COVID-19 roundup: biopharmas scramble to reassess clinical timelines; plus CEPI-Dynavax, and emergency approvals for Vero, Fosun
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More than a dozen biopharmas Thursday announced delays or disruptions to clinical programs and regulatory timelines as companies begin to turn their attention to managing their trials through the COVID-19 crisis. The setbacks came as regulators granted emergency access to Vero’s portable nitric oxide delivery system and Fosun’s diagnostic, and Dynavax and CEPI expanded their partnership to boost vaccine potency.
According to a joint survey from BioCentury and BIO, concerns over trial delays due to the COVID-19 pandemic have been accelerating. On-the-fly protocol amendments are fast becoming a necessity, and companies want assurance regulators will be flexible with the resulting data sets (see “Companies Seek Regulatory Flexibility”)...