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ACG 2024: J&J data reveals new Crohn’s treatment option
More patients given subcutaneous induction and maintenance treatment with Johnson & Johnson’s biologic obtained clinical remission at 48 weeks, compared to placebo, Phase III data showed.
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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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CHMP meeting highlights – July 2024
In its July meeting, the EMA’s human medicines committee recommended 14 medicines and held a negative opinion for authorising lecanemab to treat Alzheimer’s disease.
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Lilly agrees $3.2b IBD acquisition
The acquisition, which has a value of approximately $3.2 billion, is set to support development of small molecule oral integrin therapies for conditions such as ulcerative colitis.
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CHMP meeting highlights – June 2024
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
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CHMP meeting highlights: April 2024
In its April meeting, the EMA’s human medicines committee recommended eight new medicines, including treatments for cancer and autoimmune diseases.
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First European ustekinumab biosimilar to Stelara approved
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Year in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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FDA approves first Stelara biosimilar, Wezlana
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Roche to gain rights to novel antibody for IBD
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FDA grants first approval for multiple sclerosis biosimilar
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Eli Lilly ulcerative colitis antibody drug doubles remission rates
Mirikizumab, the first therapeutic antibody tested for blocking interleukin-23 in ulcerative colitis has demonstrated strong efficacy in two Phase III trials.
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NICE recommends Rinvoq® for Crohn’s
AbbVie’s Rinvoq® will be the first JAK inhibitor available for treatment of Crohn’s in England and Wales, following NICE approval.
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Merck to develop mAb through $10.8b acquisition
Through a $10.8 billion acquisition, Merck has agreed to buy Prometheus Biosciences to advance development of a novel monoclonal antibody for immune conditions.
