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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: GPs Create Expert Group to Liaise With EMA (5 May 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Posts Draft Guideline on Clinical Trials of Acute Coronary Syndrome Treatments The European Medicines Agency (EMA) has released a draft guideline about the clinical development of treatments for acute coronary syndrome (ACS). EMA drafted the text to update a pair of existing guidance documents, which have been rendered outdated by advances in the diagnosis, treatme...
  • Advisory Committee Votes Against Label Expansion for J&J/Bayer's Xarelto

    The US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against Johnson & Johnson and Bayer's co-developed oral anticoagulant drug Xarelto (rivaroxaban), which the companies were looking to market as a therapy for Acute Coronary Syndrome (ACS). Xarelto is already FDA-approved for reducing the risk of blood clots in limited populations. The advisory committee had expressed some doubts regarding the drug on 22 May, saying m...
  • Reviewers Express Doubts in Advance of Xarelto Review

    An advisory committee to the US Food and Drug Administration (FDA) gave US-based manufacturer Johnson & Johnson's (J&J) blood thinner Xarelto (rixaroxaban), experimentally used to treat acute coronary syndrome (ACS), mixed reviews after taking issue with the quality of data used to support the drug. CNBC reports the panel of advisors was particularly troubled by missing data , including 12% of patients in the study and several deaths which were not counted in ...