The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has recommended that romidepsin, intended for treating peripheral T-cell lymphoma, be rejected. By blocking the activity of histone deacetylases, "involved in turning genes on and off within cells", it was expected that romidepsin would play a definite role in reducing rate of growth and division of cancer cells. Among the reasons noted for refusal of marketing this drug, the CHMP mentioned that Celgene Europe, the company applying for authorization, "failed to provide an adequate certificate of Good Manufacturing Practice for the site where the medicine is manufactured." By law, it is required that a company provide this certficate.
To read more about the rejection of romidepsin, click here.
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