Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter, Lantheus.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: American Medical Association, Bayer AG, Snomed International.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akari, Arca, Ascendis, Eli Lilly, Epirium, Eyegate, Indian, Innovent, Kahr, Kineta, Pliant, Redhill, Regeneron, Seattle Genetics, Theranexus.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Azurrx, Blade, Boehringer, Botanix, Eloxx, Epirium, Nektar, Sapience, Vaccibody, VBL.
HONG KONG – Diagnostic kits are in the spotlight as Vietnam battles a resurgence of COVID-19 cases, after a wave of community infections started appearing in late July. A new outbreak has infected more than 220 people since July 25, most of whom came from the coastal city of Da Nang.
Reports out of Russia that the country approved a COVID-19 vaccine came with more questions than answers, as some in the rest of the world fretted over the apparently paltry degree of testing. Though the product has not completed phase III trials – human research thus far has involved only two groups of volunteers of 38 people each – Russia President Vladimir Putin is said to have declared Gam-COVID-Vac adequately studied.
“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines.
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