Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alveo, Cardiacsense, Kantaro, Surgical Planning Associates, Visby.
Under threat of emerging variants, the EU is taking to heart lessons learned so far in the global COVID-19 pandemic to accelerate the review of vaccines, improve data sharing from clinical trials and address the difficulties inherent in the mass production of vaccines that may contain up to 400 components.
Another monoclonal antibody therapy has entered the pandemic fray with the FDA granting emergency use authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg and etesevimab (JS016 or LY-CoV016) 1,400 mg as a cocktail for treating mild to moderate COVID-19 in patients aged 12 and up at high risk for progressing to severe COVID-19 and/or hospitalization.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Adaptive Phage, AIM Immunetech, Astrazeneca, Biontech, Eli Lilly, I-Mab, Merck, Panbela, Pfizer, RDIF, Regeneron, Sanifit, Sanofi, Takeda, Vico.
HONG KONG – Celltrion Inc. has received conditional marketing authorization from the Ministry of Food and Drug Safety (MFDS) for its anti-COVID-19 monoclonal antibody, Regkirona (regdanvimab, also known as CT-P59), in South Korea. It’s the first company to receive approval for a COVID-19 antibody treatment developed in South Korea, a MFDS spokesman told BioWorld.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ava, Bactiguard, Nyxoah, Soundbite Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beyond Medical Technologies, Biodesix, Biotelemetry, Canary Health Technologies, Foxsemicon Integrated Technologies, GE Healthcare, Kayan Health, Predictiv Care, Prophase Labs, Royal Philips, Smartbreast, SyntheticMR, Tissium, Trisalus, United Imaging, Zavation Medical Products.
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