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FDA issued proposed orders to remove the 510(k) exemption and establish special controls for most blood lancets, and require PMAs for one super-risky category of the finger-prick devices. The goal is to reduce infectious disease transmission.
Stock prices for Ambit Biosciences and Emergent BioSolutions dipped after abstracts for their data presentations at the upcoming American Society of Hematologists (ASH) Annual Meeting and Exposition became public on 7 November, and GlycoMimetics postponed its initial public offering on 8 November, but all three companies have data worth watching when ASH welcomes doctors and scientists to New Orleans from 7 to 10 December.
The General and Plastic Surgery Devices advisory panel strongly supported FDA’s proposal to reclassify blood lancets from class I to class II or III during a June 26 meeting. Panelists raised concerns, in particular, about the safety of multi-use blood lancets.
With a pair of PDUFA dates this year, Theravance is thinking ahead how to pass potential royalties to investors while continuing to fund its pipeline. The biopharma said it would separate into two public companies: a royalty play to return cash to shareholders and an R&D pipeline story.
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