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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 The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions.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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October 28, 2014
09:37 EDTMRKActive equity options trading
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07:27 EDTMRKFDA PDUFA Date for Merck's MK-3475 is October 28, 2014
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07:16 EDTMRKInvestors overlooking Merck positive points, says SunTrust
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October 27, 2014
20:54 EDTMRKLeerink's major pharma analyst holds an analyst/industry conference call
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16:36 EDTMRKOn The Fly: Closing Wrap
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09:37 EDTMRKMerck slips lower after results, levels to watch
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08:30 EDTMRKMerck sees FY14 gross margin slightly lower vs. FY13
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07:29 EDTMRKWorldwide Business Research to hold a conference
ProcureCon Pharma 2014 is being held in Philadelphia on October 27-29.
07:06 EDTMRKMerck reports Q3 Pharmaceutical sales down 4% to $9.13B
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07:03 EDTMRKMerck narrows 2014 EPS outlook to $3.46-$3.50, consensus $3.47
Now sees 2014 revenue $42.4B-$42.8B, consensus $42.55B.
07:01 EDTMRKMerck reports Q3 EPS ex-items 90c, consensus 88c
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06:46 EDTMRKMerck granted Breakthrough Therapy Designation for KEYTRUDA by FDA
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October 24, 2014
13:35 EDTMRKMerck weekly volatility elevated into Q3 and outlook
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07:37 EDTARIAARIAD announces CHMP adopts final opinion on Iclusig
ARIAD Pharmaceuticals announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted its final opinion on Iclusig following the recommendations made by the Pharmacovigilance Risk Assessment Committee earlier this month. The PRAC conducted an 11-month review of the available data on Iclusig and consulted with a scientific advisory group in oncology. This week, the EMA recommended that Iclusig continue to be used in accordance with its already approved indications as a treatment of certain leukaemias and confirmed that the benefit-risk profile of Iclusig continues to be positive in each of these indications. The EMA also recommended additional warnings in the European product information to minimize the risk of vascular events. The company said, "We are now well positioned to complete pricing and reimbursement negotiations in Europe and to ensure that Iclusig is available to appropriate Philadelphia-chromosome positive leukaemia patients."
October 22, 2014
07:35 EDTMRKCardiometabolic Health Congress to hold annual meeting
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October 20, 2014
08:06 EDTMRKMerck, Sanofi unit announce pediatric hexavalent vaccine BLA
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07:34 EDTMRKAdvaxis names Mauro Chief Medical Officer
Advaxis (ADXS) announced that it has appointed David Mauro, as executive vice president, Chief Medical Officer Mauro most recently served as executive director, section head oncology clinical development at Merck (MRK). In connection with his appointment, Mauro received a one-time inducement award of 165K restricted shares, of which 55K are fully vested and as of the grant date. The remaining shares vest annually over a two-year period.
07:19 EDTMRKIBC Life Sciences to hold a conference
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07:11 EDTMRKAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
October 17, 2014
07:58 EDTMRKDeutsche Bank specialty pharma analyst holds analyst/industry conference call
Specialty Pharmaceuticals Analyst Gilbert provides of preview of The Improved Reduction of Outcomes: Vytorin Efficacy Internal Study (IMPROVE-IT) on an Analyst/Industry conference call to be held on October 17 at 10 am.
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