U.Va. Materials On Topamax Alcohol Study Draw Public Citizen’s Ire
This article was originally published in The Pink Sheet Daily
Johnson & Johnson’s Ortho-McNeil unit tells “The Pink Sheet” DAILY that the firm was not aware of the materials published by the University of Virginia and “was not involved in [their] preparation.”
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The hits just keep on coming for Genzyme. On a March 2 call with investors, the firm had to announce not just a "complete response" letter for its 2000-liter scale-up of Myozyme (which will be called Lumizyme for the larger production scale), but also that its Allston Landing manufacturing site had received a 483 report from FDA and a subsequent warning letter
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