Category Archives: Regulatory

Five Measures to Cope with the Side Effects of Health Reform

By Sydney Rubin. With more than 8 million Americans now signed up for health insurance through state health exchanges, The Affordable Care Act (ACA) has begun delivering benefits and new insurance protections to a large swath of Americans, many of whom had no health insurance before. People previously rejected by insurers due to pre-existing conditions […]
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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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EMA Calls Out to Companies Developing Ebola Treatments

The European Medicines Agency (EMA) is reviewing available information on Ebola treatments currently under development to “facilitate evidence-based decision-making” by health authorities. At the moment there are no approved medicines to protect from or treat Ebola. Some experimental treatments have reportedly shown encouraging results in the laboratory or in animals, but they have not yet […]
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EFPIA Promises Stronger Ties with China

The European Federation of Pharmaceutical Industries and Associations (EFPIA) reports that it has “strengthened its commitment in China”. Federation delegates are this week concluding a visit to Beijing to establish “a better understanding of the numerous healthcare reforms underway in China … and explore closer paths of cooperation in global drug development between China and […]
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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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