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Invossa Gene Therapy Controversy Grows As Government, Patients Take Action

 
• By Jung Won Shin

While the eventual fate of Kolon Life’s gene therapy Invossa is still undecided after interim results from an ongoing probe into its composition, controversy over the product is growing as patients seek compensation from the company and government, and calls grow for a wider investigation.

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Korea Confirms Invossa Distributed In Korea Has Different Cell Composition • Source: Shutterstock

South Korea’s drug ministry has confirmed that an active cell component of the version of Kolon Life Science Inc.’s gene therapy Invossa (TG-C) distributed in the country differs to that described in the data submitted at the time of approval, in line with the same test result for the version of the therapy being used in ongoing US clinical trials.

The ministry will now probe further why this has happened before potentially imposing administrative measures on the company, and also...

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More from South Korea

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
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A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges

New Era Begins In Korea: Policy Predictions For Biopharma

 
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DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
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More from Asia

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

New Era Begins In Korea: Policy Predictions For Biopharma

 
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As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.

Australia Looks To Modernize Human Tissue Laws, Improving Access For Researchers

 
• By Eliza Slawther

Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.