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FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, for First-Line Treatment of Advanced Melanoma, and Grants Priority Review
2015-08-18 14:00:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Merck Provides Additional Update: FDA Extends Action Date for Additional sBLA in Ipilimumab-Refractory Advanced Melanoma KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks anti-PD-1 therapy. Merck is seeking approval for KEYTRUDA, at the currently approved dose of 2 mg/kg every three weeks, for the first-line treatment of unresectable or metastatic melanoma patients. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orInvestors:Justin Holko, 908-740-1879An Phan, 908-255-6325 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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In Interim Results from Phase 3 Study, Mercks Investigational Ebola Vaccine Efficacious; Study is Continuing
2015-07-31 14:10:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. Global Collaboration Enabled Vaccine to Move from First-in-Human Studies to Initial Phase 3 Results Within One Year KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (known as MSD outside the US and Canada) said today that its investigational Ebola vaccine candidate, rVSV-ZEBOV, was found to have 100 percent efficacy in an analysis of interim data from a Phase 3 ring vaccination trial in Guinea. Preliminary conclusions from this study, which is continuing, were published on-line today in The Lancet. Language: English Contact: MerckMedia Contacts:Pam Eisele, 267-305-3558orInvestor Contacts:Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
European Commission Approves Mercks Anti-PD-1 Therapy, KEYTRUDA (pembrolizumab), for Both First-line and Previously-treated Patients with Advanced Melanoma
2015-07-22 13:00:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. KEYTRUDA Demonstrated Superior Survival versus Ipilimumab in a Phase 3 Clinical Trial KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the treatment of advanced (unresectable or metastatic) melanoma in adults. The European Commission approval of KEYTRUDA is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Language: English Contact: MerckMedia:Pamela Eisele, (267) 305-3558orAn Phan, (908) 255-6325orInvestor:Joseph Romanelli, (908) 740-1986orJustin Holko, (908) 740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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European Commission approves Merck's $17 billion Sigma-Aldrich buy
2015-06-15 22:35:49| Chemicals - Topix.net
The European Commission said on Monday it had approved German drugmaker Merck's $17 billion acquisition of Sigma-Aldrich Corp following the U.S. company's pledges to sell assets in Germany. "The decision is conditional on the divestment of certain Sigma-Aldrich assets, including manufacturing assets in Germany, the rights to certain brands and a sales force," the Commission said in a statement.
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european
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TECOS, Mercks Cardiovascular Safety Trial of JANUVIA (sitagliptin), Met Primary Endpoint in Patients with Type 2 Diabetes
2015-06-08 22:30:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Findings Published in the New England Journal of Medicine and Presented at the American Diabetes Association Scientific Sessions Treatment with Sitagliptin Did Not Increase the Risk of Major Adverse Cardiovascular Events in the Primary Composite Endpoint, or Hospitalization for Heart Failure, Compared with Placebo KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the primary results of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), a placebo-controlled study of the cardiovascular (CV) safety of Mercks DPP-4 inhibitor, JANUVIA (sitagliptin), added to usual care in more than 14,000 patients. Language: English Contact: MerckMedia:Pam Eisele, 267-305-3558orKim Hamilton, 908-740-1863orInvestors:Joe Romanelli, 908-740-1986orJustin Holko, 908-740-1879 Media Capsule: Please Activate Javascript !function(d, s, id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https',dt=new Date().getTime();if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+"://s3.amazonaws.com/contentcapsule.com/clients/Merck/tags/d5542d85-2f26-45dc-b64c-3ee84a4312ff_reg_frame.js?dt="+dt;fjs.parentNode.insertBefore(js,fjs);}}(document,"script","contentcapsule-embed-d5542d85-2f26-45dc-b64c-3ee84a4312ff"); Ticker Slug: Ticker: MRK Exchange: NYSE read more
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