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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
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
Maryland-based Novavax has signed an agreement with Fujifilm Diosynth Biotechnologies to manufacture the bulk drug substance for Novavax’s COVID-19 vaccine candidate NVX-CoV2373. 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
Dynavax has partnered with Taiwan-based Medigen Vaccine Biologics to develop a COVID-19 vaccine candidate. The partners will evaluate Medigen’s recombinant form of the SARS-CoV2 spike protein combined with Dynavax’s CpG1018 adjuvant. Read More