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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Ireland Starts Consultation on Biosimilar Policy (17 August 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU Regulatory news. Ireland Starts Consultation on Biosimilar Policy, Immediately Receives Pushback From Industry Ireland has started a consultation on how to increase access to biosimilars. The delayed document calls for feedback on pharmacy-led substitution of biosimilars, quotas for use of biologic copycats and other ways to increase uptake, although doubts remain about whether the gove...
  • Feature ArticlesFeature Articles

    A Closer Look at Strategic Alliances Between Drugmakers and CROs

    Alliances between the pharmaceutical industry and contract research organizations (CROs) have evolved over the past three decades from transaction-based relationships to truly collaborative strategic partnerships. Although the traditional fee-for-service outsourcing model still exists, an increasing number of pharmaceutical companies and CROs have formed enduring partnerships. Strategic alliances represent the highest level of integration between pharmaceutical companies...
  • Feature ArticlesFeature Articles

    Sunshine Comes to Clinical Trials: Sponsors, CROs, Physicians and Teaching Hospitals Need to Prepare for Federal Financial Disclosure

    A provision of the healthcare reform law has created a new need for clinical trial sponsors and other participants to be open about financial relationships. On 19 December 2011, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule that would require applicable manufacturers, including many clinical trial sponsors, to disclose certain financial relationships with physicians and teaching hospitals. The concept is nothing new, as the rule implement...