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Gene Therapy’s Roller Coaster Ride

Executive Summary

With big pharma on board, disappointments like the threatened EU market removal of pioneering Glybera and the Celladon trial failure give the field of gene therapy a bumpy ride after some major highs.

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Gene Therapy: Cures Within Reach

After rocky beginnings, there is increasing optimism about the potential for gene therapy to make an impact in rare disease. Promising data from late-stage clinical trials, improved safety, and the first Western regulatory approval of a gene therapy are now driving numerous initial public offerings, venture capital financings, and tie-ups with major pharmaceutical companies.

Gene/Cell Therapies: Still Just A ‘Science Project’?

While an increasing number of South Korean biotech firms are looking to advance into overseas gene and cell therapy markets as part of the government's plan to develop these areas as a new growth engine, a U.S. regulatory expert has cautioned it is risky for bioventures to focus only on the gene and cell sectors while they still face major regulatory and commercialization hurdles.

Gene/Cell Therapies: Still Just A ‘Science Project’?

While an increasing number of South Korean biotech firms are looking to advance into overseas gene and cell therapy markets as part of the government's plan to develop these areas as a new growth engine, a U.S. regulatory expert has cautioned it is risky for bioventures to focus only on the gene and cell sectors while they still face major regulatory and commercialization hurdles.

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