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Indonesia acts to over-ride patents on HIV drugs

Posted: Published on October 13th, 2012

JAKARTA (Reuters) - Indonesia's government has taken steps to over-ride patents on a range of HIV drugs, highlighting a growing trend by Asian states to allow local production of cheap generic drugs that cut into sales of global pharmaceutical companies. President Susilo Bambang Yudhoyono quietly issued a decree last month authorizing government use of patents for seven HIV/AIDS and hepatitis B medicines held by the likes of Merck & Co, GlaxoSmithKline, Bristol-Myers Squibb, Abbott and Gilead. The international trade body representing major drugmakers said the move set "a negative precedent". Individual companies affected did not provide immediate comment. The decree states Indonesia implemented the measures to "meet the urgent need for antiviral and antiretroviral treatments". An estimated 310,000 people are living with HIV in Indonesia, Southeast Asia's largest economy. The prevalence rate among the 15 to 49-year-old population is 0.2 percent, according to 2009 statistics from the U.N. Aids website. Unreported cases mean that the true figure could be higher. Under World Trade Organisation rules member countries are permitted to take measures to over-ride patents when it is deemed necessary to protect public health. Yudhoyono signed the decree without fanfare on September 3 and it was only recently highlighted by … Continue reading →

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Walgreen Reminded of Europe Risks With Docmorris Flop

Posted: Published on October 13th, 2012

As Walgreen Co. (WAG) spends $6.7 billion on a foray into Europe, a small German online pharmacy offers a reminder about the potential pitfalls. Ralf Daeinghaus sold his DocMorris online pharmacy to Celesio AG (CLS1) in 2007 for about 200 million euros ($258 million), and the buyer set in motion an expansion plan to bring lower- cost drugs to more European consumers. Five years later, Celesio has written down the value of DocMorris to 40 million euros and put the business up for sale, stymied by laws against corporate ownership of drugstores. With medical costs rising and Europes governments cutting spending amid the debt crisis, the idea of increased competition in health-care retailing should be more appealing than ever. Yet Daeinghauss entrepreneurship ran up against the political clout of German pharmacists and European opposition to a freer market in medicine sales. Walgreen, the largest U.S. drugstore chain, bought 45 percent of Alliance Boots GmbH in August, with the option to buy the remainder. Its really crazy, isnt it? Daeinghaus, 45, said as he sat in a coffee shop this month near his office in Dusseldorf. Its not a problem to liberalize the market a bit. When theres competition, there are … Continue reading →

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Walgreen reminded of European risks with Celesio's flop

Posted: Published on October 13th, 2012

As Deerfield-based Walgreen Co. spends $6.7 billion on a foray into Europe, a small German online pharmacy offers a reminder about the potential pitfalls. Ralf Daeinghaus sold his DocMorris online pharmacy to Celesio AG in 2007 for about $258 million, and the buyer set in motion an expansion plan to bring lower- cost drugs to more European consumers. Five years later, Celesio has written down the value of DocMorris to 40 million euros and put the business up for sale, stymied by laws against corporate ownership of drugstores. With medical costs rising and Europes governments cutting spending amid the debt crisis, the idea of increased competition in health-care retailing should be more appealing than ever. Yet Daeinghauss entrepreneurship ran up against the political clout of German pharmacists and European opposition to a freer market in medicine sales. Walgreen, the largest U.S. drugstore chain, bought 45 percent of Alliance Boots GmbH in August, with the option to buy the remainder. Its really crazy, isnt it? Daeinghaus, 45, said as he sat in a coffee shop this month near his office in Dusseldorf. Its not a problem to liberalize the market a bit. When theres competition, there are price and quality improvements. … Continue reading →

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Pharmacy company linked to meningitis outbreak slashes workforce

Posted: Published on October 13th, 2012

BOSTON (Reuters) - The pharmacy company linked to the deadly meningitis outbreak has cut more than half of its workforce, affecting about 40 employees, according to people familiar with the situation. New England Compounding Center of Framingham, Massachusetts, confirmed on Friday it has cut jobs. The company did not provide any more details about the reduction. "The events of the past two weeks are a great tragedy, and the thoughts and prayers of all those connected to New England Compounding Center continue to be with the individuals and families affected," the company said in a statement. "As a result of these events, on Thursday and Friday of this week NECC informed employees of a workforce reduction at the company - a necessary step under the current circumstances." NECC said its singular focus continues to be the national recall of all of its products, "and working with the Centers for Disease Control, the U.S. Food and Drug Administration, the Massachusetts Department of Public Health and Board of Registration in Pharmacy on their ongoing investigation." (Reporting by Tim McLaughlin; Editing by Gary Hill) Read more: Pharmacy company linked to meningitis outbreak slashes workforce … Continue reading →

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Pharmacy at Center of Meningitis Outbreak

Posted: Published on October 13th, 2012

The compounding pharmacy at the center of the fungal meningitis outbreak was not following the requirements of its state license, according to a spokeswoman for the Massachusetts Department of Public Health. The New England Compounding Center in Framingham, Mass., shipped more than 17,000 vials of a steroid -- now implicated in the outbreak -- to pain clinics in 23 states. But Dr. Madeleine Biondolillo, director of the state's Bureau of Health Care Safety and Quality, said the company was meant to make up drugs only in response to a doctor's prescription for an individual patient. Read this story on http://www.medpagetoday.com. "This organization chose to apparently violate the licensing regulations under which they were allowed to operate," Biondolillo told reporters in a telephone news conference Thursday. FDA spokeswoman Dr. Deborah Autor told MedPage Today the agency has legal remedies available, including the ability to seize products and to lay criminal charges, but she did not elaborate further. A 2006 warning letter to the company, charging it was acting more like a drug manufacturing firm than a compounding pharmacy, elicited assurances that patient safety was being protected and that applicable laws and regulations were being obeyed, Autor said. If the current investigation … Continue reading →

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Leading Researchers to Unite at Texas State Capitol for Regenerative Medicine and Stem Cell Research

Posted: Published on October 13th, 2012

AUSTIN, Texas, Oct. 12th, 2012 /PRNewswire-USNewswire/ -- Prominent stem cell scientists, physicians, and advocates from leading medical facilities and research institutions across Texas and California will highlight the 3rd Annual Stem Cell Research Symposium: Spotlight on Texas, on October 19, 2012, at the Texas State Capitol. This free, public symposium, produced and co-hosted by the Austin-based nonprofit Texas Cures Education Foundation (Texas Cures), is designed to educate the public about the exciting stem cell research andclinical trials currently under way in Texas.The event will also include a discussion of recent Texas laws affecting stem cell research, the potential economic impact of stem cell research and highlight the current progress in one of the most promising areas of medicine. This year, more than a dozen local and national advocacy groups, institutions and foundations showed their support for the efforts of the hosting organizations Texas Cures and Texans for Stem Cell Research including the Genetics Policy Institute, Alliance for Regenerative Medicine and Texans for Advancement of Medical Research. The symposium begins at 8:30 a.m. in the Capitol Extension Auditorium (E1.004), located at the Texas State Capitol Building. Admission is free and open to the public.Registration is recommended. This program unites the diverse … Continue reading →

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Sarepta To Present Addl. Phase IIb Data Of Eteplirsen To Treat DMD – Quick Facts

Posted: Published on October 12th, 2012

(RTTNews.com) - Sarepta Therapeutics Inc. (SRPT) said Friday that data from a Phase IIb study of its investigational drug eteplirsen for the treatment of boys with Duchenne muscular dystrophy will be presented on October 13 at the World Muscle Society in Perth, Australia. The presentation will describe new and previously reported efficacy and safety data from the Phase IIb study examining 48 weeks of treatment with eteplirsen in boys with Duchenne muscular dystrophy, or DMD. Results from the Phase IIb extension study confirmed that eteplirsen met the primary efficacy endpoint, increase in novel dystrophin, and achieved a significant clinical benefit on the primary clinical outcome, the 6-minute walk test over the placebo/delayed treatment cohort. Additional data to be presented includes: individual patient data on the primary endpoint of change in dystrophin-positive fibers from baseline; additional biochemical findings including RT-PCR and western blot images from selected patients; additional information on the two patients in the 30 mg/kg cohort who showed a rapidly progressive decline on the 6-minute walk test and were excluded from the analysis. Data to be presented will also include summary of treatment-emergent adverse events comparing eteplirsen-treated patients versus placebo, which demonstrated that eteplirsen was well-tolerated through 48 weeks … Continue reading →

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Sarepta Therapeutics to Present Additional 48-Week Data From the Phase IIb Study of Eteplirsen for the Treatment of …

Posted: Published on October 12th, 2012

CAMBRIDGE, MA--(Marketwire - Oct 12, 2012) - Sarepta Therapeutics ( NASDAQ : SRPT ), a developer of innovative RNA-based therapeutics, announced today that data from a Phase IIb study evaluating eteplirsen, an investigational treatment for boys with Duchenne muscular dystrophy (DMD), will be presented Saturday, October 13th at the World Muscle Society in Perth, Australia.Principal investigator, Jerry R. Mendell, M.D. of Nationwide Children's Hospital, will present the data in an oral presentation of the abstract titled, "Results at 48 Weeks of a Phase IIb Extension Study of the Exon-Skipping Drug Eteplirsen in Patients with Duchenne muscular dystrophy (DMD)."Dr. Mendell will present tomorrow from 2:30 to 4:00 p.m. WST UTC +8 hours/2:30 to 4:00 a.m. EDT. The presentation will describe new and previously reported efficacy and safety data from the Phase IIb study examining 48 weeks of treatment with eteplirsen in boys with DMD.Results from the Phase IIb extension study confirmed that treatment with Sarepta's lead exon-skipping compound, eteplirsen, met the primary efficacy endpoint, increase in novel dystrophin, and achieved a significant clinical benefit on the primary clinical outcome, the 6-minute walk test (6MWT) over the placebo/delayed treatment cohort. Additional data to be presented includes: Dr. Mendell's presentation will be posted … Continue reading →

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Brain Implant Detects, Responds to Epilepsy

Posted: Published on October 12th, 2012

Medtronic's device can sense changes in brain activity related to disease. Golden Cosmos Next year, medical researchers will test in patients a one-of-a-kind brain implant that can sense electrical activity in the brain while simultaneously emitting electric pulses, says device developer Medtronic. Deep-brain stimulators are mainly used to regulate the movement problems associated with Parkinson's and other diseases, but they are also used in Europe and Canada to treat epilepsy and are being used experimentally to treat severe depression and obsessive-compulsive disorder. But doctors must use trial and error to determine the best parameters for the electrical stimulation programmed into each patient's chip. The smarter brain stimulator is an improved version of Medtronic's existing deep-brain stimulator device, which has already been implanted in more than 80,000 people around the world. Medtronic has added an extra chip so that it can detect electrical activity and respond automatically to changes in the brain. "If you are in the brain already, you might as well take advantage of the fact that you can listen in," says Lothar Krinke, who manages the Deep Brain Stimulation division at Medtronic. This means the device could respond automatically when a patient's symptoms grow stronger, or could turn … Continue reading →

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For people with epilepsy, Halloween strobes can cause seizures

Posted: Published on October 12th, 2012

By MARY SHEDDEN | The Tampa Tribune Published: October 12, 2012 Updated: October 12, 2012 - 1:15 PM Universal Orlando's Halloween Horror Nights seems like an entertaining way to spend an evening to a lot of folks -- including, at one time, Christina Wagner. Why wouldn't a theme park packed with ghoulish characters, gory mayhem and a cacophony of blood-curdling screams appeal to an 18-year-old and her friends? So off they went. But Wagner discovered something far more terrifying there, and twisted her fake fear into reality. An unexpected encounter with flashing strobe lights suddenly placed the young woman, who has epilepsy, at risk for seizure. Once she realized what was happening, she closed her eyes and got out of there. Wagner, now 32, escaped safely and hasn't visited a haunted house since. "If I have a feeling something is going to happen, I remove myself and I calm down," Wagner says. "I know my limitations." Nearly 3 million Americans have at some point in their life been diagnosed with epilepsy, a brain disorder that triggers a wide range of attacks, from a mild, disorienting stupor to full-blown grand mal seizures or convulsions. Prescription drugs and careful attention to stress … Continue reading →

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