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Merck Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease

2015-04-23 09:30:00| Merck.com - Research & Development News

Dateline City: VIENNA C-SURFER Trial is First to Investigate an All-Oral Ribavirin-Free Hepatitis C Treatment Regimen in Treatment-Nave and Treatment-Experienced Patients with Advanced Chronic Kidney Disease Infected with Hepatitis C Virus Genotype 1 VIENNA--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentation of data from C-SURFER, the companys Phase 2/3 clinical trial evaluating the investigational once-daily treatment regimen of grazoprevir (100mg) and elbasvir (50mg) in patients with advanced chronic kidney disease (CKD) infected with chronic hepatitis C virus (HCV) genotype 1 (GT1).1 Treatment-nave patients and patients who failed prior pegylated interferon HCV therapy, with or without cirrhosis, all of whom had Language: English Contact: Media:Doris Li, 908-246-5701orSarra Herzog, 201-669-6570orInvestors:Joe Romanelli, 908-740-1986orJustin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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Enanta Announces 95 percent SVR12 Rate In AbbVie's Phase 3 Study Of All-Oral Treatment For Hepatitis C Virus In Japanese Patients

2015-02-04 07:01:33| drugdiscoveryonline Home Page

Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, recently announced topline Phase 3 results from the GIFT-1 study, AbbVie’s investigational, all-oral, ribavirin-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir (OBT/PTV/r) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection in Japan

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Isis Pharmaceuticals announces initiation of ISIS-SMN Rx Phase 3 study in children with SMA

2014-11-25 16:58:52| Biotech - Topix.net

Isis Pharmaceuticals, Inc. announced today the initiation of a pivotal Phase 3 study evaluating ISIS-SMNRx in approximately 120 non-ambulatory children with spinal muscular atrophy . SMA is a severe and rare genetic neuromuscular disease characterized by muscle atrophy and weakness.

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MSD Announces Positive Study Investigating the Use of Pembrolizumab Compared to Chemotherapy in Patients with Ipilimumab-Refractory Advanced Melanoma

2014-11-16 10:25:00| Merck.com - Research & Development News

Dateline City: ZURICH Pembrolizumab Demonstrated Superiority to Chemotherapy for Primary Endpoint of Progression-Free Survival Findings Presented for First Time at Society of Melanoma Research (SMR) 2014 International Congress ZURICH--(BUSINESS WIRE)--MSD, known as Merck in the United States and Canada, announced today that a pre-specified analysis of investigational data from a pivotal Phase 2 study (KEYNOTE-002) showed pembrolizumab, the companys anti-PD-1 therapy, substantially improved the primary endpoint of progression-free survival (PFS, as assessed by RECIST 1.1, independent central review) (HR 0.57 and 0.50 for 2 mg/kg and 10 mg/kg every three week doses, respectively), compared to chemotherapy (P<0.0001 for both comparisons) in patients with ipilimumab- Language: English Contact: MSDMedia:Lainie Keller, +1-908-236-5036Claire Mulhearn, +1-908-236-1118orInvestor:Joseph Romanelli, +1-908-423-5185Justin Holko, +1-908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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Merck Announces Positive Study Investigating the Use of KEYTRUDA (pembrolizumab) Compared to Chemotherapy in Patients with Ipilimumab-Refractory Advanced Melanoma

2014-11-16 10:25:00| Merck.com - Research & Development News

Dateline City: ZURICH KEYTRUDA Demonstrated Superiority to Chemotherapy for Primary Endpoint of Progression-Free Survival Findings Presented for First Time at Society of Melanoma Research (SMR) 2014 International Congress ZURICH--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that a pre-specified analysis of investigational data from a pivotal Phase 2 study (KEYNOTE-002) showed KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, substantially improved the primary endpoint of progression-free survival (PFS, as assessed by RECIST 1.1, independent central review) (HR 0.57 and 0.50 for 2 mg/kg and 10 mg/kg every three week doses, respectively), compared to chemotherapy (P<0.0001 for both comparisons) Language: English Contact: MerckMedia:Lainie Keller, 908-236-5036Claire Mulhearn, 908-236-1118orInvestor:Joseph Romanelli, 908-423-5185Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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