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Tag: investigational
Merck Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA for Investigational Ebola Zaire Vaccine (V920)
2016-07-25 14:00:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced two regulatory milestones for the companys investigational vaccine for Ebola Zaire, V920 (rVSVG-ZEBOV-GP, live attenuated): the U.S. Food and Drug Administration (FDA) has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) status. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Skip Irvine, 215-652-6059orInvestors:Teri Loxam, 908-740-1986Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Data for Merck's Investigational Once-Daily Formulation of ISENTRESS (raltegravir) Show That at Week 48, a Regimen Containing the Once-Daily Dosing Formulation...
2016-07-22 13:00:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. Resulted in Non-Inferior Efficacy and Safety to a Regimen Containing the Approved Twice-Daily Formulation EMA Accepts File Application, Plans Underway to Submit for Licensure to FDA This Year KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced efficacy and safety data in previously untreated adults with HIV-1 infection for the companys investigational once-daily formulation of ISENTRESS (raltegravir), known as raltegravir 600 mg (to be given as 2 x 600 mg), from the ongoing Phase 3 pivotal trial called ONCEMRK. Language: English Contact: MerckMedia:Pam Eisele, 267-305-3558Carmen de Gourville, 267-305-4195orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab
2016-07-21 22:30:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today said that the U.S. Food and Drug Administration (FDA) has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending Biologics Licensing Application (BLA) for bezlotoxumab, an investigational agent for prevention of Clostridium difficile (C. difficile) infection recurrence. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Robert Consalvo, 908-236-1127orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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update
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Results of Phase 2 Study of Mercks Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Presented at ASM Microbe
2016-06-20 18:30:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. Pivotal Phase 3 Studies Ongoing in Treatment of Serious Bacterial Infections KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that a Phase 2 study of relebactam, the companys investigational beta-lactamase inhibitor, in combination with imipenem/cilastatin (an approved carbapenem antibiotic), in patients with complicated urinary tract infections, met its primary endpoint. Language: English Contact: MerckMedia:Pamela Eisele, (267) 305-3558orRobert Consalvo, (908) 295-0928orInvestor:Teri Loxam, (908) 740-1986orAmy Klug, (908) 740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Mercks Investigational Insulin Glargine, MK-1293, Met Primary Endpoint in Two Phase 3 Studies, Showing Non-Inferiority to Lantus
2016-06-13 16:30:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. Data in Patients with Type 1 and Type 2 Diabetes Presented for the First Time at the 76 th Scientific Sessions of the American Diabetes Association KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from two Phase 3 studies evaluating MK-1293, Mercks investigational, follow-on biologic* insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes. Language: English Contact: MerckMedia:Doris Li, 908-246-5701Kristen Drake, 908-334-4688orInvestor:Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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