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REGULATORY NEWS
Now that the market has opened for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, the next question is reimbursement. Will payers balk at an annual price tag upward of $14,000 for the new cholesterol-lowering biologics when statins are available for as little as a few dollars a month?
The FDA needs to apply the brakes on its headlong rush to adopt quality metrics for the manufacturing of drugs, the agency was told Monday.
For personalized medicine to deliver on its promise of tailoring treatments to the patient, incentives may be needed to spur the development of diagnostics that can identify those who would benefit from a specific drug.
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