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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.
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June 29, 2015
08:39 EDTMRKMerck says Phase 3 Emend data shows it provides 'greater protection' from nausea
Merck announced results from a Phase 3 study investigating the safety and efficacy of single-dose Emend for Injection, Merck’s substance P/neurokinin receptor antagonist, in combination with other anti-vomiting medicines, for the prevention of chemotherapy-induced nausea and vomiting, or CINV, in adult cancer patients receiving moderately emetogenic chemotherapy, or MEC. In the study, the first to evaluate an intravenous NK-1 receptor antagonist for the prevention of CINV associated with MEC, the single-dose Emend for Injection regimen provided greater protection from nausea and vomiting following administration of chemotherapy versus an active control of placebo with other anti-vomiting medicines. These data were presented in an oral session at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology Annual Meeting on “Supportive Care in Cancer” in Copenhagen.
June 24, 2015
09:07 EDTMRKCAR-T cancer drug researchers seen as M&A targets, Bloomberg says
Juno Therapeutics (JUNO), Kite Pharma (KITE) and Bluebird Bio (BLUE) are trading well above their IPO levels as takeovers predictions have spurred interest and share increases for the developers of CAR-T gene therapies, said Bloomberg's "Real M&A" column, quoting Dimo Dimov, a professor at the University of Bath’s School of Management, as having said that companies such as Pfizer (PFE), Merck (MRK), Roche (RHHBY) and AstraZeneca (AZN) are "closely watching" the firms. Cellectis (CLLS), which is working with Pfizer on its own approach to CAR-T therapy, has said it wants to bring its therapy to market and doesn’t anticipate a sale, the report noted. Reference Link
June 21, 2015
13:14 EDTMRKMerck shares could return 25%, Barron's says
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