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Tag: hepatitis
FDA warns of deadly liver damage with AbbVie hepatitis drugs
2015-10-25 14:37:13| Biotech - Topix.net
Federal health officials are warning doctors and patients that two hepatitis C drugs from AbbVie can cause life-threatening liver injury in patients with advanced forms of the disease. The Food and Drug Administration said Thursday it will require AbbVie to add new warnings to Viekira Pak and Technivie after reported deaths and liver transplants in patients who already had liver damage caused by hepatitis C. The warning could reshape the growing field of high-priced drugs to treat the virus, which also includes Gilead Sciences' blockbuster medications Sovaldi and Harvoni.
Tags: damage
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deadly
FDA adds liver warning to AbbVie hepatitis C drugs
2015-10-23 01:36:32| Biotech - Topix.net
Federal health officials are warning doctors and patients that two hepatitis C drugs from AbbVie can cause life-threatening liver injury in patients with advanced forms of the disease. The Food and Drug Administration said Thursday it will require AbbVie to add new warnings to Viekira Pak and Technivie about their risks for patients who already have advanced liver damage caused by hepatitis C. The warning could reshape the growing field of high-priced drugs to treat the virus, which also includes Gilead Sciences' blockbuster medications Sovaldi and Harvoni.
Tags: warning
drugs
adds
liver
Merck to Present New Data on Investigational Chronic Hepatitis C Treatment Elbasvir/Grazoprevir at The Liver Meeting 2015, Including Phase 3 Results in Selected Difficult-to-Treat Populations
2015-10-20 16:35:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. New Data Will Also be Presented from Phase 2a C-CREST Trials of Mercks Investigational Triple-Combination Chronic Hepatitis C Therapies KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new data from clinical trials of its investigational treatment portfolio for chronic hepatitis C virus (HCV) are scheduled to be presented at The Liver Meeting 2015 (the 66th annual scientific congress of the American Association for the Study of Liver Diseases) in San Francisco, from Nov. 13-17, 2015. Mercks late-stage investigational portfolio includes elbasvir/grazoprevir1, MK-36822 and MK-84083. Language: English Contact: MerckMedia:Doris Li, 908-246-5701Sarra Herzog, 908-740-1871orInvestors:Teri Loxam, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Results from Mercks Phase 3 Study of Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir in Patients with Advanced Chronic Kidney Disease Published in The Lancet
2015-10-06 01:01:00| 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 the publication of results from C-SURFER, the first Phase 31 clinical trial to investigate an all-oral, ribavirin-free chronic hepatitis C virus (HCV) treatment regimen in treatment-nave and treatment-experienced patients with advanced chronic kidney disease (CKD) stages 4 or 5 and chronic HCV genotype 1 (GT1) infection. Language: English Contact: MerckMedia Contacts:Doris Li, 908-246-5701Sarra Herzog, 201-669-6570orInvestor Contacts:Teri Loxam, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Merck Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Genotypes 1, 4 and 6 Infection
2015-07-28 12:30:00| Merck.com - Research & Development News
Dateline City: KENILWORTH, N.J. Company Granted FDA Priority Review with Target Action Date of January 28, 2016 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Language: English Contact: MerckMedia:Doris Li, (908) 246-5701Sarra Herzog, (201) 669-6570orInvestor:Joe Romanelli, (908) 740-1986Justin Holko, (908) 740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: and
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