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Grazoprevir/Elbasvir, Mercks Investigational Chronic Hepatitis C Therapy, Granted FDA Breakthrough Therapy Designations; New Phase 2 and 3 Data in Multiple HCV Patient Types to be Presented at The International Liver CongressTM 2015

2015-04-08 13:00:00| Merck.com - Corporate News

Dateline City: KENILWORTH, N.J. Congress Highlights Include Results from Trials in a Wide Range of HCV Patients -- Patients with Chronic Kidney Disease, HIV Co-infection, Cirrhosis, and Prior Treatment Failures Company Remains on Track for NDA Filing with the U.S. FDA During First Half of 2015 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that grazoprevir/elbasvir, an investigational single tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection, has received two new Breakthrough Therapy designations from the U.S. Language: English Contact: MerckMedia:Doris Li, 908-246-5701Sarra Herzog, 908-740-1871orInvestors:Joe Romanelli, 908-740-1879Justin Holko, 908-740-1986 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: the data international types

Ethicon EVARREST Fibrin Sealant Patch Now FDA Approved for Liver Surgery

2015-04-06 22:34:24| Food - Topix.net

Ethicon , a part of J&J , received expanded FDA indication for its EVARREST Fibrin Sealant Patch to be used to help control bleeding during adult liver surgeries. The device is bioabsorbable and contains human thrombin and fibinogen proteins that participate in clot formation.

Tags: approved surgery patch liver

Therapure Innovations Receives FDA Approval To Proceed With A Phase 1 Clinical Trial Of The Targeted Liver Cancer Therapeutic TBI 302

2015-04-01 08:23:10| drugdiscoveryonline Home Page

Therapure Innovations, a division of Therapure Biopharma Inc., recently announces that the U.S. Food and Drug Administration (FDA) has given the company approval to proceed with a Phase 1 clinical trial of TBI 302, a targeted therapeutic for the treatment of liver cancer

Tags: trial phase approval cancer

New market for liver disease spawns race for better testing

2015-03-15 14:14:15| Biotech - Topix.net

As drugmakers develop new medicines to battle a liver disease epidemic, they have created an urgent need for better diagnostics to select patients for treatment and assess their drugs' effectiveness. A handout combination image of MRI scans shows a healthy liver compared with that of an obese 12-year-old suffering from NASH NEW YORK: As drugmakers develop new medicines to battle a liver disease epidemic, they have created an urgent need for better diagnostics to select patients for treatment and assess their drugs' effectiveness.

Tags: market testing race disease