Catalent, Inc
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Latest From Catalent, Inc
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.
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.
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.
Regeneron Raises Possibility Of Quick CRL Resolution For High-Dose Eylea
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.
Company Information
- Industry
- Contract Research, Toxicology Testing-CRO
- Services
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Pharmaceuticals
- OTC, Consumer
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Drug Delivery
- Controlled Release
- Macromolecule
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Biotechnology
- Drug Discovery Tools
- Large Molecule
- Synthesis Technologies, Production Processes
- Other Names / Subsidiaries
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- Accucaps Industries Limited
- Catalent U.K. Swindon Zydis Limited
- Cook Pharmica LLC
- Juniper Pharmaceuticals
- Molecular Profiles Ltd.
- Columbia Laboratories, Inc.
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