Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

A Glimpse Of Light For Kolon As US Invossa Trials To Resume

FDA Lifts Clinical Hold

Executive Summary

Following the long-awaited decision from the US FDA, Kolon TissueGene will resume Phase III clinical trials of the cell and gene therapy for degenerative osteoarthritis TG-C (Invossa) in the US this year.

You may also be interested in...



Merck KGaA Finds The Right Home For Disease-Modifying OA Agent In Novartis

Novartis has added an anti-osteoarthritic Nanobody, M6495, to its growing pipeline of candidates for the condition, in a €450m agreement with Merck KGaA that sees the latter deliver on its plans to find new homes for its osteoarthritis pipeline.

Kolon TissueGene Faces Delisting In Korea On Invossa Uncertainties

Kolon TissueGene is facing delisting in South Korea after the recent revocation of approval of gene therapy Invossa, which could fuel legal action from shareholders. The company still hopes to resume Invossa trials in the US by submitting additional data demanded by the FDA.

Invossa Approval Revoked As Korea Confirms False Data Submission

In a worst case scenario for the country’s first approved gene therapy, South Korea has cancelled the global-first approval of Kolon Life’s Invossa and asked prosecutors to press criminal charges against the company, which it concluded submitted false data to support approval. The major blow to the company comes as it is already facing lawsuits from patients and investors, and has prompted a broader regulatory overhaul for novel biologic therapies.

Topics

Related Companies

UsernamePublicRestriction

Register

OM003387

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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