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EU agency says weight-loss drugs risk acceptable

Posted: Published on February 17th, 2012

LONDON (Reuters) - The European Medicines Agency has decided that the benefits of orlistat-containing weight loss drugs, including GlaxoSmithKline's Alli and Roche's Xenical, outweigh the risk of very rare liver-related side effects. The regulator launched a review of the drugs in September in light of some rare cases of severe liver injury among patients. It said on Thursday that the drugs were beneficial in the treatment of obese or overweight patients with a body mass index (BMI) of 28 or above. However, it recommended that labelling for the medicines, including nationally authorized orlistat-containing generics, was harmonized to ensure the warning about liver damage was consistent. It stressed that cases of severe liver disease linked to the drugs were very rare. There with 21 cases of severe liver toxicity reported where Xenical was considered a possible cause from 1997 to January 2011, it said, and nine reports of liver failure in people using Alli between May 2007, when it was first marketed, and January 2011. To put that in context, Xenical and Alli together were estimated to have been used by over 53 million people worldwide, with over 20 million in the European Union, it said. GlaxoSmithKline has put Alli up … Continue reading

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Online tools aimed at educating parents about synthetic drugs

Posted: Published on February 17th, 2012

By Carol Cratty, CNN updated 8:39 PM EST, Thu February 16, 2012 STORY HIGHLIGHTS The Partnership at Drugfree.org unveils online info tools on synthetics The kits include a podcast and video, a slide cast and a printable guide Poison control centers see a huge jump in synthetic-drug-related calls Drug policy director: Spice, K2, other synthetics "can cause serious harm" Washington (CNN) -- For parents who are mystified by drugs with names like Spice and bath salts: There's now a kit to help you out. The Partnership at Drugfree.org on Thursday unveiled tools available online to help adults understand synthetic drugs and urged them to talk to kids about their dangers. "These are threats that were not around when they, themselves, were teenagers," said Steve Pasierb, president and CEO of the drug education organization. The kits include a podcast and video, a slide cast and a printable guide with information on street names for drugs, what kinds of medical problems they can cause, and tips on how to tell whether their children might be using synthetic marijuana or stimulants. Pasierb and Gil Kerlikowske, director of National Drug Control Policy, met with officials from government and anti-drug groups to discuss how to … Continue reading

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NABP Supports Legislation Aimed to Protect Patients from Counterfeit Drugs and Fake Online Pharmacies

Posted: Published on February 17th, 2012

To: HEALTH, MEDICAL AND NATIONAL EDITORS Association Issues Statement of Support for Online Pharmacy Safety Act of 2011 MOUNT PROSPECT, Ill., Feb. 16, 2012 /PRNewswire-USNewswire/ -- The National Association of Boards of Pharmacy(R) (NABP(R)) has documented thousands of fake online pharmacies that endanger the lives of unsuspecting American consumers by distributing counterfeit, adulterated, and substandard drug products, often without requiring a valid prescription. By implementing safeguards, such as a federal registry that would assist consumers in identifying safe Internet pharmacies, The Online Pharmacy Safety Act of 2011 (SB 2002), would help to protect the public health, and NABP has issued a letter expressing the Association's strong support of the legislation. Describing the thorough accreditation process of the NABP Verified Internet Pharmacy Practice Sites (VIPPS(R)) and Veterinary-Verified Internet Pharmacy Practice Sites (Vet-VIPPS(R)) programs, the letter to the bill's sponsors, Senator Dianne Feinstein (D-CA) and Senator Jeff Sessions (R-AL), indicates the Association's strong support for the reference to these accreditation programs in the Online Pharmacy Safety Act. Recognized as the gold standard of accreditation for Internet pharmacies, VIPPS and Vet-VIPPS are recommended to consumers by Food and Drug Administration, the Partnership for Safe Medicines, and the Alliance for Safe Online Pharmacies (ASOP). … Continue reading

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'Pharmacy on a chip' gets closer

Posted: Published on February 17th, 2012

16 February 2012 Last updated at 15:21 ET By Jonathan Amos Science correspondent, BBC News, Vancouver The futuristic idea that microchips could be implanted under a patient's skin to control the release of drugs has taken another step forward. US scientists have been testing just such a device on women with the bone-wasting disease osteoporosis. The chip was inserted in their waist and activated by remote control. A clinical trial, reported in Science Translational Medicine, showed the chip could administer the correct doses and that there were no side effects. The innovation has also been discussed here at the annual meeting of the American Association for the Advancement of Science (AAAS). One of the designers, Prof Robert Langer from the Massachusetts Institute of Technology (MIT), claimed the programmable nature of the device opened up fascinating new avenues for medicine. "You could literally have a pharmacy on a chip," he said. "This study used the device for the treatment of osteoporosis. However, there are many other applications where this type of microchip approach could improve treatment outcomes for patients, such as multiple sclerosis, vaccine delivery, for cancer treatment and for pain management." The work is described as the first in-human testing … Continue reading

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University of Maryland Professor To Head Accreditation Council for Pharmacy Education

Posted: Published on February 17th, 2012

Newswise — Robert Beardsley, RPh, PhD, has devoted his entire career to making pharmacists the best health care professionals they can be. In recognition of his outstanding leadership in the field, the Accreditation Council for Pharmacy Education (ACPE) has made Beardsley its top officer. The ACPE is an autonomous agency that determines the accreditation of U.S. professional degree programs in pharmacy and providers of continuing pharmacy education. It elected Beardsley president of its ruling board of directors for 2012-2013. Beardsley is a professor and vice chair for education in the Department of Pharmaceutical Health Services Research at the University of Maryland School of Pharmacy in Baltimore, where he instructs students in the social behavioral aspects of pharmacy, with topics ranging from patient counseling to care of the terminally ill. For the past 15 years, Beardsley has taken part in ACPE's evaluation site visits to various pharmacy schools nationwide. He says, "The visits are designed to improve the quality of programs by evaluating their strengths and weaknesses." The visiting teams then make recommendations to the ACPE board for future action, such as to continue the school as is or to take some other action - from issuing warnings to calling for … Continue reading

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Histogenics to Present at 7th Annual New York Stem Cell Summit

Posted: Published on February 17th, 2012

WALTHAM, Mass.--(BUSINESS WIRE)-- Histogenics Corporation, a privately held regenerative medicine company, today announced that the Company will present at the 7th Annual New York Stem Cell Summit on February 21st at Bridgewaters New York City. Kirk Andriano, Ph.D., Vice President of Research and Development for Histogenics, will speak about current and future cell therapies being developed by the Company as it works toward commercialization. Lead candidates include NeoCart®, an autologous bioengineered neocartilage grown outside the body using the patient’s own cells for the regeneration of cartilage lesions, and VeriCart™, a three-dimensional cartilage matrix designed to stimulate cartilage repair in a simple, one-step procedure. NeoCart recently entered a Phase 3 clinical trial after reporting positive Phase 2 data, in which all primary endpoints were met and a favorable safety profile was demonstrated. Dr. Andriano earned his BS in chemistry and biology from Utah State University and his MS and Ph.D. in bioengineering from the University of Utah. Prior to his work at Histogenics, he was the Chief Technology Officer for ProChon Biotech, Ltd. which was acquired by Histogenics in May 2011. About Histogenics Histogenics is a leading regenerative medicine company that combines cell therapy and tissue engineering technologies to develop highly … Continue reading

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World Stem Cells, LLC. Stem Cell Treatments In Cancun at Advanced Cellular Medicine Clinic

Posted: Published on February 17th, 2012

World Stem Cells, LLC Stem Cell Therapy at a state of the art clinic in beautiful Cancun. The clinic is staffed by top specialist in the field of stem cell implants and a new laboratory to support the stem cell treatments given. (PRWEB) February 16, 2012 World Stem Cells, LLC. contract laboratory Advanced Cellular Engineering Lab (Ingenieria Celular Advanzada S.A. de C.V.) a new adult stem cell laboratory being built in Cancun, Mexico to support Stem Cell research, stem cell clinical trials and stem cell treatments. This was accomplished by private funding in conjunction with World Stem Cells, LLC worldstemcells.com a US patient management company, Medicina Biocelular Avanzada , S.E. de C.V. a Mexican patient management company and Advanced Cellular Medicine Clinic of Cancun, a Stem Cell treatment Clinic owned and operated by Dr. Sylvia M. Abblitt a well known board certified hematologist and oncologist, in Cancun. Uniquely, Dr. Abblitt is one of a limited number of physicians licensed to perform autologous and allogeneic stem cell transplants. Dr. Abblitt has been utilizing stem cell therapies with successes for many years. She is the president and lab director of Advanced Cellular Engineering Lab (Ingenieria Celular Advanzada S.A. de C.V.). Her extensive … Continue reading

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Most epilepsy surgery candidates don't opt for it

Posted: Published on February 16th, 2012

Living with epilepsy can be arduous if symptoms aren't well-controlled. For some people, that means medication. For others, it may mean surgery. But despite a recent study showing that epilepsy surgery can be highly effective in the long term, just a fraction of those who suffer with the seizure disorder actually opt for it. Affecting some 3 million Americans and 50 million people worldwide, epilepsy is a neurological condition that produces brief disturbances in the brain's electrical functions that can cause seizures and other symptoms. According to the Epilepsy Foundation, in seven out of 10 cases, the cause of epilepsy isn't known; in other cases, head injuries, lack of oxygen during birth, brain tumors or infections such as meningitis and encephalitis are the culprits. Seizures can be a tremendous burden. For those who don't respond to medication, seizures may occur daily, weekly, monthly or even less frequently, but the results can be devastating. Those with epilepsy may not be allowed to drive, employment can be difficult and they're at risk for injuries, including falls and drowning because seizures are unpredictable. It's estimated that 60 percent to 70 percent of those with epilepsy remain seizure-free with medication. Those who don't respond … Continue reading

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Epilepsy Community Has Major Concern Over Release of Anticonvulsant Drug Comparison Report

Posted: Published on February 16th, 2012

Newswise — WEST HARTFORD, CT, February 16 -- Leading representatives of the American Epilepsy Society, American Academy of Neurology, and the Epilepsy Foundation today reported they have grave concerns about the implications and potential misuse of the anticonvulsant (AED) drug comparisons study recently released by the U.S. Agency for Health Research and Quality (AHRQ). The study’s intent is to provide an evidence-based analysis of the Effectiveness and Safety of Antiepileptic Medications in Patients With Epilepsy. But the AHRQ report has little clinical value according to the specialists in neurology and epilepsy and could negatively impact patient care. The AHRQ report is an examination of the comparative efficacy, safety, and tolerability of newer versus older and innovator versus generic antiepileptic medications. The representatives and their organizations strongly support evidence–based medicine and comparative effectiveness research, which they believe improves quality of care. At issue, however, is the study focus, which fails to recognize the different types of epilepsy and deals with this multiform disorder as if it were a monolithic and homogeneous condition. The study further compares effectiveness of old-line anticonvulsants to newer epilepsy drugs irrespective of epilepsy type. Given that seizures have vastly different pathologies and the use of AEDs differs … Continue reading

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New research fundraiser puts focus on autism center

Posted: Published on February 16th, 2012

A fundraising blitz by the Office of the Vice President for Research’s first development director hopes to make a proposed autism research center a reality. The University has stayed committed to the autism and neuro-developmental disorder center since its conception in 2010, but Vice President for Research Leo Chalupa said the project cannot move forward unless newly hired Heather Russell can raise the capital for it. Chalupa has said $10 million is needed to completely launch an autism research center, but University spokeswoman Jill Sankey said Tuesday that the development of a center could begin with a portion of that sum raised. Chalupa said Russell, a former development director for the Texas-based Autism Treatment Center who started at the University last week, has a tough task ahead of her. “The reason autism was targeted for raising money is because it’s expensive,” Chalupa said. “It’s very broad. It varies in everything from lab work with animals to human brain imaging to things like that. So it’s expensive.” He has set a goal for Russell to raise $2 million to $3 million this year, which could get a lift from forging partnerships with private foundations, and continue fundraising over the next three … Continue reading

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