News

EMA advises on compassionate use of daclatasvir

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The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given an opinion on the use of daclatasvir in combination with sofosbuvir in the treatment of chronic (long-term) hepatitis C virus (HCV) infection, in a compassionate-use programme. Click here to read the full press release.

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EMA recommends the granting of marketing authorisation for Sovaldi (sofosbuvir) to treat CHC

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The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Sovaldi (sofosbuvir) intended for the treatment of chronic hepatitis C. Click here to read the full press release. 

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FDA Approves Olysio (simeprevir) to treat chronic hepatitis C virus infection

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The U.S. Food and Drug Administration approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection. Olysio is a protease inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. It is to be used as a component of a combination antiviral treatment regimen. Click here to read the full press release.

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Letter to Secretary Sebelius on ACA Allowance of Drug Copay Programs

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The Fair Pricing Coalition and Treatment Action Group are requesting that Secretary of Health and Human Services Kathleen Sebelius issue clear guidance to allow drug industry-sponsored assistance programs for drugs without generic equivalents in the ACA health plans, so that patients with serious illnesses can be protected from immediate and insurmountable out-of-pocket cost barriers as the nation's health care system adapts during the ACA transition.Click here to read the letter and sign-on as an organization or as an individual. 

 

 

Project Inform Seeks Director of Federal and State Affairs

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Project Inform is seeking a Director of Federal and State Affairs. This position will focus primarily on federal and California hepatitis C policy advocacy. Deadline for submission is December 13, 2013. Click here for more information.

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IDSA Press Release: Passage of PEPFAR Stewardship Act

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WASHINGTON, DC – The U.S. Senate’s unanimous and decisive passage Monday night of legislation extending the President’s Emergency Plan For AIDS Relief for five more years gives hope to millions of people around the world still in need of services to prevent and treat HIV, renews a commitment to the  most ambitious and effective health response this country has undertaken, and acknowledges the importance of this historic program to the American people. Click here to read the full press release from the IDSA Center for Global Health Policy and HIVMA.

 

 

Abstract Submission Open for 18th International Workshop on HIV Observational Databases

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The 18th International Workshop on HIV Observational Databases (IWHOD) will be held March 27 - 29, 2014 in Sitges, Spain. Click here for more information and to submit abstracts. The deadline for abstract submission is December 11, 18:00 UK. 

 

Viral Hepatitis Action Plan - 2012 Highlights of Federal Efforts

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The HHS Office of HIV/AIDS and Infectious Disease Policy (OHAIDP) has shared a new report that features 2012 highlights of federal efforts to implement the Action Plan for the Prevention, Care and Treatment of Viral Hepatitis

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Revised FDA Draft Guidance on Clinical Development of Treatment for Chronic Hepatitis C

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OCT-29-13 The Food and Drug Administration has published draft guidance to assist sponsors in the clinical development of direct-acting antiviral drugs for the treatment of chronic hepatitis C  from the initial pre­-investigational new drug application (pre-IND) through the new drug application and postmarketing stages. Click here to read the draft guidance.
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FDA Advisory Committee Meetings October 24/25

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OCT-24/25-13  The Food and Drug Administration  Antiviral Drugs Advisory Committee will convene two meetings on October 24th and 25th, 2013 to discuss new drug applications for simeprevir and sofosbuvir, respectively.  
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