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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
A federal judge has issued a preliminary injunction blocking Charles River Laboratories (CRL) from harvesting the blood of horseshoe crabs for use in bacterial contamination tests for drugs and vaccines — a move that could lead to a shortage of the much-needed tests. Read More
Manufacturing of Johnson & Johnson (J&J)’s COVID-19 vaccine at Emergent BioSolutions’ Bayview, Md., plant remains on pause as the FDA assesses the company’s response to troubling observations by agency officials at the facility last month. Read More
The agency laid out a lengthy list of harmonized regulatory tools and concepts to improve the management of postapproval changes and to enhance transparency. Read More
For new indications of COVID-19 products, the need for two separate assessment reports will depend on the complexity of the application, the agency said. Read More