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  • Regulatory NewsRegulatory News

    FDA Adds Boxed Warning to Hepatitis C Drugs, Warns of Hepatitis B Reactivation Risk

    The US Food and Drug Administration (FDA) on Tuesday warned of serious risks for some patients who have been infected with the hepatitis B virus (HBV) and are being treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus (HCV). FDA identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs between 22 November 2013 and 18 July 2016. Of the cases reported, two pati...
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    European Regulatory Roundup: Advances in Hepatitis C Care Prompt EMA to Revise Guidance (14 July 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Fast Advance in Hepatitis C Care Prompts EMA to Revise Clinical Trial Guideline EMA has proposed changes to its guideline on clinical trials of direct acting antiviral hepatitis C drugs. The revisions are intended to ensure the guideline reflects the dramatic changes that have happened in the hepatitis C sector since Gilead introduced its blockbuster Sovaldi (sofosbuvi...
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    Asia Regulatory Roundup: China Fast Tracks Hepatitis C, Cancer Drug Approvals (26 April 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Puts Hepatitis C, Cancer Drugs on Regulatory Approval Fast Track China has granted priority review status to a clutch of drugs being developed by Western companies. The products affected by the actions include the expensive hepatitis C drugs from Gilead Sciences and other manufacturers that have transformed treatment of the disease in the West. Versions of Gilead’s b...
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    European Regulatory Roundup: Germany Joins EU Medical Countermeasure Procurement Alliance (21 April 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Adopts Rules for Public Hearings on Safety Reviews Ahead of dry run in July The Pharmacovigilance Risk Assessment Committee (PRAC) has adopted rules of procedure for public hearings on safety reviews. PRAC, which could hold its first public hearing by the end of the year, is working on the initiative to give its members a way to gather the views of patients on safety is...
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    Counterfeit Versions of Gilead’s Blockbuster Hepatitis C Drug Found in Israel

    Counterfeits of Gilead’s mega-blockbuster hepatitis C treatment Harvoni, which is generating billions per quarter in sales for the company, are emerging in Israel. Switzerland’s drug regulator Swissmedic said over the weekend that the plastic bottles of the counterfeits, which originated in India, were imported via a Swiss trading company and “contain white instead of genuine yellow film-coated tablets,” the regulator said. Swissmedic is working with other EU authoritie...
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    European Commission Says Compulsory Licensing can Only Happen at National Level

    After being questioned by a member of the European Parliament, the European Commission (EC) says neither it nor the European Medicines Agency (EMA) have the power to acquire patents or issue a compulsory license. Background In the past two years, drugmakers have launched several drugs to treat hepatitis C (HCV), a disease which left untreated can lead to cirrhosis or liver cancer. The new generation of HCV treatments, led by Gilead's Sovaldi and Harvoni, are highly eff...
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    Gilead to Offer Free HCV Treatment in Georgia

    Gilead Sciences has launched an initiative to provide its hepatitis C (HCV) treatment Sovaldi to patients in the Republic of Georgia free of charge. The move is part of an effort by Gilead to demonstrate that its products can drastically reduce HCV prevalence, which the company hopes will encourage more widespread use of Sovaldi and its successor, Harvoni. In its first year, the program will cover treatment for 5,000 patients, with Gilead looking to expand the program t...
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    FDA Changes Policy Hours Before Approvals, Giving Companies Gift Potentially Worth Billions

    On Friday, two companies were the lucky recipients of gifts never before given by the US Food and Drug Administration (FDA)—gifts potentially worth millions, if not billions of dollars in value. Background In the US, pharmaceutical manufacturers who obtain approval to market a "new" drug from FDA are eligible for varying degrees of market- (rather than patent-) based exclusivity. For New Chemical Entities (NCEs), that means five years of protection during which time FD...