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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
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
Pfizer confirmed that it plans to charge $19.50 per dose of its COVID-19 vaccine in the U.S., with a total cost of about $40 for a two-dose regimen. Read More