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Archives
Category Archives: MS Treatment
Researchers Identify Potential Therapy Target in MS
Posted: Published on February 1st, 2013
Newswise Seattle, January 30, 2013) Researchers from Benaroya Research Institute at Virginia Mason (BRI) have found that proteins in the IL-6 signaling pathway may be leveraged as novel biomarkers of multiple sclerosis (MS) to gauge disease activity and as a target for new therapies. The research, which investigated how several components involved in immune response differ between MS patient and control samples, was conducted by a team of researchers at BRI led by Dr. Jane Buckner in collaboration with Dr. Mariko Kita at Virginia Mason Medical Center and was published today in Science Translational Medicine. Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system affecting an estimated 400,000 people in the United States. MS is more prevalent in the Northwest region of the U.S. than almost anywhere else in the world. In the Northwest, the likelihood of being diagnosed with MS (2 in 1,000) is double that across the U.S. (1 in 1,000). Under normal circumstances, effector T cells protect us from infection and cancer and it is the job of regulatory T cells to keep the effector T cells from attacking healthy tissue, thereby preventing autoimmune diseases such as MS. MS occurs when the immune … Continue reading
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Feature: MS MR unmasked: “We never intended to be this mysterious band”
Posted: Published on January 30th, 2013
Ahead of their appearance at Laneway Festival, DARREN LEVIN unmasks the duo behind New Yorks Tumblr-glitch-pop duo MS MR. In an age of full disclosure and rampant TMI, New Yorks MS MR did a very unusual thing indeed. They kept their identities under wrap long enough to release a debut EP, Candy Bar Creep Show, last year through Tumblr of all places, only revealing their true selves when their music had properly hit critical mass. Now, the cats out of the bag: The band is helmed by Neon Gold Records founder Lizzy Plapinger and Idaho-born producer Max Hershenow, who have turned their dark and mysterious bedroom project into a fully-fledged Tumblr-glitch-pop band (their words). Ahead of their debut Australian tour for [aa,artist:Laneway Festival], the pair spoke rather excitedly to FL about their developing live show, a forthcoming full-length album and the importance of anonymity. I bet you didnt think youd be talking to a journalist in Australia a year ago. Lizzy: [Laughs] No, we definitely didnt. Max: Weve been blown away by the experience so far. Lizzy: But now its really lovely. We have an Australian connection. Do you know much about Laneway? Lizzy: Weve been fans of the festival … Continue reading
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Rogue Immune Cells Tied to MS Point to New Drug Target
Posted: Published on January 30th, 2013
Researchers identified a possible culprit for immune cells resistance to regulation in a small study of multiple sclerosis patients, suggesting a potential new target for treatment. T-cells, when working properly, are an important part of the immune systems arsenal for fighting off invaders. In MS patients, however, they can ignore the controlling orders from regulatory cells and attack the central nervous system, researchers found in a study published today in the journal Science Translational Medicine. Scientists at Virginia Mason Medical Center in Seattle identified a protein called interleukin-6, or IL-6, as a reason for those cells going rogue in patients with relapsing-remitting MS, the most common form of the disease. We identified a new problem in multiple sclerosis that hadnt been identified before, Jane Hoyt Buckner, an author of the paper and associate director of Virginia Masons Benaroya Research Institute, said today in a telephone interview. Then we were able to show why that happens in MS patients, which is this enhanced responsiveness to the cytokine IL-6. People with relapsing-remitting MS have more receptors for IL-6 on the surface of their T-cells, suggesting IL-6 may be a good target for therapy, Buckner said. More than 2.1 million people worldwide have … Continue reading
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New drill-less technique may reduce kids' fear of the dentist
Posted: Published on January 29th, 2013
Children have been shown to significantly prefer a new way of treating tooth decay that doesnt involve needles or drills. Dr Lyndie Foster Page, head of preventive and restorative dentistry at the University of Otago Dental School, and colleague Ms Dorothy Boyd, a specialist paediatric dentist, trained 10 Hawkes Bay dental therapists to use the new Hall technique as part of a feasibility study funded by the Health Research Council of New Zealand (HRC). The Hall technique, which was developed by Scottish dentist Dr Norna Hall, involves placing a stainless steel crown over a baby molar tooth to seal the decay in, rather than the conventional method of removing the decay with a drill and then placing a filling. Starved of nutrients, the decay then stops or slows down. The crown stays in place until it falls out naturally with the tooth at about age 10. Of the nearly 190 children between 5 and 8 years old who took part in the Hawkes Bay study, just over half were Mori. Nearly 100 children received treatment for their decayed teeth using the Hall technique, while the remainder were treated using conventional methods. Many of the children already had six or seven … Continue reading
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Sanofi Filing for Lemtrada MS Drug Accepted for Review by FDA
Posted: Published on January 29th, 2013
The U.S. Food and Drug Administration accepted Sanofi (SAN)s application for approval of the multiple sclerosis drug Lemtrada, five months after rejecting an initial filing because of the way data was formatted. Sanofis Genzyme unit expects a decision by the agency in the second half of the year, the Paris-based company said in a statement today. The FDA refused to accept the first Lemtrada filing and asked that the company modify the presentation of data to allow regulators to better navigate the application, Sanofi said Aug. 27. Chief Executive Officer Chris Viehbacher is counting on new drugs to help boost earnings at Frances biggest drugmaker. Investors still underestimate the companys pipeline of experimental medicines, he said in an interview Jan. 25. Sanofi also has applied for marketing authorization for Lemtrada in the European Union, and the European Medicines Agency is expected to rule in the second quarter, according to the statement. Sanofi, which obtained Lemtrada in the $20.1 billion purchase of Genzyme in 2011, is developing the medicine in collaboration with Bayer AG. (BAYN) Sanofi rose 0.5 percent to close at 73.09 euros Jan. 25 in Paris trading. The stock has gained 2.4 percent this year. The FDA in September … Continue reading
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FDA accepts application for new Sanofi MS drug
Posted: Published on January 29th, 2013
NEW YORK (AP) -- French drugmaker Sanofi said Monday that the Food and Drug Administration will review its experimental multiple sclerosis treatment Lemtrada. Genzyme, Sanofi's U.S. biotech business, said the FDA will conduct a standard 10-month review and will make a decision on the drug in late 2013. Sanofi wants to market Lemtrada as a treatment for relapsing multiple sclerosis. German drugmaker Bayer will have an option to help market the drug in the U.S. if it is approved. Genzyme filed for marketing approval of Lemtrada in June, but the FDA refused the application because it wanted Genzyme to make changes to its application. European Union regulators are also reviewing the drug. Sanofi also gave an update on early sales of Aubagio, an MS drug that was approved in September 2012 and launched in October. The company said more than 80 percent of U.S. multiple sclerosis specialists have written a prescription for the drug. About half of the patients who are taking Aubagio were most recently treated with Teva Pharmaceutical Industries Ltd.'s drug Copaxone or Biogen Idec Inc.'s Avonex. About 20 percent of patients hadn't been treated before. U.S shares of Sanofi fell 17 cents to $49.10 in morning trading. … Continue reading
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UPDATE 4-Despite Biogen profit dip, shares rise on MS drug optimism
Posted: Published on January 29th, 2013
* Net profit falls on tax error * 2013 forecast weaker than expected * Q4 adjusted earnings $1.40/shr vs $1.46 view (Updates with CFO and analyst comments) By Toni Clarke BOSTON, Jan 28 (Reuters) - Biogen Idec Inc (NasdaqGS: BIIB - news) said fourth-quarter net profit fell slightly due to a tax accounting error, but the company's shares rose more than 3 percent Monday on higher-than-expected drug sales and optimism over a new multiple sclerosis treatment. The oral drug BG-12, to be sold under the brand name Tecfidera, is expected to become a leading treatment for multiple sclerosis after its planned second quarter introduction. Gene Mack, an analyst at Brean Capital LLC, estimates that by 2015, Tecfidera will account for $1.4 billion, or roughly 25 percent, of the company's multiple sclerosis drug sales. In the fourth quarter, global sales of Biogen's multiple sclerosis drug Tysabri rose 14 percent to $433 million a year ago, while sales of another MS treatment, Avonex, rose 7 percent to $753 million, the company said. Biogen markets Tysabri in conjunction with Elan Corp Plc. "We believe we are entering into an era of significant long-term growth driven by multiple potential new product launches," George Scangos, … Continue reading
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Genzyme’s LEMTRADA™ (alemtuzumab) Application for MS Accepted for Review by the FDA
Posted: Published on January 29th, 2013
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi Company (EURONEXT: SAN and NYSE: SNY), announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companys supplemental Biologics License Application (sBLA) file seeking approval of LEMTRADA (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS). The company also reported key highlights from the U.S. launch of once-daily, oral AUBAGIO (teriflunomide). LEMTRADA sBLA Accepted by FDA The FDA has accepted for standard review the companys sBLA file seeking approval of LEMTRADA. Genzyme expects FDA action on the application in the second half of 2013. Genzyme has already submitted its marketing authorization application for LEMTRADA to the European Medicines Agency (EMA) and the review process is underway. The Committee for Medicinal Products for Human Use (CHMP) opinion for LEMTRADA is expected in Q2 2013. The LEMTRADA clinical development program includes CARE-MS I and CARE-MS II (Comparison of Alemtuzumab and RebifEfficacy in Multiple Sclerosis), randomized Phase III studies comparing LEMTRADA to a standard of care MS treatment, Rebif,in patients with relapsing-remitting MS who were nave to prior treatment or who had relapsed while on prior therapy, respectively. Genzyme announced publication of results of these studies in The Lancet in November 2012. AUBAGIO … Continue reading
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PsorCARE Program by LEO Pharma Asia Focuses on Treatment Adherence to Improve Psoriasis Treatment Outcomes
Posted: Published on January 28th, 2013
SINGAPORE, Jan. 28, 2013 /PRNewswire/ -- Psoriasis is a little-understood skin condition that carries a strong social stigma through its emotional impact on sufferers that can far outweigh the disease's physical impact. That is why proper support and guidance from healthcare providers is crucial in achieving optimal treatment adherence, one of the main challenges in psoriasis management. (Logo: http://www.newscom.com/cgi-bin/prnh/20110606/460992 ) LEO Pharma, the global leader in dermatology care, announced the launch of the PsorCARE program in Asia, starting with Singapore, on 26 January 2013. The first-of-its-kind initiative in the region, PsorCARE, which stands for "Psoriasis Coach All-Round Education", will kick off on 26 January, 2013. Developed by LEO Pharma Asia and PsorAsia, PsorCARE's goal is to enhance the counseling skills of healthcare practitioners for optimal patient-healthcare provider relationship leading to better treatment outcomes for those who suffer from the skin condition Psoriasis. "LEO Pharma is committed to bringing this program to Asia because we are aware of the challenges that patients with Psoriasis face in their everyday lives. We want patients with Psoriasis to know that trained support is available and that it is possible for them to live life as normally as possible. Our ultimate aim is to give … Continue reading
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Biogen Advances with MS Candidate
Posted: Published on January 26th, 2013
Biogen Idec (BIIB) recently announced positive top-line data on its phase III multiple sclerosis candidate, peginterferon beta-1a. Results from the ADVANCE study showed that peginterferon beta-1a met the primary endpoint as well as secondary endpoints. Detailed Results Two doses (once in two weeks and once in four weeks) of peginterferon beta-1a were compared to placebo in the study that was conducted to evaluate the safety and efficacy of the candidate in patients suffering from relapsing-remitting multiple sclerosis (RRMS). Both dosing regimens met the primary endpoint of annualized relapse rate (ARR) at one year. While ARR reduction was 35.6% in the two-week regimen, the four-week regimen saw a 27.5% reduction in ARR. Secondary endpoints included reduction of the risk of 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (38% for both dosing arms), reduction in the proportion of patients who relapsed (39% the two-week dosing arm and 26% in the four-week dosing arm) and reduction in the number of new or newly enlarging T2-hyperintense lesions on brain MRI scans (67% in the two-week dosing arm and 28% in the four-week dosing arm). Biogen said that safety and tolerability profiles were favorable in both arms. Biogen intends to … Continue reading
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