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EU approves Lilly's weekly diabetes drug Bydureon

Associated Press
June 21, 2011
Keywords
Eli Lilly and Co., Health Care, Health Care & Insurance, Health Care & Life Sciences, Pharmaceutical, R&D
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European Union regulators have approved the first once-per-week diabetes medication, the companies that developed the drug said Tuesday.

Indianapolis-based Eli Lilly and Co., San Diego-based Amylin Pharmaceuticals Inc. and Alkermes Inc. said they received marketing approval for Bydureon, a drug that is intended to help patients control their blood sugar in combination with other diabetes medications. The drug is designed to increase the body's insulin production.

Bydureon is a version of Lilly and Amylin's diabetes drug Byetta, which was approved in the U.S. in April 2005 and in Europe in November 2006. Byetta, or exenatide, is taken twice a day. Alkermes, based in Waltham, Mass., created the technology that gradually releases the drug over the course of a week.

Common side effects of Bydureon included mild to moderate nausea, vomiting, diarrhea, and constipation

The companies have not received approval to sell Bydureon in the U.S. The Food and Drug Administration declined to approve Bydureon in October, asking the companies to run a thorough study that evaluated effects of bigger doses of Bydureon on patients' heart rates. The agency also requested results from a study intended to evaluate the efficacy, and labeling of the safety and effectiveness, of the commercial formulation of Bydureon.

Lilly, Amylin and Alkermes plan to submit that information in late 2011.

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  1. liek the rest of America

  2. These quaint,obsessed musings by the stalkers are certainly entertaining, but I'm trying to figure out what, if anything, all the yelping below has to do with Zak Brown.

  3. It's evident that Moffett was pushing the right buttons and corporate America is now trying to squash him. He just wanted to withdraw the free pilot services provided to the company by the pilots to try and put some pressure on a company that has not been interested in negotiating a contract in over 5 years. The company does not provide a contract because not having one has saved them a bundle of money. Shame on any Republic pilots not standing behind their union leader just because things are getting tough, can you not see such strategic moves by the company as putting the last union president in a corporate position and into THEIR pocket. Do you really believe the last union president is so appalled at the attempts by Moffett, do you not remember his oppositions to the company? We stood behind him. It has been proven over and over again for thousands of years without fail, a man cannot serve two masters. Anyone that believes people vote contrary to their paycheck and livelihood deserve to be taken advantage of, the recent statements by the former union president are laughable as he denounces the current union president from his new corporate position. Have you ever seen a drafted sports player score points for his previous team, it cannot be done, he is not on the pilots side anymore, he gets his money a different way now than you and I do, and he should not be allowed to remain on the seniority list. A drafted player brings strength, credibility, tactical knowledge, and a strategic advantage to his NEW team, he would not be drafted or paid were it otherwise. We are all forced to choose only one side to play for and support, not doing so has many references in life such as insider trading and shaving points, all illegal for good reason. This basic fact is why corporate moguls, scientist, and engineers all sign non-discloser agreements and non-compete clauses, as protection in case they are lured into switching sides as our former union president has done. No NFL coach ever drafted a player so that both teams could benefit and better understand each other, they are recruited to win the game against that former team, period. Likewise the company does not recruit the former union president by accident or mutual understanding, its strategy. Don't confuse playing the game with good sportsman-like conduct in support of common business and prosperity goals, with the requirement to only play for one side. Good men we all love and favor fall subject to this manipulation, often without their knowledge, and it is not a betrayal of their friendship to oppose them when they switch sides. If we did not love and trust them, they would not have been chosen and lured to the other side in the first place. The deception by the drafted player is not made at a conscious level, it's just human nature and it's all about money and power which corrupts our ability to be objective and loyal to two masters. This is why our court system created the defense attorney, and why our military created counter intelligence. Its strategy and its propaganda, and it works, and that's why the "powers to be" manipulate the chess pieces by sometimes changing their colors. Some players know they are being manipulated when their color is changed, but it brings them more money and power so they do not care. The rest have good intentions but do not even realize they are being manipulated. This tactic is also known by another name, Divide and Conquer. In battle sending an imperfect message with an imperfect team is obviously not ideal, but it's still being sent by YOUR team, your union leader, a leader that has common goals and common rewards with you, they are the best, because we have elected them to do a job for us. If you are not backing Moffett but believing the spin by those that have recently switched sides, you are taking food out of your own mouth. Showing unity and backing an imperfect situation still results in taking just as much ground, it's about unity and bargaining power. It's not necessary to wait around for that perfect attack because it will never come, the company will spin and attempt to destroy anyone that gets in their way. Ultimately it's not about any specific attack anyway, ASAP or whatever it makes no difference, it is and always has been only about power. If this company cared about safety it would not build pairings with 8 hour overnights, come on, are you that naive? Besides, do you really think Hoffa cares, no, he got a call from corporate America and was squeezed into denouncing Moffett. If he didn't they would spin the safety card against him and the Teamsters National with implication for truckers, future contracts, insurance rates etc...saying something like the Teamsters use safety as a bargaining chip, blah blah blah... Do you really think any pilot is going to do something unsafe for the contract, absolutely not, the only ones threatening safety here is the company with reduced rest, fatigue, and poverty. Do you not find it odd that Hoffa and the Teamsters are opposing a Teamster president publicly? Would the Teamsters National not normally support and work with one of their own? Why did they not sit down and help him strategize, correct any mistakes, and charge ahead? Would the Teamsters National not normally support and leverage a contract for all those pilots that have been paying Teamster dues, isn't that why we have all been paying Teamster dues in the first place? I sure haven't been paying dues so that the Teamsters National could come along and write this kind of an article undercutting our union leader and our unity. Whose side is the Teamsters National really on, it's obviously not the Republic pilots side.

  4. No matter what Moffatt does the company is going to spin it like he is the terrorist and brainwash people like you into believing it, wake up, back your players that are trying to change things for you and your livelihood. Where has Hoffa been for the last 6 years, except collecting our dues. Seriously, do you really think an FO going for upgrade, signed off by a checkairman ready for the upgrade, who then fails, is not even capable of returning as a First Officer.

  5. whoa!

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