LONDON – Researchers at Birmingham University are looking for commercialization partners after finding a happy medium between the speed but limited accuracy of COVID-19 lateral flow antigen tests, and the use of slower but more accurate PCR and other RNA amplification diagnostics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Globus Medical, Spectrum Solutions.
The HHS Advisory Committee on Immunization Practices that had mixed opinions in June on the necessity of boosters will have a chance to consider new data when it meets again Aug. 24. Since that June adcom, COVID-19 infection rates have risen steadily and the FDA allowed for a third dose of the mRNA vaccines in certain adults with compromised immune systems.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aequus, Alzamend, Aobiome, Arthrosi, Azurrx, Cellular Engineering Technologies, Eli Lilly, Endocan Solutions, ERS Genomics, Glow Lifetech, HCW Biologics, Ico, Jaguar Health, Lixte, Nirvana Life Sciences, Revision, Satellos, Senhwa, Valeo.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carrick, Edgewise, Eli Lilly, Enlivex, Galmed, Inxmed, Jupiter, Merck & Co., Oncolys, Pfizer, Sesen, Therapeutic Solutions.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has cleared Speedx Pty Ltd.’s PlexPCR SARS-CoV-2 test, which detects all current circulating variants of the SARS-CoV-2 virus at a time when most of the country is in lockdown as the delta variant circulates.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Eli Lilly, Exact Sciences, Genotests, Insulet, Jenavalve, Photocure, Thermo Fisher Scientific.
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