The U.S. FDA reported that 28 serology tests for antibodies for the SARS-CoV-2 virus either have been withdrawn from the market by the sponsor or delisted by the agency for failure to comply with its notification process for emergency use authorization (EUA). The agency said the list of unavailable tests will be updated over time. For his part, Commissioner Stephen Hahn said the move was undertaken “to ensure that Americans have access to trustworthy tests.”
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avra, Cls Laserthermia Systems, Infinite Mind, Kahala Biosciences, Orasure, Osang Healthcare, Ra Medical, Rymedi, SG Blocks, Tiziana.
LONDON – Human challenge specialist Open Orphan plc has raised £12 million (US$14.6 million) in a placing to accelerate development of COVID-19 challenge study models, to meet demand from vaccines and therapeutics developers worldwide.
Scaling up to manufacture a massive volume of a COVID-19 vaccine, drug or innovative device that’s still in early stage development is easier said than done, especially in a global pandemic that has the supply chain stretched beyond capacity.
Mammoth Biosciences Inc., of South San Francisco, and London-based Glaxosmithkline plc (GSK) have joined forces to develop a point-of-care test to detect active COVID-19 infections using Mammoth’s CRISPR-based DETECTR platform. The two companies hope to submit an application to the U.S. FDA for emergency use of the test before the end of the year.
BioWorld looks at translational medicine, including: SIRPa blockade wakes up macrophages post-infection; Lasting immunity to SARS-CoV-2 looks possible; Atherosclerosis, AD meet at the myelin; T cell aging induces broad senescence; P53 loss leads to immune evasion; Early roots of ALS visible in teeth; SLAPping down MDR gram-negatives; ALK is candidate thinness gene; Can N-BPs become MVP again?