Category Archives: Europe

EMA Delays Adoption of Policy on Publishing Trial Data

The European Medicines Agency (EMA) has postponed formal adoption of the policy on publication of clinical trial data. An EMA press statement said that “[f]urther clarifications on wording and practical arrangements will be discussed by Board members”, whose additional contributions will now be considered with a view to reaching final agreement at the Management Board meeting on 2 October. […]
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Further Boost for Europe’s Largest Healthcare Partnership

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has announced the launch of IMI2, with a budget of €3.3 billion (US$ 4.5 bn). IMI (the Innovative Medicines Initiative) is a public-private partnership (PPP) between the European Commission and EFPIA, and was already the largest healthcare PPP in Europe. The budget for its first phase (2008-2013) […]
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European Pharma Policy Reaches "New Level of Timidity"

By Peter O’ Donnell, Applied Clinical Trials. The European Union has managed to snatch defeat from the jaws of opportunity once more! A long-heralded document portentously entitled “Pharmaceutical industry: a strategic sector for the European economy,” and supposedly initiating a new start in long-term thinking about boosting the drug industry, squeezes the thinnest and weakest […]
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Industry Challenged: “Do More for Teenagers with Cancer”

By Leela Barham. Accessing the latest cancer drugs always seem to be controversial. Not just because of the money but also because of the complexities of accessing treatments during their development. This seems to be especially the case for young people with cancer, according to the UK’s Teenage Cancer Trust. 
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Value-Based Assessment in the UK: The Industry View

By Leela Barham. In the UK, Value-Based Pricing (VBP) has morphed into Value-Based Assessment (VBA), with the National Institute for Health and Care Excellence (NICE) tasked with taking the loose policy concepts (established as far back as 2010) and actually implementing them. Earlier this year, NICE set out its approach, which boiled down to taking a […]
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