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News Breaks
November 29, 2012
08:10 EDTMRKMerck withdraws Marketing Authorisation Application for ridaforolimus in Europe
Merck has formally notified the European Medicines Agency of Merck's decision to withdraw the Marketing Authorisation Application for ridaforolimus. Merck said that the withdrawal of ridaforolimus was based on the provisional view of the Committee for Medicinal Products for Human Use that the data available to date and provided in the Marketing Authorisation Application were not sufficient to permit licensure of ridaforolimus in the European Union for the maintenance treatment of patients with soft tissue sarcoma or primary malignant bone tumor. Although the application for these uses was withdrawn, Merck is studying ridaforolimus in combination with other drugs in other tumor types.
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