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Shire Announces FDA Approval of VPRIV for Gaucher Disease
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For more info visit www.newsinfusion.com Cambridge, MA, US February 26, 2010 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has granted marketing approval for VPRIV, a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of Type 1 Gaucher disease in pediatric and adult patients. The FDA designated VPRIV for Priority Review and granted marketing approval in just 6 months. VPRIV offers patients and their physicians a new treatment option at a critical time, as the supply of the previously approved ERT for Gaucher disease is uncertain and remains disrupted. We have had the opportunity to use VPRIV in clinical trials and actively participated in the expanded access program. We appreciate the support Shires management team has provided during the last few months to ensure continuity of care for nearly 50 of our patients with Gaucher disease. We are confident the team Shire has put into place will ensure a seamless transition into the post-regulatory period, said Gregory M. Pastores MD, Associate Professor of Neurology and Pediatrics at the NYU School of Medicine in New York. VPRIV offers patients a therapeutic option that is safe and effective, and our experience with VPRIV has helped build confidence in its use, bolstered by data on low frequency of antibody formation. Shire recognizes that the treatments it develops for life-altering diseases <b>...</b> |
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Why So Serious? the FDA the e-cig and you
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if i could be serious for a moment , i wanted to touch on a sensitive subject with e-smokers and vapers alike. The FDA has basically been given permission to take your rights away , and it's being funded by big tobacco , Phillip Morris specifically my advice... get information out there about these devices and how they have changed your life , we are all very passionate about these things , and i would hate to see thousands of vapers considering going back to the cancer sticks. get active , talk to people , support our US suppliers continue on like nothing is changing. Dont back down , dont be afraid and don't let anyone take these away from us. keep on vaping!! |
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FDA: A History Trailer
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This is the trailer for a 82 minute documentary on the history of the US FDA. For more info visit www.fdahistory.com |
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Levaquin Pharmaceutical sales rep Corrupt FDA Google: "Death by Levaquin" for my blog
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This video is the experience of a drug rep who took Levaquin three years ago. Tens of Thousands are damaged every year from these antibiotics. We need to make this known to the media. Please email me at JFratti@Comcast.net Help us get our horror story to the national and local media. This poisoning needs to be stopped. Doctors either dismiss or deny this toxicity. " |
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Smallest Heart Pump Receives 510(k) Clearance from FDA
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Impella 2.5 Cardiac Assist Device Now Available to Doctors and Patients in the US The US Food and Drug Administration (FDA) just cleared the Impella 2.5 Cardiac Assist Device for immediate use. Designed for cardiac arrest and heart attack patients, it pumps up to 2.5 liters of blood per minute, and supports the heart in situations when it cannot function on its own. Each year over a million people in the US have a heart attack, according to the National Institutes of Health. Of that statistic, half of them die and many are left with permanent heart damage. As the world's smallest Ventricular Assist Device (VAD), this technology provides patients with immediate, sustained coronary perfusion when their heart is unable to do so. The Impella 2.5 is inserted percutaneously in the catheterization laboratory (cath lab) through the femoral artery into the left ventricle. It is the only device designed to actively unload blood from the ventricle and is approved for short term use for up to six hours. Today's clearance allows Abiomed to begin selling the device for use to the estimated 14000 interventional cardiologists at approximately 1700 heart hospitals in the United States. For more information, go to www.abiomed.com. Produced for Abiomed, Inc. |
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Fight Back Against the FDA and Big Pharma (All Jacked Up)
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This segment from the documentary film All Jacked Up features Mike Adams (the Health Ranger) talking with Bobby Rice about how We the People can defend ourselves against the marketing lies, junk science and massive chemical onslaught dumped onto consumers by Big Pharma and the US Food and Drug Administration. Features a cartoon segment and an urgent call for action to protect ourselves and our children from the deadly chemicals fed to us by food corporations and drug companies. |
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Rudy Defends His Oxycontin Work, Evades Marijuana Question
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At a Town Hall Meeting, St. Anselm's College. Nov. 5 -- Manchester, NH |
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Levaquin reaction FDA failure Google: "Death by Levaquin" for my website
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Video from a victim of Levaquin, visit: ww.fqvictims.org or www.fluoroquinolones.org Help us get on local or national media. Tens of Thousands of us are damaged by Levaquin, Cipro, Avelox and other quinolones. |
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Global Pulse - 07/19/07: Made in China vs. Made in US
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(July 19, 2007) With the execution of a top Chinese drug official, Global Pulse explores the worldwide product recalls, and presents the Chinese perspective. We also explore how in the US, the FDA has approved drugs with unknown and unexplored side effects. ---Global Pulse is a fast-moving and informative television and web series that helps you navigate the news of the world by comparing and contrasting TV news reports. See all the episodes of Global Pulse at linktv.org --- |
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WARNING: FDA CRACK DOWN ON VITAMINS!
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The FDA can't even regulate the quality of imported FOOD grade wheat gluten which has killed thousands of animals across the USA and now they want to take on the task of regulating the vitamins, herbal supplements and massage oils that have been around for decades. What do you think? Please watch this weekend's episode of KBTV and leave your comments in the box provided! |
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Bayer Exposed ( HIV Contaminated Vaccine )
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www.whale.to [Video] Bayer Sells AIDS-Infected Drug Banned in US in Europe, Asia - Unearthed documents show that the drug company Bayer sold millions of dollars worth of an injectable blood-clotting medicine -- Factor VIII concentrate, intended for hemophiliacs -- to Asian, Latin American, and some European countries in the mid-1980s, although they knew that it was tainted with AIDS. Bayer knew about the fact that the drug was tainted and told the FDA to keep things under wraps while they made a profit off of a drug that infected its patients. If these allegations are true, then both Bayer and the FDA are at fault for this catastrophe. FDA regulators helped to keep the continued sales hidden, asking the company that the problem be ''quietly solved without alerting the Congress, the medical community and the public,'' according to the minutes of a 1985 meeting octomedia Vaccine Information and Awareness sites: thinktwice.com www.vaclib.org |
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FDA Approves First Drug to Help Patients with Parkinson's Di
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August 2006 (Medialink) -- Statistics: According to the National Parkinson Foundation (NPF), dementia is one of the complications most feared by Parkinson's disease patients and caregivers. Of the 1.5 million Americans living with the disease, an estimated 40% develop dementia. Story: The US Food and Drug Administration (FDA) has approved Exelon (rivastigmine tartrate) for the treatment of mild to moderate Parkinson's disease dementia, making it the first approved medication available for the treatment of this condition. The risk of developing dementia is approximately four to six times higher among Parkinson's patients than among elderly people without the disease. The primary symptoms of Parkinson's disease dementia include cognitive impairment and neuro-psychiatric symptoms (eg, depression, hallucinations, anxiety and apathy). These symptoms impact the patient's quality of life, course of the disease and caregiver distress. While this drug is now being used to treat Parkinson's patients with dementia, for years it has been used to in the treatment of Alzheimer's disease. Produced for Novartis Pharmaceuticals Corporation |
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