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Stony Brook Medicine has launched an FDA-approved, randomized investigational new drug (IND) trial to determine whether plasma from people who have recovered from COVID-19 can aid in the recovery of patients currently fighting the disease. Chembio Diagnostics Inc.'s COVID-19 rapid serological point-of-care test will be used to identify potential plasma donors.
LONDON – These are hardly times for a fanfare, but this month saw the unveiling of a new name in bioprocessing, following the formal closing of the $21.4 billion sale of GE Healthcare’s Life Sciences to Danaher Corp. The business, now renamed Cytiva, has turnover of $3.3 billion, nearly 7,000 employees and operations in 40 countries. More than 75% of FDA-approved biologic drugs use its products in their manufacture.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Johnson & Johnson, Takeda Pharmaceutical.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch Therapeutics, Cytosorbents.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apollo Endosurgery, Atricure, Eos imaging, Kolon Tissuegene, Piranha Medical, Pluristem, Predictive Biotech, Predictive Technology, Rethink My Health, Scworx, Shockwave Medical, Staar Surgical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allen Technologies, Alphatec Holdings, Auburn University, Avacta Group, Biobot Analytics, Biodesix, Chembio Diagnostics, Cryo Innovations, Cytiva, Genomoncology, Hai Kang, HPC-AI, Integra Lifesciences, Intuitive, JMA, Labcorp, Myomo, Myriad, Nanomix, National Supercomputing Centre, Novacyt Group, Organovo, Pacific Biosciences of California, Pharmacyte, Phunware, Ping An Good Doctor, Predictive Laboratories, Resolution Medical, Roji Health Intelligence, Tarveda Therapeutics, Vitalhub, Wellgistics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Arch, Arcturus, Ascletis, Astrazeneca, Athersys, Beigene, Can-Fite, Fennec, Hope, Merck, Predictive Biotech, Proteostasis, Ridgeback.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 89bio, Alimera, Cannabics, Celltrion, CNS, Coherus, Connectyx, Enlivex, Fulcrum, Gilead, La Jolla, Medgenome, Ocular, Orgenesis, Pluristem, Redhill, Tamir, Thermogenesis, Vaxil, WPD.
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