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Ferring’s Fecal Transplant Gets Through AdComm, Aided By Preference For Standardized Product

Executive Summary

US FDA's Vaccines and Related Biological Products Advisory Committee endorses Rebyota for recurrent C. difficile infection; most panelists prefer a product whose manufacturing will be regulated, even one with lingering concerns about efficacy or safety, over the current landscape.

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November Gloom? US FDA’s Goal Dates Include Hard Calls On Ferring Rebyota, Y-mAbs’ Omblastys

November should see FDA action on what could be the first standardized fecal microbiota transplant product, rare cancer therapies from Y-mAbs and Spectrum, uniQure/CSL’s hemophilia B gene therapy and Provention Bio’s biologic to delay type 1 diabetes.

How The Curtain Finally Closed On Ferring/Blackstone’s Gene Therapy Venture FerGene

Having failed to live up to its promising beginnings, FerGene, the gene therapy firm founded with the backing of Ferring and Blackstone to advance the former’s candidate for bladder cancer is back under the Swiss pharma's wing. However, doubts about its future and that of nadofaragene firadonavec remain.

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

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