Author Archives: Guest Blogger

US Company Awarded UK's First "Promising Innovative Medicine" Designation

By Leela Barham. The UK’s Medicines and Healthcare Regulatory Authority (MHRA) has awarded Northwest Biotherapeutics, Inc. (Bethesda, MD) the very first “Promising Innovative Medicine”, or PIM designation, for the company’s DCVax-L product.
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UK Postpones Decision on Value-Based Assessment — Again

By Leela Barham. Value-based Pricing (VBP) was first discussed as far back as 2007 by the UK’s consumer authority, the now defunct Office of Fair Trading (OFT).  The general concept of VBP was to set almost provisional prices based on the expected value of new medicines using immature data, with provisions to ‘correct’ the price […]
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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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Doctors, Data, and Drug Development

It is estimated that applying big data strategies could potentially generate up to $100 billion in value annually across the US healthcare systems, specifically by optimizing innovation and improving the efficiency of research and clinical trials. With the advent of global CROs entering into the capital intensive sector of healthcare reimbursements, supporting pharmaceutical and biotech […]
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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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