'Diagnose and adios'*

Biogen Idec Lobbying Efforts

I pay about $1,800 a month for Avonex. Here's one way Biogen spent $1.2 million, paying lobbying firms.

Pharmaceuticals spent $226,999,560 on lobbying last year.

All I can say is F*CK Them!

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Tags: healthcare

Second death may doom multiple sclerosis drug

Cambridge life-sciences company Biogen Idec Inc. last night was plunged deeper into crisis by news that yet another patient taking its troubled Tysabri drug had died of the rare condition PML.     

That's the third patient discovered to have developed PML, a neurological disorder, while taking Tysabri and the second to die from the disease. ``This is a worst-case scenario,'' Sanford C. Bernstein analyst Geoffrey Porges said last night. ``There is now a 1-in-10 chance that this drug ever comes back.''

More here.

 

Biogen Idec Turns to Expert for Tysabri Help

To get answers about why two patients taking its new multiple sclerosis drug Tysabri apparently came down with a rare, often deadly brain disease, Biogen Idec Inc. of Cambridge is turning to Dr. Igor J. Koralnik, a 42-year-old neurologist at Beth Israel Deaconess Medical Center who may know more about the disease than anyone else.

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Biogen, Elan Voluntarily Withdraw MS Drug

More info here.

Biogen, Elan Suspend Tysabri After Death

Biogen Idec and Elan Corporation Plc on Monday suspended sales of their much-heralded new multiple sclerosis drug Tysabri after a patient died from a rare but frequently fatal central nervous system disease.

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Biogen Idec Retools After FDA Clears Drug but Not Its Moniker

It seemed as if the Food and Drug Administration liked everything about Biogen Idec's new drug for multiple sclerosis.

Early this year, the FDA encouraged Biogen Idec and its partner, Elan Pharmaceuticals, to submit an application for approval a year ahead of schedule. The companies sought clearance based on one year of data from a pair of pivotal clinical trials, instead of two years, as originally planned. The agency said it would give the experimental drug priority review, cutting four months off the wait for an answer.

The agency's Nov. 23 ruling gave the companies the go-ahead to sell the drug as a stand-alone therapy or in combination with Avonex, Biogen Idec's big-selling MS drug.

Wall Street analysts called the dual approval a home run.

But there was one thing the regulators didn't like about the new drug: the name.

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Five big medical, health-care advances for 2004

Promising new drug to treat multiple sclerosis

Multiple sclerosis is an autoimmune disease that typically hits people around age 30, setting them up for periodic symptoms resulting from brain and spinal inflammation, said Dr. Richard Rudick, director of the Cleveland Clinic's Mellen Center for Multiple Sclerosis Treatment and Research.

M.S. eventually disables people, robbing them of their vision and the ability to walk and function, he said.

"The key to treating M.S. is to have an effective mechanism to block brain inflammation and using that in the early stage of the disease before developing brain injury and neurological disability," Rudick said.

For the past 10 years, patients typically have been treated with copaxone or interferon, which can cause flu-like symptoms as a side effect. But last month, the FDA approved Tysabri, a biological product known as a monoclonal antibody made by Biogen Idec (BIIB) and Elan (ELN), and that seems to offer patients more benefits, Rudick said.

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Irish drugmaker Elan narrows quarter loss

Irish pharmaceutical company Elan Corp.'s first-quarter loss narrowed amid reduced operating expenses.

The company also said it is on track to seek approval for its highly anticipated multiple sclerosis drug, Antegren....

Elan is developing Antegren with Biogen Idec Inc., of Cambridge, Mass. In February, the two companies said they planned to file for approval of Antegren a year ahead of schedule. Biogen Idec already sells the MS drug Avonex.

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Biogen Idec, Elan to submit MS drug for European approval

Biogen Idec and Elan Corp. plc said Tuesday that they plan to submit their multiple sclerosis drug Antegren for approval in Europe.

The filing will be made to the European Agency for the Evaluation of Medicinal Products in the summer of 2004.

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Biogen Idec and Elan to Seek Earlier MS Drug Approval

Biogen Idec Inc. and Elan Corp. said they will apply for U.S. approval of their experimental Antegren multiple sclerosis drug by July, speeding potential clearance of the product by as much as year. Shares of both companies soared.

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Elan Says Antegren Trial for Crohn's Successful

Irish pharmaceutical firm Elan Corp Plc raised market hopes for its much-vaunted experimental drug Antegren on Thursday after it announced successful results from a key clinical trial on Crohn's disease.

Data from Phase III studies of Antegren's effect on MS are expected by late 2004 or early 2005.

More here.