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Merck Provides Update on European Medicines Agency Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir

2015-12-18 14:00:00| Merck.com - Research & Development News

Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has responded to the companys marketing authorization application (MAA) for elbasvir/grazoprevir (50mg/100mg), which is under review for the treatment of adult patients with chronic hepatitis C (HCV) infection. Language: English Contact: MerckMedia:Doris Li, 908-246-5701Sarra Herzog, 201-669-6570orInvestors:Teri Loxam, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: application marketing update agency

 

Dompe's investigational biotech molecule receives orphan drug...

2015-12-08 10:08:14| Biotech - Topix.net

The Dompe biopharmaceutical company announced today that the Committee for Orphan Medicinal Products of the European Medicines Agency has officially designated recombinant human Nerve Growth Factor - the investigational biotech molecule developed by Dompe based on research by Nobel Laureate Rita Levi Montalcini - as an orphan drug for the treatment of neurotrophic keratitis. NGF is the first neurotrophic factor to be identified and purified, and represents one of the most interesting topics being studied in medicine today and specifically in ophthalmology.

Tags: drug receives biotech molecule

 
 

The Investigational New Drug (IND) Submission - Tips to Win the First Time

2015-12-08 09:45:08| drugdiscoveryonline News Articles

Date: Thursday, January 21, 2016 Time:1pm - 2:30pm EST US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts and Job Aids!

Tags: the time tips win

 

Merck Announces Initial Results for KEYTRUDA (pembrolizumab) with Novel Immunotherapy Combinations from Three Investigational Studies Presented at the Society for Melanoma Research International Congress

2015-11-21 22:30:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. In Addition, Longer Term Follow-Up Single-Agent Data for KEYTRUDA Shows Continued Superior Overall Response Rate and Progression Free Survival Compared to Ipilimumab KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced findings from three studies investigating the use of KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, in combination with three other immunotherapies epacadostat, IMLYGICTM (talimogene laherparepvec), and ipilimumab in patients with advanced melanoma. Language: English Contact: MerckMedia:Pamela Eisele, (267) 305-3558orAn Phan, (908) 255-6325orInvestors:Teri Loxam, (908) 740-1986orJustin Holko, (908) 740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: results international research society

 

Merck Announces Presentation of Results from Two Phase 2 Studies of Investigational Triple-Combination Chronic Hepatitis C Therapy at The Liver Meeting

2015-11-16 14:30:00| Merck.com - Research & Development News

Dateline City: KENILWORTH, N.J. Merck Advances to Part B of C-CREST Phase 2 Clinical Development Program KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of results from the initial phase (Part A) of the companys C-CREST 1 and 2 Phase 2 clinical development program evaluating two investigational all-oral, triple-combination treatment regimens a regimen of grazoprevir1, MK-36822 and elbasvir3; and a regimen of grazoprevir, MK-3682 and MK-84084 in treatment-nave patients with chronic hepatitis C virus (HCV) genotypes (GT) 1, 2 or 3 infection. Language: English Contact: MerckMedia:Doris Li, 908-246-5701Sarra Herzog, 201-669-6570orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: the results studies meeting

 

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