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.
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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 89bio, Aslan, Bausch Health, Kolon, Lilly, Nextcure, Prolynx.
A new, worldwide coalition of plasma companies seeking to develop and deliver a hyperimmune immunoglobulin therapy for fighting COVID-19 takes the view that many hands make light work.
DUBLIN – At the best of times, drug development is, of course, a complex problem. It is all the more demanding still in the middle of a pandemic, when the threat to human life is increasing exponentially, and health care systems are buckling under an extraordinary burden. Optimizing the development of drugs and vaccines in order to quickly generate high-quality evidence of their safety and efficacy is, therefore, a critical task, but an online webinar organized by the drug development consultants Certara LP, in conjunction with the Bill and Melinda Gates Foundation, suggested that, at this stage of the crisis, that lesson has yet to be absorbed.
The Korea Export Import Bank (KEXIM) took a step toward fulfilling its mandate to finance Korean companies’ overseas expansion by seeking managers for a new ₩400 billion (US$328 million) fund.
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