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Merck Announces FDA Acceptance of New Drug Application for an Investigational Tablet Formulation of the Antifungal NOXAFIL (posaconazole)

2013-04-10 14:30:00| 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 announced that its New Drug Application for an investigational, tablet formulation of the company's antifungal agent, NOXAFIL (posaconazole), has been accepted for review by the U.S. Food and Drug Administration (FDA). Language:  English Contact HTML:  MerckMedia:Pam Eisele, (908) 423-5042Robert Consalvo, (908) 423-6595orInvestor:Carol Ferguson, (908) 423-4465Justin Holko, (908) 423-5088 Ticker Slug:  Ticker: MRK Exchange: NYSE read more

Tags: the application drug acceptance

 

Merck to Present New Data on VICTRELIS (boceprevir) and Investigational Compounds MK-5172 and Vaniprevir for Chronic Hepatitis C Virus at The International Liver CongressTM / 2013 EASL Annual Meeting

2013-04-08 16:37:00| Merck.com - Product News

Dateline City:  WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that two analyses of VICTRELIS (boceprevir) and data from Phase II studies of two of Mercks investigational medicines for chronic hepatitis C virus (HCV) genotype 1, MK-5172 and vaniprevir (MK-7009), will be presented at the 2013 International Liver Congress (EASL) Annual Meeting. The meeting will take place in Amsterdam from April 24-28, 2013. Language:  English Contact HTML:  MerckMedia:Caroline Lappetito, 267-305-7369Sarra Herzog, 908-423-6154orInvestors:Carol Ferguson, 908-423-4465Justin Holko, 908-423-5088 Ticker Slug:  Ticker: MRK Exchange: NYSE read more

Tags: data international present meeting

 
 

Merck Announces FDA Acceptance of Biologics License Application for Investigational Grass Pollen Allergy Immunotherapy Tablet

2013-03-27 13:00:00| 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 that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT. Language:  English Contact HTML:  MerckMedia:Pam Eisele, (908) 423-5042Tracy Ogden, (267) 305-2301orInvestors:Justin Holko, (908) 423-5088 Ticker Slug:  Ticker: MRK Exchange: NYSE read more

Tags: application license acceptance grass

 

Merck and Luminex Corporation Enter Agreement to Develop Companion Diagnostic to Support Investigational BACE inhibitor Clinical Development Program for Alzheimers Disease

2013-03-13 13:30:00| Merck.com - Research & Development News

Dateline City:  WHITEHOUSE STATION, N.J. & AUSTIN, Texas Collaboration to Support Patient Selection for the Clinical Development of MK-8931, Mercks Lead Investigational Medicine for Alzheimers Disease WHITEHOUSE STATION, N.J. & AUSTIN, Texas--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Luminex Corporation (NASDAQ:LMNX) have signed a collaboration and license agreement to develop a companion diagnostic device that will be evaluated to help screen patients for recruitment into Merck's clinical development program for MK-8931, a novel oral beta amyloid precursor protein site cleaving enzyme (BACE) inhibitor and Merck's lead investigational candidate for Alzheimer's disease (AD). Language:  English Contact HTML:  Media Contacts:MerckCaroline Lappetito, 267-305-7639orLuminexMimi Torrington, 512-219-8020mtorrington@luminexcorp.comorInvestor Contacts:MerckCarol Ferguson, 908-423-4465orLuminexMatt Scalo, 512-336-3587mscalo@luminexcorp.com Ticker Slug:  Ticker: MRK Exchange: NYSE Ticker: LMNX Exchange: NASDAQ read more

Tags: support enter development program

 

Oramed Pharmaceuticals Moves Forward With Investigational New Drug Application For Oral Insulin

2013-02-27 01:19:04| drugdiscoveryonline News Articles

Oramed Pharmaceuticals Inc. (NASDAQ:ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has been in communication with the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application for oral insulin

Tags: application forward drug oral

 

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