October 31st, 2006 in UncategorizedSara Lee Food & Beverage Co. is recalling its 12-ounce Premium White Hamburger Buns in North and South Carolina.
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Salmonella outbreak in Tennesse and other states
Closed Published by FDA - Topix.net October 31st, 2006 in UncategorizedHealth officials say a salmonella outbreak potentially linked to produce has sickened at least 172 people in 18 states, including Tennessee.
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FDA OKs Bionovo breast cancer drug test (bizjournals.com via Yahoo! Finance)
Closed Published by Yahoo! News Search Results for Food and Drug Admin October 31st, 2006 in Yahoo FDA News, Regulatory AffairsThe Food and Drug Administration accepted Bionovo Inc.’s protocol for an early-stage clinical trial of BZL101, a drug for metastatic breast cancer.
FDA OKs Bionovo breast cancer drug test
Closed Published by Live Search News: "Food and Drug Administration" October 31st, 2006 in Regulatory AffairsSan Francisco Business Journal - The Food and Drug Administration accepted Bionovo Inc. ’s protocol for an early-stage clinical trial of BZL101, a drug for metastatic breast cancer. Emeryville-based Bionovo (OTCBB: BNVI) said Tuesday that the Phase I/II trial will be run at 10 …
Cytel’s Dr. Jerald S. Schindler Speaks on Adaptive Clinical Designs…
Closed Published by FDA - Topix.net October 31st, 2006 in UncategorizedCytel Inc, the leading provider of clinical trial consulting services and software, announced today that Cytel’s Dr.
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AVANIR Receives FDA Approvable Letter for Zenvia for the Treatment of …
Closed Published by FDA - Topix.net October 31st, 2006 in UncategorizedAVANIR Pharmaceuticals announced that it has received an approvable letter from the U.S. Food and Drug Administration for Zenvia for the treatment of involuntary emotional expression disorder .
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CytRx Gets European Orphan Drug Status
Closed Published by Live Search News: "Food and Drug Administration" October 31st, 2006 in Regulatory AffairsMSN MoneyCentral - In May 2005, the company received orphan drug status from the Food and Drug Administration. The FDA status provides similar incentives, and seven years of U.S. marketing exclusivity upon approval. © 2006 The Associated Press. All rights reserved …
Staph Vaccine Shows Promise in Mouse Study
Closed Published by National Institutes of Health (NIH) News Releases October 31st, 2006 in NIHNational Institute of Allergy and Infectious Diseases (NIAID), Staph Vaccine Shows Promise in Mouse Study, October 30, 2006
Sanofi’s profit falls, still beats forecasts
Closed Published by FDA - Topix.net October 31st, 2006 in UncategorizedSanofi-Aventis posted a better-than-expected third-quarter profit Tuesday due to generic rivalry to heart drug Plavix and government health cuts.
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Bioniche to Present at Rodman & Renshaw 8th Annual Healthcare Conference
Closed Published by FDA - Topix.net October 31st, 2006 in UncategorizedBioniche Life Sciences Inc. , a research-based, technology-driven Canadian biopharmaceutical company, today announced that Graeme McRae, President & CEO, is scheduled to present at the Rodman & Renshaw 8th …
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Precautionary Recall Alert: Sara Lee Premium White Hamburger Buns in North Carolina and South Carolina
Closed Published by Food and Drug Administration October 31st, 2006This limited recall is being conducted as a precaution because the 4,826 packages included may contain undeclared milk, posing a potential risk to milk-allergic individuals because the ingredient statement does not include milk.
Penwest Pharmaceuticals Widens 3Q Loss
Closed Published by Live Search News: "Food and Drug Administration" October 31st, 2006 in Regulatory AffairsMSN MoneyCentral - The companies were partnering to develop a high blood pressure treatment, but the Food and Drug Administration rejected the application, ending their agreement. In addition, royalties from Mylan Pharmaceuticals slipped, the company said. © 2006 The …
CytRx’s Arimoclomol Granted Orphan Drug Designation in European
Closed Published by Live Search News: "Food and Drug Administration" October 31st, 2006 in Regulatory AffairsMSN MoneyCentral - Food and Drug Administration for the treatment of ALS in May 2005. Orphan drug status in the U.S. holds numerous potential benefits, including opportunities for grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits …
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