US Elections 2020
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Germany uses government facilitated price negotiations between publicly funded insurers and manufacturers that are based on an independent assessment of how much added value a drug provides.
EUA request for COVID-19 vaccine is unlikely before late November; the CEO’s frequent comments that the timetable isn’t politically motivated are unusual to say the least.
‘Senator, please stop undermining confidence in a vaccine,’ Pence says when confronted with the accusation that the administration is politicizing the COVID vaccine development effort.
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.
Textualist judges appointed by President Trump during his term may block a potential President Biden’s attempts to shift the government’s legal policies.
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.
House Oversight Committee plans to grill more companies on pricing later this year, but rushed rollout of reports from a long-running investigation, combined with competing higher profile news events, seemed to dampen the blow of the latest drug pricing scrutiny. Democrats failed to offer any new, unified solutions for their grievances with industry, while Republicans largely rushed to pharma’s defense.
Pfizer CEO Albert Bourla said he is disappointed in the US politicization of a COVID-19 vaccine in a letter to employees. ‘We are moving at the speed of science,’ he said.
Bristol Myers Squibb CEO Giovanni Caforio, former Celgene CEO Mark Alles and Teva CEO Kare Schultz fielded roughly four hours of questioning at an oversight hearing on pricing practices for Revlimid and Copaxone.
After US President Trump said vaccine developers could develop a COVID-19 vaccine faster if it weren't for politics, Moderna CEO Bancel said no political party has asked the company to move faster or slower.
Trump and Biden trade barbs in debate that included a suggestion by the president that coronavirus vaccine development delays are political and saw Biden questioned on whether he was contributing to vaccine hesitancy.
In remarks fleshing out the ‘EUA Plus’ guidance before it became a political football, Operation Warp Speed’s Slaoui said that an FDA analysis concluded that 90% of adverse events related to vaccination take place within the first 42 days.
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