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.
Research at Pardes Biosciences Inc. has led to the identification of cysteine protease inhibitors, particularly 3C-like proteinase (3CLpro, Mpro, nsp5; SARS-CoV-2) and Mpro (HCoV-229E virus) inhibitors, reported to be useful for the treatment of viral infections.
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 World Health Organization (WHO) is calling on manufacturers of those drugs to extend the geographic scope of their licensing agreements to allow competition and price reductions so the treatments can be used where they’re needed most.
Additional early-stage research and drug discovery news in brief, from: Alpha Cancer Technologies, Hillstream Biopharma, Tonix Pharmaceuticals Holding.
Although COVID-19 may be more severe in people with HIV (PWH), the underlying biological mechanisms among PWH treated with antiretroviral therapy (ART) remain largely unknown.
