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.
LONDON – The World Health Organization’s (WHO) mission to Wuhan has rejected accidental laboratory escape as the source of the SARS-CoV-2 pandemic, but failed to uncover satisfactory evidence of its exact origin.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Astrazeneca, Bausch Health, Brainstorm Cell, BMS, China Oncology Focus, Edding, Immunomet, Navidea, RDIF, Sorrento, Triastek.
The Biden administration said it will use the U.S. Defense Production Act to grapple with the COVID-19 pandemic in a plan that includes a large increase in vaccine purchases. Also on tap is an increase in production of at-home test by six companies in addition to Ellume Ltd., of Perth, Australia, which will ship more than 8 million of their tests to the U.S. by the end of the year.
CEO Mitchell Steiner said Veru Inc. at first downplayed the prospects of oncology candidate VERU-111 in COVID-19 treatment but now, with positive phase II data in hand, the company has a moral obligation to push onward to late-stage research.
RSS
