Catalent, Inc
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Latest From Catalent, Inc
Product Quality ‘Wild Card’? Sarepta’s Gene Therapy Manufacturing Process Change Means More Empty Capsids
SRP-9001 intended for commercialization is not analytically comparable to the product used in earlier clinical studies; FDA CMC reviewer said agency does not mandate the extent of empty or full capsids but, instead, looks at the totality of data to assess safety and efficacy.
Gene Therapy: Four-Month Lag In Commercial Access Protects EMBARK Study, Sarepta Says
Company’s prediction that Duchenne muscular dystrophy patients likely would not be able to access SRP-9001 until four months after accelerated approval eased some US FDA panelists’ concerns about interference with the ongoing confirmatory trial.
Gene Therapy: Four-Month Lag In Commercial Access Protects EMBARK Study, Sarepta Says
Company’s prediction that Duchenne muscular dystrophy patients likely would not be able to access SRP-9001 until four months after accelerated approval eased some US FDA panelists’ concerns about interference with the ongoing confirmatory trial.
Sarepta Prepared For DMD Gene Therapy Launch Despite Regulatory Setbacks
Despite obstacles on the regulatory path for the firm’s Duchenne muscular dystrophy gene therapy, analysts and Sarepta itself seem confident about accelerated approval prospects, with plans already in place for launch.
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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