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Almost half of all pharmaceutical companies had more than 1,000 leaked employee credentials exposed on the deep web in the past three months, and nearly 10 percent of pharma manufacturers are now considered highly susceptible to a ransomware attack. Read More
The FDA issued a warning letter to Everett, Wash.-based North American Hirudin Biotech Products for marketing unapproved and misbranded drugs. Read More
The FDA refuted CytoDyn’s claims about the efficacy of the company’s experimental HIV drug leronlimab as a COVID-19 treatment based on data from two late-stage trials. Read More
The U.S. is expected to agree with other large wealthy countries to push for voluntary licensing of COVID-19 vaccine patents instead of waivers, according to a draft statement set to be adopted by G20 countries on Friday. Read More
HHS’ Health Resources and Services Administration (HRSA) has issued letters to six prominent pharma companies that have declined to offer 340B drug discounts to clinics and hospitals serving low-income populations, warning the companies that they face a $5,000 fine for every instance they continue to withhold the discounts. Read More
Armed with findings that AbbVie imposed multiple and steep price hikes for Humira and Imbruvica and engaged in “legally questionable tactics” to delay rival biosimilars, House Democrats Tuesday asked the Federal Trade Commission (FTC) to conduct a formal investigation into the pharma giant. Read More
Sponsors using master protocols to test new drugs and therapies for treating or preventing COVID-19 should base their analyses on comparisons between control arm participants who were concurrently randomized, the FDA advised in a final guidance released yesterday. Read More