Access Biologicals LLC brought online newly released seroconversion panels that measure the level of antibodies against SARS-CoV-2 in blood samples, allowing researchers to determine vaccine efficacy. The panels can detect the point when seroconversion occurs and assess the efficacy of a vaccine against new and existing strains of the novel coronavirus. To build the panels, the Vista, Calif.-based company collected blood samples prior to vaccination and after the first and second doses. The plasma was then tested for IgG antibodies to the S1 and S2 spike proteins of the novel coronavirus using enzyme-linked immunosorbent assays (ELISA) and chemiluminescent assays (CLIA).
LONDON – Memed Diagnostics Ltd. has adapted the point-of-care test it developed to distinguish bacterial from viral infections to enable rapid assessment of the severity of COVID-19 infections in patients being admitted to the hospital. The triaging tool, Memed COVID-19 Severity, has received a CE mark in Europe and is ready for commercial rollout. After securing the CE mark, Memed is now pursuing emergency use authorization for the test from FDA.
PERTH, Australia – Australia was one of the first nations to slam its borders shut during the pandemic, praising its efforts in containing COVID-19 infections.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Allegro Ophthalmics, Cassava, Da Volterra, GNT, Inmune, Iveric, Lee's, Radius, Sorrento, Synaptogenix, Tarsus, Tonix, Virios.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Alere, Beckman Coulter, Eyenuk, Gamidor Diagnostics, Pixcell Medical, Quidel, Speedx, Sqi Diagnostics.
The first COVID-19 patient has been enrolled the U.S. NIH’s ACTIV-4 Host Tissue trial, a study of four agents designed to fight dysregulation of the renin-angiotensin-aldosterone system and the immune system caused by a COVID-19 infection.
As the COVID-19 pandemic continues to impact the FDA’s inspection program, U.S. lawmakers are worrying about what that may mean for future drug approvals.
“We are . . . concerned that we have not yet seen the full impact of delayed inspections, particularly in the case of preapproval inspections,” the bipartisan leadership of the House Energy and Commerce Committee and its Health Subcommittee said in a July 22 letter to acting FDA Commissioner Janet Woodcock.
Shionogi & Co. Ltd. started a phase I trial in Japan for S-217622, its orally administered 3CL protease inhibitor for treating COVID-19. Should the drug be approved by Japanese regulators, it would be the first Japanese-developed COVID-19 treatment to be approved in the country.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Moderna, Rhythm.
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