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Archive for the 'Crohn' Category

FDA Approval Of Cimzia(R) For Crohn’s Disease Represents Latest Milestone For Nektar’s PEGylation Technology Platform

The U.S. Food and Drug Administration (FDA) approved UCB’s Cimzia(R) (certolizumab pegol) for reducing the signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy. Cimzia(R) is the first and only PEGylated Fab’ fragment of a humanized anti-TNF-alpha antibody approved by the FDA.

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FDA Approves Cimzia To Treat Crohn’s Disease

A new drug has been approved to help sufferers of Crohn’s disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn’s disease who have not responded to conventional therapies. This product was approved with a Medication Guide.Crohn’s disease is a chronic, inflammatory bowel disease that affects more than 1 million men and women worldwide. It has no cure and its cause is unknown.

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Cimzia® Approved In United States For Crohn’s Disease

According to a press release from UCB on April 22, 2008, a newpegylatedanti-TNFα, will be made available in the United States under thename Cimzia® in the next few days. This will be a new,promising option for patients suffering from moderate to severe Crohn’sDisease. Crohn’sDisease (CD) is a gastrointestinal disorder which is indicated bychronicinflammation of the wall of the digestive tract, usually in the ileumor large intestines.

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For Crohn’s Patients, Omega-3 Fatty Acids Not Effective In Preventing Relapse

Administrationof omega-3 fatty acid supplements did not appear to improve the rate ofrelapse in patients with Crohn’s disease, according to a study releasedon April 9, 2008 in JAMA. Crohn’sDisease is a gastrointestinal disorder which is indicated bychronicinflammation of the wall of the digestive tract, usually in the ileumor large intestines.

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Large Multi Center Study Suggests New Genetic Markers For Crohn’s Disease

What is believed to be the largest study of its kind for the genetic roots of inflammatory bowel diseases has suggested new links to Crohn’s Disease as well as further evidence that some people of Jewish descent are more likely to develop it.

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CHMP Upholds Negative Opinion For The EU Application For Cimzia(R) In The Treatment Of Crohn’s Disease

UCB announced that the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) has rejected the appeal following CHMP refusal of the Marketing Authorization Application (MAA) for Cimzia® (certolizumab pegol) in the treatment of patients with Crohn’s disease, a chronic and debilitating inflammatory disease.

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Food For Life Baking Co., Inc. Recalls Spelt Bread , California - Product Contains Undeclared Wheat

Food For Life Baking Company of Corona, California is voluntarily recalling 2,241 cases of Spelt Bread (UPC# 07347200168) because they contain spelt grain which is known to be a hybrid of wheat. People who have allergies to wheat or those with Celiac Disease may run the risk of a serious or life threatening allergic reaction if they consume spelt products. The recalled products were sold nationwide through health food distributors and natural food retailers.

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CHMP Upholds Negative Opinion For The EU Application For Cimzia® In The Treatment Of Crohn’s Disease

UCB announced today that the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) has rejected the appeal following CHMP refusal of the Marketing Authorization Application (MAA) for Cimzia® (certolizumab pegol) in the treatment of patients with Crohn’s disease, a chronic and debilitating inflammatory disease.

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Early Data On Cimzia® Shows Promise In Crohn’s Patients Without Infliximab

Datafrom the WELCOME trial presented at the third congress of the EuropeanCrohn’s and Colitis Organisation (ECCO) show that, at the six weekmark, Cimzia® (certolizumab pegol) is effective in Crohn’s patientsshowing intolerance or no response to infliximab. Crohn’sDisease (CD) is a gastrointestinal disorder which is indicated bychronicinflammation of the wall of the digestive tract, usually in the ileumor large intestines.

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Hope For Crohn’s Patients With Fistulas Found In HUMIRA/Adalimumab

At the recent European Crohn’s and Colitis Organization (ECCO) annualmeeting in Lyon, France, Abbott Laboratories announced that HUMIRA(Adalimumab) is successful in the treatment of fistulas in susceptibleCrohn’s patients. Crohn’sDisease (CD) is a gastrointestinal disorder which is indicated bychronicinflammation of the wall of the digestive tract.

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