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Invossa Fallout: Call For Review Of All Korea-Approved Cell Therapies

 
• By Jung Won Shin

Although the big decision has been made for Invossa in Korea, things have not settled down and there have been calls for re-examination of all approved cell therapies, the recall of R&D grants provided to Kolon and expansion of a probe into the company’s leadership and government officials.

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Invossa Fallout Might Spread To Other Cell Therapies • Source: Shutterstock

Following the shocking withdrawal of approval in South Korea of Kolon Life Science Inc.’s cell and gene therapy Invossa (TG-C), a local pharmacist organization has questioned whether the problems relate only to Invossa and has urged the government to launch a full-scale re-examination of all 16 cell therapies approved in the country.

The Invossa incident has revealed the Ministry of Food and Drug Safety’s (MFDS) weak management of cell and gene therapies, so “we have to raise the most important question. Is...

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Korean Pharma Industry Proposes Policies As Election Nears

 
• By Jung Won Shin

As South Korea gears up for a snap presidential election, its biopharma industry proposes key desired policies to candidates, most of whom have not laid out detailed plans of their own for the sector.

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

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.

Korea To Revise ‘Innovative Company’ Criteria Amid Calls From Foreign Industry

 
• By Jung Won Shin

South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.

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