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FDA Accepts for Review Merck’s Biologics License Application for V503, Investigational 9-valent Human Papillomavirus Vaccine
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 Biologics License Application for V503, its investigational 9-valent human papillomavirus (HPV) vaccine, has been accepted for standard review by the U.S. Food and Drug Administration. About Merck Language: English Contact: ...
Source: Merck.com - Research and Development News - February 20, 2014 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Merck Enters Strategic Collaborations with Amgen, Incyte and Pfizer to Evaluate Novel Combination Anti-cancer Regimens with MK-3475
Dateline City: WHITEHOUSE STATION, N.J. Merck Also to Initiate Phase I “Signal Finding” Study with MK-3475 in 20 New Cancer Types WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today it has signed three separate clinical collaboration agreements, through subsidiaries, with Amgen Inc., Incyte Corporation and Pfizer Inc. to evaluate novel combination regimens with MK-3475, Merck’s invest...
Source: Merck.com - Research and Development News - February 5, 2014 Category: Pharmaceuticals Tags: Oncology Newsroom Research and Development News Corporate News Latest News Source Type: news

Merck Statement on FDA Advisory Committee Meeting for RAGWITEK™ (Short Ragweed Pollen Allergen Extract), an Investigational Sublingual Allergy Immunotherapy Tablet
Dateline City: WHITEHOUSE STATION, N.J. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today said it was pleased with the positive discussion of RAGWITEK™ (Short Ragweed Pollen Allergen Extract) at the Allergenic Products Advisory Committee meeting of the U.S. Food and Drug Administration (FDA). Language: English read more (Source: Merck.com - Research and Development News)
Source: Merck.com - Research and Development News - January 29, 2014 Category: Pharmaceuticals Tags: Merck MRK MSD Ragweed RAGWITEK Research and Development News Corporate News Latest News Source Type: news

Merck Statement on FDA Advisory Committee for Vorapaxar, Merck’s Investigational Antiplatelet Medicine
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 said it was pleased with the U.S. Food and Drug Administration (FDA)’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar. Vorapaxar is the company’s investigational antiplatelet medicine for the reduction of atherothrombotic events, when added to standard of care, in patients with a history of heart attack and no his...
Source: Merck.com - Research and Development News - January 15, 2014 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Merck Initiates Rolling Submission of U.S. Biologics License Application for MK-3475, an Investigational Anti-PD-1 Immunotherapy, in Patients with Advanced Melanoma
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 company’s investigational anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated wi...
Source: Merck.com - Research and Development News - January 13, 2014 Category: Pharmaceuticals Tags: Oncology Newsroom Research and Development News Corporate News Latest News Source Type: news

Merck Collaborates with GlaxoSmithKline to Evaluate Novel Combination Regimen for Advanced Renal Cell Carcinoma
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 the initiation of a clinical trial to evaluate the combination of the company’s investigational anti-PD-1 immunotherapy, MK-3475, and GlaxoSmithKline’s orally administered kinase inhibitor, pazopanib, in advanced renal cell carcinoma. Language: English Contact: ...
Source: Merck.com - Research and Development News - December 18, 2013 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

FDA Approves Merck’s NOXAFIL® (posaconazole) Delayed-Release Tablets
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 U.S. Food and Drug Administration (FDA) has approved NOXAFIL® (posaconazole) 100 mg delayed-release tablets. NOXAFIL delayed-release tablets are a new formulation with a loading dose of 300 mg (three 100 mg delayed-release tablets) twice daily on the first day, followed by a once-daily maintenance dose of 300 mg (three 100 mg delayed-release tablets) s...
Source: Merck.com - Research and Development News - November 26, 2013 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Additional Interim Data for Merck’s Investigational Anti-PD-1 Immunotherapy, MK-3475, Shows Estimated Overall Survival Rate of 81 Percent at One Year in Patients with Advanced Melanoma
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: ...
Source: Merck.com - Research and Development News - November 18, 2013 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Merck’s New Drug Application for an Investigational Intravenous (IV) Formulation of NOXAFIL® (posaconazole) Receives FDA Priority Review
Dateline City: WHITEHOUSE STATION, N.J. Marketing Authorization Application also Filed with the European Medicines Agency WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational intravenous (IV) solution formulation of the company's antifungal agent, NOXAFIL® (posaconazole), has been accepted for priority review by the U.S. Food and Drug Adm...
Source: Merck.com - Research and Development News - November 18, 2013 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Interim Data to Be Presented for MK-3475, Merck’s Investigational Anti-PD-1 Immunotherapy, in Patients with Advanced Melanoma
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, will present additional data from patients with advanced melanoma from the Phase IB trial of MK-3475 on Monday, Nov. 18 at the 10th International Congress of the Society for Melanoma Research in Philadelphia. MK-3475 is Merck’s investigational anti-PD-1 immunotherapy. Language: English Contact: ...
Source: Merck.com - Research and Development News - November 15, 2013 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Merck’s Investigational Grass Sublingual Allergy Immunotherapy Tablet Significantly Reduced Allergy Symptoms and Need for Symptom-Relief Medication in Adults and Children in Pivotal Phase III Study
Dateline City: WHITEHOUSE STATION, N.J. Data to be Presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced data for its investigational Timothy grass sublingual allergy immunotherapy tablet (MK-7243) from a study involving 1,501 North American adult and pediatric patients. Language: ...
Source: Merck.com - Research and Development News - November 9, 2013 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Merck’s Investigational 9-valent HPV Vaccine, V503, Prevented 97 Percent of Cervical, Vaginal and Vulvar Pre-cancers Caused by Five Additional HPV Types, in Phase III Study
Dateline City: WHITEHOUSE STATION, N.J. Immunogenicity non-inferior to GARDASIL® for original four HPV types Merck expects to file Biologics License Application with U.S. FDA in 2013 WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that in the pivotal Phase III efficacy study, its investigational 9-valent HPV vaccine (V503) prevented approximately 97 percent of...
Source: Merck.com - Research and Development News - November 4, 2013 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Merck Announces Presentation of Interim Data from Study of Investigational Combination of HCV Therapies MK-5172 and MK-8742 at the 2013 American Association for the Study of Liver Diseases (AASLD) Annual Meeting
Dateline City: WHITEHOUSE STATION, N.J. Sustained virologic response at post-treatment follow-up week 12 (SVR 12) seen in 100 percent of patients to date in two of the three combination arms studied WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the presentation of interim data from the ongoing C-WORTHY Study, a Phase II clinical trial evaluating the efficacy and safety of an all-oral re...
Source: Merck.com - Research and Development News - November 2, 2013 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Merck Announces Presentation of Interim Data from Phase 1B Study of MK-3475, Investigational anti-PD-1 Immunotherapy, in Previously-Treated Patients with Non-Small Cell Lung Cancer (NSCLC) at 15th World Conference on Lung Cancer
Dateline City: WHITEHOUSE STATION, N.J. Phase II/III Trial of MK-3475 in Patients with NSCLC Currently Enrolling WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of interim data from a Phase 1B trial (PN001) evaluating MK-3475, an investigational anti-PD-1 immunotherapy, in patients with previously-treated non-small cell lung cancer (NSCLC). The data were presented today...
Source: Merck.com - Research and Development News - October 29, 2013 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Merck Provides Update on Investigational 9-valent HPV Vaccine V503 to U.S. Advisory Committee on Immunization Practices
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 provided an overview of the clinical trial program for V503, the company’s investigational 9-valent human papillomavirus (HPV) vaccine, to the Advisory Committee on Immunization Practices in the United States. Merck said that the pivotal efficacy trial is complete, the primary endpoints have been met and the company expects to submit a Biologics License Application for ...
Source: Merck.com - Research and Development News - October 24, 2013 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news