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In a stunning departure from how FDA guidances are issued by the agency, President Donald Trump said Wednesday evening that he might move to reject a guidance that is expected to impose stricter thresholds for any COVID-19 vaccine Emergency Use Authorizations (EUAs). Read More
The House voted to pass a short-term funding measure to keep the government running through Dec. 11 at fiscal 2020 funding levels for fiscal 2021, which begins Oct. 1. Read More
In a Senate hearing yesterday, Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, said that “some time by November or December we will know” which of the three COVID-19 vaccine candidates now in late-stage trials — soon to be joined by a fourth — are safe and effective. Read More
Johnson and Johnson (J&J) yesterday became the fourth drugmaker to begin a large-scale phase 3 trial of a COVID-19 vaccine candidate — and it will be the largest late-stage trial of a COVID-19 vaccine to date. Read More
In a proposed rule released yesterday, the FDA clarifies how it determines whether products are intended for use as drugs or devices and how it decides if approved products are intended for a new use. Read More
Chinese drugmakers Sinovac Biotech and CanSino Biologics yesterday began separate late-stage trials of their COVID-19 vaccines in Turkey and Pakistan. Read More
New York biotech Codagenix announced Tuesday that the Serum Institute of India has begun manufacturing its intranasal COVID-19 vaccine candidate, CDX-005. Read More
The National Institutes of Health (NIH) yesterday announced the expansion of two late-stage trials of convalescent plasma in the wake of the FDA’s Emergency Use Authorization (EUA) for the investigational COVID-19 treatment. Read More
Gary Kobinger, the leader of the Canadian research team that developed a highly effective Ebola vaccine, has stepped down from Canada’s COVID-19 vaccine task force, calling for greater transparency from the group. Read More