Friday, August 01, 2008

Two fresh cases of brain infection linked to Biogen/Elan's Tysabri

Two fresh cases of brain infection linked to Biogen/Elan's Tysabri
Biogen Idec and Elan Corp have suffered a stock slide in after-hours trading after the firms revealed two new cases of progressive multifocal leukoencephalopathy, in MS patients being treated with Tysabri, the brain infection that led to the drug being withdrawn in 2005
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Two fresh cases of brain infection linked to Biogen/Elan's Tysabri

01 August 2008

Biogen Idec and Elan Corp have suffered a stock slide in after-hours trading after the firms revealed two new cases of progressive multifocal leukoencephalopathy, in multiple sclerosis patients being treated with Tysabri, the brain infection that led to the drug being withdrawn in 2005.
In a filing to the US Securities and Exchange Commission, the two companies said they had notified the relevant regulatory agencies of two confirmed cases of PML in MS patients treated with Tysabri (natalizumab). The first case involves a treatment-naive patient who had been taking the drug as monotherapy for around 17 months, but “remains clinically stable and ambulatory at home”.

The second case involves a patient, who is currently hospitalised, who was taking Tysabri as monotherapy for 14 months but has a history of prior disease-modifying therapies including azathioprine and beta-interferons. These are the first cases to be recorded since the reintroduction of natalizumab in the USA and approval in Europe two years ago. Biogen and Elan had voluntarily withdrawn the drug a year earlier after three patients developed PML.

Since re-introduction, Tysabri has boomed and earlier this month the two companies noted that some 31,800 patients were being treated with the drug, which had second-quarter sales of $200 million. It has also recently been approved in the USA as a treatment for Crohn's disease.
Given the increase in patients on Tysabri, fresh cases of PML come as no surprise and the fact that the plight of the two patients, who are both in the European Union, has been identified so quickly is proof that Biogen and Elan’s stringent monitoring programme for the therapy is working. Nevertheless, as Morgan Stanley analyst Steven Harr has pointed out in a research note, doctors may be less keen to start patients on Tysabri as they are reminded of the long-term potential safety issues.

This is the second blow in as many days for Elan’s stock which lost one-third of its value on Wednesday over mixed data from a Phase II trial of the experimental Alzheimer's drug bapineuzumab which is being developing with Wyeth. The Irish firm and Biogen will host a conference call to discuss the cases at 1:30 this afternoon, UK time.

By Kevin Grogan

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Daily Living with MS

The image “http://www.msanswers.ca/App_Themes/AskTheExpert_English/Images/question_buttonEN.gif” cannot be displayed, because it contains errors.

Dr. Short

Medical Chair Neurorehabilitation Program QEII Health Sciences Centre
View BIO

Q :
Is it possible for optic neuritis to cause a severe sensitivity to sunlight? I have a client who is experiencing this very symptom. As soon as she gets out in the sun, she feels like going to sleep almost immediately. Sunglasses have helped, but not entirely. She has seen an optometrist who has suggested it could be a residual effect of the optic neuritis which she has had under control for the last year.

A :
Optic Neuritis can be associated with pain but this usually occurs with eye movement. Having said this although less common light sensitivity could be associated with residual nerve damage from optic neuritis. If the optic neuritis was previously controlled (no symptoms) then it would be important to have this new symptom checked out by your MS neurologist to make sure that there is not new inflammation in the eye causing the new problem.
8/1/2008 6:16:59 AM
More answers from Dr. Christine Short
More answers in the category: Daily Living with MS

http://www.msanswers.ca/QuestionView.aspx?L=2&QID=2032




Nerves of sponge?

The unassuming cells of a sea sponge may hold a clue to the origin of the nervous system

By Megan Scudellari

Nerves of sponge?

Nerves of sponge?

Posted by Megan Scudellari

[Entry posted at 31st July 2008 05:00 PM GMT]

The unassuming cells of a sea sponge may hold a clue to the origin of the nervous system, according to a paper published next Tuesday, August 5th, in Current Biology. The detection of proneural pathways in the ancient organism suggests that genes for neurogenesis evolved earlier than previously believed.

Researchers have widely believed that nerve cells evolved after the divergence of sponges, which lack organs and nervous systems, from the rest of the animal kingdom (bilaterians). But Bernard Degnan of the University of Queensland in Australia and colleagues detected the expression of two key components of neuronal differentiation in bilaterians, Notch-Delta signaling and basis helix loop helix (bHLH) genes, in the surface cells of the sea sponge Amphimedon queenslandica.

"Notch signaling is the most important pathway in neurogenesis," said Hugo Bellen, a neuroscientist at Baylor College of Medicine, who was not involved in the study. "It's surprising that it [developed] so early in evolution."

The team scanned the genome of Amphimedon, the first sponge to have its full genome sequenced, for gene homologs to bHLH and Notch signaling pathway genes. After identifying them in the genome, the team carried out in situ hybridizations to prove that the genes are expressed in the outer layer of cells of a late Amphimedon embryo.

Then in a functional study, the scientists injected Xenopus and Drosophila embryos with transcribed mRNAs from one of the Amphimedon homologs, AmqbHLH1. Neurogenin is the most important gene for neuron differentiation in Xenopus, a vertebrate, while Drosophila relies primarily on another proneural gene, atonal.

Although each species has both genes, swapping the primary gene expressed, neurogenin for atonal and vice versa, results in minimal neuron growth.

However, expression of AmqbHLH1 induced proneural activity in both species, mimicking the proneural gene of choice: neurogenin in Xenopus and atonal in Drosophila.

It is "compelling evidence of the deep conservation of this system," wrote Degnan in an Email, indicating that the proneural pathways existed at the dawn of the Metazoa, some 50 million years earlier than previously thought.

Degnan describes the globular cells as a layer of sensory cells "akin to a disconnected nerve net." But Bellen said he hesitates to refer to them as sensory cells, as their function was not determined in the paper. "It'd be nice to know exactly what these cells do."
Degnan and his team are currently working to determine if the cells have sensory function, and their data suggest the cells are involved in sensing the environment, Degnan noted.



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Stem cell strength in numbers

Posted by Andrea Gawrylewski

[Entry posted at 30th July 2008 08:46 PM GMT]
Embryonic stem cells are a tricky business, as evidenced by Advanced Cell Technology's recently announced financial woes. The technology is too nascent for guaranteed returns, but potential payoffs could be huge. Increasingly, biotechs are looking to navigate the uncertain funding waters by forging partnerships with pharmaceutical companies.
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"The more serious problem is going to lie in long term funding," Elizabeth Donley, CEO of Stemina Biomarker Discovery, a privately owned embryonic stem cell biotech in Wisconsin, told The Scientist.
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Such partnerships may help tide companies over during a time when venture funding is tight. "Anything which is early stage in the biotech industry is having a tough time raising money," Alan Lewis, CEO of Novocell, a biotech in California developing human embryonic stem cell technology, told The Scientist. "Investors by and large are looking for quicker exits, supporting companies which are later stage, clinical stage."

While Novocell has benefited from state funding thanks to California's proposition 71, they're getting creative for the long term. 'In the last four to five months we've been talking to big pharma and that has been quite a positive experience. We've discovered that a number of companies are willing to consider embryonic stem cell research, especially for their drug discovery programs." Also, Lewis added, a number of the pharma companies he's talked with are setting up their own regenerative medicine divisions. "Investors love it when big pharmas are stepping up, then the exit looks different; someone else is paying for research and there is the potential for mergers and acquisitions."

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Comment | Forward

The Maryland state insurance commissioner's office has ruled that the $18 million payout promised to a departing health plan CEO should be cut in half, ruling that the severance deal was inappropriate. Health plan CareFirst BlueCross BlueShield, which has 3 million members in the metro D.C. area, is headquartered in Owings Mills, Md.

Under the ruling, former CEO William Jews will still get $9 million, including $2.2 million he's already been paid. Jews, who was CareFirst's CEO from 1993 to 2006, was forced out of the company. The severance deal was part of the terms of his departure. In his statement regarding the severance cut, Insurance Commissioner Ralph Tyler criticized Jews' performance, which seems to have figured in the state's decision. "The company, under Mr. Jews' leadership, strayed significantly from its nonprofit mission," Tyler said.

CareFirst, which tried to convert to for-profit status in 2002, has come under withering criticism for amassing large surpluses. It's also gone head to head with the D.C. government over the extent--or lack thereof--of its charitable activities.
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Two fresh cases of brain infection linked to Biogen/Elan's Tysabri
Biogen Idec and Elan Corp have suffered a stock slide in after-hours trading after the firms revealed two new cases of progressive multifocal leukoencephalopathy, in MS patients being treated with Tysabri, the brain infection that led to the drug being withdrawn in 2005
arrowread more



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