We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
FDA Commissioner Stephen Hahn assured House lawmakers yesterday that the agency will maintain its regulatory independence in reviewing COVID-19 vaccine candidates, staying at arm’s length from the Trump administration’s Operation Warp Speed, which aims to have an effective vaccine by year’s end. Read More
With just six months to go before the end of the transition period in the UK’s exit from the European Union, European drug industry groups said they are “extremely concerned” about the lack of progress in trade talks and they are urging negotiators to agree to drug supply chain protections outside of the talks. Read More
In a victory for Mylan, a West Virginia federal court has invalidated a key patent on Biogen’s blockbuster multiple sclerosis drug Tecfidera (dimethyl fumarate). Read More
The UK government’s decision to ban the export of dexamethasone, the inexpensive anti-inflammatory drug that’s shown promise as a COVID-19 treatment, is getting pushback from within the country. Read More
Amarin has settled with Canada-based generic drugmaker Apotex to avoid patent litigation relating to its planned generic of Amarin’s cardiovascular drug Vascepa (icosapent ethyl). Read More
The FDA has been forced to streamline its guidance development process during the COVID-19 pandemic, and the change is likely to shape its approach beyond the pandemic, says Center for Biologics Evaluation and Research (CBER) Director Peter Marks. Read More
A federal appeals court has upheld a lower court’s ruling that HHS lacks the authority to require drugmakers to disclose the list prices of drugs in television advertisements. Read More
Trump administration officials announced yesterday that 300 million doses of a COVID-19 vaccine should be available by January 2021 under Operation Warp Speed although they stressed there’s no guarantee that a vaccine will be available by then. Read More
In a move to lessen India’s dependence on imports, the government is offering incentives to increase domestic manufacturing for certain drug starting materials, intermediates and active pharmaceutical ingredients (APIs). Read More
Hydroxychloroquine and chloroquine were dealt another blow as treatments for COVID-19 yesterday when the FDA revoked its Emergency Use Authorization (EUA) for the drugs — and warned that combining the antimalarials with Gilead Sciences’ remdesivir can decrease the antiviral activity of remdesivir. Read More