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Merck Initiates Rolling Submission of U.S. Biologics License Application for MK-3475, an Investigational Anti-PD-1 Immunotherapy, in Patients with Advanced Melanoma

2014-01-13 14:30:00| Merck.com - Research & Development News

Dateline City: WHITEHOUSE STATION, N.J. Expects to Complete Application in First Half of 2014 WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, said today it has started a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application for MK-3475, the companys investigational anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated with ipilimumab. A rolling submission allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis. Language: English Contact: MerckMedia:Ian McConnell, 908-423-3046Claire Mulhearn, 908-423-7425orInvestors:Carol Ferguson, 908-500-1101Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: with advanced application license

 

Alnylam Acquires Investigational RNAi Therapeutic Assets from Merck

2014-01-13 07:51:19| Biotech - Topix.net

Alnylam Pharmaceuticals, Inc. , a leading RNAi therapeutics company, announced today the acquisition of Merck's wholly owned subsidiary Sirna Therapeutics, Inc. , comprising intellectual property and RNAi assets including pre-clinical therapeutic candidates, chemistry, siRNA-conjugate and other delivery technologies.

Tags: assets therapeutic acquires merck

 
 

Merck Statement on FDA Advisory Committee for GRASTEK (Timothy Grass Pollen Allergen Extract), Mercks Investigational Sublingual Allergy Immunotherapy Tablet

2013-12-13 01:17:00| Merck.com - Product News

Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today issued the following statement after the conclusion of the Allergenic Products Advisory Committee of the U.S. Food and Drug Administration (FDA) meeting to discuss GRASTEK (Timothy grass pollen allergen extract). Language: English Contact: MerckMedia:Pamela Eisele, 908-423-5042orRobert Consalvo, 908-423-6595orInvestors:Carol Ferguson, 908-423-4465orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: statement committee advisory grass

 

Merck Advances Development Program for Investigational Alzheimers Disease Therapy, MK-8931

2013-12-10 13:00:00| Merck.com - Product News

Dateline City: WHITEHOUSE STATION, N.J. Data Monitoring Committee recommends continuation of Phase II/III EPOCH study in mild to moderate disease patients Merck also plans to initiate dosing in Phase III study of prodromal disease patients WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today provided an update on the development program for MK-8931, a novel investigational oral -amyloid precursor protein site-cleaving enzyme (BACE) inhibitor. Language: English Contact: MerckMedia:Caroline Lappetito, 267-305-7639Justine OMalley, 908-423-2021orInvestors:Carol Ferguson, 908-423-4465Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: development program disease therapy

 

Additional Interim Data for Mercks Investigational Anti-PD-1 Immunotherapy, MK-3475, Shows Estimated Overall Survival Rate of 81 Percent at One Year in Patients with Advanced Melanoma

2013-11-18 18:00:00| Merck.com - Research & Development News

Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced additional data for MK-3475, an investigational anti-PD-1 immunotherapy, in patients with advanced melanoma that showed an estimated overall survival rate of 81 percent at one year across all MK-3475 monotherapy doses evaluated. Language: English Contact: MerckMedia:Ian McConnell, 908-423-3046orClaire Mulhearn, 908-423-7425orInvestors:Carol Ferguson, 908-423-4465orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: with year data advanced

 

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