Inflammatory Bowel Disease

Discussing the latest advances in Crohn’s disease and ulcerative colitis

Items Tagged ‘FDA’

February 10th, 2017

FDA Approves Biosimilar to Humira

By Kanaaz Pereira kanaazpe

The FDA recently approved a biosimilar (trade name, Amjevita) to Humira (adalimumab). A biosimilar is a biological product that is highly similar to the originator drug, and has no clinical differences in terms of safety and effectiveness. Dr. Edward Loftus , M.D., talks about the potential of this drug to offer patients with chronic inflammatory diseases such as Crohn’s and ulcerative colitis an […]

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Tags: Amjevita, biosimilar, Crohn's disease, Edward Loftus, FDA, Humira, IBD, ulcerative colitis


May 6th, 2016

FDA Approves of Biosimilar to Infliximab

By Kanaaz Pereira kanaazpe

The FDA recently approved of a biosimilar (CT-P13) to infliximab, which is used for treating IBD patients, as well as patients suffering from rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. The new drug would be the first biosimilar monoclonal antibody approved in the United States. Dr. Edward Loftus, M.D., explains how biosimilars work, and discusses […]

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Tags: biosimilar, CT-P13, Edward Loftus, FDA, IBD, infliximab, rheumatoid arthritis


April 8th, 2015

New Treatment for Ulcerative Colitis

By Margaret Shepard, Communications Specialist Margaret_Marie

Edward Loftus Jr., M. D., discusses the recent Food and Drug Administration approval of a new treatment for ulcerative colitis. Dr. Loftus explains the process Uceris, a budesonide foam, went through to receive FDA approval. The phase three trials found higher remission rates, improvement in disease activity, and rectal bleeding. The new drug will be […]

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Tags: Edward Loftus, FDA, ulcerative colitis


July 1st, 2014

FDA Approves Entyvio to Treat Ulcerative Colitis and Crohn’s Disease

By Margaret Shepard, Communications Specialist Margaret_Marie

Edward Loftus Jr, M. D., discusses the recent FDA approval of Entyvio to treat ulcerative colitis and Crohn’s disease.   Entyvio represents a relatively new class of medications for inflammatory bowel disease (IBD). It’s a biologic drug containing an antibody against the molecule alpha 4 beta 7. This is a targeted biologic for blood vessels […]

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Tags: Crohn's disease, Edward Loftus, Entyvio, FDA, ulcerative colitis


June 5th, 2014

Etrolizumab and IBD

By Margaret Shepard, Communications Specialist Margaret_Marie

Edward Loftus Jr., M. D., discusses a recently published article in The Lancet about the phase two trial of Etrolizumab, which is a drug for patients with moderate to severe ulcerative colitis.   The molecule of this drug is an antibody directed at a substance called beta seven integrin. Integrins are molecules that act with […]

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Tags: Edward Loftus, Etrolizumab, FDA, IBD, The Lancet, ulcerative colitis


February 11th, 2014

Vedolizumab Being Reviewed by the FDA

By Margaret Shepard, Communications Specialist Margaret_Marie

Ed Loftus, M.D., discusses recent developments on a drug, vedolizumab, that is currently being reviewed by the Food and Drug Administration for inflammatory bowel disease. Vedolizumab is thought to be more gut specific and potentially have fewer adverse side effects. http://www.youtube.com/watch?v=A2km-E53sLI In December, an advisory committee convened by the FDA met to review all the data […]

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Tags: Edward Loftus, FDA, Vedolizumab


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