Chinese biotech firm Beigene Ltd. said its second-generation BTK inhibitor, Brukinsa (zanubrutinib), has won approval in China for two indications, entering a market dominated by Imbruvica (ibrutinib, Johnson & Johnson/Abbvie Inc.). The NDA approval came eight months after Brukinsa’s clearance in the U.S.
The latest global regulatory news, changes and updates affecting biopharma, including: Biomedical Advanced Research and Development Authority, Biotechnology Innovation Organization, Council of State Bioscience Associations, FDA, HHS, U.S. Department of Agriculture, U.S. House, U.S. House Select Subcommittee on the Coronavirus Crisis, U.S. Senate.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Global Blood Therapeutics, Immune, Immunic, Immuron, Revive, Saniona.
The U.S. FDA’s effort to marry its quality systems regulations with ISO 13485 has hardly gone off without a hitch, but Melissa Torres, director of international programs at the FDA’s device center, said the agency is “very hopeful” it can publish a draft rule for that task by the end of this year.
Minneapolis-based startup Nuvaira Inc. has received breakthrough device designation from the U.S. FDA for its Dnerva lung denervation system to reduce the risk of moderate-to-severe exacerbations of chronic obstructive pulmonary disease (COPD) in patients receiving optimal care. The bronchoscopic procedure works by disrupting pulmonary nerve input to the lung, improving symptoms and stabilizing lung function.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chembio Diagnostics, Edwards, Genetron Health, Laminate Medical Technologies, Nuvaira, Surmodics.
The nationwide recall of the fourth-most prescribed drug in the U.S. is expanding, with Teva Pharmaceutical Industries Ltd. and Marksans Pharma Ltd. being the latest manufacturers to announce voluntary recalls of metformin hydrochloride extended-release tablets due to the possibility of excessive levels of N-nitrosodimethylamine (NDMA).
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