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Early Findings with KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, in Patients with Advanced Pleural Mesothelioma Presented at AACR Annual Meeting
2015-04-19 18:45:00| Merck.com - Product News
Dateline City: PHILADELPHIA KEYTRUDA Demonstrated 28 Percent Overall Response Rate and 76 Percent Disease Control Rate in Difficult-to-Treat Cancer First Findings from KEYNOTE-028, Mercks Innovative Basket Trial in 20 Cancers PHILADELPHIA--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentation of data investigating the use of KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, in 25 patients with advanced pleural mesothelioma, a difficult-to-treat cancer of the lining of the lungs, abdomen and other organs. The early findings presented showed an overall response rate (confirmed and unconfirmed) of 28 percent with KEYTRUDA in patients with tumors that expressed PD-L1. Language: English Contact: Media:Pamela Eisele, 267-305-3558Claire Mulhearn, 908-236-1118orInvestors:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, Demonstrates Superior Survival, Progression Free Survival and Overall Response Rate Compared to Ipilimumab an Anti-CTLA-4 Therapy...
2015-04-19 14:30:00| Merck.com - Product News
Dateline City: PHILADELPHIA ...in a Phase 3 Study of Patients with Advanced Melanoma Data from KEYNOTE-006 Study Presented at AACR Annual Meeting and Published in the New England Journal of Medicine Merck Plans to Submit sBLA for First-Line Indication in Advanced Melanoma in Mid-2015 PHILADELPHIA--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from the randomized, pivotal Phase 3 study, KEYNOTE-006, in the treatment of unresectable advanced melanoma. In the study, KEYTRUDA (pembrolizumab) was statistically superior to ipilimumab for progression-free survival (PFS), overall survival (OS), and overall response rate (ORR). On March 24, 2015, Merck announced that KEYNOTE-006 would be stopped early based on these data (link). Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orClaire Mulhearn, 908-236-1118orInvestors:Joseph Romanelli, 908-740-1986orJustin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Merck's potential HCV drug gets special FDA designation
2015-04-08 14:57:08| Biotech - Topix.net
Merck & Co. said Wednesday that the Food and Drug Administration granted the pharmaceutical company's developing hepatitis C treatment two special designations.
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Grazoprevir/Elbasvir, Mercks Investigational Chronic Hepatitis C Therapy, Granted FDA Breakthrough Therapy Designations; New Phase 2 and 3 Data in Multiple HCV Patient Types to be Presented at The International Liver CongressTM 2015
2015-04-08 13:00:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. Congress Highlights Include Results from Trials in a Wide Range of HCV Patients -- Patients with Chronic Kidney Disease, HIV Co-infection, Cirrhosis, and Prior Treatment Failures Company Remains on Track for NDA Filing with the U.S. FDA During First Half of 2015 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that grazoprevir/elbasvir, an investigational single tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection, has received two new Breakthrough Therapy designations from the U.S. Language: English Contact: MerckMedia:Doris Li, 908-246-5701Sarra Herzog, 908-740-1871orInvestors:Joe Romanelli, 908-740-1879Justin Holko, 908-740-1986 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Mercks Pivotal KEYNOTE-006 Study in First-Line Treatment for Advanced Melanoma Met Co-Primary Endpoints and Will be Stopped Early
2015-03-24 13:30:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. KEYTRUDA Demonstrated Superior Overall Survival and Progression-Free Survival Compared to Ipilimumab KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the randomized, pivotal Phase 3 study (KEYNOTE-006) investigating KEYTRUDA (pembrolizumab) compared to ipilimumab in the first-line treatment of patients with advanced melanoma has met its two primary endpoints of progression-free survival and overall survival. The trial will be stopped early based on the recommendation of the studys independent Data Monitoring Committee. Language: English Contact: MerckMedia:Pam Eisele, 267-305-3558orClaire Mulhearn, 908-236-1118orInvestors:Joseph Romanelli, 908-740-1986orJustin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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