Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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

Executive Summary

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.

You may also be interested in...



Korea Suspends First Approved Gene Therapy Pending Component Discrepancy Probe

South Korea’s first approved gene therapy has been suspended from sale in the country, while recruitment in an ongoing US Phase III program has been temporarily halted, after findings that an active cell component may differ from the data submitted at the time of approval. While both manufacturer and regulator see no safety risk, results from an official Korean probe are due in mid-April.

Robust Appetite For Biosolution IPO As OA Cell Therapy Nears Commercialization

Biosolution's IPO, which was priced at the high end of the range despite dampened biotech sentiment following the arrest of Nature Cell's CEO, is poised to help accelerate commercialization of the South Korean cell therapy company's osteoarthritis treatment CartiLife and the progress of other pipeline assets.

Disease Modifying Status Targeted As Kolon's Novel OA Therapy Enters US Phase III

With the removal of an FDA clinical hold, Kolon TissueGene is set to begin a US Phase III trial for Invossa, its first-in-class cell and gene therapy, for osteoarthritis of the knee. The planned study, which is larger and longer than the product's Korean Phase III program, will be under the spotlight as it will determine whether Invossa can be designated as the world's first disease-modifying drug in osteoarthritis, and is being designed accordingly.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC099123

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel