Lead Product(s) : Darvadstrocel
Therapeutic Area : Gastroenterology
Study Phase : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : Alofisel
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
February 18, 2022
Lead Product(s) : Darvadstrocel
Therapeutic Area : Gastroenterology
Highest Development Status : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Vedolizumab,Ciprofloxacin
Therapeutic Area : Gastroenterology
Study Phase : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : Entyvio
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 17, 2021
Lead Product(s) : Vedolizumab,Ciprofloxacin
Therapeutic Area : Gastroenterology
Highest Development Status : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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