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The company will also pay $10 million to settle accusations by the Federal Trade Commission that it engaged in anticompetitive activities to block generic competition for Suboxone. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) announced at its July meeting that it is reviewing trial data on dexamethasone for the treatment of COVID-19. Read More
Taro Pharmaceuticals has agreed to pay $205 million to settle charges by the Department of Justice that it conspired with other drugmakers to rig prices on various generic drugs. Read More
The Patent Trial and Appeals Board (PTAB) has dismissed claims by Moderna that a Canadian rival’s patent on lipid nanoparticle (LNP) technology is invalid, in a ruling that could have implications for Moderna’s COVID-19 vaccine candidate mRNA-1273. Read More
Taro has also reached a tentative agreement with the DOJ to pay $213.3 million to resolve separate claims related to federal healthcare programs. Read More
Drug industry representatives offered their wish lists to the FDA for reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2023 through 2027 in a public meeting last week. Read More
President Trump issued four executive orders Friday he said would “completely restructure the prescription drug market,” including one that would require Medicare to “purchase drugs at the same price as other countries” unless drugmakers come up with alternate price-cutting plans by Aug. 24. Read More
The Department of Justice (DOJ) said yesterday it will not stand in the way of pharmaceutical companies sharing information on the manufacturing of monoclonal antibodies for the treatment of COVID-19 patients. Read More
The House voted 224 to 189 Friday to pass a fiscal 2021 appropriations bill that would give the FDA $3.2 billion in funding, an increase of $40.8 million from fiscal 2020. Read More
Sponsors and manufacturers will have to provide the FDA an annual summary of their compassionate use drug administration under a proposed agency rule released yesterday. Read More