Category Archives: Europe

What's the Future of European Health Policy?

What can be gleaned about the direction that health policy will take for the next five years under the new European Commission, scheduled to take office at the beginning of November? Peter O’ Donnell address this question in his new Applied Clinical Trials column here.
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Global Gaps in Standards Threaten Biosimilar Development

Although biopharmaceutical companies and regulatory authorities have made considerable progress in establishing policies for bringing biosimilars to market, key differences and gaps in requirements for testing and documenting product similarity still characterize the European Union, the U.S. and other regions. The EU’s European Medicines Agency (EMA) has set the regulatory pace, with 18 products approved since 2006, […]
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PPRS Payments Now Worth £150m in the UK

By Leela Barham. A second payment has now been made under the UK’s Pharmaceutical Price Regulation Scheme (PPRS). Adding a further £76m to the £74m for the first quarter of 2014, the payments received by the Department of Health (DH) now total £150m (US$244m).  Payments are a new feature of the long-standing voluntary PPRS. The […]
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European Pharma: Paying the Price of Pharmacovigilance

Pharmacovigilance controls are becoming firmly embedded in the European Union’s post-authorization regulatory system, with the European Medicines Agency (EMA) acting as the pivot for an EU-wide network of agencies monitoring medicines throughout their market lifespan. The new pharmacovigilance activities stemming from the EU legislation, the first stage of which was approved four years ago, relate […]
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BMS and Merck Race to Melanoma Treatment Market

Merck’s Keytruda, recently approved in the US to treat patients with advanced melanoma that have stopped responding to other cancer therapies, will soon face strong competition from Bristol-Myers Squibb’s (BMS) Opdivo,  an analyst from research and consulting firm GlobalData has reported.
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