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Early trial data from Johnson & Johnson’s COVID-19 vaccine candidate AD26.COV2.S has shown that a single dose was enough to generate a strong antibody response. Read More
Operation Warp Speed, the Trump administration’s COVID-19 vaccine and treatment initiative, is in “full alignment” with the FDA raising the bar on what’s required for an Emergency Use Authorization of a COVID-19 vaccine, the top adviser to the initiative says. That contradicts what President Trump has been saying. Read More
Humanigen has teamed up with Massachusetts-based Thermo Fisher Scientific, which will help manufacture the drug substance for Humanigen’s COVID-19 monoclonal antibody lenzilumab. Read More
Gilead Sciences has agreed to pay $97 million to settle Department of Justice (DOJ) claims that it illegally channeled Medicare copays for its pulmonary arterial hypertension (PAH) drug Letairis (ambrisentan) through a charitable foundation. Read More
In a letter to Eli Lilly this week, HHS General Counsel Robert Charrow rebuked the company over its plans to cut discounts offered through the federal government’s 340B Drug Pricing Program. Read More
The UK is launching the first COVID-19 challenge trials, in which healthy volunteers will be exposed to the virus to assess the safety and effectiveness of vaccine candidates, the government says. Read More
The head of the FDA’s vaccine advisory committee has recused herself from its upcoming COVID-19 vaccine review to avoid any appearance of a conflict of interest stemming from her leadership role in Moderna’s vaccine trial. Read More
In a letter sent yesterday, leaders of the House Energy and Commerce Committee demanded that the HHS Office of Inspector General (OIG) conduct a full investigation into politically motivated interference by the White House in the affairs of the Centers for Disease Control and Prevention (CDC) during the pandemic. Read More
New York Gov. Andrew Cuomo is threatening not to distribute FDA-approved COVID-19 vaccines in his state until they receive approval from a state task force of scientists, doctors and health experts. Read More
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Thursday that White House interference with the FDA’s policies for authorizing a COVID-19 vaccine would be “troublesome.” Read More