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Levo Therapeutics, Inc.

https://www.levotx.com/

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The US biotech has released new positive data from two late-stage studies in the rare disease after the US FDA asked for more controlled data following an initial disappointment.

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US FDA’s 2022 Novel Agent Actions Suggest Acceleration In Use Of Complete Response Letters

COVID does not appear to be a driving factor, and letters are split almost equally between clinical and quality concerns.

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COVID-Infected Trials: Issues Arise In US FDA Reviews, But Nothing Decisive – Yet

Complications in analysis due to the impact of COVID on trial conduct are a common factor in two recent negative advisory committee reviews, but it is safe to say that both applications were rejected primarily for other reasons. When will COVID issues be decisive for FDA?

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Deal Watch: Sanofi To Tap Owkin’s AI, Machine Learning In Oncology

French pharma makes $180m equity investment in Owkin under collaboration targeting four cancer types. Pyramid gets global license to MPS1 precision cancer candidate from Voronoi.

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