Category Archives: Regulatory

Medicare Data Raises Questions About Drug Costs

The recently released Medicare data on payments to individual doctors doesn’t provide specifics on prescription drug outlays, but opens the door to scrutiny of Medicare reimbursement for medicines delivered in physician offices, writes Jill Wechsler. The Centers for Medicare and Medicaid Services (CMS) has released data on payments to some 880,000 healthcare providers who collectively […]
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Is Gilead’s $1000 Pill Worth It?

The Department of Veterans Affairs and other California panels’ solution to the new and extremely costly hepatitis (Hep) C drugs (Sovaldi and Olysio) is to reserve them for the patients with advanced liver diseases, including those awaiting transplants. What should the patients of “milder” cases do then? Twiddle their thumbs and wait for drugs in […]
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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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