While European health care systems have historically lagged the U.S. in terms of digital adoption, a report by investment firm Albion VC is highlighting how the pandemic has created the momentum for change.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Ivwatch, Kleiner, Welldoc.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Clearside, Demerx, Hightide, Hoth, Hutchmed, J&J, Lyra, Moderna, Poxel, PTC, Rhovac, Small Pharma, Stoke, Vigeo, Zenith.
Trimers of nanobodies, a simpler form of antibody made by some animal species, were effective at preventing and treating COVID-19 in preclinical studies, researchers reported in the Sept. 22, 2021, issue of Nature Communications.
Fresh data from Johnson & Johnson show COVID-19 protection dramatically increased with a booster shot of its single-dose vaccine, adding momentum to the U.S. drive for boosters.
The COVID-19 pandemic is still swirling about, and rapid antigen tests are still playing a vital role in pushing back against the COVID-19 pandemic, and Australia’s TGA has responded with a guidance on when software used with rapid antigen tests qualifies as a regulated device. The TGA has classified such software as a class 3 device when used with a rapid antigen self-test, thus requiring a separate regulatory application before it can be eligible for entry in the Australian Register of Therapeutic Goods (ARTG).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogen, Biontech, Celltrion, Exelixis, Forge, Incyte, Luye, Marinus, Pfizer, Rhythm, Samsung.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Gemina Labs, Medalliance, Merit Medical, Retina-AI Health.
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