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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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May 22, 2015
10:52 EDTMRKJPMorgan says Actavis shares cheap compared to peers
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07:22 EDTMRKMerck receives positive CHMP opinion for Pembrolizumab in advanced melanoma
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07:15 EDTMRKMerck receives positive CHMP opinion for KEYTRUDA in advanced melanoma
Merck announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma, as both first-line therapy and in previously treated patients. The CHMP positive opinion for KEYTRUDA, which is based on data in more than 1,500 adult patients with advanced melanoma, will now be reviewed by the European Commission for central marketing authorization in the European Union.
May 19, 2015
07:28 EDTMRKUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 19 at 8 am; not all company presentations may be webcasted. Webcast Link
06:55 EDTMRKGenocea could be takeover target after data, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff expects Genocea Biosciences (GNCA) will report positive Phase II GEN-003 post-immunization results late in Q2. GEN-003 is a therapeutic vaccine for genital herpes targeting Herpes Simplex Virus Type 2. Positive GEN-003 data could position Genocea as a potential acquisition target by a larger vaccine player, Tenthoff tells investors today in a research note. Large vaccine makers include Sanofi (SNY), Merck (MRK), GlaxoSmithKline (GSK), Pfizer (PFE) and Novartis (NVS). The analyst reiterates an Overweight rating on Genocea with a $14 price target. Shares of the clinical-stage vaccine developer with a $227M market capitalization closed yesterday up 83c to $10.22.
May 14, 2015
09:22 EDTMRKLeerink pharma/biotech analysts hold an analyst/industry conference call
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May 13, 2015
18:33 EDTMRKMerck to present new Keytruda data on 10 types of cancer at 2015 ASCO meeting
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13:12 EDTMRKSen. Sanders urges VA to break patents on Gilead hepatitis C drugs
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May 12, 2015
13:13 EDTMRKExpert says Norway biosimilar case an 'outlier,' CT Financial News reports
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06:09 EDTMRKThreshold announces Merck receives FDA Fast Track designation for evofosfamide
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