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Home › investigational

 

Tag: investigational

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

Results from Investigational IMPROVE-IT Study of VYTORIN (ezetimibe and simvastatin) Published in the New England Journal of Medicine

2015-06-03 23:00:00| Merck.com - Product 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 that the New England Journal of Medicine published the results of the IMPROVE-IT trial, an investigational study comparing treatment with VYTORIN (ezetimibe and simvastatin) to treatment with simvastatin alone in more than 18,000 patients presenting with acute coronary syndromes. Language: English Contact: MerckMedia:Pamela Eisele, (267) 305-3558Tracy Ogden, (267) 305-2301orInvestor:Justin Holko, (908) 740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: of results study journal

Alnylam Receives Orphan Drug Designation From The United States Food & Drug Administration For Revusiran, An Investigational RNAi Therapeutic For The Treatment Of Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis)

2015-06-03 06:41:56| drugdiscoveryonline Home Page

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced recently that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to revusiran, an investigational RNAi therapeutic, for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR amyloidosis)

Tags: united states united states food

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

2015-05-28 22:30:00| Merck.com - Research & Development 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 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 for review Merck's application as filed. Language: English Contact: MerckMedia:Doris Li, 908-246-5701orSarra Herzog, 908-740-1871orInvestors:Joe Romanelli, 908-740-1986orJustin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: and single application treatment

Plexxikon and Merck to Collaborate on Combination Study Evaluating Investigational Immuno-oncology Regimen

2015-05-07 14:30:00| Merck.com - Product News

Dateline City: BERKELEY, Calif., and KENILWORTH, N.J. Study will Evaluate Mercks Anti-PD-1 Therapy, KEYTRUDA (pembrolizumab), in Combination with Plexxikons PLX3397 BERKELEY, Calif., and KENILWORTH, N.J. May 7, 2015 Plexxikon Inc., a member of Daiichi Sankyo Group, and Merck (NYSE:MRK), known as MSD outside the US and Canada, through a subsidiary, today announced a collaborative clinical trial that will evaluate the combination of PLX3397, Plexxikons investigational CSF-1R inhibitor, and KEYTRUDA (pembrolizumab), Mercks anti-PD-1 therapy, which provides the potential for a double blockade of cancer-induced immune suppression. Language: English read more

Tags: study combination evaluating collaborate

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