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Indiana board revokes license of New England compounding pharmacy tied to fatal meningitis

Posted: Published on February 12th, 2013

The Indiana Board of Pharmacy agreed to revoke the New England Compounding Centers license for its connection to the fatal meningitis outbreak. The Massachusetts-based pharmacy reached a voluntary revocation agreement Friday with Indiana Attorney General Greg Zoellers office, which the board approved Monday in Indianapolis, according to a news release from Zoeller's office. Public health and safety is a top priority and todays action was a necessary step to ensure this company, which put patients unnecessarily at risk, does not operate within our states borders going forward, Zoeller said in the release. Zoeller said a license revocation means the company cannot operate in Indiana for at least seven years. The company could apply for a new license after that time, but the board would have to approve the license application. In November, the Indiana Board of Pharmacy voted to indefinitely suspend the compounding pharmacy's non-resident pharmacy license and the Attorney Generals office recently filed a licensing complaint against the company. Zoeller said the pharmacy failed to ensure its epidural steroid injections were safe for patients, which led to devastating harm. As of Feb. 4, the U.S. Centers for Disease Control and Prevention identified 10 deaths and 79 total cases of … Continue reading

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UCSF-Safeway Pharmacy Alliance Aims to Help Customers Quit Smoking

Posted: Published on February 12th, 2013

Newswise The UCSF School of Pharmacy has partnered with Safeway Inc. to help Safeway customers quit smoking, by connecting them with specially trained pharmacists to learn about smoking-cessation programs and other resources. Under the partnership, Safeways pharmacists will be trained in proven smoking-cessation counseling techniques using a program developed by the UCSF pharmacy faculty. The stores also will locate non-prescription, nicotine-replacement therapies near store pharmacy areas, giving customers convenient access to a pharmacist to answer questions. The partnership is designed to give Safeway customers access, in a community setting, to the patient-care expertise of the UCSF School of Pharmacy. The school, which has the nations top-ranked pharmacy degree program, pioneered the field of clinical pharmacy in the 1960s to provide direct interactions between hospital patients and pharmacists. Pharmacists are often the most accessible health care provider for patients within their own communities, but we havent maximized their expertise in that setting, said B. Joseph Guglielmo, Jr., PharmD, interim dean of the UCSF School of Pharmacy. This project offers Safeway customers the full patient-care skill set of pharmacists with a goal of helping customers prevent and manage their chronic medical conditions. The project initially will focus on 20 pharmacy stores in … Continue reading

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Sarepta Bear Speaks: Eteplirsen Accelerated Approval Will Be Denied

Posted: Published on February 12th, 2013

NEW YORK (TheStreet) -- Many investors are smitten with Sarepta Therapeutics (SRPT) and its lead compound, eteplirsen, a novel experimental drug for Duchenne Muscular Dystrophy (DMD), which aims to help patients produce a normal amount of dystrophin, a protein required for correct muscle function. Sarepta bulls are so smitten with the company that they believe FDA will allow eteplirsen to be filed for accelerated approval on the basis of a single phase IIb study. Sarepta is meeting with FDA in the first quarter to discuss this issue. Under accelerated approval regulations, FDA allows the early approval of drugs to treat serious disease that fill unmet medical needs. The approvals are based on clinical trials that assess efficacy using surrogate endpoints. "The FDA bases its decision on whether to accept the proposed surrogate endpoint on the scientific support for that endpoint. The studies that demonstrate the effect of the drug on the surrogate endpoint must be adequate and well-controlled studies, the only basis under law for a finding that a drug is effective," the FDA's regulations state. [Emphasis mine.] Unlike the bulls, I believe Sarepta is extremely unlikely to convince FDA the eteplirsen data warrant accelerated approval. Instead, it's much more … Continue reading

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Epileptics 'face work bias'

Posted: Published on February 12th, 2013

11 February 2013 Last updated at 04:42 ET Nearly one in five people in Ireland would not employ someone with epilepsy, a new survey suggests. More than 37,000 people in Ireland, aged over five years, have a diagnosis of the disease. However, nearly 20% of people surveyed in the Republic of Ireland said, if given the choice, they would not employ someone with the condition. Research carried out by Epilepsy Ireland suggests that there is still stigma and lack of understanding. More than 1,000 people took part in the survey published on Monday 11 February, European Epilepsy Day. Peter Murphy of Epilepsy Ireland said: "Public awareness and understanding of the condition remains poor and negative attitudes towards epilepsy are a major challenge for many people living with the condition. "In fact, myths, misconceptions, fear and discrimination still surround epilepsy, often causing more distress than the condition itself and having a huge impact on people's quality of life." One in 20 people will have a single epileptic seizure at some time in their lives. The findings contrast with the fact that epilepsy is the most common, serious neurological condition in Ireland. See the rest here: Epileptics 'face work bias' … Continue reading

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Warning of 'negative attitudes' to epilepsy

Posted: Published on February 12th, 2013

The Irish Times - Tuesday, February 12, 2013 RONAN McGREEVY Myths surrounding epilepsy often cause more distress to people with the condition than the condition itself, it has been claimed. A new survey has found that one person in five would not employ somebody with epilepsy even though the illness is treatable. Speaking on European Epilepsy Day yesterday, Epilepsy Ireland deputy chief executive Peter Murphy said poor and negative attitudes towards epilepsy persisted and had a huge impact on the quality of the lives of those with epilepsy. Brainwave, a charity that helps people with epilepsy, changed its name yesterday to Epilepsy Ireland. A representative sample of Irish adults found half the public believed there was still a stigma surrounding the condition. Commenting on the survey, Mr Murphy said that although epilepsy was the most common serious neurological condition in Ireland and there had been considerable advances in treatment, public awareness and understanding of the condition remains poor, and negative attitudes towards epilepsy are a major challenge for many people living with the condition. Read more: Warning of 'negative attitudes' to epilepsy … Continue reading

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NeuroSigma Invited to Present an Overview of eTNS for the Treatment of Epilepsy and Depression at The Royal Society of …

Posted: Published on February 12th, 2013

LOS ANGELES, Feb. 11, 2013 /PRNewswire/ -- NeuroSigma, Inc., a California-based medical device company, today announced that Christopher DeGiorgio, M.D., Vice President of Neurology at NeuroSigma and Professor of Neurology at the University of California, Los Angeles (UCLA), and Colin Kealey, M.D., Manager of Business Development at NeuroSigma, will present in London, an overview of external trigeminal nerve stimulation (eTNS) for the treatment of epilepsy and depression at The Royal Society of Medicine's Sixth Medical Innovations Summit on February 16, 2013. Now available in the European Union, with a physician's prescription, the Monarch eTNS System consists of a small stimulator that can be placed in a pocket or worn at the waist, and an electric patch that is placed on the forehead. The patch stimulates the trigeminal nerve through the surface of the skin, and is used primarily while the patient is asleep. A Phase II randomized controlled clinical trial, conducted at UCLA and the University of Southern California (USC), for the use of eTNS for the treatment of drug-resistant epilepsy showed a robust effect on seizure frequency and mood. At the end of the eighteen week treatment period, more than 40% of patients experienced a greater than 50% reduction … Continue reading

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Autism. 2 1/2 year old boy. Non verbal. Autistic behavior. – Video

Posted: Published on February 12th, 2013

Autism. 2 1/2 year old boy. Non verbal. Autistic behavior. remihealth.com 2 1 year old autistic non verbal boy. Started treatment on Feb 11, 2013. By: remihealthservice … Continue reading

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STAR Trainings at Kennedy Krieger – Be an Effective Play Partner With Your Child – Video

Posted: Published on February 12th, 2013

STAR Trainings at Kennedy Krieger - Be an Effective Play Partner With Your Child Sharing Treatment and Autism Resources (STAR) Parent Trainings at Kennedy Krieger Institute. STAR parent trainings provide parents and family members of children diagnosed with autism spectrum disorders (ASD) with a comprehensive offering of current resources available on autism, as well as an overview of research-based treatment elements that have been recommended for program design and delivery in the educational system(s). To learn more about STAR Parent Trainings at Kennedy Krieger, visit: http://www.kennedykrieger.org By: KennedyKrieger … Continue reading

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STAR Trainings at Kennedy Krieger – Strategies to Enhance Functional Participation in Daily Living – Video

Posted: Published on February 12th, 2013

STAR Trainings at Kennedy Krieger - Strategies to Enhance Functional Participation in Daily Living Sharing Treatment and Autism Resources (STAR) Parent Trainings at Kennedy Krieger Institute. STAR parent trainings provide parents and family members of children diagnosed with autism spectrum disorders (ASD) with a comprehensive offering of current resources available on autism, as well as an overview of research-based treatment elements that have been recommended for program design and delivery in the educational system(s). To learn more about STAR Parent Trainings at Kennedy Krieger, visit: http://www.kennedykrieger.org By: KennedyKrieger … Continue reading

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Infants' Inattentiveness Might Signal Later Autism, Study Says

Posted: Published on February 12th, 2013

FRIDAY, Feb. 8 (HealthDay News) -- Attention problems might be seen in 6-month-old infants who are later diagnosed with autism, a new study says. Yale School of Medicine researchers found that these infants paid less attention to people's overtures and activities than infants who did not develop autism, according to the study recently published online in the journal Biological Psychiatry. This information could be used to identify infants at greatest risk of developing autism and provide them with early treatment, the researchers said. "This work is highly consequential for identifying new treatment targets and early intervention strategies," said Katarzyna Chawarska, associate professor at the Yale Child Study Center and a study co-author. The study included 67 infants at high risk for developing autism and 50 low-risk infants. Their eye movements were tracked while they watched a video of a woman doing everyday things, such as making a sandwich, looking at toys, or speaking. Compared to the other infants, those who were later diagnosed with autism spent less time watching the social activities depicted in the video. When they did pay attention, these infants spent less time watching the woman's face. Autism is a neurodevelopmental disorder characterized by impaired communication and … Continue reading

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