Panel Nixes Tolvaptan On Weak Efficacy Data And Liver Risks
This article was originally published in The Pink Sheet Daily
Small, unclear drug effect and hepatotoxicity take down Otsuka’s tolvaptan kidney disease indication at Cardiovascular and Renal Drugs Advisory Committee review.
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US Remains Conservative On Vaccine Dosing Regimens As CDC’s ACIP Highlights Minimal Comfort With Relying On Unproven Correlates
The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices concerns about making COVID-19 vaccine dose regimen changes based on unproven immune correlates of protection could be a warning sign to sponsors about roadblocks they might face if updating vaccines to address viral variants or conducting pediatric studies relying on such surrogate endpoints.