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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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    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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    Sovaldi Patent Rejected in China Following Third-Party Challenge

    China's patent office has rejected a patent related to Gilead Science's blockbuster hepatitis C (HCV) drug Sovaldi. Background The rejection comes one month after the Initiative for Medicines, Access & Knowledge (I-MAK) filed several patent challenges against Gilead in China. I-MAK has also filed similar challenges in Argentina, Brazil, Russia and Ukraine, all citing Sovaldi's high price as a barrier to access in many middle-income countries where licensed generic ve...
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    HCV, Cancer Drugs Added to Essential Medicines List as WHO Calls for Lower Prices

    The World Health Organization (WHO) has issued a loud call for improving access to several high-profile—and high-cost—medicines by placing them on its 19th Model List of Essential Medicines released today. The updated list features 36 new medicines, including treatments for tuberculosis, HIV, hepatitis C (HCV) and cancer, and signifies a shift in WHO's approach to securing access to new and innovative medicines. Background For nearly 40 years, WHO has maintained...
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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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    Bangladeshi Company Launches Copy of Gilead's Sovaldi at 99% Discount

    A generic drug maker has launched its copy of Gilead Sciences' hepatitis C drug Sovaldi—which costs $84,000 in the US—which it will sell in Bangladesh for just $900 under the brand name Hopetavir, Bloomberg reports . Incepta Pharmaceuticals, a Bangladeshi company, is selling a 12-week course of a generic version of Gilead Sciences' Sovaldi for $900—almost 99% less than Gilead’s US price for the drugs—and has its eye on other markets where Sovaldi is not patent...
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    Follow the Rules, Indian Court Tells Patent Office in Sovaldi Case

    A prominent Indian court has ruled that India's patent office erred when it invalidated a patent application owned by the pharmaceutical company Gilead, giving the company another chance to save its patent on the hepatitis C drug Sovaldi while the patent office revisits the application. Monday, Regulatory Focus  reported the outcome and major themes of the court’s decision. In this article Focus will take a closer look at the facts of the case and the court’s judg...
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    Indian Court Sides with Gilead in Patent Dispute

    The Delhi High Court has ruled that India’s patent office failed to follow proper procedures in evaluating Gilead’s patent application, LiveMint reports. The ruling invalidates the Patent Office’s recent decision to reject Gilead’s patent application for one of the active metabolites of its hepatitis C drug Sovaldi. Background On 13 January 2015, India’s Patent Office rejected a patent application for a compound produced by the body as it metabolizes Sovaldi. Gi...
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    Gilead Seeks Regulatory Shortcut to Bring New HCV Drug to India

    Gilead Sciences announced it is extending licensing agreements with eight Indian generic manufacturers to include rights to make a yet-to-be approved drug in combination with Sovaldi (sofosbuvir). Background: A New Drug In a press release on Gilead’s website, the company says the new combination, if approved, would be the first treatment that effectively treats all six genotypes of hepatitis C (HCV). Previous treatments for HCV tended to be effective in select subpopu...