PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options.
When SARS-CoV-2 first emerged in 2020, with respiratory symptoms as the most obvious feature of infection, the most obvious comparison was to influenza. COVID-19, of course, was never just another flu.
LONDON – The latest data from the large-scale randomized U.K. COVID-19 infection survey confirm vaccines are less effective against the Delta variant of SARS-CoV-2 that is now dominant across the U.S., Europe and elsewhere in the world.
The FDA’s emergency use authorization (EUA) program is still active in the area of tests and test kits, which is due in part by the emergence of the Delta variant of the SARS-CoV-2 virus and the associated warnings that the effectiveness of vaccines may be declining. One example of the sustained emphasis on testing is the EUA granted to Thermo Fisher Scientific Inc. for two PCR test kits that can detect the latest variants of the virus, a demonstration that the demand for these updated tests seems unlikely to ebb anytime soon.
Exevir Bio NV is honing its attack on the crowded market for COVID-19 antibodies, beginning clinical development of a potential subcutaneously administered drug targeting outpatients with early symptoms who are at risk of further progression.
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.
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.
