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First Approval For Kolon's Invossa But No Disease-Modifying Status

 
• By Jung Won Shin

Kolon Life Science's Invossa gets regulatory approval in South Korea as the world's first allogeneic cell-mediated gene therapy for degenerative osteoarthritis, but misses out on disease-modifying status, although the company hopes a large-scale Phase III study can rectify this in the US.

Red Approved Stamp with Wooden handle Rubber Stamper Isolated on White Background.

Kolon Life Science Inc. has earned its first regulatory approval for Invossa, the world's first allogeneic cell-mediated gene therapy for degenerative osteoarthritis (OA), in South Korea, after 19 years of development.

Invossa (TissueGene-C; tonogenchoncel-L) was approved as a treatment for serious OA of the knee (Kellgren & Lawrence grade 3) via a single intra-articular injection. The approval is South Korea's first...

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Pipeline Watch: Eight Approvals And Nine Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.