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chronic hepatitis C
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BMS Received Breakthrough Therapy Designation for Its Investigational DCV Dual Regimen
Feb 26, 2014Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment ...
Tags: Bristol-Myers, Medicine
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Hepatitis C Treatment Isn't Pretty
Jan 16, 2014Hepatitis C treatment isn't pretty, but the dark days of weekly injections, rough side effects and no guarantee of full recovery from the liver-damaging disease may soon be over, researchers report. Two studies, both published in the Jan. ...
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Sovaldi Has Been Approved to Treat Chronic Infection with Hepatitis C
Dec 26, 2013Sovaldi (sofosbuvir) has been approved by the U.S. Food and Drug Administration to treat chronic infection with Hepatitis C. It's considered a breakthrough medication since it's the first such drug that does not require same-time ...
Tags: Sovaldi, chronic infection, Hepatitis C
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Gilead Sciences Has Received Notice of Compliance From Health Canada
Dec 19, 2013Gilead Sciences has received notice of compliance from Health Canada for its once-daily oral nucleotide analog polymerase inhibitor Sovaldi or sofosbuvir 400mg tablets for the treatment of chronic hepatitis C or CHC infection. Sovaldi is ...
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FDA Approved Sovaldi to Treat Chronic Hepatitis C Virus Infection Without Interferon
Dec 11, 2013The U.S. Food and Drug Administration approved Sovaldi -- sofosbuvir -- to treat chronic hepatitis C virus infection without interferon, officials say. Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center ...
Tags: FDA, Sovaldi, sofosbuvir, chronic hepatitis C, health
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FDA Has Approved Sovaldi 400mg Tablets
Dec 10, 2013Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir) 400mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection ...
Tags: Gilead Sciences, Chronic Hepatitis
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FDA Has Approved Janssen Therapeutics' NS3/4A Protease Inhibitor 'Olysio'
Nov 25, 2013The US Food and Drug Administration (FDA) has approved Janssen Therapeutics' NS3/4A protease inhibitor 'Olysio (simeprevir)' for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with ...
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US FDA's Antiviral Drugs Advisory Committee Has Recommended Approval
Oct 28, 2013The US FDA's Antiviral Drugs Advisory Committee has recommended approval for Medivir's investigational protease inhibitor simeprevir (TMC435) 150mg capsules for the treatment of genotype 1 chronic hepatitis C in adult patients with ...
Tags: Medivir, Hepatitis C Patients
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US-Based Pharmaceutical Firm Merck Has Received Breakthrough Therapy
Oct 24, 2013US-based pharmaceutical firm Merck has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its investigational oral combination regimen MK-5172/MK-8742 for the treatment of chronic hepatitis C virus ...
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Janssen Research & Development Is Seeking US FDA Approval for The Use of Simeprevir
Apr 2, 2013Janssen Research & Development is seeking US FDA approval for the use of Simeprevir (TMC435) in combination with pegylated interferon and ribavirin to treat genotype 1 chronic hepatitis C in adults. The company submitted a new drug ...
Tags: Health, Medicine, pegylated interferon
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GSK Gained FDA Priority Review Status for The Supplemental New Drug Application
Dec 7, 2012GlaxoSmithKline (GSK), Ligand Pharmaceuticals' partner, has gained FDA priority review status for the supplemental new drug application for Promacta to treat thrombocytopenia in adult patients with chronic hepatitis C virus infection. ...
Tags: GlaxoSmithKline, GSK, promacta, thrombocytopenia
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FDA Granted Fast Track Designation for Idenix Pharmaceuticals' IDX719
Dec 5, 2012The US Food and Drug Administration (FDA) has granted fast track designation for Idenix Pharmaceuticals' IDX719 to treat chronic hepatitis C infection (HCV). IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a recent ...
Tags: IDX719, HCV, chronic hepatitis C infection
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Hemispherx Biopharma Has Filed an Amended NDA with ANMAT
Nov 28, 2012Hemispherx Biopharma has filed an amended NDA with ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica) for the use of Alferon N injection to treat Hepatitis C patients in Argentina. ANMAT has previously approved ...
Tags: Hemispherx Biopharma, Amended NDA, Alferon N Injection, ANMAT
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GSK Promacta Won FDA Approval as Thrombocytopenia Therapy in Chronic Hepatitis C Patients
Nov 20, 2012GlaxoSmithKline's (GSK) Promacta has won FDA approval as thrombocytopenia therapy in chronic hepatitis C patients. Promacta, brand name of eltrombopag in the US, will enable thrombocytopenia patients suffering from chronic hepatitis C ...
Tags: FDA approval, thrombocytopenia therapy, chronic hepatitis C
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GlaxoSmithKline Submitted Regulatory Applications for Eltrombopag in US, Europe
Jun 4, 2012Ligand Pharmaceuticals partner GlaxoSmithKline has submitted regulatory applications in the US and European Union for the use of eltrombopag (Promacta/Revolade) to increase platelet counts in patients with hepatitis C. A supplemental ...
