In signing an executive order (EO) on strengthening American manufacturing Jan. 25, President Joe Biden made it clear that the order is aimed at more than infrastructure. While Biden’s Build Back Better Recovery Plan calls for investing hundreds of billions of dollars in buying American products and materials to modernize the nation’s infrastructure and increase its competitiveness, “it also means replenishing our stockpiles to enhance our national security,” the president said.
The latest global regulatory news, changes and updates affecting biopharma, including: Endo, Impax under antitrust scrutiny again; More on EMA cyberattack.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Biontech, Cardiff, Cidara, Edesa, Faron, Fosun, Immunicum, Meiragtx, Merck, Mundipharma, Nanoscope, OS Therapies, Recordati, Veralox, Vertex.
Tscan Therapeutics Inc. CEO David Southwell told BioWorld that his firm’s series C financing of $100 million will allow two IND filings in liquid tumors this year and three – possibly more – in solid tumors starting next year. “We’ll be filing a lot of INDs in solid tumors,” he said. The Waltham, Mass.-based firm works with T-cell receptor-engineered T-cell therapies.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd. for its COVID-19 vaccine, branded Comirnaty, making it the first COVID-19 vaccine to receive approval in Australia.
LONDON – There is “a realistic possibility” that infection with the B 1.1.7 variant of SARS-CoV-2 is associated with a 30% to 40% increased risk of death compared to earlier variants of the virus, according to scientists on the U.K. government’s New and Emerging Respiratory Virus Threats Advisory Group. That conclusion is based on studies by three university groups, linking community PCR testing to mortality.
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