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Novartis has agreed to pay $345 million to the U.S. government to settle charges that it violated the Foreign Corrupt Practices Act (FCPA) by bribing doctors in Greece and Vietnam. Read More
As the race to develop an effective COVID-19 vaccine by year’s end gains momentum, the FDA said it plans to issue a guidance on developing and licensing them. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) yesterday recommended granting Gilead Sciences’ remdesivir a conditional marketing authorization as a COVID-19 treatment. Read More
Public Citizen has petitioned the FDA to require a black box warning for sodium-glucose cotransporter-2 (SGLT2) inhibitors used off-label for treatment of type 1 diabetes. Read More
Senior Democrats in the House unveiled a bill yesterday that would give HHS the authority to negotiate prices for hundreds of drugs and would tax noncompliant drugmakers up to 95 percent of their sales. Read More
Three high-ranking House Democrats have asked FDA Commissioner Stephen Hahn for more details of the agency’s review process for COVID-19 vaccines. Read More
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