Gottlieb’s Rx For Coronavirus
Study everything together and a scale-up manufacturing after preliminary efficacy results, former FDA commissioners Gottlieb and McClellan and their coauthors recommend in a pair of white papers on how the US should respond to the coronavirus pandemic.
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America still has a long way to go to meaningfully contribute to ending the global pandemic, but loaning AstraZeneca’s vaccine to Canada and Mexico helps counter the narrative that only China and Russia are helping the rest of the world.
A Manhattan Project-style campaign to accelerate COVID-19 treatments could help end the pandemic. But it also brings another set of layers – and yet a new group of leaders – into an already complex network.
Boehringer Ingelheim Wins Interchangeable Biosimilar To Humira, Setting Benchmark For Switching Studies
Cyltezo won’t be available until 2023 due to patent settlement with AbbVie. The second-ever interchangeable biosimilar approved by the US FDA also contains a first: published data from a switch trial.