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.
The U.S. FDA’s routine guidance agenda may be badly disrupted by the COVID-19 outbreak, but the agency continues to pump out guidances and emergency use authorizations (EUAs) directed to the pandemic. While the FDA has included only one serological test under the diagnostic EUA paradigm, Rep. Diana DeGette penned a letter inquiring into when the agency intends to move more decisively on serological tests, arguing that the absence of action on this front endangers the nation’s economic health as well as the public’s health.
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.
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