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Disclaimer: 'MS Views and News' DOES NOT endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.

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Friday, March 29, 2013

Recharge yourself—and spring forward!


With spring in the air, it's tempting to move full speed ahead. More daylight hours may mean more activities, plans and vacations. But before the calendar fills up, make sure you're recharged for the warmer months ahead.



How exactly do you recharge for spring? These simple things may help:
  • Get enough sleep. The right kind of sleep—in the right amount—is vital to all that you do. Find tips for getting a better night's sleep below.
  • Take a break. Taking a few minutes out of the daily routine—whether at work or at home—may help you feel refreshed and focused. Go for a short walk, or simply spend a few minutes relaxing with a book or TV show.
  • Take time for yourself. No matter how enjoyable, social obligations can be draining. Make sure you're taking some time to do what it is that you enjoy most.
Information provided by 

MS LifeLines® eNewsletter | MS LifeLines® - UNIQUELY [you]™
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Biogen prices new MS drug at discount to key competitors

DISCOUNTED????


WASHINGTON (Reuters) - Biogen Idec Inc said on Friday it will charge $54,900 a year for its multiple sclerosis drug, Tecfidera, which received U.S. approval on Wednesday.
The company has priced the drug at a discount to key competitors such as Novartis AG's MS pill Gilenya, which costs roughly $60,000 a year, in a bid to maximize its market share.
"We think this represents solid value to the MS community and demonstrates our commitment to patient access," said Kate Niazi-Sai, a Biogen spokeswoman.
The price is somewhat higher than the low $50,000-range expected by fund managers polled by Mark Schoenebaum, an analyst at ISI Group, but largely in line with analysts' expectations.
Tecfidera is a pill that is widely expected to become the leading oral treatment for MS, steadily taking market share from older, injectible treatments such as Teva Pharmaceutical Industries' Copaxone, which is currently the market leader.
Tecfidera is expected to generate sales of more than $3 billion, according to Thomson Reuters data.
(Reporting by Toni Clarke, editing by G Crosse)




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Thursday, March 28, 2013

NON-MS related --- TIRED of UNWANTED Solicitation calls or emails?


Visit this link - to learn how YOU MIGHT opt-out:
https://www.optoutprescreen.com/faq.htm#1_3
The above information pertains to the USA



This information provided for the many who just find all the solicitations a nuisance
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Now approved—a new pill for relapsing forms of multiple sclerosis (MS)

New and now FDA approved! Tecfidera TM (dimethyl fumarate), also known as BG-12.


Tecfidera was approved by the FDA for the treatment of people with relapsing forms of MS.



Taking Tecfidera

What you need to know before you start treatment.
Learn more here. »



Important Safety Information
Please see the full Prescribing Information and Patient Information for additional important safety information. This information is not intended to replace discussions with your doctor.

Learn More- Click here: http://www.tecfidera.com/ 


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Wednesday, March 27, 2013

Biogen's MS ORAL Drug Tecfidera (BG12) Wins FDA Nod


SILVER SPRING, Md. -- Dimethyl fumarate has won FDA approval to treat relapsing-remitting forms of multiple sclerosis and will be sold under the name Tecfidera, the agency said Wednesday.
Manufactured by Biogen Idec, the drug is also known as BG-12. It becomes the third oral disease-modifying medication available to treat MS. Others include fingolimod (Gilenya) and teriflunomide (Aubagio).
Dimethyl fumarate has a novel mechanism of action relative to existing MS drugs. It is believed to activate the nuclear factor-like 2 transcriptional pathway, thereby reducing oxidative stress that contributes strongly to demyelination.
The drug has also been used for many years in Europe and elsewhere to treat psoriasis, and has also been used as a fungicide and desiccant in furniture manufacture.
Two placebo-controlled phase III trials served as the basis for approval, the agency said. Called DEFINE and CONFIRM, they enrolled a total of some 2,700 patients. In addition to comparing the drug with placebo, CONFIRM included a third arm with open-label glatiramer acetate (Copaxone), a standard injectable MS drug.
Both trials demonstrated that dimethyl fumarate was superior to placebo in preventing relapses and delaying disability progression. It also appeared to be somewhat more effective than glatiramer acetate in CONFIRM.
The most common adverse effects were gastrointestinal complaints and flushing. The FDA also noted that the drug carries a risk of lymphocytopenia, although infections did not appear to be increased as a result in the phase III studies.
"No drug provides a cure for multiple sclerosis so it is important to have a variety of treatment options available for patients," said Russell Katz, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, in a statement announcing the approval.


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Novartis confirms growing Gilenya® clinical and real-world experience as number of patients treated increases to over 63,000


  • Growing global evidence base reinforces consistent and sustained efficacy of first once-daily oral multiple sclerosis treatment
  • Up to seven years of clinical trial experience (Phase II and III) and over two years of real-world use
  • Gilenya is the only approved MS treatment shown to consistently decrease brain volume loss across studies with a significant effect seen as early as six months
  • Low rate of brain volume loss with Gilenya sustained for up to four years in Phase III studies and for up to seven years in patients after completing a Phase II study
Basel, March 26, 2013 Latest global patient-use data show that Gilenya® (fingolimod) has been used to treat more than 63,000 patients in clinical trials and the post-marketing setting[1].
"As the first once-daily oral MS therapy, we are pleased Gilenya has played such an important role in addressing unmet medical need in the MS community in the two years following initial approvals," said David Epstein, Head of the Pharmaceuticals Division of Novartis Pharma AG. "Our growing experience reinforces Gilenya`s high efficacy and very good tolerability profile and Novartis remains committed to ensuring eligible patients have access to Gilenya."
Gilenya is the only approved treatment shown to consistently decrease brain volume loss[2],[3]. Brain volume loss is the best magnetic resonance imaging (MRI) correlate of long-term disability.  New data presented at the recent 65th Annual Meeting American Academy of Neurology (AAN), showed that Gilenya reduced the rate of brain volume loss by about one-third compared to interferon beta-1a IM or placebo in studies with over 3,600 patients with relapsing MS.[4] Patients from a Phase II study who remained on treatment for up to seven years experienced consistently low rates of brain volume loss[5].
Data has also shown significant efficacy with Gilenya in reducing relapses and slowing of six-month disability progression sustained at four years[6]. Nearly half of Gilenya patients were disease-free after one year of treatment[7],[8] and in the pivotal FREEDOMS study, eight out of ten patients on the approved dose remained on treatment at two years[2].
In clinical trials Gilenya exhibited a well-characterized safety profile and very good tolerability profile[2],[3].
Gilenya was approved based on the largest phase III clinical trial program in MS at the time of submission, which included a head-to-head study versus Avonex® (interferon beta-1a IM), a commonly prescribed treatment. Gilenya is now approved in 70 countries, and there is approximately 73,000 patient years of exposure[1].
Up to 2.5 million people worldwide are affected with MS[9], a neurodegenerative condition that often begins in early adulthood[10]. Around 70% of newly diagnosed patients with MS are in the prime of their lives - between 20 and 40 years of age - so most people are employed at the time of diagnosis. This can have a significant impact on careers, quality of life and families[11],[12].


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Major Advance in Understanding Risky but Effective Multiple Sclerosis Treatment

Mar. 26, 2013 — A new study by multiple sclerosis researchers at three  Canadian centres addresses why bone marrow transplantation (BMT) has positive results in patients with particularly aggressive forms of MS. The transplantation treatment, which is performed as part of a clinical trial and carries potentially serious risks, virtually stops all new relapsing activity as observed upon clinical examination and brain MRI scans. The study reveals how the immune system changes as a result of the transplantation. Specifically, a sub-set of T cells in the immune system known as Th17 cells, have a substantially diminished function following the treatment.


The finding to be published in the upcoming issue of Annals of Neurology and currently in the early online version, provides important insight into how and why BMT treatment works as well as how relapses may develop in MS.
"Our study examined why patients essentially stop having relapses and new brain lesions after the bone marrow transplant treatment, which involves ablative chemotherapy followed by stem cell transplantation using the patient's own cells," said Prof. Amit Bar-Or, the principle investigator of the study, who is a neurologist and MS researcher at The Montreal Neurological Institute and Hospital -The Neuro, McGill University, and Director of The Neuro's Experimental Therapeutics Program. "We discovered differences between the immune responses of these patients before and after treatment, which point to a particular type of immune response as the potential perpetrator of relapses in MS."

"Although the immune system that re-emerges in these patients from their stem cells is generally intact, we identified a selectively diminished capacity of their Th17 immune responses following therapy -- which could explain the lack of new MS disease activity. In untreated patients, these Th17 cells may be particularly important in breaching the blood-brain-barrier, which normally protects the central nervous system. This interaction of Th17 cells with the blood-brain barrier can facilitate subsequent invasion of other immune cells such as Th1 cells, which are thought to also contribute to brain cell injury.

Twenty-four patients participated in the overall clinical trial as part of the 'Canadian MS BMT' clinical trial, coordinated by Drs. Mark Freedman and Harry Atkins at the Ottawa General Hospital. The new discovery, made in a subset of patients participating in the clinical trial, was based on immunological studies carried out jointly in laboratories at The Neuro and the Université de Montréal. Results of this study not only show the clinical benefits of BMT treatment, but also open a unique window into the immunological mechanisms underlying relapses in MS. Th17 cells could be the immune cells associated with the initiation of new relapsing disease activity in this group of patients with aggressive MS. This finding deepens our understanding of MS and could guide the development of personalized medicine with a more favourable risk/benefit profile.

Among the patients treated in the Canadian MS BMT clinical trial, was Dr. Alexander Normandin, a family doctor, who was a third- year McGill medical student getting ready for his surgery exams when he first learned he had MS, "I was so engrossed in my studies that I didn't pay attention to the first sign but within a few days of waking up with a numb temple, my face felt frozen. I learned that I had a very aggressive form of MS and would probably be in a wheelchair within a year. It was a brutal blow. I became patient #19 -- of only 24 for this experimental treatment. My immune system was knocked out and then rebooted with my stem cells. Today, my MS has stabilized. I now have this disease under control and I take it one day at a time."

Both the clinical and biological studies were supported by the Research Foundation of the Multiple Sclerosis Society of Canada.


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Biogen Idec (BIIB) PLEGRIDY Met Primary Endpoint in Phase 3 ADVANCE

March 20, 2013

Biogen Idec, Inc. (Nasdaq: BIIB) announced the positive, full first-year results from its two-year pivotal Phase 3 ADVANCE study of PLEGRIDY (peginterferon beta-1a), the company’s investigational candidate for relapsing-remitting multiple sclerosis (RRMS) dosed once every two weeks or every four weeks. These data, presented today at the American Academy of Neurology’s 65th Annual Meeting, indicate that PLEGRIDY significantly reduced multiple sclerosis (MS) disease activity, including relapses, disability progression and brain lesions, compared to placebo at one year.

Study Results for Two-Week Dosing Arm at Year One:

Primary endpoint:

* PLEGRIDY met the primary endpoint of reducing annualized relapse rate (ARR) at one year by 36 percent compared to placebo (p=0.0007).

Secondary endpoints:

* PLEGRIDY reduced the proportion of patients who relapsed by 39 percent compared to placebo (p=0.0003).
* PLEGRIDY reduced the number of new or newly enlarging T2-hyperintense lesions on brain MRI scans by 67 percent compared to placebo (p<0.0001).
* PLEGRIDY also demonstrated significant positive effects on disability progression by reducing the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent compared to placebo (p=0.0383).

Additional results:

* PLEGRIDY significantly reduced the number of gadolinium-enhancing (Gd+) lesions by 86 percent compared to placebo (p<0.0001).
* The incidence of PLEGRIDY neutralizing antibodies was less than 1 percent.

PLEGRIDY dosed once every four weeks was also shown to be effective, and met the primary and secondary endpoints in the ADVANCE trial. PLEGRIDY dosed once every two weeks resulted in a numerically greater treatment effect across these relapse and MRI endpoints discussed above.

“In the first year of the ADVANCE trial, PLEGRIDY demonstrated strong efficacy. We saw a marked reduction in relapse rate and this was supported by MRI results. If approved, PLEGRIDY will make an important therapeutic option in the injectable treatment segment”, said Gilmore O’Neill, Vice President, Global Neurology Late Stage Clinical Development at Biogen Idec. “In addition to these encouraging therapeutic results, PLEGRIDY may reduce the treatment burden for patients by reducing the number of subcutaneous injections.”

PLEGRIDY showed favorable safety and tolerability profiles in ADVANCE. The overall incidence of serious adverse events (SAEs) and adverse events (AEs) was similar among the PLEGRIDY and placebo groups. The most common SAE was infections, which was balanced across all treatment groups (≤1 percent per group). The most commonly reported AEs with PLEGRIDY treatment were redness at the injection site and influenza-like illness.

PLEGRIDY is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body, enabling study of a less frequent dosing schedule. PLEGRIDY is a member of the interferon class of treatments and, if approved, would be a new addition to this class, which is often used as a first-line treatment for MS.

After completing two years in the ADVANCE study, patients have the option of enrolling in an open-label extension study called ATTAIN and will be followed for up to four years.

Source: Street Insider

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Monday, March 25, 2013

Decision Looms on New Multiple Sclerosis Drug

March 25, 2013

Will good news from Europe echo on this side of the Atlantic within the next few days? Biogen Idec (NASDAQ:BIIB  ) is certainly hoping so. The biotech's multiple sclerosis drug Tecfidera received a positive recommendation for market authorization approval from the European Union's Committee for Medicinal Products for Human Use, or CHMP, last Friday. Next up for Tecfidera is a decision by the U.S. Food and Drug Administration due this week. A final decision in Europe will come in the next two months.
Many in the MS community are anxiously awaiting availability of Tecfidera. What's behind the buzz -- and how likely is it that the MS drug will gain approval? 
Disrupting the market?While there is no cure, several treatments are currently available for slowing the progression of multiple sclerosis.  Beta interferon drugs help prevent damage to myelin, a sheath that shields nerve fibers. Leading beta interferon drugs are Biogen's Avonex, Betaseron fromBayer, and Rebif, which is co-marketed by EMD Serona and Pfizer (NYSE: PFE  ) . All three drugs are administered through injection. Common side effects include inflammation at the injection site and flu-like symptoms.
Teva Pharmaceuticals' (NYSE: TEVA  ) Copaxone also works by protecting myelin. Like the beta interferon drugs, Copaxone is taken via injection with one of the most common side effects relating to inflammation at the site of injection.  
Another treatment that has demonstrated success with slowing progression of MS is Tysabri. Biogen and Elan Pharmaceuticals (NYSE: ELN  ) co-market the drug for now, but the two companies recently announced a deal where Biogen would buy full rights for Tysabri for $3.25 billion. Similar to the other drugs already mentioned, Tysabri is administered through injection. It has some of the same kinds of side effects as the others, but also can increase the possibility of patients getting a rare brain infection that can lead to death or severe disability.
The inconvenience and possibility of reactions associated with these injections opened the door for commercial success of drugs that can be taken orally. Novartis' (NYSE: NVS  ) Gilenya was the first MS pill to gain FDA approval in 2010. Gilenya racked up 2012 sales of $1.2 billion. However, sales were dampened somewhat in early 2012 after the FDA and the European Medicines Agency announced investigations of several deaths related to heart problems in patients taking Gilenya.  
Last September, the FDA approved another oral treatment for MS -- Sanofi's Aubagio. Sanofi received good news from Europe at the same time as Biogen, getting a positive recommendation from CHMP for Aubagio last week.
However, many expect Tecfidera to become the biggest seller in the MS market with annual sales topping $3.25 billion within the next four years. With all of the treatments already available, why is there such eagerness for Biogen's new drug? Three reasons stand out.
First, like Gilenya and Aubagio, Tecfidera is a pill and therefore won't have the inconvenience and injection site reactions associated with most of the other available drugs. Second, the drug has demonstrated solid efficacy  -- reducing patients' annual relapse rate by nearly half. Third, Tecfidera's safety profile looks to be better than the others, with the most common side effects including flushing and gastrointestinal effects such as nausea and diarrhea. Biogen hopes that the drug's convenience, efficacy, and safety will score big with patients and prescribers.

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Sunday, March 24, 2013

Oral Laquinimod for Multiple Sclerosis Passes Phase 3 Extension




Teva Pharmaceutical and Active Biotech announced top-line results from an open-label extension of the Phase 3 ALLEGRO study, which assessed the progression of disability and safety of oral laquinimod in early vs. delayed-start relapsing remitting multiple sclerosis (RRMS) patients. Laquinimod is an oral, once-daily CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of MS.
The study compared the effectiveness of laquinimod in patients who received 36 months (early-start) vs. those who received 24 months of laquinimod treatment (delayed-start). Out of the 864 RRMS patients who participated in the original double-blind ALLEGRO trial, 97% enrolled in the open-label extension and 87% completed one year of the open-label phase.
During the entire duration of the study (double blind and open label phase), early start patients were less likely to experience disease progression than those with a delayed start of laquinimod (11.8% risk of confirmed disability progression vs. 16.7%, HR = 0.62, P< 0.0038).
For more information call (215) 591-3000 or visit www.tevapharm.com or www.activebiotech.com.

Article source: empr.com 
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Atrophy of the thalamus is an important predictor of clinically definite MS, study shows


Multiple Sclerosis research: the thalamus moves into the spotlight

Image of a composite of the thalamus of healthy controls  and MS patients.
This 3D view shows a composite of the thalamus of healthy controls (outlined in red) and MS patients (magenta). The whole thalamus is generally smaller in MS due to atrophy, and is also shifted (as seen in blue) slightly beyond the position of the normal thalamus due to atrophy of other parts of the brain.



BUFFALO, N.Y. – A growing body of research by multiple sclerosis (MS) investigators at the University at Buffalo and international partners is providing powerful new evidence that the brain’s gray matter reflects important changes in the disease that could allow clinicians to diagnose earlier and to better monitor and predict how the disease will progress.
Over the past three years, the UB researchers and their partners around the world, supported by an active fellowship program at UB’s Buffalo Neuroimaging Analysis Center (BNAC), have published journal papers and given presentations demonstrating that the thalamus region, in particular, is key to a host of issues involving MS.
“The thalamus is providing us with a new window on MS,” says Robert Zivadinov, MD, PhD, UB professor of neurology, BNAC director and leader of the research team. “In our recent studies, we have used large datasets to investigate the evolution of atrophy of the thalamus and its association with clinical impairment in MS, starting with the earliest stages of the disease. The location of the thalamus in the brain, its unique function and its vulnerability to changes wrought by the disease make the thalamus a critical barometer of the damage that MS causes to the brain.”
Zivadinov and UB professor of neurology Ralph Benedict discuss the new research in a video at (http://youtu.be/QhsaHeBjZrA).


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When Life Gets in the Way - a patient's story


When Life Gets in the Way
By Cherie C. Binns RN BS MSCN

I have not written much here in the past few months because life has gotten in the way of some of the creativity that has led to this series of articles.  By saying that, I am also saying that Multiple Sclerosis (MS) has been behaving for some time now freeing me to live life more on my terms and with a broader spectrum than in previous months and years.

If you have been following my writings posted on www.msviewsandnews.org under the “Ask the MS Nurse” link, you know that 2008 was a year that saw me in what looked to be more than a year long slide into progression of disability.   This, it turned out, was a result of a Urinary Tract Infection (UTI) that was not responding to traditional treatment.   Why?   Well…it was discovered that my DMT (Disease Modifying Therapy) was doing such a good job of modifying my immune system so that I  could survive an MS relapse, that I did not have the antibodies to fight a real infection elsewhere in my body.

Once the Immunologist had determined this to be the cause of my not being able to fight a simple infection, I was taken off my DMT and placed on a daily dose of IVIg (an intravenous infusion of antibodies from multiple blood donors) for a week.   That enabled me to fight the infection and a week later, for the first time in 16 months; I had a clean urine culture.  Back on my DMT, I developed another UTI within two weeks so had to come off my traditional therapy and look for another alternative to get and keep me well.



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Researchers identify a promising target for multiple sclerosis treatments


Public release date: 19-Mar-2013
A team of basic and clinical scientists led by the University of Montreal Hospital* Research Centre's (CRCHUM) Dr. Nathalie Arbour has opened the door to significantly improved treatments for the symptoms of Multiple Sclerosis (MS). In a study selected as among the top 10% most interesting articles published in the Journal of Immunology, the team identifies the elevated presence in MS patients of a type of white blood cell (CD4 T cell) that expresses NKG2C, a highly-toxic molecule harmful to brain tissues.

In close collaboration with clinicians at the University of Montreal Hospital and the Montreal Neurological Institute, McGill University, Dr. Arbour's team studied tissues from healthy subjects and MS patients. This approach enabled the team to uncover a novel mechanism by which CD4 T cells expressing NKG2C can directly target brain cells having a specific corresponding ligand found only in MS patients. "These results are very encouraging," says Arbour, "since they provide us with a much more refined picture of how the brain cells of MS patients are targeted by the immune system and provide us with a clearer understanding of how to go about blocking their action."

There is no known cure for this auto-immune disease of the central nervous system. While there are a number of approved MS therapies targeting molecules expressed by immune cells, they are sometimes too broad in their application. They can suppress the efficiency of the immune system but also open the way for serious infections in some MS patients such as progressive multifocal leukoencephalopathy, a serious viral disease that can cause death in people with severe immune deficiency, such as MS patients on immunosuppressive medication.

"Our research has made an important step in getting around this problem. Because NKG2C is specifically expressed by a subset of CD4 T cells only found in MS patients, targeting this receptor would not affect large populations of immune cells, but only those which produce the symptoms characteristic of this debilitating disease," explains Arbour.

For patients this discovery could translate into improved treatments aimed at decreasing the progression of the disease and its symptoms, without the risk of potentially lethal infections and therefore improving their quality of life.



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