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2008-01-15 08:59:38

The Food and Drug Administration (FDA) announced Monday it had approved Tysabri, a drug used to treat multiple sclerosis, for use in patients with moderate to severe Crohn's disease.However, the approval comes with a warning that the drug has the risk of causing a rare but serious brain infection.  Crohn's disease is a painful, serious, inflammatory bowel disease that afflicts over half a million people in the United States.   There is no known cure, and the disease typically...

2007-02-19 12:00:11

By Diedtra Henderson, The Boston Globe Feb. 19--WASHINGTON -- For patients suffering from a severe form of Crohn's disease, a remedy already on the shelf to treat other maladies and a brand-new drug could offer new hope. Within days, Illinois-based Abbott Laboratories expects to win federal approval to sell its drug, Humira, currently used to treat rheumatoid arthritis, psoriatic arthritis, and a disease that causes arthritis of the spine, to combat the intestinal disorder. The...

2006-06-05 16:35:00

By Susan Heavey WASHINGTON (Reuters) - U.S. health officials cleared the way on Monday for multiple sclerosis drug Tysabri to return to the market with restrictions, following its withdrawal last year when it was linked to a rare but potentially fatal brain disease. Three patients taking the drug, made by Biogen Idec Inc. and distributed by Elan Corp., had developed progressive multifocal leukoencephalopathy (PML). Two of them died. Food and Drug Administration officials, who faced calls from...

2006-06-05 13:03:11

WASHINGTON (Reuters) - Biogen Idec Inc. and Elan Corp. won permission on Monday to resume sales of their multiple sclerosis drug Tysabri, which was withdrawn last year after it was linked to a rare but potentially fatal brain disease, U.S. regulators said. The U.S. Food and Drug Administration said Tysabri must be sold under a restricted distribution plan to minimize chances of harm. Tysabri should be used as a stand-alone treatment and not with other drugs that suppress the immune...

2006-04-07 03:51:55

By Michael Smith DUBLIN (Reuters) - Elan Corp. Plc said on Friday the latest trials of its multiple sclerosis drug Tysabri showed significant positive results in patients, sending its shares higher. "The Tysabri study data show not only significant reductions in relapses and disability, but also suggest improved quality of life. This is very encouraging," the company said in a statement. Elan and drugmaker Biogen Idec faced a fresh delay in getting Tysabri back to the market last...

2006-04-07 01:44:27

DUBLIN (Reuters) - Elan Corporation Plc said on Friday the latest trials of its multiple sclerosis drug Tysabri on sufferers showed significant positive effects on their quality of life. "The Tysabri study data show not only significant reductions in relapses and disability, but also suggest improved quality of life. This is very encouraging," the company said in a statement. Elan and drugmaker Biogen Idec faced a fresh delay in getting Tysabri back to the market last month after...

2006-03-29 20:41:12

CHICAGO (Reuters) - Biogen Idec and Elan Corp said on Wednesday they have restarted a safety trial of its multiple sclerosis drug Tysabri, which the drugmakers recalled from the market after reports of rare brain infection were linked to the drug. A U.S. Food and Drug Administration panel earlier this month recommended the drug be returned to the market, with mandatory controls for risks and new cases of the fatal side effect, linked to two deaths. The companies expect an action by...

2006-03-24 17:12:52

WASHINGTON (Reuters) - A review of Biogen Idec and Elan's bid to return multiple sclerosis drug Tysabri to the market "continues to be a high priority," the Food and Drug Administration said on Friday. The FDA had delayed a decision for 90 days, the companies said on Wednesday. The agency said on Friday it had extended the review because Biogen submitted a new plan to manage serious side effects from the drug. "This application continues to be a high priority. The agency is working...

2006-03-08 15:07:29

By Lisa Richwine GAITHERSBURG, Maryland (Reuters) - A panel of independent experts on Wednesday unanimously urged the U.S. return of Biogen Idec's multiple sclerosis drug Tysabri, a medicine abruptly pulled from the market last year after it was linked to a life-threatening side effect. If the Food and Drug Administration followed the recommendation, it would signal a reversal of fortune for Biogen and partner Elan Corp. of Ireland, and a victory for MS patients who have pleaded for...

2006-03-08 13:36:22

By Lisa Richwine GAITHERSBURG, Maryland (Reuters) - Biogen Idec's multiple sclerosis drug Tysabri can return to the market as long as there are safeguards to closely monitor patients for a life-threatening side effect, a U.S. advisory panel unanimously said on Wednesday. Biogen and marketing partner Elan Corp. voluntarily suspended Tysabri sales in February 2005 after three patients developed a rare brain and spinal cord infection and two of them died. Members of the U.S. Food and...


Word of the Day
bibliopole
  • A bookseller; now, especially, a dealer in rare and curious books.
This word comes from a Greek phrase meaning 'book seller.'
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