MS Views and News Be empowered with MS views and news. To receive The MS BEACON e-Newsletter, CLICK HERE - -

Please visit our MS learning channel on YouTube, which provides hundreds of MS videos presented by MS Experts across the USA, from many of our recorded education programs. Archived here: www.youtube.com/msviewsandnews -- Additionally, please visit our Social media platforms: Facebook, Twitter, and Instagram

Important Resources for the MS community are found on the left side of this blog.

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, for your personal knowledge and to keep you informed of current health-related issues. It is not a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~


Friday, September 24, 2010

FDA Approves Gilenya (Fingolimod-FTY720) – First Oral Disease-Modifying Therapy for Relapsing MS – Expected to be available by prescription in coming weeks

Sep 22, 2010
The U.S. Food and Drug Administration has approved fingolimod capsules (Gilenya,™ Novartis International AG) for reducing the frequency of clinical relapses and delaying the accumulation of physical disability in relapsing forms of MS, making it the first oral disease-modifying therapy for the treatment of multiple sclerosis. According to Novartis, the drug will be available for prescription in coming weeks.
Gilenya (pronounced Jil-EN-ee-ah) will be available as a first-line treatment, which means that there are no recommendations in the approved labeling for people to try other MS therapies before taking Gilenya.
In June 2010, the National MS Society was among individuals and patient advocacy groups that provided public testimony at an FDA advisory committee meeting about the unmet need for more therapies for people with MS.
Comment:“The FDA’s approval of the first oral disease modifying therapy is a significant step for people with MS, and helps address the unmet need for additional therapies,” said National MS Society Chief Medical Officer Aaron Miller, MD, Professor of Neurology and Medical Director of the MS Center at Mount Sinai Medical Center in New York City. Robert Lisak, MD, Chair of Neurology and Professor of Immunology and Microbiology at Wayne State University School of Medicine in Detroit, agreed. “I welcome having another treatment option for my patients, particularly an oral medication that might make it easier for people to get on and stay on therapy. Taking a disease-modifying therapy is the best way we have of reducing MS disease activity and future deterioration. However, we will need to monitor all new therapies for any long-term safety issues.”
About Gilenya: Fingolimod is a new class of therapy for treating multiple sclerosis. It binds to a docking site (sphingosine-1-phosphate receptor, or S1P receptor) on immune cells, including T cells and B cells, which have been implicated in causing nervous system damage in MS. The drug appears to induce some immune cells to remain in lymph nodes, inhibiting them from migrating into the brain and spinal cord.
Potential Benefits and Risks: Positive results from two large-scale phase III clinical trials have been published showing that fingolimod significantly reduced multiple sclerosis relapse rates and reduced disease activity as measured by MRI. In the one-year trial comparing fingolimod to interferon beta-1a (Avonex®, Biogen Idec), fingolimod was found to have a greater impact on relapse rates and on MRI. In the two-year trial, fingolimod delayed the progression of physical disability compared to placebo. (New EnglandJournal of Medicine January 20, 2010.) Read more about these studies on our Website.
The most common adverse reactions listed in Gilenya’s prescribing information are headache, flu, diarrhea, back pain, liver enzyme elevations and cough.
The label carries warnings about other potentially serious risks, including decreased heart rate and/or other heart effects after the first dose; the potential for increased risk of infections (in clinical trials, a small number of serious herpes infections occurred, including two deaths from herpes infections that occurred in people taking a dose higher than the approved dose of Gilenya); risk of macular edema (swelling of the center of the retina inside the eye); decrease in lung function; slight increase in blood pressure; increases of liver enzymes (which could indicate liver injury), and risk of harm to fetus (Category C, based on animal studies).   
The long-term safety of Gilenya is unknown at this time. Other phase III clinical trials of Gilenya, including one involving people with primary progressive MS, are still under way, as are extension studies involving those who have completed trials. These and other post-marketing studies should provide additional data on the safety and efficacy of Gilenya.
CONTINUE to READ Information on this new medication, by clicking here

***********************************************************
"Providing You with 'MS Views and News'is what we do"
Keep Informed and up-to-date with information concerning
 Multiple Sclerosis when registered at
****************************************************************
Disclaimer:  'MS Views and News' (MSVN), 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.
****************************************************************

Invisible Symptoms of Multiple Sclerosis

"Providing You with 'MS Views and News'is what we do"
Keep Informed and up-to-date with information concerning
 Multiple Sclerosis when registered at
****************************************************************
Disclaimer:  'MS Views and News' (MSVN), 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.
****************************************************************

Thursday, September 23, 2010

RECENT Imaging study provides new view of multiple sclerosis

September 23, 2010New findings on multiple sclerosis -- immune cells also attack neurons directly
Researchers in Germany have gained new insight into how the immune system causes damage associated with multiple sclerosis, an incurable neuroinflammatory disorder. Using imaging tools which enable investigation of processes in living organisms, they were able to show a direct interaction between immune cells and neurons which plays a significant role in neuronal injury. However, this direct interaction may respond to therapeutic intervention. The study by Dr. Volker Siffrin and Professor Dr. Frauke Zipp has now been published in the journal Immunity. Credit: Dr. Volker Siffrin/Copyright: MDC
Scientists have uncovered an alternative source for some of the damage associated with multiple sclerosis (MS), an incurable neuroinflammatory disorder. The research, published online by Cell Press on September 23rd in the journal Immunity, reveals a direct interaction between immune cells and neurons that plays a significant role in neuronal injury and may respond to therapeutic intervention.
Continue Reading by clicking here

***********************************************************
"Providing You with 'MS Views and News'is what we do"
Keep Informed and up-to-date with information concerning
 Multiple Sclerosis when registered at
****************************************************************
Disclaimer:  'MS Views and News' (MSVN), 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.
****************************************************************

Wednesday, September 22, 2010

BREAKING MS NEWS: Novartis Gets FDA Approval For Multiple Sclerosis Drug Gilenya




Sept 22, 2010 - 4:30am


(RTTNews) - Novartis AG (NVSNews ) Wednesday announced that the US Food and Drug Administration approved the oral multiple sclerosis, or MS, drug Gilenya 0.5 mg daily, a first-line treatment for relapsing forms of multiple sclerosis - the most common forms of the disease.


Gilenya is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS) in adults. The drug can decrease the number of MS flare-ups or relapses. Gilenya does not cure MS, but it can help slow the build up of physical problems that MS causes.



Novartis also said the FDA approval makes Gilenya the first oral treatment indicated for relapsing forms of MS available in the US.

The company noted that Gilenya showed superior efficacy by reducing relapses by 52% at one year compared with interferon beta-1a IM, a commonly prescribed treatment. Two-year, placebo-controlled study showed that Gilenya significantly reduced the risk of disability progression.


by RTT Staff Writer
Article Source: RTT News









***********************************************************
"Providing You with 'MS Views and News'is what we do"
Keep Informed and up-to-date with information concerning
 Multiple Sclerosis when registered at
****************************************************************
Disclaimer:  'MS Views and News' (MSVN), 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.
. ****************************************************************

Tuesday, September 21, 2010

Stem Cell Strategy


Published: September  2010

The recent ruling that halts the expansion of federal funding for embryonic stem cell research points to the need for an independent Stem Cell Ethics Research Consortium.
What stem cell science needs, and what Americans should demand, is better guidance for regulatory agencies, legal and policy-making bodies. The discussion of emerging technologies for stem cell-based therapies often is driven by conflict rather than facts.
Although the lack of effective communication between scientists and the public has taken place largely in the media, an "honest broker" may be useful because the most strident opinions often are the only ones heard.
Cell-based therapies have been around for a century, but controversy heightened in the late 20th century when human fetal tissue from elective or spontaneous abortions was used as donor cells for transplantation to treat Parkinson's disease.
The failure of the scientific community to address the controversy has helped create today's heated yet poorly informed debate. This inadequacy regarding clarification of stem cell science ethics helped foster publimisperceptions that have hindered the progress of innovation.
As a result, potentially life-saving treatments have been delayed and, in some cases, impeded.

Click to continue reading




***********************************************************
"Providing You with 'MS Views and News'is what we do"
Keep Informed and up-to-date with information concerning
 Multiple Sclerosis when registered at
****************************************************************
Disclaimer:  'MS Views and News' (MSVN), 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.
. ****************************************************************

Monday, September 20, 2010

Oral Laquinimod Demonstrated Sustained Efficacy and Safety in Patients with Multiple Sclerosis

September 20, 2010


“The results from this extension study confirm the balanced efficacy, safety, and tolerability profile seen with laquinimod to date”


  • Positive benefit-risk profile of laquinimod sustained in Phase II extension study
  • 52 percent reduction (p=0.0006) in mean number of gadolinium-enhancing (GdE) T1 lesions
  • Results from pivotal Phase III studies, ALLEGRO and BRAVO, anticipated in 2011
JERUSALEM---Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced results from a 36-week active extension study evaluating two doses of laquinimod, an investigational, once-daily oral immunomodulator, for the treatment of relapsing remitting multiple sclerosis (RRMS). The double-blind, multinational study demonstrated the sustained positive benefit-risk profile of laquinimod, which was shown to reduce Gd-enhancing (GdE) T1 lesions, while maintaining a good safety profile. These findings were published online by the journal Multiple Sclerosis.
Patients originally randomized to placebo in the core Phase II study, LAQ/5062, (published in The Lancet*) were re-randomized to either 0.3 mg or 0.6 mg laquinimod for the extension study, while patients originally randomized to active treatment continued with the same treatment assignment for an additional 36 weeks. Patients switching from placebo to an active treatment of laquinimod showed a 52 percent reduction in the mean number of GdE lesions (p=0.0006), a marker of disease activity. In patients initially randomized to 0.6 mg laquinimod, the reduction of MRI activity was maintained. Additionally, treatment with laquinimod was associated with a sustained reduction in relapse rate, no evidence of immunosuppression and good safety and tolerability profile.
“The results from this extension study confirm the balanced efficacy, safety, and tolerability profile seen with laquinimod to date,” explains Giancarlo Comi, M.D., the lead study author and the Director of the Department of Neurology and Institute of Experimental Neurology at the University Vite Salute, San Raffaele. “We look forward to the results of the Phase III ALLEGRO and BRAVO studies in 2011, and the potential of this novel agent to address the current unmet need for MS patients seeking a safe, effective and well tolerated oral therapy.”
Laquinimod received Fast Track designation from the U.S. Food and Drug Administration (FDA) in February 2009. Two global Phase III clinical studies, ALLEGRO and BRAVO are currently ongoing, with results anticipated during Q1 and Q3 2011, respectively.
* Comi G. et al. (2008). Effect of laquinimod on MRI-monitored disease activity in patients with relapsing remitting multiple sclerosis: a multicentre, randomized, double-blind, placebo-controlled phase IIb study. The Lancet; 371:2085-92.

Continue reading


***********************************************************
"Providing You with 'MS Views and News'is what we do"
Keep Informed and up-to-date with information concerning
 Multiple Sclerosis when registered at
****************************************************************
Disclaimer:  'MS Views and News' (MSVN), 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.
. ****************************************************************