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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.
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.
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.
On its Q2 earnings call, Regeneron said its 8mg formulation of aflibercept could obtain US FDA approval this quarter, despite receiving a complete response letter in June. Refiling’s fate tied to review of pozelimab.
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- Accucaps Industries Limited
- Catalent U.K. Swindon Zydis Limited
- Cook Pharmica LLC
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- Columbia Laboratories, Inc.
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