The next phase of testing for the COVID-19 pandemic will hopefully include the roll-out of tests for neutralizing antibodies for the SARS-CoV-2 virus, but there are some roadblocks. The FDA’s Tim Stenzel said the agency has a limited amount of information to offer regarding emergency use authorizations for these tests, a predicament that might not resolve until several applicants are in and the agency can see some information that will aid in development of performance and validation standards.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3D Med, 7D Surgical, Abiomed, Invo Bioscience, M.I. Tech, Todos Medical.
Courtesy of a $50 million series A, Adagio Therapeutics Inc. will join a raft of other companies attempting to end the COVID-19 pandemic with antibodies.
LONDON – Pharmaceutical companies and academic researchers working on COVID-19 vaccines are being targeted by Russian state-sponsored hackers, according to the U.K. National Cyber Security Centre (NCSC). The U.K. view is endorsed by the U.S. National Security Agency and Canada’s Communications Security Establishment, and the three agencies have issued a joint statement advising companies how to protect against these attacks.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinical Computer Systems, Diacarta, Edwards, Huntleigh Healthcare, Icad, Paragon 28.
Keeping you up to date on recent developments in orthopedics, including: Primitive stem cells point to new bone grafts for stubborn-to-heal fractures; Orthopedic surgeons issue guidelines on resuming elective surgery amid COVID-19 pandemic; Cardiac CT can double as osteoporosis test; Novel bone imaging approach provides insights into the progression of knee osteoarthritis.
CAJICA, Colombia, and BEIJING – Last week Sinovac Biotech Ltd., of Beijing, announced the approval by Anvisa, the Brazilian health care surveillance agency, to start phase III trials to test the efficacy and safety of its inactivated COVID-19 vaccine being developed by Sinovac Life Sciences, a subsidiary of the Chinese company, in the Latin American country.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avicenna.AI, Corneat Vision, Dante Labs, GI Supply, Hd Medical, Qubyx, Revamp Medical, Vela Diagnostics, Vitls, Viveve.
