Tocilizumab COVID-19 Study Shows Bias Against Observational Studies, Harvard Prof Says
Study showing Roche’s Actemra decreased mortality in COVID-19 patients in ICUs by almost 10% was initially rejected by journal editors and then ignored by guideline writers and regulators. FDA officials and industry reps discuss what needs to be done to advance use of real-world evidence from observational studies.
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The RECOVERY trial has found Actemra to help cut deaths and speed recovery – and UK doctors are not waiting for Roche to complete own studies.
Effort to replicate clinical trial results with real-world data could eventually allow for increased use in drug development.
Of the 16 products whose Orange Book patent listings have been challenged by the FTC, six have no generic competitors and two faced first generic launches this year. A review of their patent and pricing battles shows the difficulties in developing generics for these complex drugs.