The impact of the COVID-19 pandemic has reached into quarters that are not historically problematic for makers of diagnostics, including China’s import and export practices for test kits. According to one caller on an FDA diagnostic town hall, export officials in China have a blacklist and a whitelist for test kits, but there is some dispute as to whether kits that are eligible for distribution in the U.S. can get off the blacklist unless that kit is specifically called out via the emergency use authorization (EUA) program.
The U.S. FDA granted Gtx Medical BV a breakthrough device designation for its implantable Go-2 Targeted Epidural Spinal Stimulation (TESS) system. The device enabled patients who had sustained traumatic spinal cord injuries to regain voluntary control over previously paralyzed muscles and walk again four or more years after paralysis, according to a study previously published in Nature.
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.