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    NICE Backs Five New Drugs, Gives Conditional Recommendation to GSK's Benlysta

    The UK's National Institute for Health and Care Excellence (NICE) on Wednesday issued recommendations for six drugs after agreeing to discounts with their respective manufacturers, clearing the drugs for use by the country's National Health Service (NHS). The drugs include two cancer drugs from Novartis, Zykadia (ceritinib) and Mekinist (trametinib); two PCSK9 inhibitors, Sanofi's Praluent (alirocumab) and Amgen's Repatha (evolucumab); AbbVie's Humira (adalimumab); and G...
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    Biosimilars in the EU: Lower Costs, Increased Patient Access, IMS Report Finds

    For those tracking the contentious debate over drug and biologic price hikes in the US, an IMS Health report released on Monday offers the latest evidence yet that a robust biosimilars market can not only lower prices across drug classes but also increase patient uptake of such treatments. “The increased competition affects not just the price for the directly comparable product but also has an effect on the price of the whole product class,” the report says. “In countr...
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    EU Ombudsman Calls on EMA to Release Redacted Humira Study Data

    The EU Ombudsman is calling for the European Medicines Agency (EMA) to release more information from three clinical trials for one of the most commercially successful drugs of all time, AbbVie's arthritis drug Humira (adalimumab), and says EMA should also make changes to how it handles disclosing information in the future. Specifically, the ombudsman suggests that going forward, EMA should require companies applying for EU marketing authorization to provide the agency wi...