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Research and Markets: Global Multiple Sclerosis Drug Pipeline Capsule – 2012

Posted: September 15, 2012 at 10:11 pm

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/k4b4f3/global_multiple_sc) has announced the addition of the "Global Multiple Sclerosis Drug Pipeline Capsule - 2012" report to their offering.

This report is an outline of all the key research and development (R&D) activities of the global Multiple Sclerosis drug market. It covers information on key pipeline molecules in various stages of R&D including all the phases of clinical trials, preclinical research, and drug discovery. The report is up-to-date with full coverage of the licensing activities and partnerships.

This report helps executives to keep a track of their competitors and understand their pipeline molecules. The information presented in this report can be used for identifying the partners, prioritizing, evaluating opportunities, developing business development strategies, and executing in-licensing and out-licensing deals.

The report provides information on pipeline molecules by company and mechanism of action across the different stages of R&D. It includes registered / preregistered stage, phase 3 clinical trial, phase 2 clinical trial, phase 1 clinical trial, preclinical research, and drug discovery. It also provides information on pipeline molecules developed in leading geographies including the U.S., Canada, France, Germany, U.K., Italy, and Spain by various stages of R&D. Licensing activities and partnerships in the Multiple Sclerosis drug market is thoroughly covered by company and licensee with the deal summary.

Key Features of the Report:

- Multiple Sclerosis: Overview

- Multiple Sclerosis Drug Pipeline Overview

- Multiple Sclerosis Phase 3 Clinical Trial Drug Pipeline Insights

- Multiple Sclerosis Phase 2 Clinical Trial Drug Pipeline Insights

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Research and Markets: Global Multiple Sclerosis Drug Pipeline Capsule - 2012

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FDA Approves New Multiple Sclerosis Drug Aubagio

Posted: September 15, 2012 at 10:11 pm

By Matt McMillen WebMD Health News

Reviewed by Laura J. Martin, MD

Sept. 13, 2012 -- The FDA has approved Aubagio (teriflunomide), a new drug for the treatment of multiple sclerosis (MS). The once-a-day tablet will be prescribed to adults with relapsing forms of the chronic, incurable disease.

In a two-year study, the Aubagio reduced yearly relapses by nearly a third compared to placebo. It also slowed the progression of the disease.

"We are greatly encouraged to see a new oral therapeutic option become available to people living with MS," said Timothy Coetzee, PhD, chief research officer at the National MS Society, in a news release issued by the drug's developer, Genzyme.

MS is the most common disabling neurological disease among young adults, according to the National Institute of Neurological Disorders and Stroke. About 400,000 people in the U.S. have MS. As many as two-thirds of them are women. The disease is usually diagnosed between the ages of 20 and 50.

MS often gradually worsens over time. It causes fatigue, pain, vision and muscle problems, and other difficulties.

Aubagio does not come without risks. The drug's label will include a boxed warning that alerts to the risk of potentially fatal liver problems. The label advises that patients' liver function should be tested before starting Aubagio and while on the drug.

The box warning also mentions the risk of birth defects. Women should not be pregnant when they start the drug and must use birth control while taking it.

Other possible side effects include diarrhea, abnormal liver tests, nausea, and hair loss.

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FDA Approves New Multiple Sclerosis Drug Aubagio

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Aubagio (teriflunomide) Approved For Multiple Sclerosis Treatment, FDA

Posted: September 15, 2012 at 10:11 pm

Editor's Choice Main Category: Multiple Sclerosis Also Included In: Regulatory Affairs / Drug Approvals Article Date: 15 Sep 2012 - 0:00 PDT

Current ratings for: Aubagio (teriflunomide) Approved For Multiple Sclerosis Treatment, FDA

1.5 (2 votes)

According to experts, the Multiple Sclerosis prescribing market is worth $12 billion annually. If Aubagio becomes popular, it has the potential to become a major earner for its makers, Sanofi-Aventis. However, it is entering a highly-competitive market with very effective existing medications. Novartis' Gilenya and Tysabri from Elan Corp are said to be more effective than teriflunomide.

Director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said:

Multiple sclerosis is a long-term autoimmune, inflammatory disease of the central nervous system. Communication between the brain and other parts of the body are disrupted. Multiple Sclerosis is one of the most common causes of neurological disability in young adults. Twice as many females live with MS than males.

People with MS have episodes of relapses (worsening function), followed by remissions (recovery). Eventually, remission periods may be incomplete as the disease progresses. Aubagio has been approved for the initial phases of the disease.

According to clinical trial results, the following side effects among people taking Aubagio were reported: hair loss, nausea, abnormal liver test results, and diarrhea.

Aubagio contains a Boxed Warning explaining to doctors and their patients that there is a risk of liver problems, which may sometimes be fatal, as well as birth defects. Doctors should carry out blood tests beforehand to make sure liver function is normal. During treatment with Aubagio, liver functions tests should be performed periodically.

The Boxed Warning also alerts prescribers and their patients about some animal studies which linked the drug with a higher risk of fetal harm. That is why Aubagio is labeled as a Pregnancy Category X drug, meaning that female patients of childbearing age should have negative pregnancy test results (and use effective birth control therapy) before being considered for Aubagio treatment.

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Aubagio (teriflunomide) Approved For Multiple Sclerosis Treatment, FDA

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Gingko biloba does not improve cognition in multiple sclerosis patients, study finds

Posted: September 15, 2012 at 10:11 pm

ScienceDaily (Sep. 13, 2012) Many people with multiple sclerosis for years have taken the natural supplement Gingko biloba, believing it helps them with cognitive problems associated with the disease.

But the science now says otherwise. A new study published in the journal Neurology says Gingko biloba does not improve cognitive performance in people with multiple sclerosis. The research was published in the Sept. 5, 2012, issue of Neurology, the medical journal of the American Academy of Neurology. The current study was a more extensive look at the question after a smaller 2005 pilot study suggested there might have been some cognitive benefits in MS patients using the supplement. That study found that Gingko seemed to improve attention in MS patients with cognitive impairment.

But the larger follow-up study, conducted with patients at the Portland and Seattle Veterans Affairs medical centers, found no cognitive benefits to using Gingko.

"It's important for scientists to continue to analyze what might help people with cognitive issues relating to their MS," said Jesus Lovera, M.D., the study's lead author, a former fellow at the Portland VA Medical Center and former instructor in Oregon Health & Science University's Department of Neurology, where he did much of the work on the study. Lovera is now with the Department of Neurology at the Louisiana State University Health Sciences Center.

"We wanted to follow up on the earlier findings that suggested there may be some benefit. But we believe this larger study settles the question: Gingko simply doesn't improve cognitive performance with MS patients," said Lovera.

About one-half of people with MS will develop cognitive problems, and those cognitive problems can be debilitating in some people, said Dennis Bourdette, M.D., a co-author of the study, co-director of the VA MS Center of Excellence-West at the Portland VA Medical Center and chairman of the OHSU Department of Neurology. The most common problems relate to memory, attention and concentration, and information processing.

There is no known treatment that can improve cognition with MS patients -- which is partly why MS patients and researchers had hoped that Gingko biloba could help.

Lovera was also the lead author in the 2005 study, conducted at OHSU. That study included 39 participants who were given Gingko biloba or a placebo. The new study included 120 participants given Gingko or a placebo.

The study was supported by a grant from the U.S. Department of Veterans Affairs Rehabilitation Research and Development Service.

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Gingko biloba does not improve cognition in multiple sclerosis patients, study finds

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Dementia-Hearing Loss Link Prompts BHI to Urge Hearing Checks Among Baby Boomers, Gen Xers in Recognition of World …

Posted: September 15, 2012 at 10:11 pm

WASHINGTON, Sept. 11, 2012 /PRNewswire/ -- As evidence increases showing that there may be a connection between hearing loss and dementia, the Better Hearing Institute (BHI) is urging hearing checks among Baby Boomers and Gen Xers. Because most hearing loss can be managed with hearing aids, BHI also is encouraging those with hearing loss to be fitted with hearing aids when appropriate. BHI's outreach efforts come in recognition of World Alzheimer's DaySeptember 21.

To make it easier for anyone to determine if they need a comprehensive hearing test by a hearing healthcare professional, BHI is offering a free, quick, and confidential online hearing check atwww.hearingcheck.org.

Several studies have looked at the relationship between hearing loss and cognitive function. One such study,conducted by researchers at Johns Hopkins and the National Institute on Aging, and published in theArchives of Neurology, found that seniors with hearing loss are significantly more likely to develop dementia over time than those who retain their hearing. The study also found that the more hearing loss they had, the higher their likelihood of developing dementia.

According to the Johns Hopkins press release on the study, the reason for the link between the two conditions is unknown, but the investigators suggest that a common pathology may underlie both or that the strain of decoding sounds over the years may overwhelm the brains of people with hearing loss, leaving them more vulnerable to dementia. They also speculate that hearing loss could lead to dementia by making individuals more socially isolated, a known risk factor for dementia and other cognitive disorders.

According to BHI, these research findings should prompt people to take hearing loss seriously. BHI encourages Boomers and Gen Xers especially to get their hearing tested by a hearing healthcare professional who can provide a thorough examination and, if needed, fit them for hearing aids.

In an effort to improve the quality of life for people with Alzheimer's disease, BHI advocates that hearing checks, hearing healthcare, and hearing aids when appropriate, be included in their regimen of care. According to the Institute, unaddressed hearing loss can present an added, unnecessary strain on individuals with Alzheimer's disease, and also on caregivers who suffer from hearing loss themselves. BHI also advocates that hearing checks and hearing healthcare be part of the diagnostic process.

Studies show that although a significantly higher percentage of people with Alzheimer's disease may have hearing loss, they're also much less likely to receive attention for their hearing needs than their normally aging peers.

Research also shows that the use of hearing aids among Alzheimer's patients with hearing loss, in combination with appropriate aural rehabilitation in a multidisciplinary setting, can help alleviate the symptoms of depression, passivity, negativism, disorientation, anxiety, social isolation, feelings of helplessness, loss of independence and general cognitive decline.

Because healthy hearing helps people remain socially and cognitively engaged, BHI urges all Baby Boomers, Gen Xers, and others to make hearing checks a regular part of their preventive healthcare.

About Alzheimer's Disease

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Dementia-Hearing Loss Link Prompts BHI to Urge Hearing Checks Among Baby Boomers, Gen Xers in Recognition of World ...

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Dementia patient’s family: “We needed justice”

Posted: September 15, 2012 at 10:11 pm

COLLIER COUNTY, FL -

A veteran dementia patient was found lying in the woods, nearly dead. Five years later, his family says they finally have justice.

"We needed justice for my grandfather and people needed to be held accountable for their actions," said Dederick's granddaughter Lauren Carey, who searched tirelessly for five days to find her missing grandfather.

Then 88-year-old Loren Dederick, who passed away last year, went missing in 2007 after a medical transport mix-up.

A jury found TLC Non-Emergency Medical Transport at fault ordered the company to pay Dederick's family $700,000 for his injuries and mental anguish.

"He laid there for five days with no food or water and no way out," said Dederick's. "He was dirty, ant bites all over, dehydrated and just really scared."

"He was getting close to the time where he probably couldn't sustain himself any longer," said Dederick's daughter Donna Ward.

The World War II veteran was taken to NCH North Naples hospital for chest pain on September 21, 2007.

When he was released, NCH accidentally gave a TLC transport driver Dederick's old address, the HarborChase assisted-living facility on Airport-Pulling Road in Naples.

The driver, 44-year-old Dimas Herrera, took Dederick to that wrong address. According to testimony, nurses at the assisted-living center told Herrera that Dederick didn't live there.

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