Category Archives: MS Treatment

DUBLIN--(BUSINESS WIRE)-- TYSABRI is an important treatment option for thousands of people living with MS BIOGEN IDEC AND ELAN SUBMIT APPLICATIONS FOR FIRST-LINE USE OF TYSABRI IN ANTI-JCV ANTIBODY NEGATIVE PATIENTS WITH MS - Marketing Applications Supported by Risk Stratification Data - Weston, Mass. & Dublin January 16, 2013 Today Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that they have submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) requesting updates to the TYSABRI (natalizumab) labels. The applications request an expanded indication that would include first-line use for people living with certain relapsing forms of multiple sclerosis (MS) who have tested negative for antibodies to the JC virus (JCV). A formal assessment of both applications is ongoing. These submissions are supported by risk stratification data and a risk algorithm that enables physicians and individuals living with MS to make informed decisions when considering treatment with TYSABRI. If approved, a first-line label will allow all appropriate anti-JCV antibody negative patients to consider TYSABRI early in the course of treatment, regardless of the level of disease activity or prior treatment history. TYSABRI is a highly efficacious treatment that has been shown to … Continue reading →

(Adds analyst comment, background) * Firms hope new test will pave way for wider use of drug * Tysabri highly effective but PML risk has curbed uptake LONDON, Jan 16 (Reuters) - Biogen Idec (NasdaqGS: BIIB - news) and Elan have filed for approval to sell their drug Tysabri as a first-line treatment for multiple sclerosis, a move that could boost sales of the drug. Demand for Tysabri has been curtailed due to concerns over its association with a potentially fatal infection known as progressive multifocal leukoencephalopathy, or PML, which is caused by the JC virus. Now (Other OTC: NWPN - news) , however, there is a test for the virus to predict if patients are at risk of developing PML, opening the possibility that Tysabri could be used more widely and at an earlier stage of treatment. Biogen and Elan said on Wednesday they had submitted applications to the U.S. Food and Drug Administration and the European Medicines Agency seeking approval for first-line use in patients with relapsing forms of multiple sclerosis (MS) who have tested negative for antibodies to the JC virus. The JC virus is generally harmless, but in people with weakened immune systems, such as those … Continue reading →

Elan and Biogen Idec hope Tysabri would be used more widely and at earlier stage of treatment for MS Elan and Biogen Idec have filed for approval to sell their drug Tysabri as a first-line treatment for multiple sclerosis. The move that could boost sales of the drug. Demand for Tysabri has been curtailed due to concerns over its association with a potentially fatal infection known as progressive multifocal leukoencephalopathy, or PML, which is caused by the JC virus. Now, however, there is a test for the virus to predict if patients are at risk of developing PML. This opens the possibility that Tysabri could be used more widely and at an earlier stage of treatment. Elan and Biogen said today they had submitted applications to the US Food and Drug Administration and the European Medicines Agency seeking approval for first-line use in patients with relapsing forms of multiple sclerosis (MS) who have tested negative for antibodies to the JC virus. The JC virus is generally harmless, but in people with weakened immune systems, such as those using immune system-suppressing drugs like Tysabri, it can lead to an increased chance of developing PML. Tysabri use is currently limited to between … Continue reading →

LONDON (Reuters) - Biogen Idec and Elan have filed for approval to sell their drug Tysabri as a first-line treatment for multiple sclerosis, a move that could boost sales of the drug. Demand for Tysabri has been curtailed due to concerns over its association with a potentially fatal infection known as progressive multifocal leukoencephalopathy, or PML, which is caused by the JC virus. Now, however, there is a test for the virus to predict if patients are at risk of developing PML, opening the possibility that Tysabri could be used more widely and at an earlier stage of treatment. Biogen and Elan said on Wednesday they had submitted applications to the U.S. Food and Drug Administration and the European Medicines Agency seeking approval for first-line use in patients with relapsing forms of multiple sclerosis (MS) who have tested negative for antibodies to the JC virus. The JC virus is generally harmless, but in people with weakened immune systems, such as those using immune system-suppressing drugs like Tysabri, it can lead to an increased chance of developing PML. Tysabri use is currently limited to between 10 and 12 percent of treated MS patients, due to the risk of PML, and analysts … Continue reading →

WESTON, Mass. & DUBLIN--(BUSINESS WIRE)-- Today Biogen Idec (BIIB) and Elan Corporation, plc (ELN) announced that they have submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) requesting updates to the TYSABRI (natalizumab) labels. The applications request an expanded indication that would include first-line use for people living with certain relapsing forms of multiple sclerosis (MS) who have tested negative for antibodies to the JC virus (JCV). A formal assessment of both applications is ongoing. These submissions are supported by risk stratification data and a risk algorithm that enables physicians and individuals living with MS to make informed decisions when considering treatment with TYSABRI. If approved, a first-line label will allow all appropriate anti-JCV antibody negative patients to consider TYSABRI early in the course of treatment, regardless of the level of disease activity or prior treatment history. TYSABRI is a highly efficacious treatment that has been shown to slow disability progression by 42 54 percent and reduce annualized relapse rates by 68 percent. Our anti-JCV antibody test, STRATIFY JCV, helps to determine the most appropriate patients for TYSABRI and the data collected to date supports our recent filing for first-line use, said Alfred Sandrock, … Continue reading →

THE WOODLANDS, Texas--(BUSINESS WIRE)-- Opexa Therapeutics, Inc. (OPXA), a company developing Tcelna, a novel T-cell therapy for multiple sclerosis (MS), today announced that it has received a letter from The NASDAQ Stock Market LLC notifying the Company that it has regained full compliance with the NASDAQ Capital Market's minimum bid price continued listing requirement. The letter noted that as of December 31, 2012, the Company evidenced a closing bid price of its common stock in excess of the $1.00 minimum requirement for at least ten consecutive trading days. Accordingly, the Company has regained compliance with NASDAQ Marketplace Rule 5550(a)(2) and NASDAQ considers the matter closed. The Company has submitted its plan to regain compliance with NASDAQs minimum stockholders equity listing standard set forth in listing rule 5550(b)(1), and NASDAQ is currently reviewing the plan. If the Companys plan is accepted, NASDAQ may grant an extension until May 25, 2013 for the Company to regain compliance with the minimum stockholders equity standard. About Opexa Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as MS. The Companys leading therapy, Tcelna, is a personalized cellular immunotherapy treatment that is in late stage … Continue reading →

Lindsay B. Eastman, DDS, MS, PA, provides technologically advanced gum disease treatment with the Laser Assisted New Attachment Procedure. The laser procedure allows Dr. Eastman to eliminate gum disease from the mouths of patients without using a scalpel to cut away the diseased tissue, and downtime is much shorter than with traditional treatment methods. (PRWEB) January 14, 2013 Although there are literally millions of people across the country suffering from gum disease, many of them do not get treatment. Whether they are putting it off because of lack of time or out of fear of traditional treatment methods, the results are the same; they are putting themselves at risk. Not only can periodontal disease cause painful gums that may bleed easily and lead to possible tooth loss, but it has also been scientifically connected to serious health issues. Some of these complications include low birth-weight babies, heart disease and pancreatic cancer. The technologically advanced LANAP gum disease treatment procedure provides a new take on treatment methods. Rather than utilizing a scalpel to cut away diseased gum tissue, the new protocol uses a very specialized and sophisticated laser. The PerioLase MVP-7 laser is designed to eradicate bacteria and dissolve away diseased … Continue reading →

Hudson, OH (PRWEB) January 14, 2013 onPoint Oncology is pleased to announce that Rhoda Dunn is the companys newest Principal. Ms. Dunn will focus on her core areas of synergistic expertise: coverage, reimbursement, and patient access. For over 13 years, Ms. Dunn has led numerous client engagements to assess the impact of government policy, pricing and reimbursement, and payer utilization management on the adoption and utilization of cancer therapeutics. She has also delivered numerous projects that have supported go/no-go decisions for pipeline compounds, such as disease state opportunity and reimbursement assessments. Besides extensive experience with many disease states, Ms. Dunn has become a domain expert on the treatment of advanced prostate cancer. Prior to joining onPoint Oncology, Ms. Dunn edited and authored a variety of reports, including the 2009 edition of Oncology Market Access Europe and the 2011 and 2012 editions of Oncology Market Access US for her previous employer, Kantar Health. Ms. Dunn began her career in medical publishing, where she spent 5 years garnering in-depth content development and publishing experience. She then applied this knowledge to medical education before focusing her efforts on marketing for the past 15 years. Ms. Dunn earned a B.A. in English from the … Continue reading →

KALAMAZOO, MI The U.S. Food and Drug Administration approvedPfizer Inc. and EMD Serono, Inc.s single-use, auto-injector treatment device for multiple sclerosis patients called Rebif Rebidose on Jan. 3. We are pleased to announce the FDA has approved Rebif Rebidose which provides people living with relapsing MS another option to meet their injection needs," said James Hoyes , president of EMD Serono, Inc. With this approval, all three delivery options of Rebif, which comes in prefilled syringes, Rebiject II and now Rebif Rebidose, will be available in the U.S. for patients treating their relapsing forms of MS. The pharmaceutical companies say the auto-injector device is designed to assist with ease of use as an alternative delivery option. Rebif Rebidose will be available in a monthly pack in doses of 22 micrograms and 44 micrograms and in a titration pack. The treatment device was evaluated in a 12-week, single-arm study for the self-administration of Rebif with respect to ease of use in 109 patients with relapsing MS, who were receiving Rebif 44 microgram three times weekly for more than 12 weeks, continued MS therapy using Rebif Rebidose for 12 weeks. The results of the Rebif Rebidose user trial showed that the majority … Continue reading →

FORT WORTH, Texas, Jan. 13, 2013 (GLOBE NEWSWIRE) -- Back to Health Family Chiropractic in Fort Worth, TX announced that the practice has had significant success using chiropractic care to help manage and significantly lessen the symptoms of multiple sclerosis (MS). To better educate individuals about the benefits of spinal adjustments, the practice is offering a free video series on its website, http://backtohealthtexas.com. The videos include testimonials from patients about how the ways spinal adjustments have helped alleviate their symptoms including tingling, muscle weakness, numbness and back pain. Ft. Worth chiropractor Dr. Chris Michlin is expanding access to free online information about the benefits of chiropractic care for MS symptoms. "Chiropractic care is often an effective alternative to or partner with medication in the treatment of MS," said Dr. Michlin. "Our online video series is designed to educate patients and their families about how spinal adjustments work and why they can make a difference for managing MS." While there is no currently known cure for MS, traditional medical treatments rely on medication to manage MS symptoms, reduce the frequency of attacks and modify the disease's course. According to Dr. Michlin, many patients and their families wonder if medication is really … Continue reading →