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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
AstraZeneca has reached an agreement with Europe’s Inclusive Vaccines Alliance to provide up to 400 million doses of its COVID-19 vaccine at no profit starting by the end of the year. Read More
Attorneys general from all 50 states have filed a lawsuit against dozens of generic drugmakers alleging price fixing for more than 80 topical drugs. Read More