Genzyme Fabrazyme
FDA indicates "there is no need for a December advisory committee review" of the agalsidase beta BLA, Genzyme announces. The company said that it had expected a review by the Endocrinologic and Metabolic Drugs Advisory Committee on December 7-8. Genzyme expects FDA action on the application by Jan. 13
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Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry
Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.