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Genta Files for Genasense OK in Europe Tuesday January 3, 9:05 am ET Genta Expects European Regulators to Begin Reviewing Genasense Application Within Month
BERKELEY HEIGHTS, N.J. (AP) -- Biopharmaceutical company Genta Inc. said Tuesday it expects European regulators to begin reviewing a marketing application for its skin-cancer treatment later in the month. The company said it completed the application for its Genasense cancer drug to treat advanced skin cancer, and expects the European Medicines Agency to begin validating the application at a meeting in late January.
Genta said it expects to begin receiving questions from the agency about 120 days later. Approval by the agency would apply to all 25 member states in the European Union.
Genasense acts by blocking a protein that helps cancer cells resist chemotherapy drugs.
The company filed an application with the Food and Drug Administration Dec. 29 for the drug to treat chronic lymphocytic leukemia, a cancer that attacks white blood cells.
Genta shares rose 7 cents, or 4.8 percent, to $1.53 in premarket activity.
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