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The FDA cited Sunrise, Florida-based over-the-counter drugmaker Clientele for batch testing and other quality failures observed during an inspection. Read More
The FDA issued a lengthy warning letter to Illinois-based HNC Products for a subpar out-of-specification investigation and the lack of validation testing for its over-the-counter sunscreen products. Read More
A federal court of appeals has rejected a novel plan that would have brought every community in the U.S. into a class-action suit along with 1,300 cities and counties that are suing opioid makers. Read More
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