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June 16, 2020

Coronavirus company news summary – Lilly starts Phase III trial of baricitinib – FDA revokes emergency license for hydroxychloroquine

By Allie Nawrat

16 June 2020 

The US Food and Drug Administration (FDA) has revoked the emergency use authorisation (EUA) for anti-malarials, chloroquine phosphate and hydroxychloroquine sulfate, to treat some hospitalised Covid-19 patients. According the FDA, the known and potential benefits of the drugs no longer outweigh the known and potential risks for the authorised use.

Researchers at Imperial College London are set to begin clinical trials of a new Covid-19 vaccine this week. The vaccine candidate’s tolerability and effectiveness will be assessed in 300 healthy volunteers. Based on the results, Phase III trials will be started later this year in nearly 6,000 participants.

Catalent Biologics has signed an agreement with AstraZeneca for the manufacture of Covid-19 vaccine candidate. As part of the deal, Catalent will offer vial filling and packaging capacity to AstraZeneca at its manufacturing facility in Anagni, Italy, as well as prepare for large-scale commercial supply.

Eli Lilly has started enrolment for a Phase III clinical trial of an oral JAK1/JAK2 inhibitor, baricitinib, for the treatment of adults hospitalised due to Covid-19. The trial will be conducted in 400 patients across the US, Europe and Latin America.

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