Category Archives: MS Treatment

JON CHASE FOR THE BOSTON GLOBE Susan Cohn-Child said the pill would be a game changer, especially for patients who have difficulty injecting themselves. For 15 years, Susan Cohn-Child has injected herself with a multiple sclerosis drug at least once a week to keep the disease in check. But Cohn-Child and thousands of other MS patients may soon be able to replace their needles with a pill being developed by Biogen Idec Inc. Following promising clinical trial results that sent Biogen Idec shares soaring last spring, the Weston biotechnology company yesterday filed a new drug application with the Food and Drug Administration seeking approval to sell the oral treatment, now known as BG-12. Most existing treatments for the autoimmune disorder, which affects about 400,000 people in the United States, require regular injections or intravenous infusions. One other oral treatment exists, but there is hope that the new Biogen Idec drug will prove a more effective option. Cohn-Child, 47, a financial manager who volunteers with the National Multiple Sclerosis Society to raise awareness about the disease, said the pill would be a game changer, especially for patients who have difficulty injecting themselves. The Acton mother currently uses Avonex, also made by … Continue reading →

27-02-2012 03:48 S2 Slimming dedicated to enhance your lifestyle through a series of centuries old techniques, Manual Hand Therapies. S2 Slimming is founded by Ms Stella Lim who possessed over 20 years of experience in slimming and successfully mastered the hand skills originated from Hong Kong in aim to improve one's overall wellbeing through the basics of wellness... S2 Slimming had accreditation by Malaysia Book of Record in "The Most Weight Lost Campaign", there are total 50 contestants to lost 500kg in 3 months. For more info: Facebook: http://www.facebook.com/MyS2Slimming Website: http://www.s2slimming.com.my Visit link: S2 Slimming Signature Treatment … Continue reading →

- EMA Submission Anticipated within the Coming Days - WESTON, Mass.--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: BIIB) announced the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of BG-12 (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS). The regulatory submission was based on BG-12’s comprehensive development program, in which BG-12 demonstrated significant reductions in MS disease activity coupled with favorable safety and tolerability in the Phase 3 DEFINE and CONFIRM studies. “While there have been important therapeutic advances in MS over the last 15 years, there is still a significant unmet need for new and innovative therapies that target the disease in different ways” “While there have been important therapeutic advances in MS over the last 15 years, there is still a significant unmet need for new and innovative therapies that target the disease in different ways,” said Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development. “Based on the robust clinical efficacy and safety data seen in our Phase 3 studies, we believe BG-12 has the potential to become an important oral treatment option for MS patients.” Biogen Idec … Continue reading →

The Appalachian Trail is 2200 miles of raw nature. It passes through 14 states. At times a treacherous terrain that starts in Georgia and ends in Maine. It will take Tim Cook six months to walk its entire path.   But this is a journey to find a cure for the only person who really understands why he is doing it. "Cathy and I met when we were down in Bernie, Texas, just outside of San Antonio.   In fact we were the only two people above the age of sixteen and under the age of eighty that were single so," Tim remembers.  They've been together ever since.   If you've ever met the cooks you know you've just experienced something special.  A bond they've leaned on for the last two years.  That's because two years ago when Cathy lost sight in one of her eyes, she was diagnosed with Relapsing Remitting Multiple Sclerosis.   April Brownlee with the National Multiple Sclerosis Society explains what MS. is, ". . .the coating on your nerves is called Myelin it wears away for whatever reason the body eats away at that coating, and it basically causes your body to short circuit." SOT Cathy recalls how she … Continue reading →

WESTON, Mass.--(BUSINESS WIRE)-- Today Biogen Idec (NASDAQ: BIIB - News) announced that the U.S. Food and Drug Administration (FDA) has approved two separate dosing innovations designed to improve the treatment experience for patients receiving once-a-week AVONEX for relapsing forms of multiple sclerosis (MS). AVONEX PEN, the first intramuscular (IM) autoinjector approved for MS, incorporates a smaller needle and easier administration to help patients reduce anxiety about AVONEX self-injection. A new dose titration regimen, which gradually escalates the dose of AVONEX at treatment initiation, reduces the incidence and severity of flu-like symptoms that can occur at the beginning of therapy. “AVONEX has been an effective treatment for MS for more than 15 years, and data have shown it to have the highest adherence rate among currently marketed injectable therapies,” said Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development. “However, anxiety around administration and the potential for flu-like symptoms can be a barrier for some patients. AVONEX PEN and the new titration regimen reflect our commitment to enhancing the Biogen Idec products that people with MS rely on today.” AVONEX PEN (AVONEX 30mcg/0.5mL solution for injection) is an automated injection device designed to be easier to use … Continue reading →

By Chris Reidy, Globe Staff Biogen Idec Inc., a Weston-based biotechnology company known for its multiple sclerosis drugs, said it has submitted a New Drug Application to federal regulators to get approval to market a potential new MS treatment known as BG-12. In December, Biogen Idec shares hit their high for 2011 after the company released promising results from a clinical trial of BG-12. BG-12, the company’s designation for dimethyl fumarate, would be taken twice a day in pill form, and it is designed to treat of relapsing-remitting multiple sclerosis, sometimes called RRMS, the most common form of MS, Biogen Idec said in a press release. Two other Biogen Idec MS drugs are delivered differently. Tysabri is administered in a once-a-month infusion, and Avonex is injected once a week, the company said. Biogen Idec, which said today that it had submitted a New Drug Application to the US Food and Drug Administration, added that it plans to submit a similar request to European regulators within the next few days. Biogen Idec said it anticipates hearing from regulatory authorities regarding the status and acceptance of its BG-12 submissions “within the next couple of months.” In a separate press release this morning, … Continue reading →

carly weeks From Tuesday's Globe and Mail Published Monday, Feb. 27, 2012 4:23PM EST Last updated Monday, Feb. 27, 2012 4:29PM EST Serious safety concerns over a popular oral medication used to treat multiple sclerosis have prompted Health Canada to launch a full investigation. The department made the announcement on Monday after reports of 11 deaths worldwide that have been linked to the drug fingolimod. When fingolimod, sold under the brand name Gilenya, was approved in Canada last March, it was known the drug could increase the risk of heart problems, such as a decreased or abnormal heart rate, after the first dose. But Health Canada and many other regulators around the world ruled that the benefits of the drug outweighed the risks. More related to this story None of the deaths linked to Gilenya occurred in Canada. But Health Canada has received 52 reports of adverse events linked to fingolimod since last April. At least 14 reports came from patients who experienced a decreased heart rate after taking the drug. Other reported problems include blood pressure fluctuation, fatigue and dizziness. Gilenya, marketed by Novartis, is the first oral medication approved for treatment of relapsing-remitting MS, the most common form … Continue reading →

TORONTO - Health Canada is reviewing a new multiple sclerosis drug that has been linked to 11 deaths. There have been no reports of deaths in Canada of people taking the Novartis drug, which is sold under the brand name Gilenya. Health Canada says that of the deaths outside the country, it's not clear whether the drug itself caused them, or whether other factors played a role. Both the U.S. Food and Drug Administration and the European Medicines Agency had earlier announced that they were undertaking reviews of Gilenya. Gilenya is used for treatment of relapsing-remitting MS to reduce the frequency of attacks and to delay physical disability; it is generally recommended when other MS treatments have not been effective or cannot be tolerated. At the time the drug was authorized, it was known that certain types of heart rhythm disturbances can be seen with Gilenya use and the Canadian labelling contains several warnings to this effect. But Health Canada says it felt the drug's benefits outweighed its risks. Of the 11 reported deaths, four involved serious heart-related events — three were heart attacks and another a disturbance of the heart rhythm. The seven other deaths are unexplained, including one … Continue reading →

Health Canada is reviewing a new multiple sclerosis drug that has been linked to 11 deaths. There have been no reports of deaths in Canada of people taking the Novartis drug, which is sold under the brand name Gilenya. Gilenya, also called fingolimod, is taken once a day for people with the relapsing-remitting form of MS. (Novartis) Health Canada says that of the deaths outside the country, it's not clear whether the drug itself caused them, or whether other factors played a role. Both the U.S. Food and Drug Administration and the European Medicines Agency had earlier announced that they were undertaking reviews of Gilenya. Gilenya is used for treatment of relapsing-remitting MS to reduce the frequency of attacks and to delay physical disability; it is generally recommended when other MS treatments have not been effective or cannot be tolerated. At the time the drug was authorized, it was known that certain types of heart rhythm disturbances can be seen with Gilenya use and the Canadian labelling contains several warnings to this effect. But Health Canada says it felt the drug's benefits outweighed its risks. Of the 11 reported deaths, four involved serious heart-related events — three were heart attacks … Continue reading →

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