• Regulatory NewsRegulatory News

    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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    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...