HONG KONG – Chinese med-tech regulators said in December that conditional approvals are now available to medical devices after the government created speedy review channels for devices that the country needs.
The FDA's revised draft guidance for clinical decision support (CDS) systems was intended to fix several glaring holes in the first draft, but multiple stakeholders argued that the second draft contradicts the related provisions of the 21st Century Cures Act when it comes to CDS systems that purport to drive or guide clinical decision making.
HONG KONG – Aiming to attract more active innovation to its medical device industry, South Korea updated some of its industry regulations through 2019. The ultimate goal was to make it easier for advanced medical technologies that use artificial intelligence (AI), robotics and 3D printing that have yet to penetrate the market due to inefficient approval processes.
BEIJING – Chinese regulators granted the marketing nod to Beijing-based Beigene Ltd.‘s PD-1 antibody, tislelizumab, for treating patients with classical Hodgkin lymphoma (cHL) who have received at least two prior therapies. To be sold under the Chinese trade name Baize’an, tislelizumab is Beigene’s first drug to win approval in China, following an FDA approval for its BTK inhibitor, Brukinsa (zanubrutinib), last month.
BEIJING – Chinese regulators granted the marketing nod to Beijing-based Beigene Ltd.‘s PD-1 antibody, tislelizumab, for treating patients with classical Hodgkin lymphoma (cHL) who have received at least two prior therapies. To be sold under the Chinese trade name Baize’an, tislelizumab is Beigene’s first drug to win approval in China, following an FDA approval for its BTK inhibitor, Brukinsa (zanubrutinib), last month. “We are preparing the commercialization of tislelizumab, and we will start supplying the drug soon,” Beigene’s media relations officer, Min Xiao, told BioWorld Asia.
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