Tag Archives: Multiple Sclerosis

Business, Finance, Occupation & Industry

Beloved Disney Mouseketeer and Iconic Teen Star Annette Funicello Dies at Age 70

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By Business Wirevia The Motley Fool

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Beloved Disney Mouseketeer and Iconic Teen Star Annette Funicello Dies at Age 70

BURBANK, Calif.–(BUSINESS WIRE)– Actress Annette Funicello, long-time Disney and Beach Party star, passed away on Monday April 8 at Mercy Southwest Hospital in Bakersfield, CA, at the age of 70. She died peacefully from complications due to Multiple Sclerosis, a disease she battled for over 25 years. Beloved by television viewers in the 50s for her stint on Disney’s original The Mickey Mouse Club, and by film buffs for her numerous roles in a series of popular teen-oriented movies in the 60s, Funicello became a pop culture icon.

Annette Funicello 1942-2013 Attribution (C) Disney

Commenting on her passing, Bob Iger, Chairman and CEO of The Walt Disney Company, said, “Annette was and always will be a cherished member of the Disney family, synonymous with the word Mousketeer, and a true Disney Legend. She will forever hold a place in our hearts as one of Walt Disney‘s brightest stars, delighting an entire generation of baby boomers with her jubilant personality and endless talent. Annette was well known for being as beautiful inside as she was on the outside, and she faced her physical challenges with dignity, bravery and grace. All of us at Disney join with family, friends, and fans around the world in celebrating her extraordinary life.”

Diane Disney Miller, daughter of Walt Disney, added, “Everyone who knew Annette loved and respected her. She was one of the loveliest people I’ve ever known, and was always so kind to everyone. She was also the consummate professional, and had such great loyalty to my father. Annette will always be very special to me and Ron.” Diane’s husband, Ron Miller, who helmed the Disney company in the 1980s and worked with Annette when he was a young assistant on The Mickey Mouse Club, recalled, “She was always in good spirits and ready to help out if she needed to step in when something unexpected happened.”

Oscar®-winning composer and Disney Legend Richard Sherman, who, with his late brother Robert, wrote many of Annette’s biggest song hits, said, “Annette’s sweet, unassuming spirit, her love of people, and her capacity to exude kindness and good feelings to everyone she met was part of her beautiful charisma. Because the songs we wrote for her brought us to the attention of Walt, Bob and I always referred to Annette as our ‘lucky star.’ My wife, Elizabeth, joins me in sending a heartfelt aloha with much love to our ‘Pineapple Princess.'”

…read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Genzyme's Once-daily, Oral AUBAGIO® (teriflunomide) Approved in Argentina for the Treatment of Relap

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By Business Wirevia The Motley Fool

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Genzyme’s Once-daily, Oral AUBAGIO ® (teriflunomide) Approved in Argentina for the Treatment of Relapsing Multiple Sclerosis

Approval Expands Footprint of AUBAGIO Across Three Continents and Further Advances Genzyme’s Global MS Franchise

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today Argentina‘s National Administration of Drugs, Food and Medical Technology (ANMAT) has approved once-daily, oral AUBAGIO® 14 mg as a new treatment indicated for patients with relapsing forms of multiple sclerosis (MS).

“Studied in one of the largest clinical trial programs of any MS treatment, AUBAGIO has had consistent effects across all the important measures of MS disease activity including slowing the progression of disability, reducing the number of brain lesions as detected by MRI and reducing relapses. The clinical data supporting AUBAGIO confirm its importance as a new treatment option for MS patients,” said Dr. Jorge Correale, Head of Neuroimmunology and Demyelinating Diseases, Raul Carrea Institute for Neurological Research FLENI, Argentina.

The decision by ANMAT represents the first approval for once-daily, oral AUBAGIO in Latin America. AUBAGIO is also approved in both the United States and Australia, with additional marketing applications under review by regulatory authorities around the world.

“The approval in Argentina of once-daily, oral AUBAGIO represents another important advancement for the Genzyme MS Franchise,” said Bill Sibold, SVP, Head of MS Business, Genzyme. “Genzyme is committed to becoming leaders in MS and developing differentiated treatments that can address the diverse needs of the MS community. Now approved on three continents, AUBAGIO‘s established efficacy and convenient dosing can provide many patients with an attractive alternative to frequent and potentially burdensome injections.”

The ANMAT approval of AUBAGIO was based on safety and efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. The ongoing AUBAGIO clinical development program, involving more than 5,000 patients in 36 countries, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years.

“AUBAGIO, in its clinical studies, has shown favorable efficacy and a well-characterized safety profile. With its once-daily oral administration and tolerability, AUBAGIO should contribute positively to the care of patients with Multiple Sclerosis,” said Dr. Edgardo Cristiano, Head of the Neurology Department of the Hospital Italiano de Buenos Aires, Argentina.

About AUBAGIO ®

AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Opexa Therapeutics to Present at the Regenerative Medicine – A Fundamental Shift in Science & Cultur

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By Business Wirevia The Motley Fool

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Opexa Therapeutics to Present at the Regenerative Medicine – A Fundamental Shift in Science & Culture Conference

THE WOODLANDS, Texas–(BUSINESS WIRE)– Opexa Therapeutics, Inc. (NAS: OPXA) , a biotechnology company developing Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), today announced that Neil K. Warma, President and Chief Executive Officer, will present at The Second International Vatican Adult Stem Cell Conference: Regenerative Medicine — A Fundamental Shift in Science & Culture, taking place from within The Vatican, April 11-13, 2013.

The conference is part of a five-year collaboration between The Stem for Life Foundation, a not-for-profit organization devoted to raising global awareness of the therapeutic potential of adult stem cells, NeoStem, a leader in the emerging cellular therapy industry and The Vatican’s Pontifical Council for Culture and its foundation, called STOQ International (Science, Theology and the Ontological Quest). Among the conference goals are to raise awareness of existing therapies, reduce misperceptions surrounding the field of cellular research and to foster dialogue among researchers, physicians, philanthropists, faith leaders and policy makers to identify unmet medical needs that can benefit from the development of cell therapies.

“Opexa is proud to be a part of this international forum designed to highlight the important contributions made by the cell therapy industry to date and to increase awareness of cellular research and the potential of cell therapies to address unmet medical needs,” commented Neil K. Warma, President and Chief Executive Officer of Opexa.

Opexa will be included in a special luncheon, Living with Multiple Sclerosis, featuring Meredith Vieira from NBC news and Richard M. Cohen, journalist and husband of Ms. Vieira.

About Tcelna

Tcelna is a personalized therapy that is specifically tailored to each patient’s disease profile. Tcelna is manufactured using ImmPath™, Opexa’s proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, attenuated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response. Opexa believes the potential combination of efficacy, superior safety, excellent tolerability and administration may position Tcelna as the MS treatment of choice as compared …read more

Source: FULL ARTICLE at DailyFinance

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The Lancet Publishes SELECT Study Evaluating Efficacy and Safety of Daclizumab HYP in Multiple Scler

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By Business Wirevia The Motley Fool

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The Lancet Publishes SELECT Study Evaluating Efficacy and Safety of Daclizumab HYP in Multiple Sclerosis

-Data Demonstrated That DAC HYP Significantly Reduced Annualized Relapse Rate by up to 54 Percent at One Year-

-Phase 3 Study Underway to Further Assess Once-Monthly DAC HYP for Multiple Sclerosis-

WESTON, Mass.–(BUSINESS WIRE)– Today Biogen Idec (NAS: BIIB) announced that results from the daclizumab high-yield process (DAC HYP) SELECT clinical trial have been published as an online article in The Lancet. SELECT was a Phase 2b study designed to determine the efficacy and safety of DAC HYP in patients with relapsing-remitting multiple sclerosis (RRMS).

Published results demonstrate that both 150 mg and 300 mg subcutaneous injections of DAC HYP, administered once every four weeks, met the study’s primary endpoint by significantly reducing annualized relapse rate (ARR) by 54 percent (p<0.0001) and 50 percent (p=0.0002), respectively, compared to placebo at one year. In addition, results demonstrated that DAC HYP reduced multiple sclerosis (MS) brain lesions compared to placebo.

“DAC HYP represents the type of innovative research we are focused on cultivating as part of our MS pipeline because it potentially targets the disease in a new way,” said Gilmore O’Neill, M.D., vice president, Medical Research at Biogen Idec. “Based on these initial data from SELECT, we believe DAC HYP would complement our robust portfolio of four approved MS products by potentially offering people with MS a new treatment alternative. We look forward to continuing to work with our partners at AbbVie to progress the DAC HYP program further.”

Both doses of DAC HYP met key secondary endpoints in the study by significantly reducing the proportion of patients who relapsed at one year, as well as MS brain lesion activity, including the cumulative number of new gadolinium-enhancing (Gd+) lesions between weeks eight and 24 and the number of new or newly enlarging T2-hyperintense lesions at one year. Both doses of DAC HYP also demonstrated a trend in improvements in quality of life (QoL) compared to placebo as measured by the Multiple Sclerosis Impact Scale (MSIS-29) physical impact score.

“Because MS is unique to each person, we need a variety of treatment options to attack the disease in different ways,” said Ralf Gold, M.D., professor/chair of the Department of Neurology at St. Josef-Hospital/Ruhr-University in Bochum, Germany, and …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Biogen Idec's TECFIDERA™ (Dimethyl Fumarate) Approved in US as a First-Line Oral Treatment for Multi

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By Business Wirevia The Motley Fool

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Biogen Idec’s TECFIDERA™ (Dimethyl Fumarate) Approved in US as a First-Line Oral Treatment for Multiple Sclerosis

– Offers a Broad Spectrum of Patients with Relapsing Forms of MS an Effective and Convenient Treatment Option –

– Reduces Relapses and Disability Progression –

– Strengthens Biogen Idec’s Portfolio of Innovative Treatments for People Living with MS –

WESTON, Mass.–(BUSINESS WIRE)– Today Biogen Idec (NAS: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TECFIDERA™ (dimethyl fumarate), a new first-line oral treatment for people with relapsing forms of multiple sclerosis (MS). Biogen Idec will make this oral capsule available to people living with MS in the United States in the coming days.

Image of Biogen Idec‘s TECFIDERA(TM) (dimethyl fumarate) which was approved by the U.S. FDA on March 27, 2013 for relapsing multiple sclerosis. (Photo: Business Wire)

TECFIDERA has been clinically proven to significantly reduce important measures of disease activity, including relapses and development of brain lesions, as well as to slow disability progression over time, while demonstrating a favorable safety and tolerability profile.

“With the FDA approval of TECFIDERA, we will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill – a combination we believe will have a significant positive impact on the way people live with this chronic disease,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “Biogen Idec is committed to delivering innovative treatments and setting new standards for the next generation of medicines. We believe TECFIDERA will raise expectations for what people living with MS can achieve with their therapy.”

The FDA approval of TECFIDERA is based on data from a robust clinical development program that included DEFINE and CONFIRM, two global Phase 3 studies that enrolled more than 2,600 patients. In the ongoing extension study, ENDORSE, some patients receiving TECFIDERA have been followed for more than four years.

In DEFINE, TECFIDERA, administered twice daily, significantly reduced the proportion of patients who relapsed by 49 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), …read more
Source: FULL ARTICLE at DailyFinance

Articles of Interest

Montel Williams: Medical Marijuana ‘Just Like Any Other Plant-Based Medicine’ (VIDEO)

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By The Huffington Post News Editors

Montel Williams joined HuffPost Live host Ahmed Shihab-Eldin Tuesday and spoke out in favor of medical marijuana.

“[Marijuana] is just like any other plant-based medicine on this planet,” Williams, who is battling Multiple Sclerosis, said. The former talk show host called on the government and pharmaceutical companies to invest in research so that patients like him could have a “quality medication” that isn’t tainted by chemicals.

“I want a pharmaceutical company to step up to the plate and do what’s right,” he said.

Read More…
More on Marijuana

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Source: FULL ARTICLE at Huffington Post

Business, Finance, Occupation & Industry

CHMP Issues Positive Opinion for TECFIDERA™ (Dimethyl Fumarate) as a First-Line Treatment for Multip

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By Business Wirevia The Motley Fool

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CHMP Issues Positive Opinion for TECFIDERA ™ (Dimethyl Fumarate) as a First-Line Treatment for Multiple Sclerosis in the European Union

-European Commission Decision Anticipated In Second Quarter of 2013-

WESTON, Mass.–(BUSINESS WIRE)– Today Biogen Idec (NAS: BIIB) announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) recommending a marketing authorization be granted for TECFIDERA™ (dimethyl fumarate) as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMP, on the basis of quality, safety and efficacy data submitted by Biogen Idec, considers there to be a favorable benefit-to-risk balance for TECFIDERA.

The CHMP‘s recommendation is now referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. The U.S. Food and Drug Administration is expected to make a decision on the marketing application for TECFIDERA in the United States in the coming days.

“With the CHMP‘s positive opinion for TECFIDERA, we are one step closer to offering the European MS community a treatment with compelling efficacy and a favorable safety profile in the convenience of a pill – a combination we believe will have a significant positive impact on the way people live with this chronic disease,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “Biogen Idec is committed to delivering innovative treatments and setting new standards for the next generation of medicines. We believe TECFIDERA will raise expectations for what people living with MS can achieve with their therapy.”

The CHMP opinion for TECFIDERA is based on data from a large clinical development program that included two global Phase 3 studies, DEFINE and CONFIRM, involving more than 2,600 RRMS patients, as well as an ongoing extension study in which some patients have been followed for more than four years. In DEFINE, TECFIDERA, administered twice-daily, significantly reduced the proportion of patients who relapsed by 49 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), and 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily TECFIDERA significantly reduced ARR by 44 percent (p<0.0001) and the proportion of patients who relapsed by 34 percent (p<0.0001) compared to placebo at two years. While not statistically significant, TECFIDERA showed a 21 percent reduction in 12-week confirmed disability progression in CONFIRM. In addition, both studies showed TECFIDERA significantly reduced lesions in the brain …read more
Source: FULL ARTICLE at DailyFinance

News, Politics, Government

Effect of MS You May Not Know

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Effect of MS You May Not Know

Alamy

Most people are aware that Multiple Sclerosis impairs you physically, but there’s another reality that 50 percent will also have to face.

Subtle symptoms of those affected

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Valuable Use for Umbilical Cord Post-Birth

…read more
Source: FULL ARTICLE at AOL