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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
Since February, the FDA has approved nearly 300 manufacturing changes to help speed drugs to market for COVID-19 patients, FDA Commissioner Stephen Hahn said this week. He was touting the agency’s prompt response to the pandemic. Read More
Clinical research on human drugs that contain cannabis can be conducted legally as long as the amount of the substance in the investigational product is within limits set by a new FDA draft guidance. Read More
The Department of Justice announced yesterday that two Chinese hackers have been indicted on charges of trying to hack COVID-19 vaccine research in the U.S. Read More