Clinical / R&D
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Latest From Research & Development
In addition to our daily in-depth coverage of key regulatory events relating to the coronavirus pandemic, we’re bringing you selected brief insights into the impact on biopharma commercial activities.
In addition to our daily in-depth coverage of key events relating to the COVID-19 pandemic, we’re bringing you a periodic round-up of other developments. This edition covers Europe and other countries.
Wave’s Duchenne muscular dystrophy drug and Lilly’s chronic pain R&D will test the agency’s CID meeting pilot program, while FDA issues draft guidance that highlights potential uses for complex innovative trial designs.
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.
Company expects clinical trials to begin by September and says first batches could be available for emergency use authorization in early 2021; J&J pledges vaccine will be available to public on not-for-profit basis.
Health-system pharmacist organization assesses the evidence behind off-label use of existing drugs for COVID-19, along with top investigational prospects like Gilead’s remdesivir.
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