S&E Briefs: The Good and The Bad Of COVID-19 On Biotech's Top Line
Regeneron's COVID-19 antibody cocktail helped drive 38% growth for the company, while Global Blood Therapeutics' Oxbryta continues to face headwinds and Horizon focuses on relaunches.
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When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval
More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.
The second quarter could mark a financial turning point for big pharma as demand rebounds from the pandemic, but variability remains across portfolios and therapeutic areas.
A second FDA safety labeling update for Intercept’s Ocaliva might open a market opportunity in second-line PBC for Phase III candidates at CymaBay and Genfit.