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Mass. Pharmacy Industry Resists Call For Stricter Regulation

Posted: Published on October 11th, 2012

Workers at J.E. Pierce Apothecary, a compounding pharmacy in Brookline. (Curt Nickisch/WBUR) BOSTON A second compounding pharmacy in Massachusetts has agreed to temporarily shut down. Ameridose of Westborough is run by the same executives who run the Framingham company that produced the steroid linked to a deadly outbreak of fungal meningitis. More than 130 people in 11 states have been sickened. Twelve have died. But unlike New England Compounding Center, Ameridose is not issuing recalls while regulators inspect its facility. The investigation into the mounting death toll linked to NECC is prompting many to call for greater regulation of such compounding pharmacies. Still, many in the industry say that will likely only make things worse. Smaller Pharmacies Forced To Adapt Ever since the news broke that a compounding pharmacy in Massachusetts was been linked to a growing roster of dead patients, Greg Laham has been upset. Its really a shame, Laham said. Its a horrible thing. Laham is the owner of a different compounding pharmacy, one of dozens around the state, Sullivans in Roslindale. The store opened the year Fenway Park did 100 years ago. Mr. Sullivan started the business in 1912. Theres been three owners, Laham said. He, another … Continue reading

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State suspends license of pharmacy linked to meningitis outbreak

Posted: Published on October 11th, 2012

The Massachusetts pharmacy linked to a nationwide deadly meningitis outbreak has had their license suspended to distribute prescription drugs in Ohio. The decision comes as Ohio health officials said they have notified nearly every Ohioan who received the recalled steroid suspected in 12 deaths and 137 infections nationally. Kyle Parker, director of the Ohio Board of Pharmacy, announced on Wednesday the summary suspension of the license of New England Compounding Center of Framingham, Mass. In a statement, the state pharmacy board said the suspension was made after discussions with the Ohio Department of Health. The pharmacy board found clear and convincing evidence that the continuation of New England Compounding Centers professional practice presented a danger of immediate and serious harm to others, the statement said. The Centers for Disease Control and Prevention Nationally said all of the people sickened received the epidural steroid injections of allegedly contaminated methylprednisolone acetate compounded by the Massachusetts pharmacy, which has ceased operations since the outbreak was identified. The pharmacy has voluntarily recalled all of its products, including the injectable steroid. Ohio has recorded one rare form of fungal meningitis infection, an unidentified 65-year-old male. The drug was administered to 424 patients through four pain … Continue reading

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Questions raised about meningitis pharmacy

Posted: Published on October 11th, 2012

Published: Oct. 10, 2012 at 5:26 PM BOSTON, Oct. 10 (UPI) -- Massachusetts officials said an executive of a sister company of the pharmacy linked to the meningitis outbreak recused herself as a state regulator. Sophia Pasedis, vice president of regulatory affairs and compliance at Ameridose, which shares the same owner as that of the New England Compounding Center in Framingham, Mass., was appointed to the 11-member Massachusetts Board of Registration in Pharmacy in June 2004 and reappointed in 2008, The Boston Globe reported. The New England Compounding Center is at the center of the fungal meningitis outbreak that has killed 12 and sickened 137 in 10 states. The compounding pharmacy in Framingham, Mass., produced about 13,000 doses of the injectable steroid methylprednisolone acetate used to treat back pain. The investigation into the exact cause of the outbreak is ongoing locally and nationally. The Centers for Disease Control and Prevention in Atlanta said its preliminary analyses showed all infected patients received an injection of preservative-free methylprednisolone acetate, a steroid prepared by the New England Compounding Center. "The compounding center voluntarily surrendered its license at the request of the state of Massachusetts and at the direction of public health officials, announced … Continue reading

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Pharmacy linked to meningitis recalls all products- Congress investigates deadly meningitis outbreak

Posted: Published on October 11th, 2012

The pharmacy responsible for manufacturing contaminated steroid shots suspected in a meningitis outbreak, which has killed 12 and sickened more than 120 around the U.S., has set up a recall operations center to properly remove its products from circulation. Since the September 25 recall of three lots of a steroid produced by the New England Compounding Center (NECC), the outbreak has spread to 10 states and infected 137 people, according to state health departments and the Centers for Disease Control and Prevention Brad Puffer, director of communications for the office of Massachusetts Attorney General Martha Coakley, said he could not "confirm or deny" a criminal investigation into the company. Also of interest one of the NECCs owners, Sophia Pasedis, also owns a related pharmacy nearby; one of its executives is a board member and former president of the state agency that regulates pharmacies. The Boston Globe reported that Sophia Pasedis was appointed to the 11-member Massachusetts Board of Registration in Pharmacy in both 2004 and 2008. She also serves as the vice president of regulatory affairs and compliance at Ameridose in Westborough which has the same ownership as the Framingham-based NECC. The state Public Health Department, which oversees the pharmacy … Continue reading

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Pharmacy Automation: Technologies and Global Markets

Posted: Published on October 11th, 2012

NEW YORK, Oct. 11, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue: http://www.reportlinker.com/p096626/Pharmacy-Automation-Technologies-and-Global-Markets.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pharmacies_and_Drug_Stores REPORT HIGHLIGHTS -The global market for pharmacy automation increased from $2.1 billion in 2006 to $2.3 billion in 2007. It should reach $3.6 billion by 2012, a compound annual growth rate (CAGR) of 9.4%.-By 2012, the inpatient pharmacy automation market is expected to be worth nearly $2.9 billion, a CAGR of 9.8%.-The outpatient pharmacy automation segment will continue to experience moderate growth through 2012, with a CAGR of 7.8% over the next 5 years. INTRODUCTION Although pharmacy automation dates back to the 1970s with the introduction of pill counting machines, the pharmacy automation market is anticipated to make generous strides in technology and efficiency through the forecast period outlined in this study. The continually increasing demand for accuracy, safety, industry standards, and competency in the pharmacy environment by regulatory authorities, manufacturers, healthcare professionals, and consumers has forced the growth of this market. New opportunities in various settings will continue to surface-from small, private, family-owned pharmacies to large hospital and mail-order service facilities, such as Medco Health Solutions, Inc. Many small, private pharmacies are still conducting operations through manual and … Continue reading

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Nobel prize winner in medicine warns of rogue 'stem cell therapies'

Posted: Published on October 11th, 2012

Nobel laureate Shinya Yamanaka warned patients on Tuesday about unproven "stem cell therapies" offered at clinics and hospitals in a growing number of countries, saying they were highly risky. The Internet is full of advertisements touting stem cell cures for just about any disease -- from diabetes, multiple sclerosis, arthritis, eye problems, Alzheimer's and Parkinson's to spinal cord injuries -- in countries such as China, Mexico, India, Turkey and Russia. Yamanaka, who shared the Nobel Prize for Medicine on Monday with John Gurdon of the Gurdon Institute in Cambridge, Britain, called for caution. "This type of practice is an enormous problem, it is a threat. Many so-called stem cell therapies are being conducted without any data using animals, preclinical safety checks," said Yamanaka of Kyoto University in Japan. "Patients should understand that if there are no preclinical data in the efficiency and safety of the procedure that he or she is undergoing ... it could be very dangerous," he told Reuters in a telephone interview. Yamanaka and Gurdon shared the Nobel Prize for the discovery that adult cells can be transformed back into embryo-like stem cells that may one day regrow tissue in damaged brains, hearts or other organs. "I … Continue reading

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StemGenex™ on Adult Stem Cell-Based Therapy for Multiple Sclerosis

Posted: Published on October 11th, 2012

LA JOLLA, Calif., Oct. 10, 2012 /PRNewswire/ --New research directions are being explored to find therapies for hard to treat diseases. One exciting new approach is the use of autologous Adult Stem Cells. Multiple Sclerosis (MS) is one of the many notable diseasesadult stem cell therapycould potentially impact. Multiple Sclerosis (MS) is a disorder in which an individual's own immune system attacks the 'myelin sheath'. The myelin sheath serves to protect the nerve cells within the body's central nervous system (CNS). The damage caused by MS may result in many types of symptoms including: (Photo: http://photos.prnewswire.com/prnh/20121010/LA89802-INFO) Currently there is no cure for MS, but MS stem cell therapiesattempt to slow the disease's progression and limit symptoms. Since adult stem cells have the ability to differentiate into many different types of cells, such as those required for proper functioning and protection of nerve cells, the use of adult stem cells for MS therapy could be of substantial value. Adult stem cells can be isolated with relative ease from an individual's own 'adipose' (fat) tissue. As a result, adult stem cell therapy is not subject to the ethical or religious issues troubling embryonic methods. Encouragingly for MS treatment potential, scientific researchers have … Continue reading

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DART completes successful trials on Duchenne biomarker

Posted: Published on October 10th, 2012

DART Therapeutics CEO Gene Williams says the company is competing against DMD, a fatal disease for which there is no treatment. Wednesday, October 10, 2012 DART Therapeutics LLC, a biotech focused on finding therapies for Duchenne Muscular Dystrophy (DMD), a progressive and fatal neuromuscular disease for which there is no current treatment, has completed tests on a new biomarker intended to speed drug development by cutting the number of patients needed for new drug trials by half. Cambridge-based DART conducted the trials from February through August of this year on 61 boys with DMD and 31 without. Newly appointed CEO Gene Williams told Mass High Tech that the biomarker - a device which measures a muscles response to a tiny electrical impulse - provides a more exact way to measure a potential drugs affects than the current standard for muscular diseases, which is to measure how far a patient can walk in six minutes. The so-called six-minute walk measurement can vary widely among boys, who might walk faster or slower depending on mood, said Williams. That means trials on potential DMD drugs must be large enough to factor out such variables, and as a result, many companies never test promising … Continue reading

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DART sees success with Duchenne biomarker

Posted: Published on October 10th, 2012

DART Therapeutics CEO Gene Williams says the company is competing against DMD, a fatal disease for which there is no treatment. Wednesday, October 10, 2012 DART Therapeutics LLC, a biotech focused on finding therapies for Duchenne Muscular Dystrophy (DMD), a progressive and fatal neuromuscular disease for which there is no current treatment, has completed tests on a new biomarker intended to speed drug development by cutting the number of patients needed for new drug trials by half. Cambridge-based DART conducted the trials from February through August of this year on 61 boys with DMD and 31 without. Newly appointed CEO Gene Williams told Mass High Tech that the biomarker - a device which measures a muscles response to a tiny electrical impulse - provides a more exact way to measure a potential drugs affects than the current standard for muscular diseases, which is to measure how far a patient can walk in six minutes. The so-called six-minute walk measurement can vary widely among boys, who might walk faster or slower depending on mood, said Williams. That means trials on potential DMD drugs must be large enough to factor out such variables, and as a result, many companies never test promising … Continue reading

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DART Therapeutics Completes Study of New Biomarker for Duchenne Muscular Dystrophy

Posted: Published on October 10th, 2012

CAMBRIDGE, Mass., Oct. 10, 2012 /PRNewswire/ -- DART Therapeutics, LLC, an innovative, new-model biotechnology firm focused on developing therapies for Duchenne Muscular Dystrophy (DMD), announced today the successful completion of a study to evaluate a promising new biomarker for DMD. The biomarker, electrical impedance myography (EIM), is a non-invasive and simple-to-use technique that allows the operator to measure the health of a muscle and track its changes over time. The information can help researchers evaluate how well a treatment is working to halt disease progression, which could support more precise drug therapy for DMD boys and faster, less expensive drug development for the disease overall. DMD is a progressive and fatal neuromuscular disease for which there is no effective treatment. Current drug development efforts rely on patient outcomes measurements that are either invasive and poorly tolerated or highly subjective and prone to variability. This can have a negative impact on the value of the studies, which must generate results that can be measured and reproduced over time. EIM is based on the observation that as a muscle becomes progressively diseased, an applied weak electrical current moves through it differently. The technique could provide drug developers with a highly precise way … Continue reading

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