Weekly Top News – IBD – April 9, 2019

Idacio (adalimumab biosimilar) / Fresenius Kabi
Fresenius Kabi receives European Commission approval for adalimumab biosimilar Idacio (Fresenius Kabi Press Release) – Apr 3, 2019 – “Fresenius Kabi…announced today that the European Commission (EC) granted marketing authorization for IDACIO®, an adalimumab biosimilar, for all indications of the reference medicine.”
European regulatory


Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104 US launch estimate: 2023 (H.C. Wainwright & Co) – Apr 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 66838015; Page no: 1; REPORT TITLE: “RedHill Biopharma Ltd.- Focus on Talicia; Adjusting PT to $16.00 on changes to RHB-104 outlook; Reiterate buy”; AUTHOR: Ramakanth, Swayampakula, et al; DATE: 02/27/2019
Launch US


Entyvio SC (vedolizumab SC) / Takeda
European Medicines Agency accepts Takeda’s Marketing Authorization application for a subcutaneous formulation of vedolizumab for maintenance therapy in moderately to severely active ulcerative colitis and Crohn’s Disease (Businesswire) – Apr 1, 2019 – “Takeda…announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Line Extension Application for a subcutaneous (SC) formulation of the gut-selective biologic vedolizumab for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). Takeda proposes to make vedolizumab SC available in both pre-filled syringe and pen options.”
European regulatory


Remsima SC (infliximab biosimilar SC) / Celltrion
Celltrion completes FDA application for phase 3 trial of Remsima SC (Yonhap News Agency) – Apr 1, 2019 – “South Korea’s leading biopharmaceutical firm Celltrion announced Monday that it has completed the U.S. Food and Drug Administration’s investigational new drug (IND) application for Remsima SC….Celltrion plans to further expand its phase 3 clinical trials of Remsima SC to other countries with the aim to win U.S. FDA approval by 2020….Remsima SC will be under patent protection until 2037…”
BLA • IND • Patent


Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Prescription of antibiotics for adults with acute diarrhoeal infections in Korea: a population-based study (ECCMID 2019) – Apr 5, 2019 – Abstract #P2034; Pres time: Apr 15, 2019; 01:30 PM – 02:30 PM; “…The antibiotics most frequently prescribed for both monotherapy and combination regimens in patients with ADI were fluoroquinolones (29.80%), rifaximin (26.82%), second-generation cephalosporins (9.21%), third-generation cephalosporins (7.25%), trimethoprim/sulfamethoxazole (5.54%), and ß-lactam/ß-lactamase inhibitors (5.30%)… This study revealed differences between the antibiotics used to treat ADI in Korea and those recommended by the guidelines for treatment of ADI. Multifaceted efforts are necessary to strengthen physicians’ adherence to the published guidelines.”


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