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.
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.
After being hit with the major financial market meltdown when the COVID-19 outbreak decimated U.S. capital markets during March that saw the valuations of public biopharmaceutical companies developing new medicines plummet, it appears that they have put that reversal behind them with a dramatic price surge in April.
Having a COVID-19 therapy approved through an emergency use authorization (EUA) is not the same as having access to it, even if it’s free. Accounting for one-third of the nearly 4 million COVID-19 cases confirmed globally as of Monday and 28.5% of the 278,957 deaths, the U.S. is getting 40% of the 1.5 million vials of remdesivir Gilead Sciences Inc. is donating worldwide.
LONDON – Support is growing for human challenge trials in COVID-19 to be approved in order to speed up development of effective vaccines against the pandemic infection.
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