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...The therapy in question is Tysabri, and for many MS patients it appears to halt progression of the degenerative neurological disorder. But a year ago... corporate partners Biogen and Elan "voluntarily" withdrew their drug because of FDA pressure and litigation fear after two patients developed a rare brain infection. That infection might have been linked to Tysabri, since the drug works by suppressing parts of the immune system. But these patients also had other immuno-suppressive therapies, and in any case the MS patients were almost all willing to run the risk.... But shortly before the deadline, the FDA announced it...

The Food and Drug Administration said yesterday that it would allow some patients in a clinical trial to resume treatment with Tysabri, a multiple sclerosis drug that was abruptly withdrawn from the market a year ago because of safety risks. The decision appears to strengthen the probability that Tysabri, developed by Biogen Idec and Elan, will be allowed to return to the market. The F.D.A. is scheduled to decide on that question by the end of March. "You can certainly deduce that we've concluded that there are at least some people for whom the risk is worth it," Dr. Robert...

Drug withdrawal a travesty for MS sufferersMichael Fumento (archive) April 28, 2005 | Print | SendThe yanking from the market of both Vioxx and Bextra, members of a new generation of pain relievers called COX-2 inhibitors, has critics ripping raw flesh off the Food and Drug Administration. Inevitably, both the agency and pharmaceutical companies are under intense pressure to over-scrutinize new drugs. But over-caution can also cause tremendous, as multiple sclerosis sufferers using a recently-pulled drug called Tysabri can attest.Tysabri belongs to an incredibly promising new class of biotech drugs called monoclonal antibodies. Monoclonals have repeatedly shown an ability to...

The makers of the multiple sclerosis drug Tysabri said yesterday that a second patient who used the drug had been confirmed to be suffering from a rare but deadly brain infection. The confirmed diagnosis is likely to somewhat diminish the chances that the drug will be able to return to the market. The makers of the drug, Biogen Idec and Elan, halted sales and clinical trials on Monday, saying that one patient in a clinical trial had died from the brain infection and a second patient from the same trial, who was still alive, was also suspected of having it....

By THE ASSOCIATED PRESS BOSTON (AP) -- The makers of Tysabri, a new drug used to treat multiple sclerosis, announced Monday they are voluntarily suspending sales of the drug after one patient died and another developed a serious disease of the central nervous system.Stocks of both Biogen Idec Inc. and Elan Corp. tumbled, while shares of ther makers of rival MS drugs rose.The biotechnology companies said in a news release that they have suspended supplying and marketing the drug Tysabri and advised doctors to suspend prescribing the medication. The companies also have stopped using the drug in clinical trials.The companies...

July 25, 2003, 9:50 a.m. Last Stop on the Oslo Road? Deciphering W.’s vision. By Barbara Lerner hy did he do it? Why did George W. Bush go to Aqaba and agree to do his best to implement the Four Powers roadmap? Why is he following through assiduously, hosting Abu Mazen Friday and Sharon again next week? The roadmap is this year's version of the Oslo plan to produce "peace in the Middle East" by creating a 23rd Arab state called Palestine. This idea has been the driving force, the unquestioned idee fixe of American policy in the region for...

JERUSALEM -- Life is brisk and life goes on, but life has changed here. The public places are sparsely populated. The usually bustling hotels are nearly empty. Jerusalem has seen 2,000 businesses go bankrupt in the past year as life has turned inward. Nights out have been replaced, said one friend, with "popcorn and a DVD." Jerusalem is particularly vulnerable to terrorism because here Jew and Arab live cheek by jowl and Israel refuses to erect yet more walls in this, its capital. The threat is not just suicide bombings. Random stabbings are frequent. And a stabbing betrays a deeper...