Viscogliosi Brothers, LLC
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US FDA’s global first for Moderna’s vaccine gets a small mention as agency looks to pharmacovigilance, follow-up studies for both coronavirus inoculations that have now been authorized. Moderna's 18 December EUA comes after an even faster review than for Pfizer/BioNTech's vaccine.
Steve Cutler, head of the CRO that conducted Pfizer’s study, tells the Pink Sheet that starting clinical trials in weeks, as opposed to months, should be possible post-pandemic.
Continuing parent firm Gilead’s busy deal-making year in immuno-oncology, Kite gets option rights to new targets. Boehringer teams with Israel’s BiomX in IBD research.
Three years after the US FDA released a guidance to use real-world evidence in premarket applications, the stakeholder group MDIC has unveiled a framework for how IVD RWE can be captured and used by sponsors for premarket applications.
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