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Mercks Investigational Beta-lactamase Inhibitor Relebactam (MK-7655) Granted Qualified Infectious Disease Product (QIDP) and Fast Track Designations by FDA

2014-09-04 15:00:00| Merck.com - Corporate 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, announced today that the U.S. Food and Drug Administration (FDA) has designated relebactam (previously known as MK-7655), the companys investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product (QIDP) with designated Fast Track status. Language: English Contact: Media:Caroline Lappetito, 267-305-7639orRobert Consalvo, 908-423-6595orInvestors:Joseph Romanelli, 908-423-5185orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: product fast track disease

 

Pfizer Announces FDA Acceptance Of And Priority Review Designation For Biologics License Application For Investigational Meningococcal B Vaccine

2014-09-03 12:22:48| drugdiscoveryonline Home Page

Pfizer Inc. recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds

Tags: review application license acceptance

 
 

Merck to Present New Data in Five Tumor Types from Studies Evaluating Pembrolizumab, the Companys Investigational Anti-PD-1 Antibody, at ESMO 2014

2014-09-02 14:30:00| Merck.com - Corporate News

Dateline City: WHITEHOUSE STATION, N.J. First Presentation of Findings in Gastric and Bladder (Urothelial Tract) Cancers WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from ongoing clinical trials evaluating the anti-tumor activity of pembrolizumab, the companys investigational anti-PD-1 antibody, at the European Society of Medical Oncology (ESMO) 2014 in Madrid, Spain, September 26 30. Language: English Contact: MerckMedia Contacts:Ian McConnell, 908-423-3046Claire Mulhearn, 908-423-7425Investor Contacts:Joseph Romanelli, 908-423-5185Justin Holko 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: data present types studies

 

Merck Initiates Phase 3 Study of Letermovir, an Investigational Antiviral for Prevention of Cytomegalovirus (CMV) Infection in High-Risk Bone Marrow Transplant Patients

2014-07-24 14:30:00| 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 that the first patient has been enrolled in a global Phase 3 clinical study of letermovir (MK-8228), an investigational antiviral agent. Language: English Contact: MerckMedia:Pam Eisele, 267-305-3558orRobert Consalvo, 908-423-6595orInvestor:Joseph Romanelli, 908-423-5185orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: study phase patients prevention

 

Merck Announces Data from Investigational Phase 3 Study on EMEND (aprepitant) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children Undergoing Emetogenic Chemotherapy

2014-06-30 14:00:00| Merck.com - Research & Development News

Dateline City: WHITEHOUSE STATION, N.J. Merck Planning Regulatory Submissions in the U.S. for EMEND in Pediatric Setting Including New Suspension Formulation in Second Half of 2014 WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from a global, investigational Phase 3 study to evaluate the safety and efficacy of EMEND (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years. Language: English Contact: MerckMedia:Pam Eisele, 267-305-3558orClaire Mulhearn, 908-423-7425orInvestors:Joseph Romanelli, 908-423-5185orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: data study children phase

 

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