LONDON – Companies represented in the expert group brought together by the World Health Organization (WHO) to work on the development of COVID-19 vaccines have signed a pledge to strengthen collaboration and sharing of data.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 7 Hills, Alnylam, AVM, Epirium, Grid, Kadmon, KD Pharma, Lifemax.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aldeyra, Amgen, Astrazeneca, Beigene, Bioinvent, Calithera, Cytokinetics, Healios, Madrigal, Outlook.
In order to redirect health care resources and protect patients during the COVID-19 pandemic, many drug companies have paused enrollment in some or all of their ongoing clinical trials. But patients still in the studies need to be followed for safety and efficacy, creating challenges for the industry.
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.
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