Category Archives: Regulatory

Biopharmaceuticals: Approvals Rate Best in Five Years

Overall, last year can be considered quite a successful one in terms of new product approvals. Nineteen products containing new biopharmaceutical molecular entities were approved in the United States and/or the European Union. These approval numbers are above average compared to the previous five years, which recorded a mean approval rate of 13 products. The […]
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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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Medicare Payment Data Raises Questions About Drug Costs

Even though the just-released Medicare data on payments to individual doctors doesn’t provide specifics on prescription drug outlays, it opens the door to sharp scrutiny of Medicare reimbursement for medicines delivered in physician offices. The Centers for Medicare and Medicaid Services (CMS) has released data on payments to some 880,000 health care providers who collectively […]
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UK: Lord Saatchi's Innovation Bill Divides Healthcare Community

By Leela Barham. Few would argue with the desirability of innovation — something new, something that delivers value. And innovation in pharmaceuticals is a range from a more convenient way for patients to take a medicine, to treating a disease that couldn’t be treated before. Pretty much everyone will agree that not only do they […]
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"Work to Be Done" on EU Clinical Trials Regulation, Says Industry

The European Parliament yesterday voted towards the adoption of the new Clinical Trials Regulation, which removes the legal framework for pharma to not publish its data by stating that information from  trial study reports should not be considered commercially confidential.
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