Coronavirus Notebook: Fauci Calls For Restraint In Disclosing Early Data; Bipartisan Lawmakers Want Warp Speed Audit
Dispatches from a world turned upside down also include the conditional approval of remdesivir in South Korea.
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BIO Calls For Journal Publication Of COVID-19 Trial Data, Independent FDA
In an open letter to the biopharmaceutical industry, BIO lays out principles for conducting COVID-19 clinical trials and disclosing and using the data. Senator Durbin asks eight vaccine makers backed by Operation Warp Speed how they will withstand political pressure to speed up the approval process.
US DoJ Lets Biotechs Share Manufacturing Details To Speed Launch Of COVID-19 Therapies
Companies are shielded from antitrust concerns by Justice Department as they jointly prepare to manufacture whichever monoclonal-antibody-based coronavirus therapies emerge from development.
Real-World Evidence Likely Untainted By COVID-19 Journal Article Debacle
Retraction of Lancet, NEJM studies does not signal doubts about the utility of RWE for evaluating drug efficacy and safety; instead, it highlights importance of transparency, validation and audit trails for real-world datasets, and lack of familiarity with RWE methods among medical journal peer reviewers, experts say.