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Inovio Pharmaceuticals has released data from the phase 1 clinical trial of its COVID-19 vaccine candidate showing it was safe and well-tolerated and induced immune responses in a majority of participants. Read More
The University of Oxford is resuming recruitment this week for its global clinical trial of hydroxychloroquine and chloroquine, which was paused after a now-retracted study found the antimalarial drugs had no benefit as a treatment for COVID-19. Read More
FDA Commissioner Stephen Hahn said yesterday that he was “optimistic” that more than one COVID-19 treatment could be available by the fall in addition to Gilead Sciences’ remdesivir, which has already received Emergency Use Authorization from the agency. Read More
Any COVID-19 vaccine the FDA approves would have to be at least 50 percent more effective than a placebo, according to a new guidance it released yesterday. Read More
The FDA cited USV Private for multiple violations at its drug manufacturing facility in Daman, western India, including invalidating out-of-specification (OOS) results without any justification. Read More
The FDA will allow sponsors to extrapolate efficacy results from adult studies to use in pediatric studies of anti-infective drugs, as long as the disease process and the effects of the drug are similar in both populations. Read More
The FDA issued Intercept Pharmaceuticals a complete response letter for its investigational drug, obeticholic acid (OCA), for liver fibrosis due to nonalcoholic steatohepatitis (NASH). Read More
The University of Oxford is ready to launch a phase 3 trial in Brazil of AstraZeneca (AZ)’s COVID-19 vaccine candidate, considered by the World Health Organization (WHO) to be the frontrunner in the research race. Read More
After weeks of waiting, Gilead Sciences announced yesterday that it will charge U.S. insurers $3,120 for a six-vial, five-day course of remdesivir, and a lower price of $2,340 for governments of developed countries, including the U.S. Read More