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MHRA approves first oral advanced therapy for Crohn’s disease
The MHRA has approved the first marketing authorisation globally for the use of RINVOQ®▼ (upadacitinib) in Crohn's disease.
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Crohn's disease (CD)
Crohn’s disease is a type of inflammatory bowel disease that may affect any part of the gastrointestinal tract from mouth to anus. Signs and symptoms often include abdominal pain, diarrhea (which may be bloody if inflammation is severe), fever, and weight loss.
Other complications may occur outside the gastrointestinal tract and include anemia, skin rashes, arthritis, inflammation of the eye, and feeling tired. The skin rashes may be due to infections as well as pyoderma gangrenosum or erythema nodosum. Bowel obstruction also commonly occurs and those with the disease are at greater risk of bowel cancer.
Crohn’s disease is caused by a combination of environmental, immune and bacterial factors in genetically susceptible individuals. It results in a chronic inflammatory disorder, in which the body’s immune system attacks the gastrointestinal tract possibly directed at microbial antigens. While Crohn’s is an immune related disease, it does not appear to be an autoimmune disease (in that the immune system is not being triggered by the body itself). The exact underlying immune problem is not clear; however, it may be an immunodeficiency state. About half of the overall risk is related to genetics with more than 70 genes found to be involved.
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First biosimilar to HUMIRA® available in US
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Citrate-free HCF of adalimumab biosimilar gets positive opinion
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Biosimilar competition saves US healthcare $21 billion
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Technologies and tactics for accelerating end-to-end biologic drug development
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Crohn’s patients achieve 65 percent clinical remission with Tremfya®
At week 48 of the Phase II trial, 65 percent of patients with Crohn's disease receiving Tremfya® achieved clinical remission.
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Stelara® shows promise to treat gut diseases in new analyses
Two new analyses displayed positive data supporting Stelara for the treatment of Crohn's disease and ulcerative colitis.
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Cell line development services market to value $2.4 billion by 2030
New report suggests the cell line development services market will witness a 14.3 percent CAGR between 2021 and 2030.
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New regulatory guidance could lead to UK biosimilar boom
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Risankizumab induces deep remissions in Crohn’s disease trial
Phase III trial data shows more than half of patients with moderate to severe Crohn's disease treated with risankizumab (Skyrizi®) 360mg achieved clinical remission in a year.
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Stelara® “a compelling option” for the treatment of Crohn’s disease
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Could precipitation reduce the cost of antibody production?
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EC approves first high concentration, low-volume adalimumab biosimilar
YuflymaTM (CT-P17) has been approved for the treatment of thirteen chronic inflammatory diseases, including rheumatoid arthritis, ulcerative colitis and psoriatic arthritis, in Europe.
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Risankizumab trials show higher clinical remission in patients with Crohn’s disease
Two Phase III trials have shown that two doses of risankizumab met the primary endpoints in patients with Crohn's disease.
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First-in-human trial to study remestemcel-L as Crohn’s disease therapy launched
A Phase I clinical trial of remestemcel-L delivered by an endoscope to patients with Crohn’s disease and ulcerative colitis has commenced.
