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[{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Receives Positive CHMP Opinion for Vedolizumab IV for the Treatment of Active Chronic Pouchitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase IV","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Takeda Pharmaceutical"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alofisel\u00ae\u25bc (darvadstrocel) Shows Clinical Remission Rate at Six-Months in the Real-World INSPIRE Study Interim Analysis Consistent with the Pivotal Clinical ADMIRE-CD Study","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase IV","country":"JAPAN","productType":"Cell and Gene therapy","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Takeda Pharmaceutical"}]

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            Alofisel is a suspension of expanded allogeneic (donor-derived), adipose-derived mesenchymal stem cells (eASC) for the treatment of complex perianal fistulas in adult patients with non-active or mildly active luminal CD.

            Lead Product(s): Darvadstrocel

            Therapeutic Area: Gastroenterology Product Name: Alofisel

            Highest Development Status: Phase IV Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 18, 2022

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            The positive opinion from the CHMP was based on the EARNEST trial, which assessed the safety and efficacy of Entyvio (vedolizumab) IV if approved it Will Be the First Authorized Treatment in Europe for active chronic pouchitis.

            Lead Product(s): Vedolizumab,Ciprofloxacin

            Therapeutic Area: Gastroenterology Product Name: Entyvio

            Highest Development Status: Phase IV Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 17, 2021

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