Augustine Commission meeting that took place on 08/05/2009 in Washington, D.C.
Discussion with Steven Sussman, Ph.D - Child & Adolescent Psychologist Co-Founder of the Child & Teen Success Centers in NY & NJ
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****.
Upcoming Killtown Feature,
<a href='*******total411.info'>Total411.info JaceyJako, Spiney, Xenomorph, Genghis6199, Webfairy, The Rabbit Hole, Coffinmanand more! Thank you! Music by Evolution Control Committee featuring Dan Rather
In the style of the "Orange Wednesdays" adverts, it's a tongue in cheek look at how the moronic committee responsible for organising a charity cabaret (for which the film was created for) put the event together much to the chagrin of the representative from the charity in question. How will the charity rep cope when faced with each ridiculously inane idea? Will Wembley Stadium be built in time? Will the mooted headliners McCartney, The Stones, The Who and The Backstreet Boys show up? Will a KFC family bucket be enough to feed 300 people? And which one is Ant and which one is Dec?
Written by Sam Holtmon & Daniel D Moses
Directed, Produced, Shot & Cut by Daniel D Moses
In 1969 the astronaughts found alien structures on the Moon and the rusians found evidence on Mars some years later! Colonel Ed Black writes, There was an extensive initial meeting in Cuba between The Delta and The Project Utopia Committee, Codename Crown, in the early Spring of 1943. A measured amount of scientific technology was provided by The Delta in return for a solemn agreement that The Delta would remain UNKNOWN BY THE GENERAL POPULATION, that they had exclusive rights to OUR Moon and would not be interfered with at any time in the future and that Army Project Echo, that bounced radio signals off OUR Moon, would be canceled. Among the technology that was provided by the Delta was transistor technology and aerodynamic technology that eventually led to jet propulsion. Well for years the scientific community would have us believe that OUR Moon is incapable of holding an atmosphere because it is too small, it does not have the gravitational ability to hold on to an atmosphere but the fact is that it does have the ability to sustain an atmosphere of at least 2 to 3 miles above it's surface and no doubt has at some point in it's history as it's topographical features would indicate. Delta are also involved with Mars and it's Moons and SATURN'S MOON TITAN. Our relations with the Delta went wrong with the death of Roosevelt and the changes that occurred under Truman and later Eisenhower. We actually double-crossed the Delta and how they turned against us, but only in a limited way. In the Kennedy years for the first time ever we began to play hard ball with the Delta, we defied them and challenged them and I think that this is all vital in order to understand where we are today. Thanks to Ed Black E-mail above dated Feb 15th 2006
The folks behind the Media Reform movement chose Memphis for their national conference. "The one thing all Americans agree upon is they think their local TV news is the worst in the country," said McChesney, a professor and author. Watch exclusive coverage when Rep. Dennis Kucinich (D- Ohio) paid a surprise visit to the National Conference for Media Reform and announced to hundreds of cheering activists that the U.S. House will created a committee on media reform and that Kucinich will be its chair.
Anderson & Anderson is the largest provider of Certified Anger Management Facilitator training in the world. Licensing agreements are now available throughout the United States, Canada and the Far East. For a list of certified providers and licensees, click here: Anderson & Anderson US Certified Providers. For a list of our products, click here: Anderson & Anderson Online Store to access our on-line store. The Anderson & Anderson model of anger management is the most effective and most widely recognized curriculum in the world. We currently have Certified Anger Management Facilitators in the United States, Canada, Guam, South Africa, Bermuda, Mexico, Cayman Islands, England, the Philippines and Italy. The Anderson & Anderson adolescent and adult curricula is now available in Spanish and English. The Anderson Anger Management/executive Coaching Program is used by Physician Well-Being Committees, Medical Quality Assurance and Hospital Chains nationwide.
President John Fitzgerald Kennedy, the 35th President of the United States, was shot during a motorcade drive through downtown Dallas this afternoon. He died in the emergency room of the Parkland Memorial Hospital 32 minutes after the attack. He was 46 years old. He is the third President to be assassinated in office since Abraham Lincoln and the first since President McKinley in 1901.
In the late afternoon the Dallas police took into custody a former Marine, one Lee H. Oswald, aged 24, who is alleged to have shot a policeman outside a theatre. He is said to have remarked only, "It is all over now." He is the chairman of a group called the "Fair Play for Cuba Committee," and is married to a Russian girl. He is described at the moment as "a prime suspect."
Welcome to Beijing 2008 ,the colours of the interlinked Olympic rings were chosen by the International Olympic Committee (IOC) , to represent the union of the 5 continents , Australia , Africa , America , Asia and Europe
Attorney General Alberto Gonzales was back in a familiar place Tuesday, on Capitol Hill testifying before the Senate Judiciary Committee about the US Attorney firings. Past Gonzales hearings have been ugly, but none have compared with the ugliness of the latest round.
Three million seniors could lose their Medicare Advantage coverage, while millions more would face benefit cuts and higher out-of-pocket health care costs under legislation passed today by the U.S. House of Representatives.
Noting that 49 percent of Medicare Advantage beneficiaries have incomes of less than $20,000 per year, Karen Ignagni, President and CEO of America's Health Insurance Plans (AHIP), said the legislation would have a devastating impact on seniors' health security.
"The House bill shreds the safety net for millions of seniors who depend on Medicare Advantage," said Ignagni.
In testimony before the Ways and Means Committee last week, Peter Orszag, Director of the non-partisan Congressional Budget Office, said that Medicare Advantage enrollment would fall by 33 percent under the legislation passed today by the House.
Good Luck, Waxman
On Tuesday House Oversight Committee Chairman Henry Waxman (D-CA) sent out a request for information to 19 different government agencies, all of which apparently took part in an expansive scheme by Karl Rove to use agency officials and resources to help Republican politicians win elections, a possible violation of the Federal Hatch Act. In today's episode we take a look back at some of the past testimony by government officials about these agency briefings to try to figure out why the scheme may have yielded poor results in the 2006 elections, and just how much work Henry Waxman has ahead of him.
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'Thinking people desperately need an alternative.'
Eric Margolis is a Contributing Editor for The American Conservative and Sun Media, and Founding Committee member of The Real News. (more) (less)
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Relief organizations say almost one third of Iraqis need emergency humanitarian aid
Tuesday July 31st, 2007
The war in Iraq has led to the greatest mass exodus of people ever in the Middle East and threatens to overtake Darfur in the numbers of displaced. A report by Oxfam International and the NGO Coordination Committee of Iraq concludes 'the slide into poverty and deprivation since the coalition forces entered the country in 2003 has been dramatic, and a deep trauma for the Iraqi people.' One in seven Iraqis have fled for fear of being killed. More than 2 million are now in Syria and Jordan. Another 2 million are believed to be living away from their homes inside Iraq, often in makeshift camps. The report says 70 per cent of Iraqis don't have adequate access to clean water, compared to 50 per cent four years ago. Humanitarian aid has also declined from 53 million in 2005 to less than 00 million last year. British journalist Patrick Cockburn writes in the Belfast Telegraph the United States 'has 18 benchmarks to measure progress in Iraq but the return of 4 million people is not among them.' APTN cameras recorded the squalid conditions for internal refugees living near Najaf.
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