Zephyrm Biotechnologies Co. Ltd. raised ¥200 million (US$29 million) in a series B financing to support phase I and II trials of the company’s human pluripotent stem cell candidates to treat lung diseases, degenerative joint diseases such as osteoarthritis, CNS diseases, inherited retinal degenerations and retinal degenerative diseases. The money will also be used for the construction of its technology platform and cell manufacturing bases.
While the pandemic is nearing its end, Chinese officials are calling for the development of novel, multivalent COVID-19 vaccines as an essential task moving forward.
While the pandemic is nearing its end, Chinese officials are calling for the development of novel, multivalent COVID-19 vaccines as an essential task moving forward. To date, China has 17 COVID-19 vaccine products that have completed or are in phase III trials, according to the NMPA.
Zephyrm Biotechnologies Co. Ltd. raised ¥200 million (US$29 million) in a series B financing to support phase I and II trials of the company’s human pluripotent stem cell candidates to treat lung diseases, degenerative joint diseases such as osteoarthritis, CNS diseases, inherited retinal degenerations and retinal degenerative diseases. The money will also be used for the construction of its technology platform and cell manufacturing bases.
There are worse things for U.S. FDA-regulated companies than a warning letter from the agency, but both Abbott Point of Care Canada Ltd., and North American Diagnostics LLC were hit with a warning letter that included citations for failure to comply with the Quality System Regulation (QSR). North American may have believed it was no longer required to comply with the QSR as it ceased the manufacture of its COVID-19 rapid antigen test kits in July 2021, but the FDA advised the company that compliance is required so long as there is some chance that an adverse event arises in connection with the company’s product.
The latest U.S. FDA emergency use authorizations to fall by the wayside, as COVID-19 continues to evolve, are the ones for the first Moderna Inc. and Pfizer Inc.-Biontech SE’s mRNA vaccines.
Additional early-stage research and drug discovery news in brief, from: Dragonfly Therapeutics, Enanta Pharmaceuticals, Enanta Pharmaceuticals, Kura Oncology, Telix Pharmaceuticals, Tonix Pharmaceuticals.
Additional early-stage research and drug discovery news in brief, from: Bioaegis Therapeutics, Evaxion Biotech, Jubilant Therapeutics, Sana Biotechnology.
As country after country downshifts out of pandemic mode, the need for affordable COVID-19 therapies continues, especially in middle-income countries that are not included in current voluntary licensing arrangements. To meet that need, the WHO is calling on manufacturers of those drugs to extend the geographic scope of their licensing agreements to allow competition and price reductions.
