Infliximab biosimilar Flixabi approved in the EU
31 May 2016 | By Victoria White, Digital Content Producer
The EC has granted marketing authorisation in the European Union (EU) for Flixabi, an infliximab biosimilar referencing Remicade...
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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.
31 May 2016 | By Victoria White, Digital Content Producer
The EC has granted marketing authorisation in the European Union (EU) for Flixabi, an infliximab biosimilar referencing Remicade...
25 May 2016 | By Victoria White, Digital Content Producer
Data shows that a greater proportion of adult patients with Crohn's disease receiving Stelara SC maintenance therapy were in clinical remission at one year...
6 April 2016 | By Victoria White, Digital Content Producer
With this approval, Celltrion's Inflectra becomes the first biosimilar monoclonal antibody (mAb) medication to receive approval in the US...
7 March 2016 | By Victoria White
BI 655066 is an anti-IL-23 monoclonal biologic antibody being evaluated in psoriasis, Crohn’s disease, psoriatic arthritis and asthma...
6 January 2016 | By Victoria White
Newly presented data from the largest real world study to date demonstrate effectiveness of biosimilar infliximab in patients with inflammatory bowel diseases who have been switched from reference infliximab...
17 December 2015 | By Victoria White
A clinical trial to test the effectiveness of a stem cell therapy among adults with difficult to treat Crohn's disease has found it is not significantly better than conventional treatment in producing sustained disease remission after one year...
3 December 2015 | By Victoria White
TxCell has agreed with Trizell to terminate the collaboration, option, development and license agreement concerning TxCell’s lead product Ovasave...
30 November 2015 | By Victoria White
Stelara (ustekinumab), approved for the treatment of plaque psoriasis and active psoriatic arthritis in many countries, is a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines...
28 October 2015 | By Victoria White
New clinical data indicate no differences in efficacy, adverse events and immunogenicity when patients with inflammatory bowel disease are switched to biosimilar infliximab Remsima from originator infliximab...
20 October 2015 | By Victoria White
New Phase 3 data show treatment with Janssen’s Stelara (ustekinumab) induced clinical response and clinical remission in patients with moderate to severe Crohn's disease who had previously failed conventional therapy.
26 August 2015 | By Victoria White
NICE has recommended Vedolizumab, the first gut-selective treatment for Crohn's Disease, for use on the NHS, recognising the innovation of the treatment...
10 July 2015 | By Victoria White
Vedolizumab, a drug to treat Crohn’s disease, has been recommended for routine NHS funding by the UK's National Institute for Health and Care Excellence...
19 May 2015 | By Victoria White
A post-hoc subgroup analysis of a Phase II trial of Celgene’s GED-0301 in patients with active Crohn's disease was presented at Digestive Disease Week...
15 April 2015 | By Victoria White
Soligenix and the FDA have reached an agreement on the design of a pivotal Phase 3 trial evaluating SGX203 in the treatment of paediatric Crohn’s disease...
24 March 2015 | By Victoria White
Janssen Health Policy Centre (Janssen Pharmaceutica NV) today unveiled the EU Disease Lens: a digital dashboard that brings insight into 15 major diseases...