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News Breaks
July 24, 2014
08:32 EDTMRKMerck initiates Phase 3 study of Letermovir
Merck announced that the first patient has been enrolled in a global Phase 3 clinical study of letermovir, an investigational antiviral agent. The multicenter, randomized, placebo-controlled study will evaluate the efficacy and safety of letermovir for the prevention of clinically-significant cytomegalovirus infection in adult CMV-seropositive recipients of allogeneic hematopoietic stem cell transplants. In the study, letermovir will be administered once daily, either as an oral tablet or IV formulation, for 14 weeks after transplant. The dose will be 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. The primary outcome measure of the study will be the percentage of participants with clinically-significant CMV infection through 24 weeks after transplant who were administered letermovir compared to placebo. Merck expects approximately 540 patients will be enrolled in the study at more than 70 centers in 20 countries, including the United States. The estimated study completion date is July 2017.
News For MRK From The Last 14 Days
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April 15, 2015
08:33 EDTMRKFDA panel results positive for Merck, says SunTrust
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April 14, 2015
13:32 EDTMRKMerck, NewLink Genetics confirm initiation of Phase 3 trial of Ebola vaccine
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April 13, 2015
08:58 EDTMRKMerck may have positive read through from briefing docs, says SunTrust
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April 9, 2015
09:25 EDTMRKPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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April 8, 2015
07:33 EDTMRKAdvaxis, Merck begin enrollment in Phase 1/2 of ADJX-PSA with Keytruda
Advaxis (ADXS) and Merck (MRK) announced that enrollment has initiated in the Phase 1/2 clinical trial evaluating the combination of ADXS-PSA, an investigational Lm-LLO immunotherapy, and Keytruda, the first anti-PD-1 therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer, or mCRPC. The clinical trial, KEYNOTE-046, is the first-in-human study of Advaxis's lead Lm-LLO immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer. ADXS-PSA and KEYTRUDA are members of a class of cancer treatments known as immuno-oncology therapies. Data from preclinical studies suggest that Advaxis Lm-LLO immunotherapies in combination with a PD-1 antibody may lead to an enhanced anti-tumor immune response. The results from KEYNOTE-046 will determine the future clinical development program for the combination.
07:04 EDTMRKMerck's investigational Hep C therapy granted breakthrough therapy designations
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April 7, 2015
07:14 EDTMRKEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.

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