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Tag: endpoints
Mercks Investigational Once-Daily Formulation of ISENTRESS (raltegravir) Meets Primary and Secondary Endpoints in Pivotal Phase 3 Study
2016-02-22 14:00:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. Results to be Presented at Future Medical Meeting, and Regulatory Submissions Planned for 2016 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced top-line results from the companys Phase 3 pivotal trial, ONCEMRK. ONCEMRK is evaluating an investigational once-daily formulation of ISENTRESS (raltegravir), known as raltegravir 600 mg (to be given as 2 x 600 mg once-daily), for previously untreated HIV-1 infected adults. Language: English Contact: For MerckMedia:Pamela Eisele, 267-305-3558orCarmen de Gourville, 267-305-4195orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: study
primary
phase
secondary
Merck and Samsung Bioepis Announce Pivotal Phase 3 Studies for Investigational Biosimilars SB4, Enbrel (Etanercept), and SB2, Remicade (Infliximab), Met Primary Endpoints
2015-06-10 14:46:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. & SEOUL, South Korea Data Presented for the First Time at the EULAR Annual Meeting Phase 1 Data for SB2, SB4 and SB5, an Investigational Biosimilar of Humira (Adalimumab), also Presented KENILWORTH, N.J. & SEOUL, South Korea--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Samsung Bioepis Co., Ltd. today announced that pivotal Phase 3 clinical studies of SB4, an investigational biosimilar of Enbrel (etanercept), and SB2, an investigational biosimilar of Remicade (infliximab), met their primary endpoints, demonstrating equivalence to the originator medicine in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy. Language: English Contact: Merck Media:Pamela Eisele, 267-305-3558Robert Consalvo, 908-236-1127orMerck Investors:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879orSamsung Bioepis Media:Jamyung Cha, (82) 32-455-6137orSamsung Bioepis Investors:Sungjoon Park, (82) 32-455-6120 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: met
primary
studies
phase
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
Why Do Preclinical Humane Endpoints Matter?
2015-03-13 12:15:35| drugdiscoveryonline Home Page
By Dale M. Cooper, DVM, MS, DACLAM, MPI Research When people are suffering or dying from disease, there’s a powerful incentive to move new treatments through the pipeline as quickly as possible. But while speed is important, it cannot come at the expense of quality and compliance. The care of animals involved in preclinical safety studies is a compliance expectation by several regulatory bodies, and because the animal is the test system, good animal welfare is also good science. Establishing humane endpoints before a study begins is the right thing to do. It is an ethical expectation of the public, and it makes good business sense; humane endpoints can reveal crucial insights on a drug candidate’s mechanism of action and strengthen the rationale for a go/no-go decision.
Tags: matter
humane
endpoints
preclinical
Smart Home Security: Protecting Wirelessly Connected Endpoints from Cyber-Attacks
2015-03-10 16:24:51| Wireless - Topix.net
The 1999 Disney Film "Smart House" depicts an intelligent, connected house in which everything within the home, from laundry and breakfast to the front door lock, is automated. In the film, the "Smart House," named Pat, decides it knows what is best for its occupants and takes over control from them.
Tags: home
security
smart
connected