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HONG KONG – Although authorities only allow studies linked to stem cells at the moment, the launch of China's first official regulations on stem cell studies may prove to be good news to the country's cell therapy industry.
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.
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