Innovative Product Development and Review
This article was originally published in RAJ Devices
FDA report outlines initiatives to improve regulatory environment
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Mereo BioPharma’s completed private placement in the US will support clinical studies of its candidate immuno-oncology product etigilimab and a later-stage anti-sclerotin antibody product with potential in the treatment of brittle bone disease.
While the AAM is lobbying for a renewed focus on domestic drug production amid fresh concerns about the globalization of the US pharmaceutical drug supply chain, the association has urged US Congress to have confidence in FDA oversight, insisting that “the US has one of the safest drug supply chains in the world.”
Korean firm Celltrion is aiming to move production of insulin pens inside Korea “for the first time” and break the stranglehold of Big Pharma insulin players in the market by launching a biosimilar product in 2025.