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Mitsubishi Tanabe Pharma Corp.

Division of Mitsubishi Chemical Holdings Corp.
www.mt-pharma.co.jp/e/

Latest From Mitsubishi Tanabe Pharma Corp.

Emmaus and Mitsubishi Tanabe Refuse To Take EU Approval Blows Quietly

Two companies explain why they believe the European Medicines Agency was wrong to say that they do not have sufficient study data to prove that their products should be approved for sale in the EU.

Europe Approvals

CHMP Highlights: No For Xyndari, Edaravone MAA Pulled And Good News For Univar’s Cufence

This month’s meeting of the European Medicines Agency’s CHMP appears to have been eventful. One marketing authorization application was rejected, one was pulled, and an earlier negative opinion was upheld. Four MAAs were recommended for approval, including a new treatment from Univar for Wilson’s disease.

Europe Regulation

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.

Gene Therapy South Korea

Companies Keep The Faith As New Products Await EMA Verdict

Mitsubishi and Emmaus Life Sciences are among the companies that will find out this week whether the European Medicines Agency's drug evaluation committee, the CHMP, will recommend their new products for EU approval.

Europe Approvals
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