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FDA Approves LIALDA™ (mesalamine), the First Oral Once-Daily Mesalamine For Patients With Active, Mild to Moderate Ulcerative Colitis Basingstoke, UK and Philadelphia, US - January 16, 2007 / PRNewswire / — Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the U.S. Food and Drug Administration (FDA) has approved LIALDA™ (mesalamine) with MMX® technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. LIALDA is the first and only FDA-approved once-daily oral formulation of mesalamine. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis. Shire will launch LIALDA in the U.S. in the first quarter of 2007. Once-daily LIALDA with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and 6 to 16 pills a day. A recent study conducted by the Crohn's and Colitis Foundation of America (CCFA) found that 65 percent of patients with ulcerative colitis are poorly compliant with their medication, citing pill burden and inconvenience associated with the medication. "As the first oral once-a-day treatment option for ulcerative colitis, the approval of LIALDA in the United States is great news for patients and physicians when managing this serious condition," said Matthew Emmens, Shire Chief Executive Officer. "Once-daily LIALDA is one of several medicines Shire expects to launch in the U.S. and Europe in 2007." The FDA approval was based on the results of two Phase III clinical studies that found LIALDA (2.4 g/day and 4.8 g/day) was effective in inducing remission in patients with active, mild to moderate ulcerative colitis compared to placebo after eight weeks of treatment. LIALDA is generally well tolerated and has a similar safety profile to other currently available mesalamines. "In clinical trials, LIALDA proved to be an effective medication, providing superior rates of remission compared to placebo for people with ulcerative colitis," said lead study investigator, Gary R. Lichtenstein, M.D., director of the Center for Inflammatory Bowel Diseases at the Hospital of the University of Pennsylvania. "This is the first new mesalamine treatment to enter the market since 2000, filling a major void for physicians and people with ulcerative colitis and simplifying treatment of this disease." "The introduction of new treatments with more convenient dosing regimens may be an important step in helping patients with ulcerative colitis remain compliant with their medication," said Jonathan Braun, M.D., Ph.D., chair of CCFA's National Scientific Advisory Committee. Shire has licensed from Giuliani S.p.A. the exclusive rights to develop and commercialize LIALDA in the U.S., Canada, Europe -- known as MEZAVANT™ -- (excluding Italy) and the Pacific Rim. Giuliani S.p.A. retains the development and commercialization rights in Italy. Cosmo Pharmaceuticals S.p.A., Milan developed the MMX technology and owns the trademark, MMX. For more information on LIALDA, please visit www.LIALDA****.
18 Jan 2007
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0:51
THE inconvenient Truth - www.sharing-center**** with Allan Rich
29 Mar 2007
508
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7:32
ACTRA Strike, An Inconvenient Truth, VO Jobs of 2006, sound like you think, Joe Cipriano teaches podcasting, and Julie Williams in the VOX Box.
18 Jul 2007
369
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2:48
more readings from my silly book, How to Worry Friends and Inconvenience People. As well as my stuff, the book features jokes from writer/performers Ben Moor, Dave Gorman and Rhodri Marsden.
31 Jul 2007
599
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2:59
Laurie David is getting divorced from Larry David (the creator of Seinfeld and Curb Your Enthusiasm). Laurie started *******www.stopglobalwarming**** and produced the movie An Inconvenient Truth. I'm an environmentalist. And it seems that Laurie likes neurotic, bald, Jewish fellows. Or can at least tolerate them for many years. So I think we'll work well together. Let's see if she agrees. If anyone knows her, please ask her to watch this.
19 Aug 2007
1266
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3:57
this is a tutorial video that shows how to build a water and preassure thrusted rocket. It's very simple to fallow, and uses materials that you can found in your house. If you have any inconvenient you can ask me. I'll be pleased to help you with clear instructions. Retihc^^.
7 Oct 2007
29409
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0:09
How to solve that inconvenient pet problem.
14 Oct 2007
1973
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1:25
Backing-up your data as often as possible is a must but most don't because the inconvenience. There are several devices and locations to backup data; external hard drives, DVD and even several online services.
2 Nov 2007
223
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1:39
Hip, Ultra-modern residences located directly on the stunning shores of Town Lake (Lady Bird Lake). Featuring 66 3 bedroom units in the front two 6 story towers with flexible floor plans ranging in size from 1500-2500 square feet. In the rear 9 and 12 story towers, an architectural marvel of 2 bedroom residences ranging in size from 1000 sq ft plus. Premier location, luxury appointments, and zen-like grounds beckon those individuals with the desire to be close to downtown without the inconveniences of downtown at their doorstep. Sitting on 4 acres of waterfront land with its own private dock, and direct hike and bike trail access, this is the new exclusive place we want you to call home.
30 Dec 2007
583
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0:22
Our studio is growing in order to make more and better shows. Sorry for any inconveniences that this may have caused, and see you on Monday!
15 Feb 2008
126
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3:09
National News From Getthedaily**** - your online source for news! In today's top stories: The Federal Reserve insists help is on the way, plus Microsoft makes European history, in a bad way, and What happened to Starbucks yesterday? Hi everyone I'm Andrea Rene for get the daily****. Let's take a look at some top national stories. This morning Federal reserve chairman Ben Bernanke appeared on Capitol Hill proclaiming that the economy is getting worse! I think we are guessed that, I mean, look at gas prices! Ouch! He warned Congress of an impending sluggish economic growth period and hinted that another interest rate cut could be coming next month. The combination of the housing slump, deteriorating job market, and increased caution on the part of lenders has only worsened the economy. However, he is hopefully that the 168 billion dollar economic stimulus plan and the interest rate cuts will provide some relief in the second half of 2008, if we can make it that far! Software giant Microsoft was backhanded by the European Commission today with a fine of 899 million Euros, or $1.35 BILLION dollars. The fine was punishment for using their high prices to discourage competition, and is part of their on-going anti-trust litigation, which Microsoft didnt seem to think was that serious. That brings their current European union fine total up to 2.5 billion dollars for abusing the dominance of PC operating system WINDOWS, the largest ever for any company in history. And, Microsoft's problems don't stop there, two new investigations were opened last month and more fines could be levied unless they clean up their act. But, given the prospect of a Yahoo and Microsoft merger, I don't think losing the money really bothers them. Did anyone else notice the mystery Starbucks closing time yesterday? No? Not a fan? Well to millions of Starbucks customers, it might have been an inconvenience, but Starbucks hopes it was worth it. The company closed its coffee shops three hours early yesterday to retrain its employees on how to make a proper espresso. All stores now proclaim "Your drink should be perfect, every time." Starbucks made the move to do a mass training because their once booming stock has fallen 50 percent since late 2006, with many customers complaining of falling quality standards. And, the world's leading coffee shop said they are committed to turning that around. Stores are now open for regular business and Starbucks will continue with more training throughout the month. You just heard some top stories from get the daily****. I'm Andrea Rene and be sure to check back for ongoing news coverage. starbucks, microsoft, espresso, coffee, anti trust, europe, euros, european, customers, stock, economy, interest rates, houses, jobs, federal reserve, chairman, capitol hill, congress, gas prices, european commission, PC, windows, monopoly, competition, anti trust, drink, perfect, training, employment, news, national, headlines, getthedaily
28 Feb 2008
340
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1:48
Diane and Dennis McCarthy both in their 60's found themselves in a predicament when he became confined to a wheelchair for several months after falling off a ladder and breaking his ankle. Diane McCarthy, Home Owner "It was three surgeries and six months of no walking which was pretty inconvenient in this split level house." They turned to Vince Butler, a CAPS contractor who is a certified aging in place specialist to help them modify their home so they could age in place. This enabled them to increase their access and maneuverability should they have other unforeseen difficulties as they age. Vince Butler, Certified Aging in Place Specialist "The CAPS training is really unique I think in the industry..."The training is focused on the needs as folks age. We look at those issues of the normal aging process as well as sort of chronic and acute conditions that can develop." Task lighting, user- friendly appliances, smooth surface flooring and curb-less shower stalls are just some of the features CAPS contractors recommend to age in place. Elinor Ginzler, AARP Dir., Livable Communities "I think this program is incredibly helpful for people who know they want to make some changes to their house�.and by locating a remodeler who�..is a Certified Aging in Place specialist they know they are going to get somebody who has been trained in this area�and make that house the best possible house over time." CAPS professionals pledge to uphold a code of ethics and are required to maintain their designation by attending continuing education programs.
10 Mar 2008
263
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0:23
CLICK . *******phonetrace.weebly**** . The link above will take you to the #1 Investigative Product currently available on the internet ! To date this system is the only way possible for anybody to gather information about callers who try to be anonymous! You will even find your own name, address, details etc. Scarey ey ! But useful if you are being harassed. This is great for impressing friends. It is also handy if you have a girlfriend or boyfriend harassing you. Nobody should put up with Continuous, Secretive, Obscene or harassing phone calls. Even if calls are not threatening they can be of great inconvenience. However now there is an option available, so you can finally put an end to these calls. In most cases, simply uncloaking the individual is enough to bring your problems to swift and successful resolutions. Often times the source of the harassing or obscene calls will show the phone number as unlisted, unpublished, non published, anonymous or private. What is the difference between the phone number labels of unlisted, unpublished, non published, private or anonymous? All the above labels essentially mean the same thing. The link above is currently the best way of finding out details about the person on the other end of the line. This is powerful information and should only be used by those who need it. Check it out Click *******richguru.awardspace**** A reverse cell phone look up can be conducted for a variety of reasons, whether it's to... * Stop a prank caller * Determine someone's exact location * See who owns an unlisted number * Research a "suspicious" number on someone's phone * Locate an old friend from high school or college * Research "missed calls" on your caller ID ...or whatever other reason you might have (as long as it's within the confines of laws and regulations). Back in the "old days" before the Internet, the only way to conduct a reverse phone look up was to hire an expensive private investigator. But now, public phone and record databases have been organized and compiled so that you can instantly look up the details about any number from the privacy of your home. // created at animoto**** (more) (less) Tags: call calls dial directory find get gossip how listed lookup mum name number phone secret to trace // created at animoto****
17 May 2008
1578
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0:28
CLICK . *******phonetrace.weebly**** .The link above will take you to the #1 Investigative Product currently available on the internet ! To date this system is the only way possible for anybody to gather information about callers who try to be anonymous! You will even find your own name, address, details etc. Scarey ey ! But useful if you are being harassed. This is great for impressing friends. It is also handy if you have a girlfriend or boyfriend harassing you. Nobody should put up with Continuous, Secretive, Obscene or harassing phone calls. Even if calls are not threatening they can be of great inconvenience. However now there is an option available, so you can finally put an end to these calls. In most cases, simply uncloaking the individual is enough to bring your problems to swift and successful resolutions. Often times the source of the harassing or obscene calls will show the phone number as unlisted, unpublished, non published, anonymous or private. What is the difference between the phone number labels of unlisted, unpublished, non published, private or anonymous? All the above labels essentially mean the same thing. The link above is currently the best way of finding out details about the person on the other end of the line. This is powerful information and should only be used by those who need it. Check it out Click *******richguru.awardspace**** A reverse cell phone look up can be conducted for a variety of reasons, whether it's to... * Stop a prank caller * Determine someone's exact location * See who owns an unlisted number * Research a "suspicious" number on someone's phone * Locate an old friend from high school or college * Research "missed calls" on your caller ID ...or whatever other reason you might have (as long as it's within the confines of laws and regulations). Back in the "old days" before the Internet, the only way to conduct a reverse phone look up was to hire an expensive private investigator. But now, public phone and record databases have been organized and compiled so that you can instantly look up the details about any number from the privacy of your home. Tags: call calls dial directory find get gossip how listed lookup mum name number phone secret to trace Phone Call - Trace a telephone number (find out who called)
10 May 2008
1536
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0:23
VISIT *******pgsecure.phonesrch.hop.clickbank**** Do you want to find somebodies details through tracing a call? If yes, then click above. The link above will take you to the #1 Investigative Product currently available on the internet ! To date this system is the only way possible for anybody to gather information about callers who try to be anonymous! You will even find your own name, address, details etc. Scarey ey ! But useful if you are being harassed. This is great for impressing friends. It is also handy if you have a girlfriend or boyfriend harassing you. Nobody should put up with Continuous, Secretive, Obscene or Harassing phone calls. Even if calls are not threatening they can be a great inconvenience. However finally there is an option available. You can now finally put an end to these calls. In most cases, simply uncloaking the individual is enough to bring your problems to swift and successful resolutions. Often times the source of the harassing or obscene calls will show the phone number as unlisted, unpublished, non published, anonymous or private. What is the difference between the phone number labels of unlisted, unpublished, non published, private or anonymous? All the above labels essentially mean the same thing. The link above is currently the best way of finding out details about the person on the other end of the line. This is powerful information and should only be used by those who need it. Check it out Click *******pgsecure.phonesrch.hop.clickba... A reverse cell phone look up can be conducted for a variety of reasons, whether it's to... * Stop a prank caller * Determine someone's exact location * See who owns an unlisted number * Research a "suspicious" number on someone's phone * Locate an old friend from high school or college * Research "missed calls" on your caller ID ...or whatever other reason you might have (as long as it's within the confines of laws and regulations). Back in the "old days" before the Internet, the only way to conduct a reverse phone look up was to hire an expensive private investigator. But now, public phone and record databases have been organized and compiled so that you can instantly look up the details about any number from the privacy of your home. Tags: call calls dial directory find get gossip how listed lookup mum name number phone secret to trace
13 Aug 2008
2322
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0:29
CLICK . *******phonetrace.weebly**** .The link above will take you to the #1 Investigative Product currently available on the internet ! To date this system is the only way possible for anybody to gather information about callers who try to be anonymous! You will even find your own name, address, details etc. Scarey ey ! But useful if you are being harassed. This is great for impressing friends. It is also handy if you have a girlfriend or boyfriend harassing you. Nobody should put up with Continuous, Secretive, Obscene or harassing phone calls. Even if calls are not threatening they can be of great inconvenience. However now there is an option available, so you can finally put an end to these calls. In most cases, simply uncloaking the individual is enough to bring your problems to swift and successful resolutions. Often times the source of the harassing or obscene calls will show the phone number as unlisted, unpublished, non published, anonymous or private. What is the difference between the phone number labels of unlisted, unpublished, non published, private or anonymous? All the above labels essentially mean the same thing. The link above is currently the best way of finding out details about the person on the other end of the line. This is powerful information and should only be used by those who need it. Check it out Click *******richguru.awardspace**** A reverse cell phone look up can be conducted for a variety of reasons, whether it's to... * Stop a prank caller * Determine someone's exact location * See who owns an unlisted number * Research a "suspicious" number on someone's phone * Locate an old friend from high school or college * Research "missed calls" on your caller ID ...or whatever other reason you might have (as long as it's within the confines of laws and regulations). Back in the "old days" before the Internet, the only way to conduct a reverse phone look up was to hire an expensive private investigator. But now, public phone and record database ...
10 May 2008
3314
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