EU Yes For TiGenix Marks Tenth ATMP Approval in Ten Years
TiGenix says its treatment for complex perianal fistulae in Crohn’s disease is the first allogeneic stem cell therapy to be approved under Europe’s centralized marketing authorization pathway.
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Stempeutics explores stem cell therapy in India for Crohn’s disease-related perianal fistulae while considering entry into other Asian markets.
Takeda has closed its $630m acquisition of European regenerative medicine company TiGenix following a successful bid process, but is facing new pressure from a group of shareholders in Japan concerned about its planned purchase of Shire – valued at around 100 times that amount.
Seven new drugs were approved in the EU in the March-April period this year: TiGenix/Takeda's Alofisel, BioCryst's Alpivab, Chiesi's Lamzede, AstraZeneca's Lokelma, Pfizer's Mylotarg, GSK's Shingrix and MSD's Steglatro.