Category Archives: Op-Ed

European Regulator’s Last Ditch Attempt at Transparency

By Peter O’ Donnell. The European Medicines Agency is determined to minimize opposition to its next moves on releasing clinical trial data. It announced last week yet another consultation on its plans to publish the results of trials — a policy it initially aimed at introducing from the beginning of this year. The latest twist […]
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UK: Further Steps Toward Value-Based Assessment

By Leela Barham. The National Institute for Health and Care Excellence (NICE) has finally published the formal consultation on value-based assessment (VBA). VBA is the new VBP, incorporating a wider assessment of value and no longer clearly linking to price in quite the way that some speculated all the way back in 2010 when VBP […]
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Making the Most of Disruptive Digital Technologies

Peter Houston looks at the pharma marketing takeaways from last week’s Digital Innovation Summit.
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Adaptive Licensing: The Start of a Slow Revolution in Europe

By Peter O’ Donnell. So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation. Is this the beginning of the end of binary decision-making on the merits of a new medicine? Has a half-century of the “yes/no” authorization process peaked, to be replaced […]
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"Close Call" for American Rx Marketers on Medicare Part D

As the U.S. heads towards a public market place in which Medicare, Medicaid, CHIPs, VA, and now Obamacare will shortly comprise almost 70% of the American healthcare market, American Rx marketers recently endured a “close call” with the U.S. Department of Health and Human Services over the arbitrary deletion of dozens of key drugs from […]
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