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The House of Representatives on Wednesday voted 402 to 23 to pass bipartisan legislation that would close an orphan drug exclusivity loophole — just one week after the bill was denied passage by House Republicans. Read More
Emergent BioSolutions CEO Robert Kramer said Wednesday that the FDA is currently assessing whether to allow the release of more than 100 million Johnson & Johnson (J&J) vaccine doses that were produced at Emergent’s beleaguered Bayview, Md., facility during the company’s highly publicized cross-contamination incident there earlier this year. 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
The Institute for Clinical and Economic Review (ICER) has determined that AbbVie’s Rinvoq (upadacitinib), a Janus kinase (JAK) inhibitor being developed to treat atopic dermatitis, is not a cost-effective treatment for the disease. Read More
In a revised guidance that will stay in effect until the end of the pandemic, the FDA explained how it will deal with drug applications when it is unable to conduct an inspection because of travel restrictions. Read More
India, which receives 70 percent of its raw materials from China, was hit on April 26 with a 15-day suspension of inbound cargo flights by China’s state-owned Sichuan Airlines. Read More