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FDA OKs Sanofis' MS Drug Aubagio

Posted: Published on September 13th, 2012

(RTTNews.com) - The U.S. Food and Drug Administration Wednesday approved Sanofi's (SNY) multiple sclerosis drug Aubagio as a once daily tablet for the treatment of adults with relapsing forms of the disease. In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo. The drug contains a Boxed Warning to the risk of liver problems, including death, and a risk of birth defects. Physicians should do blood tests to check liver function before a patient starts taking Aubagio and periodically during treatment. Also included in the Boxed Warning is an alert noting that the drug may cause fetal harm. The most common side effects of Aubagio experienced by patients in clinical trials include diarrhea, abnormal liver tests, nausea, and hair loss. Multiple Sclerosis, or MS, is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by … Continue reading

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FDA Approves Sanofi MS Drug Aubagio

Posted: Published on September 13th, 2012

By Jennifer Corbett Dooren WASHINGTON--The U.S. Food and Drug Administration Wednesday approved a Sanofi SA (SNY, SAN.FR) pill to treat multiple sclerosis, making it the second oral therapy that will be available on the U.S. market. The drug, teriflunomide, will be sold with the brand name Aubagio to treat people with the relapsing remitting form of MS. Multiple sclerosis is a progressive disease that involves damage to nerves controlling muscles and vision; it affects about 400,000 Americans and 2.5 million people world-wide. The condition causes the body's immune system to eat away at the protective covering of the nerves, or myelin, which disrupts the electrical signals between the brain and the rest of the body. Most MS patients are of the "relapsing- remitting" type, where the disease flares up periodically and largely disappears for long periods of time. Aubagio will compete with Novartis AG's (NVS) oral pill Gilenya, which was approved by the FDA in 2010 and has been available in Europe since 2011. FDA said a clinical trial showed the relapse rate for patients using Aubagio was about 30% lower than the rate for those taking a placebo, or sugar pill. The product was approved with FDA's strictest boxed … Continue reading

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FDA approves new multiple sclerosis treatment Aubagio

Posted: Published on September 13th, 2012

FDA NEWS RELEASE For Immediate Release: Sept. 12, 2012 Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA approves new multiple sclerosis treatment Aubagio The U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS). In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo, said Russell Katz, M.D., director of the Division of Neurology Products in the FDAs Center for Drug Evaluation and Research. Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients. MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline. The most common side effects of Aubagio … Continue reading

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FDA Approves Genzyme’s AUBAGIO® (teriflunomide), a Once-Daily, Oral Treatment for Relapsing Multiple Sclerosis

Posted: Published on September 13th, 2012

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has approved AUBAGIO (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). AUBAGIO has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI. We are very excited to introduce AUBAGIO as a new treatment option that can make a difference in the lives of people with multiple sclerosis, said David Meeker, President and CEO, Genzyme. The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community. The FDA approval was based on efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. In the Phase III TEMSO trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with relapsing forms of multiple sclerosis. AUBAGIO 7 mg significantly reduced the annualized relapse rate (p=0.0002) in the trial. Many people living … Continue reading

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New First-In-Class Treatment Fycompa® Launches Today for People With the Most Common Form of Epilepsy

Posted: Published on September 13th, 2012

HATFIELD, England, September 13, 2012 /PRNewswire/ -- Europe first region in the world to gain access to this new therapy for partial seizures Fycompa(R) (perampanel) is the first in a new class of epilepsy treatments, with demonstrated efficacy in partial onset seizures, in particular with secondary generalisations.[1] In Europe, perampanel is indicated for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.[1] Following the UK launch, perampanel will also be launched in Germany, Austria and Denmark this month. Discovered and developed by Eisai in the UK and Japan, perampanel is the first and only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a receptor in the brain which plays a critical role in the initiation and spread of seizures.[2] This mechanism of action is different to any other licensed AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime [1] and significantly, is the only third generation partial-onset epilepsy treatment licensed to treat adolescent epilepsy from launch. Improved epilepsy care is crucial. Currently, the cost burden of epilepsy in Europe is estimated to stand at EUR20 billion annually, [3] whilst … Continue reading

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New First-In-Class Treatment Fycompa® [black triangle drug] Launches Today for Most Common Form of Epilepsy

Posted: Published on September 13th, 2012

HATFIELD, England, September 13, 2012 /PRNewswire/ -- UK first country in Europe to gain access to new therapy for partial epilepsy Fycompa (perampanel), discovered and developed by Eisai in the UK and Japan, is launched today as the first in an entirely new class of treatment for uncontrolled partial epilepsy (the most common form of the condition). The new therapy has demonstrated efficacy in partial onset seizures, in particular with secondary generalisations. It is indicated as an adjunctive treatment for partial-onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.[1] The worldwide supply of this new drug will be manufactured, packaged and distributed from the company's new 100 million facility in Hatfield, Hertfordshire. Perampanel is the first and only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a receptor in the brain which plays a critical role in the spread of epileptic seizures.[2] This mechanism of action is different to other, currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime[1] and significantly, is the only third generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch. There are approximately 600,000 individuals in the … Continue reading

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'Stem cell hope' for deaf people

Posted: Published on September 13th, 2012

12 September 2012 Last updated at 13:00 ET By James Gallagher Health and science reporter, BBC News UK researchers say they have taken a huge step forward in treating deafness after stem cells were used to restore hearing in animals for the first time. Hearing partially improved when nerves in the ear, which pass sounds into the brain, were rebuilt in gerbils - a UK study in the journal Nature reports. Getting the same improvement in people would be a shift from being unable to hear traffic to hearing a conversation. However, treating humans is still a distant prospect. If you want to listen to the radio or have a chat with a friend your ear has to convert sound waves in the air into electrical signals which the brain will understand. This happens deep inside the inner ear where vibrations move tiny hairs and this movement creates an electrical signal. However, in about one in 10 people with profound hearing loss, nerve cells which should pick up the signal are damaged. It is like dropping the baton after the first leg of a relay race. The aim of researchers at the University of Sheffield was to replace those baton-dropping … Continue reading

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Pacific Biosciences Appoints Lucy Shapiro, Ph.D. to Board of Directors

Posted: Published on September 13th, 2012

MENLO PARK, Calif., Sept. 12, 2012 (GLOBE NEWSWIRE) -- Pacific Biosciences of California, Inc. (PACB) provider of the PacBio(R)RS High Resolution Genetic Analyzer, today announced that renowned scientist Lucy Shapiro, Ph.D. of Stanford University has joined the Company's Board of Directors. Dr. Shapiro currently serves as the Virginia and D.K. Ludwig Professor of Cancer Research and the Director of the Beckman Center for Molecular and Genetic Medicine at Stanford University's School of Medicine, where she has been as a faculty member since 1989. Dr. Shapiro is a co-founder and director of Anacor Pharmaceuticals, Inc. In 1989, Dr. Shapiro founded Stanford University's Department of Developmental Biology, and served as its Chairman from 1989 to 1997. Prior to that, Dr. Shapiro served as Chair of the Department of Microbiology and Immunology in the College of Physicians and Surgeons of Columbia University. She received a B.A. from Brooklyn College and a Ph.D. in Molecular Biology from the Albert Einstein College of Medicine. Dr. Shapiro has received numerous awards and has been elected to the National Academy of Sciences, the American Academy of Microbiology, the American Academy of Arts and Sciences and the Institute of Medicine of the National Academy of Sciences for her … Continue reading

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Gerbils regain hearing thanks to stem cell therapy

Posted: Published on September 13th, 2012

(CBS News) Scientists have restored hearing in gerbils using a stem cell therapy that may hold promise for deaf humans. Using human embryonic stem cells, researchers at the University of Sheffield were able to implant immature nerve cells into gerbils, which then regenerated and were able to improve hearing ability in the animals. The study was published on Sept. 12 in Nature. Scientists restore sense of smell to mice who were born with genetic abnormality Marvel team creates deaf superhero called Blue Ear in honor of boy According to a Nature News article on the study, more than 275 million people have moderate-to-profound hearing loss, many of whom have it caused by a disruption in communication between the inner ear and brain. Senior study author Dr. Marcelo Rivolta, a stem cell researcher at the University of Sheffield told HealthDay that about 80 to 90 percent of deafness is due to problems with cells in the inner ear. There are two types of inner ear cells. Hair cells translate vibrations into electrical signals that are transmitted via the auditory nerve to the brain. Problems with these cells are typically fixed via cochlear implant, a small device which can bypass the hair … Continue reading

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Research and Markets: Global Erectile Dysfunction Drug Pipeline Capsule – 2012

Posted: Published on September 12th, 2012

DUBLIN--(BUSINESS WIRE)-- Research and Markets (http://www.researchandmarkets.com/research/j8q69m/global_erectile_dy) has announced the addition of the "Global Erectile Dysfunction Drug Pipeline Capsule - 2012" report to their offering. Fore Pharma's latest report Global Erectile Dysfunction Drug Pipeline Capsule - 2012' is an outline of all the key research and development (R&D) activities of the global erectile dysfunction drug market. It covers information on key pipeline molecules in various stages of R&D including all the phases of clinical trials, preclinical research, and drug discovery. The report is up-to-date with full coverage of the licensing activities and partnerships. This report helps executives to keep a track of their competitors and understand their pipeline molecules. The information presented in this report can be used for identifying the partners, prioritizing, evaluating opportunities, developing business development strategies, and executing in-licensing and out-licensing deals. The report provides information on pipeline molecules by company and mechanism of action across the different stages of R&D. It includes registered / preregistered stage, phase 3 clinical trial, phase 2 clinical trial, phase 1 clinical trial, preclinical research, and drug discovery. It also provides information on pipeline molecules developed in leading geographies including the U.S., Canada, France, Germany, U.K., Italy, and Spain by various stages … Continue reading

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