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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 The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions.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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September 30, 2014
16:39 EDTMRKCMS discloses drug makers' payments to doctors, WSJ says
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08:16 EDTMRKTetraphase price target raised to $32 from $20 at JMP Securities
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September 29, 2014
07:36 EDTARIAARIAD presents updated clinical data on AP26113
ARIAD Pharmaceuticals announced updated clinical results on its investigational tyrosine kinase inhibitor, AP26113, in patients with advanced non-small cell lung cancer from an ongoing Phase 1/2 trial. These study results show sustained anti-tumor activity of AP26113 in patients with anaplastic lymphoma kinase positive NSCLC, including patients with active brain metastases. The updated Phase 1/2 trial now contains more mature data of AP26113, including increasing depth and durability of response in ALK+ NSCLC patients, as well as additional safety data. The updated results were presented on Saturday, September 27 at the 2014 European Cancer Congress held in Madrid, Spain. A total of 137 patients have been enrolled in the ongoing Phase 1/2 trial in the United States and Europe. The objectives of the Phase 1 portion of the trial were to characterize the safety and tolerability of AP26113, pharmacokinetics, and preliminary anti-tumor activity and to determine the recommended dose for further study of AP26113 in subsequent clinical trials. The trial used an open-label, dose-escalating design. The Phase 2 portion of the trial consists of five expansion cohorts. The data presented at ESMO focus on the 79 patients with a history of ALK+ NSCLC tumors in the entire trial. Fifty-six of these patients currently remain on study treatment.
07:26 EDTMRKInforma Business Information to hold a conference
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05:44 EDTMRKMerck announces early data from investigational use of KEYTRUDA
Merck announced the first presentation of data on the investigational use of KEYTRUDA, the company’s anti-PD-1 therapy, in PD-L1 positive, advanced urothelial cancer. The early findings presented showed a confirmed overall response rate of 24% with KEYTRUDA as monotherapy, as measured by RECIST v1.1, central review including a complete response rate of 10%. At the time of analysis, response durations ranged from 16+ to 40+ weeks with six of the seven responders continuing on therapy. In the ongoing study, 64% of patients screened had tumors that were determined to be positive for PD-L1 expression.
September 28, 2014
12:53 EDTMRKMerck announces first presentation of data on investigational use of KEYTRUDA
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September 26, 2014
08:31 EDTMRKLigand, Merck receive approval for NOXAFIL
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September 23, 2014
07:33 EDTMRKOphthotech names Michael Atieh as EVP, Chief Financial and Business Officer
Ophthotech Corporation (OPHT) announced that Michael G. Atieh has been named EVP, Chief Financial and Business Officer and Treasurer effective September 30. Atieh replaces Bruce A. Peacock, Chief Financial and Business Officer and Treasurer, who has notified the company of his intention to retire effective September 30. Atieh spent the majority of his career in the pharmaceutical industry with Merck and Co (MRK), where he held various senior level positions over a 20 year period including Senior Vice President-Merck Medco Managed Care, Vice President-U.S. Human Health, Vice President-Public Affairs, Vice President-Government Relations, and Treasurer.
September 22, 2014
06:51 EDTMRKMerck to host conference call
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September 18, 2014
17:57 EDTARIAARIAD CEO buys 25K shares of company stock
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08:48 EDTMRKNeogen's dairy genomic program to be marketed by Merck
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September 17, 2014
09:33 EDTMRKMerck announced positive results from Phase 3 data for omarigliptin
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08:31 EDTMRKMerck, Sun Pharma enter into licensing agreement for Tildrakizumab
Merck and Sun Pharmaceutical Industries, through their respective subsidiaries,announced an exclusive worldwide licensing agreement for Merck’s investigational therapeutic antibody candidate, tildrakizumab, which is currently being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis, a skin ailment. Under terms of the agreement, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of $80M. Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Merck is eligible to receive undisclosed payments associated with regulatory and sales milestones, as well as tiered royalties ranging from mid-single digit through teen percentage rates on sales. The transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.

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