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Merck and Samsung Bioepis Announce Pivotal Phase 3 Studies for Investigational Biosimilars SB4, Enbrel (Etanercept), and SB2, Remicade (Infliximab), Met Primary Endpoints
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 E...
Source: Merck.com - Research and Development News - June 10, 2015 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Merck and Dynavax Announce New Collaboration Investigating the Combination of Immuno-Oncology Therapies
Dateline City: KENILWORTH, N.J. & BERKELEY, Calif. Studies to Evaluate the Combination of Dynavax’s SD-101 with Two Immunotherapies from Merck’s Pipeline, KEYTRUDA® (pembrolizumab) and MK-1966 Collaboration Includes First-in-human Study for MK-1966, a New Investigational Anti-interleukin-10 (anti-IL-10) Immunomodulator from Merck’s Rapidly Growing Immuno-oncology Pipeline KENILWORTH, N.J. Language: English ...
Source: Merck.com - Research and Development News - June 1, 2015 Category: Pharmaceuticals Tags: Oncology Newsroom Prescription Medicine News Research and Development News Corporate News Latest News Source Type: news

Findings Presented at 2015 ASCO Annual Meeting Add to Breadth of KEYTRUDA® (pembrolizumab) Data; Anti-Tumor Activity Now Demonstrated in 13 Different Tumor Types
Dateline City: KENILWORTH, N.J. New Data Presented at ASCO in Multiple, Difficult-to-Treat Cancers, including Small Cell Lung, Esophageal and Ovarian Cancers Registrational Studies for KEYTRUDA Ongoing in Eight Different Tumor Types KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the first-time presentation of findings investigating the use of KEYTRUDA® (pembrolizumab), the company’s ...
Source: Merck.com - Research and Development News - June 1, 2015 Category: Pharmaceuticals Tags: Oncology Newsroom Prescription Medicine News Research and Development News Corporate News Latest News Source Type: news

Merck Submits U.S. New Drug Application for Grazoprevir/Elbasvir, an Investigational Once-Daily, Single Tablet Combination Therapy, for Treatment of Chronic Hepatitis C Genotypes 1, 4, and 6 Infection
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for grazoprevir/elbasvir (100mg/50mg), an investigational once-daily, single tablet combination therapy for the treatment of adult patients with chronic hepatitis C genotypes (GT) 1, 4 or 6 infection. Within 60 days of submission, the FDA will determine whether it will accept f...
Source: Merck.com - Research and Development News - May 28, 2015 Category: Pharmaceuticals Tags: Hepatitis C Newsroom Research and Development News Corporate News Latest News Source Type: news

Merck’s Pivotal Phase 3 C-EDGE Program Evaluating Grazoprevir/Elbasvir Shows High Sustained Virologic Responses Across Broad Range of Patients with Chronic Hepatitis C Virus Infection
Dateline City: VIENNA Data Sets Include Treatment-Naïve, Treatment-Experienced and HIV Co-Infected Patients with Chronic Hepatitis C Virus Genotypes 1, 4 or 6 Infection Merck Remains on Track to Submit New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) in First Half of 2015 VIENNA--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentations of data from the company’s ongoing C-EDGE pivotal Phase 3 clinical trial program eva...
Source: Merck.com - Research and Development News - April 24, 2015 Category: Pharmaceuticals Tags: Hepatitis C Newsroom Research and Development News Corporate News Latest News Source Type: news

Merck Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease
Dateline City: VIENNA C-SURFER Trial is First to Investigate an All-Oral Ribavirin-Free Hepatitis C Treatment Regimen in Treatment-Naïve and Treatment-Experienced Patients with Advanced Chronic Kidney Disease Infected with Hepatitis C Virus Genotype 1 VIENNA--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentation of data from C-SURFER, the company’s Phase 2/3 clinical trial evaluating the inv...
Source: Merck.com - Research and Development News - April 23, 2015 Category: Pharmaceuticals Tags: Hepatitis C Newsroom Research and Development News Corporate News Latest News Source Type: news

Merck Provides Regulatory Update on Investigational Medicine Sugammadex Injection
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, said it was informed today that the U.S. Food and Drug Administration (FDA) has cancelled the meeting of the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for March 18, 2015. The committee had planned to discuss the resubmission of the New Drug Application (NDA) for sugammadex injection, Merck’s investigational medicine for the reversal of neuromuscular blockade induc...
Source: Merck.com - Research and Development News - March 13, 2015 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Merck Announces CHMP Issues Positive Opinion for Investigational Antibiotic SIVEXTRO® (tedizolid phosphate)
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of the investigational antibiotic SIVEXTRO® (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Merck acquired SIVEXTRO as a part of its purchase, through a sub...
Source: Merck.com - Research and Development News - January 26, 2015 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Lilly, Merck Enter Collaboration Agreement to Research Immuno-Oncology Combination Regimens in Multiple Types of Cancer
Dateline City: KENILWORTH, N.J. & INDIANAPOLIS Combinations of KEYTRUDA® (pembrolizumab) with Alimta® (pemetrexed), Cyramza® (ramucirumab), or necitumumab to be explored KENILWORTH, N.J. & INDIANAPOLIS--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the US and Canada, and Eli Lilly and Company (NYSE:LLY) announced today an oncology clinical trial collaboration to evaluate the safety, tolerability and efficacy of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-...
Source: Merck.com - Research and Development News - January 13, 2015 Category: Pharmaceuticals Tags: Oncology Newsroom Research and Development News Corporate News Latest News Source Type: news

International Breast Cancer Study Group, Breast International Group and Merck Announce Opening of International PANACEA Study of Patients with HER2+ Breast Cancer
Dateline City: SAN ANTONIO Collaborative Trial is First to Investigate an Anti-PD-1 Therapy, Pembrolizumab, Combined with Trastuzumab Study to Explore Whether New Approach May Reverse Trastuzumab Resistance in Cancer with Significant Unmet Need SAN ANTONIO--(BUSINESS WIRE)--The International Breast Cancer Study Group (IBCSG), Breast International Group (BIG), and Merck, known as MSD outside the United States and Canada, today announced the opening of the PANA...
Source: Merck.com - Research and Development News - December 10, 2014 Category: Pharmaceuticals Tags: Oncology Newsroom Research and Development News Corporate News Latest News Source Type: news

Merck Announces Positive Study Investigating the Use of KEYTRUDA® (pembrolizumab) Compared to Chemotherapy in Patients with Ipilimumab-Refractory Advanced Melanoma
Dateline City: ZURICH KEYTRUDA Demonstrated Superiority to Chemotherapy for Primary Endpoint of Progression-Free Survival Findings Presented for First Time at Society of Melanoma Research (SMR) 2014 International Congress ZURICH--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that a pre-specified analysis of investigational data from a pivotal Phase 2 study (KEYNOTE-002) showed KEYTRUDA® (pembroli...
Source: Merck.com - Research and Development News - November 16, 2014 Category: Pharmaceuticals Tags: Oncology Newsroom Research and Development News Corporate News Latest News Source Type: news

MSD Announces Positive Study Investigating the Use of Pembrolizumab Compared to Chemotherapy in Patients with Ipilimumab-Refractory Advanced Melanoma
Dateline City: ZURICH Pembrolizumab Demonstrated Superiority to Chemotherapy for Primary Endpoint of Progression-Free Survival Findings Presented for First Time at Society of Melanoma Research (SMR) 2014 International Congress ZURICH--(BUSINESS WIRE)--MSD, known as Merck in the United States and Canada, announced today that a pre-specified analysis of investigational data from a pivotal Phase 2 study (KEYNOTE-002) showed pembrolizumab, the company’s ...
Source: Merck.com - Research and Development News - November 16, 2014 Category: Pharmaceuticals Tags: Oncology Newsroom Research and Development News Corporate News Latest News Source Type: news

Merck Announces Results from Phase 2 Study of Investigational Chronic Hepatitis C Treatment Grazoprevir/Elbasvir in Genotype 1 Infected Treatment-Naïve and Difficult-to-Cure Patients
Dateline City: BOSTON Final Results from the C-WORTHyStudy (Parts A and B) Presented at The Liver Meeting® and Published inThe Lancet First Wave of Phase 3 Development Program for Grazoprevir/Elbasvir is Fully Enrolled; Merck Plans to Submit New Drug Application in 2015 BOSTON--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of results from a multi-arm Phase 2 clinical trial evaluating grazoprevir/elbasvir (MK-5172/MK-8742, the company’s...
Source: Merck.com - Research and Development News - November 11, 2014 Category: Pharmaceuticals Tags: Hepatitis C Newsroom Research and Development News Corporate News Latest News Source Type: news

Merck Announces Results from Phase 2 Study of Investigational Chronic Hepatitis C Treatment Grazoprevir/Elbasvir in Genotype 1 Infected Treatment-Naïve and Difficult-to-Cure Patients
Dateline City: BOSTON Final Results from the C-WORTHy Study (Parts A and B) Presented at The Liver Meeting® and Published in The Lancet First Wave of Phase 3 Development Program for Grazoprevir/Elbasvir is Fully Enrolled; Merck Plans to Submit New Drug Application in 2015 BOSTON--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of results from a multi-arm Phase 2 clinical trial eval...
Source: Merck.com - Research and Development News - November 11, 2014 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Interim Data from Proof-of-Concept Study of Merck’s Investigational Hepatitis C Treatment Grazoprevir/Elbasvir in Combination with a Nucleotide Inhibitor (C-SWIFT study) Presented at The Liver Meeting®
Dateline City: BOSTON Merck Plans to Initiate Phase 2C-CRESTProgram to Evaluate Merck’s Triple Combination of Grazoprevir/Elbasvir with MK-3682 (formerly IDX21437), a Novel Nucleotide Inhibitor, in Q1 2015 BOSTON--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of interim data from the C-SWIFT study exploring the potential of a candidate triple-therapy regimen consisting of the fixed-dose combination of grazoprevir/elbasvir (MK-5172/MK-87...
Source: Merck.com - Research and Development News - November 9, 2014 Category: Pharmaceuticals Tags: Hepatitis C Newsroom Research and Development News Corporate News Latest News Source Type: news