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REGULATORY NEWS
Drugmakers often complain about slow regulatory review times, pointing to specific drugs that were approved months, or even years, faster in one market than in others.
HONG KONG – China has released a draft of its long-awaited first-ever regulations on stem cell studies, which provide guidance for an industry with huge scientific and commercial potential.
While the patent challenge that's delaying the launch of the first biosimilar approved in the U.S. is grabbing headlines, some lawmakers may be second-guessing the final act of the Biologics Price Competition and Innovation Act (BPCIA).
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