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News Breaks
December 14, 2012
08:07 EDTARIA, MRKEMA says Merck withdraws application for Jenzyl
The European Medicines Agency said on November 27 Merck Sharp & Dohme (MRK) officially notified the Committee for Medicinal Products for Human Use, or CHMP, that it wishes to withdraw its application for a marketing authorization for Jenzyl, for the maintenance treatment of patients with metastatic soft tissue sarcoma or bone sarcoma previously treated with chemotherapy. Jenzyl is the trade name for ridaforolimus, which is being co-developed by Merck and ARIAD Pharmaceuticals (ARIA). Jenzyl was expected to be used for the treatment of adults with soft tissue sarcoma, a type of cancer that affects the soft, supporting tissues of the body, or bone sarcoma that have spread to other parts of the body. The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions. The company had not yet responded to the last round of questions at the time of the withdrawal. Based on the review of the data and the company’s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Jenzyl could not have been approved for the treatment of patients with metastatic soft tissue sarcoma or bone sarcoma as maintenance therapy, the CHMP said.
News For ARIA;MRK From The Last 14 Days
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August 18, 2014
07:57 EDTMRKCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 13, 2014
18:02 EDTMRKMerck provides statement on role of PNEUMOVAX 23 in updated ACIP recommendations
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16:52 EDTMRKMerck confirms FDA approval of BELSOMRA
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15:30 EDTMRKFDA approves Belsomra sleep drug
The Food and Drug Administration approved Belsomra tablets for use as needed to treat difficulty in falling and staying asleep. Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Belsomra will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Belsomra is a controlled substance because it can be abused or lead to dependence. Belsomra is made by Merck, Sharpe & Dohme.
August 6, 2014
07:38 EDTARIAARIAD sees cash used in operations in FY14 $165M-$175M
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07:37 EDTARIAARIAD reports Q2 EPS (30c), consensus (29c)
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