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Entyvio (vedolizumab) / TakedaTakeda launches Vedolizumab in India for treatment of ulcerative colitis, Crohn’s Disease (Outlookindia.com) - Jul 8, 2020 - "Drug firm Takeda India on Wednesday said it has launched biological drug Vedolizumab under the brand name 'Kynteles' used for the treatment of adult patients with moderate-to-severely active ulcerative colitis and Crohn's Disease, at a price of Rs 71,310 per vial in India....'We continue to optimise our prices from patient access perspective and it is currently priced at Rs 71,310 per vial'. The recommended dose regimen of Kynteles is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter in both UC and CD, he added."
Zeposia (ozanimod) / BMSSafety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - Jul 9, 2020 - P3; N=1012; Completed; Sponsor: Celgene; Active, not recruiting --> Completed
mirikizumab (LY3074828) / Eli LillyVIVID-2: A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (clinicaltrials.gov) - Jul 7, 2020 - P3; N=778; Recruiting; Sponsor: Eli Lilly and Company; Not yet recruiting --> Recruiting
Cimzia (certolizumab pegol) / Astellas, UCB, Eli LillyUCB and Ferring Pharmaceuticals Announce Co-Promotion of CIMZIA (certolizumab pegol) for the Treatment of Adults with Moderate to Severe Crohn's Disease (PRNewswire) - Jul 7, 2020 - "Ferring will take over marketing, sales promotion, and field medical affairs activities. UCB will continue to be responsible for all product-related activities, including revenue recognition....Ferring joins with UCB to promote CIMZIA prefilled syringe for Crohn's disease in the U.S."
Avsola (infliximab-axxq) / AmgenCanada approves infliximab and filgrastim biosimilars Avsola and Nivestym (GaBI) - Jul 10, 2020 - "Canada’s drug regulator, Health Canada, has approved the infliximab and filgrastim biosimilars Avsola (ABP 710) and Nivestym."
Stelara (ustekinumab) / J&JJoint Letter to CMS Advocates Against Adding Stelara to Self-Administered Drug List (The Rheumatologist) - Jul 6, 2020 - "Most recently, the ACR partnered with the Coalition of State Rheumatology Organizations and the Arthritis Foundation to send a letter to the Centers for Medicare & Medicaid Services requesting that it review the Medicare Administrative Contractors’ (MACs) decision to add this drug to the SAD list. Keeping Stelara off the list is important to ensure continued access for patients who can’t self-administer....Implementation is now planned for 45 days after the end of the public health emergency....ACR advocacy efforts will continue to prioritize protecting patient access to Stelara under Medicare Part B."
Hulio (adalimumab biosimilar) / Mylan, Fujifilm Kyowa Kirin BiologicsMylan and Fujifilm Kyowa Kirin Biologics Announce U.S. FDA Approval of Hulio (adalimumab-fkjp) (PRNewswire) - Jul 9, 2020 - "Mylan...and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp)...for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis, in both prefilled syringe and auto-injector presentations....In accordance with its patent license agreement with AbbVie, Mylan will be able to launch Hulio in the U.S. during July 2023."
