Entyvio (vedolizumab) / TakedaEntyvio: “Extension application to introduce a new pharmaceutical form (solution for injection), associated with a new strength (108 mg) and a new route of administration (subcutaneous use)" (EMEA) - Mar 3, 2020 - CHMP Final Minutes of the meeting on 9-12 December 2019: "The Committee discussed the issues identified in this application, mainly relating to some quality and clinical issues”; “The Committee adopted the CHMP recommendation and scientific discussion together with the list of outstanding issues and a specific timetable”
Skyrizi (risankizumab) / AbbVie, Boehringer IngelheimA Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy (clinicaltrials.gov) - Mar 2, 2020 - P2/3; N=1536; Recruiting; Sponsor: AbbVie; N=720 --> 1536
brazikumab (AMG 139) / AllerganAbbVie and Allergan receive final European approval to close pending transaction (PRNewswire) - Mar 3, 2020 - "AbbVie...and Allergan plc...today announced that the European Commission has approved the divestiture of brazikumab, an investigational IL-23 inhibitor in development for autoimmune diseases, to AstraZeneca. The transaction remains subject to additional customary closing conditions...The United States Federal Trade Commission (FTC) continues to review the pending transaction...the companies have entered into a timing agreement with FTC staff that would likely result in a decision by the FTC early in the second quarter of 2020."
Entyvio (vedolizumab) / TakedaRoyalty Pharma acquires royalties on Entyvio from Massachusetts General hospital (PRNewswire) - Mar 5, 2020 - "Royalty Pharma announced today that it has acquired Massachusetts General Hospital's (MGH) royalty interest in Entyvio (vedolizumab) for $94 million. Entyvio is a monoclonal antibody that is used in the treatment of ulcerative colitis and Crohn's disease...'Through this transaction with Royalty Pharma, we'll be able to accelerate our investment in discovery and science for the benefit of patients worldwide.' "
Skyrizi (risankizumab) / AbbVie, Boehringer IngelheimThe Interministerial Commission modifies the price of 50 medicines (Acta Sanitaria) - Mar 6, 2020 - "The Interministerial Commission for the Prices of Medicines (CIPM), at its meeting held on February 4, approved three new drugs and decided to review the price of 50...as stated in the information provided by the Ministry of Health....According to the minutes of the CIPM meeting, the Commission approved three new medicines (Skyrizi, from Abbvie...The price set for this drug is € 3,833.49."