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Latest From Catalent, Inc

Deal Watch: Bayer Ties Up With Twist On Optimization Of Antibody Discovery

Plus deals involving Advanz/Dimerix, Boehringer Ingelheim/Zeiss Medical Technology, Roche/Ionis, Kriya/Everads and updates from the world of technology transfer.

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Geron’s Imetelstat Headed To US FDA Advisory Committee For MDS

Geron’s telomerase inhibitor will also get standard review for transfusion-dependent anemia in adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS), suggesting FDA reviewers may be less bullish on imetelstat’s clinical data than analysts have been.

Advisory Committees Drug Review

Geron’s Potential Blockbuster Imetelstat Faces Unexpected AdComm In MDS

Geron’s highly anticipated telomerase inhibitor has been given a user fee date by the US Food and Drug Administration next year and will also be subject to an advisory committee meeting, despite largely positive analyst sentiment on clinical results to date.

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UPDATED: Regeneron Wins Same-Day Veopoz, High-Dose Eylea US FDA Approvals

Veopoz (pozelimab) approval showed the FDA was reassured that Regeneron’s contract manufacturer is ready to supply high-dose Eylea, a key product for the company as competition picks up.

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  • Other Names / Subsidiaries
    • Accucaps Industries Limited
    • Catalent U.K. Swindon Zydis Limited
    • Cook Pharmica LLC
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    • Molecular Profiles Ltd.
    • Columbia Laboratories, Inc.
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