Regeneron Pushes Legal, Ethical Boundaries With Offer Of COVID-19 Antibody To Biden Campaign
Company may have violated FDA’s preapproval promotion restrictions by discussing compassionate use option with Joe Biden’s team and by publicizing it on TV, highlighting the fine line between making the general public aware of expanded access and touting an investigational product as useful for a particular illness.
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Coronavirus Update: Praised By Trump, Regeneron Files Antibody Cocktail For Emergency Use Authorization
Trump's praise of the therapy and talk of a 'cure' for COVID-19 has raised concerns about misinformation and pressure on the US FDA once again.
As the clock ticks down to the US election day on 3 November, President Trump maintains that the first COVID-19 vaccine emergency use approval is imminent. Meanwhile, Fujifilm Toyama's Avigan is near to Japanese approval.
Trump receives Regeneron’s experimental antibody under FDA’s expanded access program, Gilead’s remdesivir and dexamethasone. The president’s treatment choices could influence clinical trials of all COVID-19 medicines and even trial recruitment for other diseases, experts said.