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Wednesday

 

End-of-Year Task: Renewing Your DMT Prescription for 2016






























By Kim Dolce—December 8, 2015

December is upon us, and besides being the holiday season, ‘tis also the season to renew our prescriptions for disease-modifying therapies and reapply for co-pay assistance.
Read more »

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FREE MS RESEARCH UPDATE: a comprehensive overview of research findings on all of the FDA-approved disease-modifying therapies, as well as many experimental treatments



This year's expanded MS Research Update incorporates new information about the approved disease-modifying therapies (DMTs), as well as numerous experimental drugs currently under investigation for the long-term treatment of multiple sclerosis (MS). Highlights and recent research results are provided for each drug. Please note that symptom-management drugs are not included in this report.

DOWNLOAD YOUR FREE PDF OR ORDER A FREE COPY
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Sunday

 

Oral Gilenya (Fingolimod) or Intramuscular Interferon for Relapsing Multiple Sclerosis: STUDY

Saturday

 

This Could Be Game-Changing News in the Battle Against Multiple Sclerosis

























For a disease that affects more than 400,000 people in the United States and approximately 2.5 million around the globe, multiple sclerosis is arguably not getting its fair share of attention from drug developers and researchers. According to the National Institutes of Health, which has an annual budget near $40 billion, only $115 million is expected to be spent on MS research in 2015.
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Sunday

 

Wow! It's no wonder MS is seen as a Cash Cow: THESE MS DRUGS BROUGHT IN THE MOST MONEY LAST YEAR

Teva soaring out in front on a single product and it is no surprise that the Generics pack are waiting in the rear ready for the copaxone patents to expire starting May 2014. However Biogen are backing the most winners with a staggering $5.8 billion worth of business. 
#1 Glaterimer acetate Teva     $4.3 billion
#2 Avonex Biogen Idec           $3.0 billion
#3 Gilenya Novartis                 $1.9 billion
#4 Tysabri Biogen  Idec           $1.7 billion
#5 Betaseron Bayer                 $1.1 billion
#6 Tecfidera Biogen Idec        $0.9 billion
#7 Rebif EMD serono              $0.6 billion
#8 Ampyra Biogen Idec           $0.3 billion
#9 Aubagio Sanofi                   $0.2 billion
#10 Extavia Novartis               $0.2 billion

Read more »

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Data Show Declining Use of Injectables as Oral Multiple Sclerosis Therapies Gain Traction

Saturday

 

Multiple Sclerosis and Pregnancy: Current Considerations

 

HOW MS MEDICATIONS DIFFER FROM EACH OTHER

 

Tecfidera Captures the Largest U.S. Neurologist-Reported Patient Share Among Oral Disease-Modifying Multiple Sclerosis Therapies Ten Months Post-Launch

 

Tecfidera Is Off to a Quick Start

 

Synthetic Biologics Announces Issuance of U.S. Patent patents for MS and other autoimmune diseases covering the uses of its oral estriol candidate, Trimesta

 

FREE MS RESEARCH UPDATE: a comprehensive overview of research findings on all of the FDA-approved disease-modifying therapies, as well as many experimental treatments



This year's expanded MS Research Update incorporates new information about the approved disease-modifying therapies (DMTs), as well as numerous experimental drugs currently under investigation for the long-term treatment of multiple sclerosis (MS). Highlights and recent research results are provided for each drug. Please note that symptom-management drugs are not included in this report.

DOWNLOAD YOUR FREE PDF OR ORDER A FREE COPY
Read more »

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Friday

 

Biogen Idec Inc: Tecfidera Continues Its Blistering Pace

The company's new oral alternative to its top-selling Avonex racked up $286 million in third quarter sales, far above the $200 million forecast by some industry analysts. Its rapid roll-out helped it capture $876 million in revenue in 2013, including $398 million in the fourth quarter. For comparison, in the most recent quarter reported, competitor drugs Gilenya earned $521 million and Aubagio by brought in about $60 million.  read more

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Sanofi MS Drug Added With Genzyme Fails to Win FDA Approval

Sanofi (SAN) failed to win U.S. regulatory approval for its multiple sclerosis drug Lemtrada, denting the company’s ambitions of capturing a larger share of the $20 billion market for the disease.
The U.S. Food and Drug Administration said Sanofi’s Genzyme unit didn’t submit evidence from “adequate and well-controlled studies” showing that the benefits of Lemtrada outweigh its side effects, the Paris-based company said in a statement today. Sanofi disagrees with the conclusion and said it will appeal.

Lemtrada, which was approved in the European Union in September, was a key part of Sanofi’s $20.1 billion acquisition of Genzyme in 2011. The FDA indicated one or more additional trials comparing Lemtrada with another drug are needed for approval, Sanofi said. That would delay the product’s entry to a market dominated by Teva Pharmaceutical Industries Ltd. (TEVA:US)’s Copaxone, Biogen Idec Inc. (BIIB:US)’s Tecfidera, Avonex and Tysabri, Novartis AG’s (NOVN) Gilenya and Merck KGaA’s Rebif.
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BioTrends Research Group Rolls Out The TreatmentTrends: Multiple Sclerosis 2013 Report


BioTrends Research Group, a research and advisory firms for specialized biopharmaceutical issues, finds that physician-reported patient shares for Novartis's Gilenya and Biogen Idec's Tysabri are 8 percent and 10 percent among relapsing-remitting multiple sclerosis (RR-MS) patients treated with a disease-modifying therapy (DMT) across the EU5 (France, Germany, Italy, Spain and the United Kingdom); significantly higher than those reported by EU5 neurologists surveyed in 2012.
According to a release, surveyed neurologists also report that recent changes in treatment management include a shift toward earlier and more-aggressive treatment and increased use of the anti- JCV antibody assay, changes that are consistent with the increased patient shares reported for Gilenya and Tysabri. Survey data indicate that these agents occupy distinct niches, with Gilenya a preferred second-line therapy in JCV-positive patients and Tysabri a preferred second-line therapy in JCV-negative patients.

The TreatmentTrends: Multiple Sclerosis (EU) 2013 report finds that, despite fewer than 30 percent of surveyed neurologists reporting access to Genzyme's* Aubagio and Genzyme/Bayer HealthCare's Lemtrada--and given the limited time these agents had been available at the time the survey was fielded--these DMTs have nevertheless captured a 1 percent physician-reported weighted MS patient share. The data also reveal that surveyed neurologists anticipate substantial changes in DMT use in the coming months as access to Aubagio and Lemtrada expands and as new products, notably Biogen Idec's Tecfidera, become available. Neurologists indicate that Aubagio will most likely compete with first-line products (i.e., Biogen Idec's Avonex, Bayer HealthCare's Betaferon and Teva's Copaxone), while Tecfidera may replace these products as well as Merck Serono's Rebif and Gilenya. Lemtrada, conversely, will most likely compete with Tysabri or would not replace an existing DMT, suggesting anticipated use as a last-line therapy.

"The European MS market is entering a dynamic period with two recent DMT launches and as many as six new DMTs launching in the next five years," said Decision Resources Group Senior Business Insights Analyst Georgiana L. Kuhlmann, S.M. "Our data find that gains for new brands will likely come at the expense of the interferon-beta therapies and Copaxone."

BioTrends Research Group provides syndicated and custom primary market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets.
Decision Resources Group is a cohesive portfolio of companies that offers information and insights on sectors of the healthcare industry.
Read more »

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Daniel Kantor, MD, on Specialty Pharmacy in Multiple Sclerosis

In the last two decades we’ve seen really an explosion of the treatments we have for multiple sclerosis (MS),” said Daniel Kantor, MD, medical director, Neurologique, immediate past president, Florida Society of Neurology. Until recently, self-injectables and intravenous medications were the only treatment options available for patients diagnosed with MS making specialty pharmacy, “hugely important for the treatment of MS.” Today, there are 10 disease-modifying agents approved by the US Food and Drug Administration:
  • Aubagio (teriflunomide)
  • Avonex (interferon beta-1a)
  • Betaseron (interferon beta-1b)
  • Copaxone (glatiramer acetate)
  • Extavia (interferon beta-1b)
  • Gilenya (fingolimod)  
  • Novantrone (mitoxantrone)
  • Rebif (interferon beta-1a)
  • Tecfidera (dimethyl fumarate)
  • Tysabri (natalizumab)
Dr Kantor notes that specialty pharmacies ensure facilities and patients receive medications in a timely manner. Specialty pharmacies also play a crucial role in both patient education and adherence. 
- See more at: http://www.ajmc.com/conferences/ectrims2013/Daniel-Kantor-MD-on-Specialty-Pharmacy-in-Multiple-Sclerosis-#sthash.qllKQSe0.dpuf

“In the last two decades we’ve seen really an explosion of the treatments we have for multiple sclerosis (MS),” said Daniel Kantor, MD, medical director, Neurologique, immediate past president, Florida Society of Neurology. Until recently, self-injectables and intravenous medications were the only treatment options available for patients diagnosed with MS making specialty pharmacy, “hugely important for the treatment of MS.” Today, there are 10 disease-modifying agents approved by the US Food and Drug Administration:
  • Aubagio (teriflunomide)
  • Avonex (interferon beta-1a)
  • Betaseron (interferon beta-1b)
  • Copaxone (glatiramer acetate)
  • Extavia (interferon beta-1b)
  • Gilenya (fingolimod)  
  • Novantrone (mitoxantrone)
  • Rebif (interferon beta-1a)
  • Tecfidera (dimethyl fumarate)
  • Tysabri (natalizumab)
Dr Kantor notes that specialty pharmacies ensure facilities and patients receive medications in a timely manner. Specialty pharmacies also play a crucial role in both patient education and adherence. 
- See more at: http://www.ajmc.com/conferences/ectrims2013/Daniel-Kantor-MD-on-Specialty-Pharmacy-in-Multiple-Sclerosis-#sthash.qllKQSe0.dpuf
“In the last two decades we’ve seen really an explosion of the treatments we have for multiple sclerosis (MS),” said Daniel Kantor, MD, medical director, Neurologique, immediate past president, Florida Society of Neurology. Until recently, self-injectables and intravenous medications were the only treatment options available for patients diagnosed with MS making specialty pharmacy, “hugely important for the treatment of MS.” Today, there are 10 disease-modifying agents approved by the US Food and Drug Administration:
  • Aubagio (teriflunomide)
  • Avonex (interferon beta-1a)
  • Betaseron (interferon beta-1b)
  • Copaxone (glatiramer acetate)
  • Extavia (interferon beta-1b)
  • Gilenya (fingolimod)  
  • Novantrone (mitoxantrone)
  • Rebif (interferon beta-1a)
  • Tecfidera (dimethyl fumarate)
  • Tysabri (natalizumab)
Dr Kantor notes that specialty pharmacies ensure facilities and patients receive medications in a timely manner. Specialty pharmacies also play a crucial role in both patient education and adherence. 
- See more at: http://www.ajmc.com/conferences/ectrims2013/Daniel-Kantor-MD-on-Specialty-Pharmacy-in-Multiple-Sclerosis-#sthash.qllKQSe0.dpuf













See Video Here

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Surveyed Neurologists Report Significantly Higher Relapsing-Remitting Multiple Sclerosis Patient Shares for Gilenya and Tysabri, Compared With One Year Ago


The TreatmentTrends: Multiple Sclerosis (EU) 2013 report finds that, despite fewer than 30 percent of surveyed neurologists reporting access to Genzyme's* Aubagio and Genzyme/Bayer HealthCare's Lemtrada—and given the limited time these agents had been available at the time the survey was fielded—these DMTs have nevertheless captured a 1 percent physician-reported weighted MS patient share. The data also reveal that surveyed neurologists anticipate substantial changes in DMT use in the coming months as access to Aubagio and Lemtrada expands and as new products, notably Biogen Idec's Tecfidera, become available. Neurologists indicate that Aubagio will most likely compete with first-line products (i.e., Biogen Idec's Avonex, Bayer HealthCare's Betaferon and Teva's Copaxone), while Tecfidera may replace these products as well as Merck Serono's Rebif and Gilenya. Lemtrada, conversely, will most likely compete with Tysabri or would not replace an existing DMT, suggesting anticipated use as a last-line therapy.

"The European MS market is entering a dynamic period with two recent DMT launches and as many as six new DMTs launching in the next five years," said Decision Resources Group Senior Business Insights Analyst Georgiana L. Kuhlmann, S.M. "Our data find that gains for new brands will likely come at the expense of the interferon-beta therapies and Copaxone."
Click here to read more 

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Multiple Sclerosis Cases Hit 2.3 Million Worldwide


The number of people living with multiple sclerosis around the world has increased by 10% in the past five years to 2.3 million, according to the most extensive survey of the disease to date.

There have been a number of new drugs in recent years to treat MS, particularly with the introduction of a new generation of oral therapies such as Novartis' Gilenya (fingolimod), Biogen Idec's Tecfidera (dimethyl fumarate) and Sanofi's Aubagio (teriflunomide).  These medicines offer an effective alternative to older disease-modifying treatments that are given by injection.  The survey found that injectable drugs like Biogen's Avonex (interferon beta-1a) and Teva's Copaxone (glatiramer acetate) were partly or fully funded in 96% of high-income countries, while Gilenya was available in 76%.
Click here to read more 

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THIS IS MY 1ST COLUMN! IT'S ABOUT FINDING TRUE LOVE & MY MS & AN INTRO ME!

Debbie Ramsey, Columnist, MSnewsChannel.com

Well I finally get to have my voice heard and be a Columnist on MSnewsChannel.com  First of all I'll start with an introduction.

My name is Debbie and I just turned 41.  I was diagnosed at the age of 24 in May '97 but can trace back symptoms to '86 when I was 13. I started out on Avonex.  I am married to my wonderful husband Stephen.  Our anniversary is the 16th of December and it will be are 13th.  Marrying in 2000 makes it so much easier for an MS'er with brain fog to know what anniversary year it is.

He moved to be with me in Northern, VA from Wales, UK.  We met online in '98 and I was completely bedridden when he came to visit me in July of '99.  That's when he proposed to me.  I was like Quadriplegic almost.  Could only move my hands and come to find out that not only did I get the 00.1% alopecia that can get from Avonex but my body was allergic to Interferon.  Stephen came back in September and I was able to get in my wheelchair and go with my Mom to pick him up.

You could say it was God, love, or Copaxone that got me better and out of bed but I say a bit of all 3.  We lived with my Mother for the first 3 1/2 years of marriage until we could find an apartment of our own and we did in 2004 and have been living here ever since.

I'm so thankful for Stan & Stan's Angels  He's the greatest in finding out important information on MS as well get other MS'ers to get to chat with one another and be a cyber voice for happy times, sad times, and just to plain rant.  I first found him on MySpace and I went to Facebook because my in-laws were on there and Stan joined Facebook too.  He rocks and you can't help but love him.

Do we have kids?  Unfortunately No.  I always wanted them but....
Read more »

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Biogen's Tecfidera Time-Out Pays Off


Biogen (NASDAQ: BIIB  ) decided to delay the European launch of its new oral multiple sclerosis drug Tecfidera back in May, amid fears that patent protection for its 480 mg dose wasn't bulletproof from generics. That decision has now paid off.

The EU's Committee for Medicinal Products for Human Use, or CHMP, has granted Tecfidera new active substance designation, giving Biogen a 10-year window of exclusivity in the European Union, and paving the way for Tecfidera's Q1 2014 launch against competing drugs from Novartis (NYSE: NVS  ) and Sanofi (NYSE: SNY  ) .

Rapidly growing demand

Biogen's calculated risk to delay the rollout in Europe until the additional patent protections were in place looks savvy in hindsight, especially given its booming initial sales in the United States. In Q3, the drug generated $286 million in sales for Biogen, far above the $200 million some analysts forecast.

Read more »

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