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Saturday, April 18, 2015

Biogen to Focus on RRMS Disease Management, Treatment at Upcoming Conference

Biogen to Focus on RRMS Disease Management, Treatment at Upcoming Conference

Biogen plans to present new clinical data at the 67th American Academy of Neurology (AAN) Annual Meeting in Washington D.C., April 18 – 25, 2015, including numerous presentations focusing on multiple sclerosis.  In a company press release, Biogen stated “At AAN, we will feature new scientific data, including research highlighting the efficacy and favorable safety profile of TECFIDERA, the most prescribed oral medicine for relapsing MS in the US.”
shutterstock_173216819According to Kate Dawson, vice president, US Medical Affairs “Biogen is committed to exploring ways to transform the care of patients living with MS and other neurodegenerative diseases both through its broad portfolio of MS therapies and extensive pipeline, as well as innovative company initiatives. At AAN, we will feature new scientific data, including research highlighting the efficacy and favorable safety profile of TECFIDERA, the most prescribed oral medicine for relapsing MS in the US.”
TECFIDERA is an oral medication for relapsing MS. The medication has received approval in the United States, the European Union, Canada, Australia and Switzerland.
Biogen also plans to present other data regarding patient care of people with MS, and presentations will include discussions of the current “state of MS” and will highlight why patient-healthcare provider interactions are so important.
Overall, the company will present the following MS data:
1) Emerging approaches to MS management
2) Tecfidera
  • Clinical Efficacy in Newly Diagnosed Relapsing-Remitting Multiple Sclerosis Patients with Highly Active Disease
  • Long-Term Efficacy of Delayed-Release Dimethyl Fumarate for Relapsing-Remitting Multiple Sclerosis According to Prior Therapy
3) Tysabri
  • Disease Course in Multiple Sclerosis (MS) Patients Switching from Fingolimod to Natalizumab
  • Natalizumab-Treated Patients with Multiple Sclerosis Have Low Rates of Brain Volume Decrease and Low MRI Disease Activity
4) Plegridy
  • Long-Term Safety and Tolerability of Peginterferon Beta-1a
  • Long-Term Efficacy in MRI and No Evidence of Disease Activity Outcomes in Patients with Relapsing-Remitting Multiple Sclerosis Treated with Peginterferon Beta-1a
5) Zinbryta
  • Daclizumab HYP Versus Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis
  • Safety and Tolerability Results
6) Anti-LINGO-1
  • Evidence of Remyelination with the Anti-LINGO-1 Monoclonal Antibody BIIB033 after Acute Optic Neuritis 
  • Efficacy Analysis of the Anti-LINGO-1 Monoclonal Antibody BIIB033 in Acute Optic Neuritis
Anti-LINGO-1 is a medication that restores myelin — a fatty substance that facilitates nerve cell impulses by wrapping around them and providing insulation. Recent trial results indicate that anti-LINGO-1 could help to repair the damaged visual system.
RENEW is one component of Biogen Idec’s program to develop anti-LINGO-1, which includes the SYNERGY multiple sclerosis trial. SYNERGY is an ongoing, separate Phase 2 study of anti-LINGO-1 in people with relapsing multiple sclerosis. Biogen Idec expects results for the SYNERGY trial in 2016.
The presentations underscore Biogen’s continuing commitment to treating MS, using multiple therapies and approaches. At this particular conference, Biogen will be focusing predominantly on the Relapsing-Remitting form of the disease, which the majority of MS are diagnosed with.

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Thursday, April 16, 2015

FDA Approves Generic Multiple-Sclerosis Drug by Novartis’s Sandoz and Momenta

Momenta shares jump on approval of a version of Teva’s top-selling drug, Copaxone

The U.S. Food and Drug Administration approved the first generic version of Teva Pharmaceutical’s blockbuster multiple-sclerosis drug Copaxone, although it remains unclear when the copycat version may come to market.

The generic, known as Glatopa, was developed by Novartis AG’s Sandoz business and Momenta Pharmaceuticals Inc. Sandoz is evaluating the timing of the launch, Momenta said in a news release.
Shares of Momenta jumped 6.1% Thursday to $17.08.

Copaxone, an injection for multiple sclerosis, is the company’s most profitable and top-selling product, according to analysts. Teva—which is known mostly for selling generic drugs—reported $4.2 billion in revenue from Copaxone last year, representing 21% of the company’s overall revenue.
Earlier this year, the U.S. Supreme Court backed a 2011 decision that ruled that Teva’s patent on Copaxone didn’t expire until September 2015.

Denise Bradley, a spokeswoman for Teva, said Thursday that the company has acknowledged for some time that a generic version of Copaxone could enter the market and has planned for it.
Analysts at Sanford C. Bernstein agree, saying “Teva has been quite realistic about the risk to Copaxone.” Still, Teva shares fell 3.8% to $63.49.

Sandoz said MS affects about a half-million individuals in the U.S. and that about half of those diagnosed are currently being treated. Glatopa is indicated for patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging features consistent with the disease.

Write to Lisa Beilfuss at


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Multiple Sclerosis News TODAY - Clinical Trial Updates Notification Program

Clinical Trial Notification Program


Many readers of MS News Today have reached out and urged us to do more to bring additional awareness about clinical trials applicable to the MS patient community. In response, we have created a new Clinical Trial Notification Program that helps us match individuals directly to relevant clinical trials based off of their profile information. For participants in our clinical trial notification program, if your profile is a match, we may reach out directly to inform you of a clinical trial that might be specifically relevant to you.

Correspondence between MS News Today and our program participants is strictly confidential and subject to our Privacy Policy. We do not share your personal information with third parties except when you have explicitly provided us permission to do so and agree that we can share such information on your behalf. We will not use, sell, or assign your email address for any purpose other than to communicate with you about clinical trial services.

If you are interested in participating in our Clinical Trial Notification Program, please click the button below and complete a short questionnaire. If we identify a trial that your profile is a match for, we will communicate with you via email informing you of the opportunity and will provide information on the sponsor company and trial protocol. With your consent, we will then forward your information to a clinical trial study site in your area for review.

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Tuesday, April 14, 2015

Experimental multiple sclerosis therapy stops disease in its tracks

Ottawa hospital gets $4.2M grant to support clinical trial for mesenchymal stem cell therapy

CBC News Posted: Apr 13, 2015 

Alexandre Normandin, who is a practising physician, says after being diagnosed with MS he gained more empathy for his patients.
The Ottawa Hospital and the University of Ottawa have received a $4.2 million grant to support a clinical trial for stem cell therapy targeted at multiple sclerosis patients.
One Pointe-Claire man says he knows from personal experience that the treatment — mesenchymal stem cell therapy — could give someone with MS a new chance at life. 
Alexandre Normandin was diagnosed eight years ago, in his third year of medical school at McGill University.
He said what started out as a little numbness on his left temple, turned out to be rapidly progressing MS. 
"The way it was going, it wouldn't be surprising, within months [or] years, to wind up in a wheelchair," he told .CBC's Daybreak host Mike Finnerty.
When he found out about an experimental bone marrow stem-cell transplant at the Ottawa General hospital in 2008, he didn't hesitate to sign up. 
The treatment was risky — Normandin had to go through 15 days of chemotherapy in order to completely wipe his immune system and eliminate the mutation that caused his MS. 
But it worked.
Years later, Normandin runs his own medical practice.

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Dr. Oz: Montel Williams challenges multiple sclerosis with diet and supplements

Montel Williams talks about MS.
Montel Williams talks about MS.
Photo by Mark Wilson/Getty Images
Montel Williams considers himself a survivor. And, as he told Dr. Mehmet Oz when he visited his talk show on April 13, evenmultiple sclerosis couldn't stop him from achieving his goals.

Williams advocates staying hydrated with coconut water and smoothies. But not just any smoothies will do. He recommends blending fruits and vegetables such as pineapple, watermelon, blueberries, apples, bananas and spinach.

In addition, Montel credits supplements for boosting his energy and relieving pain. He uses 100-300 mg of chlorophyll and 1000 IU of vitamin D each day. Chlorophyll also can be sourced from leafy green vegetables, fresh green juice drinks, wheat grass or spirulina.
B12 also is a key component of Montel's program. While he takes injections, Dr. Oz suggests dietary sources or supplements. In addition, Three Root tea and five cloves of garlic daily are important parts of Montel's "Fountain Of Youth" energy program.
Montel isn't the only celebrity to battle multiple sclerosis. Country music star Clay Walker also struggles to control his MS, reported ABC News on April 12.

"When I was dealt that blow I was devastated being diagnosed with a debilitating disease," admitted Walker. But that was 19 years ago, and oh, how times have changed for the singer.


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LEARNING about MS Relapse

Can you recognize an MS relapse?

If you suspect that you may be having a relapse, the most important thing you can do is make an appointment to talk with your doctor as soon as possible. In the meantime, there are many common, recognizable symptoms that you can monitor and then share with your doctor to help determine if you are having a relapse. At, you have a resource for learning more about MS relapses, the accompanying symptoms, and how your MS relapse may be resolved.
Know the symptoms of an MS relapse.

  Discover more symptoms of MS relapse

Relapses can be unpredictable. Relapse symptoms can vary from person to person, and your symptoms may not be the same for each relapse. But there are questions you can ask yourself to help determine if you may be having a relapse.
Learn more about recognizing an
MS relapse.
Learn what questions to ask to determine if you may be having a relapse with the Acthar for MS Relapses Brochure

If you are having a relapse, Acthar may be able to help you recover. Studies have shown ACTH, the main ingredient in Acthar, to be effective in speeding recovery from MS relapses in adults.
Know what you can do about a relapse.
Find out how H.P. Acthar Gel (repository corticotropin Injection) can help you recover from an MS relapse

Patient Indication Statement
Acthar is a prescription medicine indicated for adults with acute relapses or flares of multiple sclerosis (MS). Studies have shown H.P. Acthar Gel to be effective in speeding recovery from an MS relapse. However, there is no evidence that Acthar affects the ultimate outcome or natural history of the disease.

Please see Important Safety Information below and full Prescribing Information.

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CME Program: Assessing Patient Adherence in MS: Clinical Decisions in the Age of Multiple Therapeutic Options

MS leaders e-mail logo header 

Dear MS-Leaders Registrant,

Can you correctly answer this question:
All of the following are indirect methods for assessing adherence to disease-modifying therapy, EXCEPT for:

A. Patient questionnaires
B. Measuring biological markers in blood or urine
C. Pill counts
D. Electronic medication monitor devices     

Participate in our Clinical Dialogue and eCase Challenge to learn the answer to this and other questions related to MS therapy.

Earn up to 1.0 Free CME/CE Credit!

Rutgers, The State University of New Jersey and Medical Logix, LLC, are currently offering this educational program certified for CME and CE credit, at no charge to participants:

Release Date: July 14, 2014
Expiration Date: July 14, 2015

This enduring material has been approved for
AMA PRA Category 1 Credits™ and ANCC contact hours.

Supported by educational grants from
Genzyme, a Sanofi Company and Teva Pharmaceuticals

Jointly Provided by The Center for Continuing and Outreach Education
at Rutgers Biomedical and Health Sciences and Medical Logix, LLC

For additional information and to view the activity, please CLICK HERE 

Please keep in mind that you will need to login with your email address and password to access this program. If you forgot your password, click on the "Forgot Password" link in the top right corner of the site.
We hope you enjoy this informative educational program!

The MS-Leaders Team

The Center for Continuing and Outreach Education at
Rutgers Biomedical and Health Sciences
 30 Bergen Street ADMC7, Newark, NJ 07101-1709

Please do not respond to this email directly. Any questions or concerns,

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The 2015 edition of MSAA's MS Research Update

The 2015 edition of MSAA's MS Research Update provides a comprehensive overview of the research findings on the 12 FDA-approved disease-modifying therapies, as well as study results on many experimental treatments currently under investigation. Directions for future research are also presented in areas such as stem-cell research, biomarkers, genetic studies, and more.
In addition to the exciting research aimed at relapsing forms of MS, several studies are also looking into the treatment of progressive forms of MS. To assist individuals interested in learning more, trials with progressive forms of MS have been highlighted in bold for quick identification.

Please also forward this email along to anyone who may be interested in this information.

Read MSAA's latest MS Research Update.

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Kineta’s dalazatide (formerly ShK-186) has a mechanism of action broad enough to treat many autoimmune diseases

Grant Awards

Kineta’s Autoimmune Program is supported by the National Institute of Health.

PI: Shawn P. Iadonato
Listed as: Funding Mechanism, Title, Application #, Collaborators (if any)

Read more, here

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A Stranger in Strange Lands - written by: WheelChair Kamikaze

Wheelchair Kamikaze

WOW! - What a fabulous writer!!  - Stu's Views

Posted: 14 Apr 2015 
Marc Stecker

Way back in the summer of 1989, just about a month before my 26th birthday, I unintentionally found myself living in South Florida. An unfortunate confluence of bad decisions on my part, ill will on the part of others, and an ample dose of plain old rotten luck landed me in an environ in which I never intended to land. Without getting into the gory details, suffice it to say that for me Florida was a refuge of last resort, a place I had visited fairly often (I’d long had family living there) but one which I’d never even considered a spot in which I might one day actually reside. In fact, if asked just a few months before if my living in Florida were even a remote possibility, I would have looked at the questioner as if they were totally insane. I knew on a very basic level that the Sunshine State and I would never make for a comfortable fit, but lo and behold, there I was, an accidental Floridian, ill-suited to the place by any number of measures.

Now, there’s nothing inherently wrong with South Florida; some people find the locale a paradise. I’m just not one of those people. Before arriving in Fort Lauderdale I had spent my young adult years living a quirky Bohemian existence, primarily in Boston but also for a short time in my native New York City. I’d never held a full-time job and had inhabited an eccentric and lively subculture of writers, artists and musicians, or at least wannabe writers, artists and musicians, that formed what sociologists refer to as an urban tribe, with its own customs, values and interests that quite often veered significantly from those of the mainstream.

In both Boston and New York such enclaves were woven into the fabric of city life and like-minded spirits abounded. Fort Lauderdale, though, held little in the way of such a community. Either by nature or nurture (or both) I was temperamentally completely at odds with the place. Whereas I’d always deeply appreciated the muted beauty of a cloudy day, Florida exalts in its status as The Sunshine State. Fort Lauderdale is renowned for its beaches; I detest the feeling of sand between my toes. If Florida is Ying, I am Yang. Despite Zen ideals, this particular combination of Ying and Yang did not produce harmony, but instead a feeling inside me of perpetual discord that eventually led to a crisis of spirit.

Despite my ongoing sense of otherness I remained in Florida for about 10 years, a fact I still have difficulty reconciling, particularly to myself. When I arrived in Florida I was pretty much out of options and had hazy plans of staying maybe 6-12 months. And then I suppose life just took over. I halfheartedly stumbled into my first ever full-time job, working as a low-level video producer for a local cable television company, a quirky enough position in which I had lots of fun but made very little money. In spite of my always feeling like a piglet among puppies I eventually managed to fashion an active social life and find friends and lovers, and though I grew extremely close to some of them, many were quite different from the folks I naturally gravitated to up North. This taught me a lesson that remains one of the few net positives that I took away from my time in Florida: to not prejudge people based on externals alone. Given half a chance, people of all stripes can be full of delightful surprises.

After a few years, my oddball job working for the cable company led to a more lucrative and much more structured position in a marketing company, and that to yet another career builder in an even more stifling corporate environment. While this evolution provided financial comfort, it also shoehorned me into a day-to-day lifestyle that only a few years earlier I had adamantly and vociferously forsworn. At times I barely recognized the clean-cut young man knotting a necktie who looked back at me in the mirror, feeling as if I were living a life deep undercover or, worse yet, as a feckless imposter. Beneath the surface my native eccentric impulses still simmered, but somewhere along the line I had allowed myself to become a passionate man living a passionless existence.

Along the road to this begrudging semi assimilation I lost track of who I once was, the essence of “me” that existed still at the core of my being. This created a spiritual and psychological void that led to terrible cognitive dissonance, manifesting as what I can only describe as a desiccation of the soul. As the years wore on I grew increasingly discontented but found myself caught in a self-imposed catch 22, shackled by the responsibilities of the very lifestyle that was causing me such massive dissatisfaction. The mental blinders I developed in a misguided attempt to stay the course served also to keep me from seeing a way out.

During my last few years in Florida I started experiencing a variety of strange physical symptoms that subsequently turned out to be a subtle presage of the physical crisis to come. Finally, after nearly a decade, the breakup of a long-term romantic relationship provided me with some long overdue escape velocity and I made my way back to New York. Despite the tropical beauty of parts of South Florida, my favorite view of the place turned out to be the one in my rearview mirror.

Arriving back in New York felt like pulling on a favorite pair of well broken-in jeans, once thought lost but happily rediscovered. Before long things started to almost magically fall into place; I reconnected with dear old friends, landed a promising high profile job in a very prestigious but funky outpost of a worldwide mega-media company, and, just a little over a year after returning to NYC, met the marvelous woman who I would eventually marry.

Things seemingly couldn’t have gone much better until – after four years back in New York and just weeks before my first wedding anniversary – the nagging physical symptoms that began back in Florida finally became too pronounced to ignore and I was soon diagnosed with progressive multiple sclerosis. Even though I’d had a sense for years that things weren’t quite right physically, nothing could have prepared me for the maelstrom that would soon erupt within and around me as I was forced into the world of creeping paralysis, once again a stranger in a very strange land, limping down a path for which no roadmap existed. My discarded crisis of spirit was now replaced by a crisis of body.

Despite the best efforts of me and my doctors my disease progressed quite rapidly. Less than four years after my diagnosis I was forced to quit work and go on long-term disability. About a year and a half later I found myself in a wheelchair, the right side of my body withering and my left side beginning to weaken. Quite unexpectedly, these developments allowed parts of me that had been buried for decades to take root and blossom. The gaping holes in my life left by the excision of work and social obligations were soon filled by pursuits and passions that had for far too long been subjugated by the realities and responsibilities of adulthood. Further, my attempts to save my own backside by learning as much as possible about my disease and the ongoing research into treating it injected a sense of purpose and glimmer of light into this murky and frightening new world.

Not to say that my getting sick was in any way fortuitous or – gack! – a blessing. But my increasing disabilities served to strip my life bare as I became less and less able to utilize the trappings of the land of the healthy, rendering an ever-increasing list of everyday objects little or no use to me, luxuries and perceived necessities that had served not too long ago as balms providing superficial comfort and satisfaction, particularly during my wayward days lurching through life in South Florida.

Slowly a curtain of artifice began to lift, and looking at the healthy world from the outside in revealed the synthetic nature of the forces driving most people’s lives; the unappeasable wants and desires conjured by insatiable consumerism, the intentional discontent fostered by a social order that thrives on keeping its populace in a perpetual state of simmering dissatisfaction. During my Florida days these machinations led me down a primrose path, but in my increasingly compromised physical state I began to see with startling clarity that the frenzied world of imposed needs and longings that I once inhabited depends on no thing – no object, person, or sense of self – ever being good enough. No wonder antidepressants are being gobbled by the ton.

Paradoxically, the crisis of body that came all too soon on the heels of my Floridian crisis of spirit allowed that spirit to take root and blossom, freed by unfortunate circumstance to flourish in the absence of any preconceived notions of success and failure. Perhaps the most maddening aspect of this creeping paralysis is that it very likely will never allow me to fully utilize the lessons learned, to put into action in that ever receding land of the healthy the bits of wisdom and insight garnered by being forced to endure what I once believed to be unendurable. Has the experience of prolonged debilitating illness left me unsuited for a life back among the healthy? Now there’s a problem I wouldn’t mind facing, to once again be a stranger in that strange land.

As for the world I now occupy, this truly bizarre land of multiple sclerosis, I intend to always be a stranger within. Although so many of my fellow inhabitants are among the most inspiring people I’ve ever come to know, I will not – I cannot – accept citizenship in this nation. If I was haphazardly thrust out of my element by my never intended move to Florida, I’m a willful alien in this place. No MS green card for me, thank you.

And so I find myself a stranger in two strange lands, the worlds of the sick and the healthy. Maybe it was my destiny to always be the stranger, or perhaps I’m just strange. In either case, vive la diffĂšrence!

Well, just as long as I don’t have to vive it in Florida…

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