Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chromacode, Illumina, Quidel.
HONG KONG – India’s Ministry of Health and Family Welfare (MOHFW) has drafted rules for the manufacturing, import and the compassionate use of unapproved drugs in the treatment of patients.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bacainn, Curis, F2G, Fulcrum, Pharnext, Redhill, Rezolute, Vertex.
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.
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