Abbott Laboratories received FDA emergency use authorization (EUA) for its COVID-19 molecular test, which will run on the company's new Alinity m system, as well as its COVID-19 antibody blood test, which will run on the Alinity i system. The two actions bring to five the number of COVID-19 tests developed by the Abbott Park, Ill.-based company to receive EUAs.
The May 12 Senate hearing regarding the COVID-19 pandemic included the usual conversations about contact tracing, but Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is “cautiously optimistic” that one of the vaccines currently in trial in the U.S. will work, but that it is unlikely a vaccine will be ready by September 2020. In contrast, Assistant Secretary for Health Brett Giroir said testing capacity may reach 50 million tests per month by that time, thanks in part to the fact that antigen testing is now part of the FDA’s emergency use authorization mechanism.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Caption Health, Cardiofocus, Cytosorbents, Helius Medical Technologies, Optiscan Biomedical, Ortho Clinical Diagnostics, Thermo Fisher Scientific, Transit Scientific.
The devastating societal and economic effects caused by the ongoing COVID-19 pandemic should sound a warning bell on how ill-prepared we are in our ability to fight lethal infectious diseases for which no effective therapies or vaccines currently exist. Indirectly, the intense public attention on companies that are engaged in developing COVID-19 cures is also spilling over to companies researching to uncover new anti-infectives that will be needed to replace the diminishing arsenal of effective therapies to combat drug-resistant bacteria and fungi. This is certainly evident among public companies in the space, with the BioWorld Infectious Diseases index showing an increasing upward trend since the beginning of the year. At market close on May 11, the index had, in fact, grown in value by a whopping 47%.
DUBLIN – The Innovative Medicines Initiative (IMI), a public-private research partnership between the European Commission (EC) and Europe’s pharmaceutical industry, has boosted funding for a fast-track response to the COVID-19 pandemic from €45 million (US$48.8 million) to €72 million.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpha Cognition, Histogen, Moderna, Seattle Genetics.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Galderma, Galera, Gamida, Genfit, Glenmark, Marker, Minoryx, Neurana, Ocular Therapeutix, Rocket, Sanofi.
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