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Amylin Pharmaceuticals to Present at The Barclays Capital 2010 Global Healthcare Conference
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN) will be presenting at the Barclays Capital Global Healthcare Conference on Wednesday, March 24, 2010 at 11:15 a.m. ET / 8:15 a.m. PT in Miami. David Maggs, M.D., vice president,...
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FDA questions delay long-acting Byetta
A once-weekly formulation of Eli Lilly and Amylin Pharmaceuticals' blockbuster diabetes medication Byetta has hit a manufacturing hurdle en route to the registration in the US.The FDA has sent the two companies a response letter indicating that there...
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Amylin, Alkermes Gain as FDA Doesnt Need More Byetta Data
March 15 (Bloomberg) -- Amylin Pharmaceuticals Inc.and Alkermes Inc. reached their highest levels in 18 months in Nasdaq trading after U.S. regulators said they didnt need more studies for a once-weekly version of the diabetes drug Byetta. The...
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Amylin, Lilly & Alkermes get US FDA complete response letter for exenatide ER
Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc.announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for Bydureon (exenatide for extended-release...
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Amylin, Lilly And Alkermes Receive Complete Response Letter From FDA For Exenatide Once Weekly Submission
Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for...
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FDA Says 'No Way!' Market Says 'Yeah, Baby!'(Byetta)
The Food and Drug Administration's response wasn't exactly what investors in Amylin Pharmaceuticals (Nasdaq: AMLN), Eli Lilly (NYSE: LLY), and Alkermes (Nasdaq: ALKS) were looking for, but they'll take it.Amylin and Alkermes are both trading up more than 13%...
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Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission
BYDUREON(TM) (exenatide for extended-release injectable suspension) Proposed Name SAN DIEGO, INDIANAPOLIS, and WALTHAM, Mass., March 15, 2010 (HSMN NewsFeed) -- Amylin Pharmaceuticals, Inc.(Nasdaq:AMLN ), Eli Lilly and Company (NYSE:LLY ) and Alkermes, Inc....
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FDA asks for risk plan info on diabetes drug
SAN DIEGO (AP) - Amylin Pharmaceuticals Inc.said Monday it received a Food and Drug Administration request for information on manufacturing and a risk mitigation plan for a potential once-weekly diabetes treatment. Amylin, along with partners Eli Lilly&...
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Biotech Stocks Hot Movers (CYTR, AMLN, CTIC, XNPT)
) Dallas, Tx - CytRx Corporation (NASDAQ:CYTR) went down 1.61% to $1.22 on 1.01 million shares after the company this week posted full-year net loss attributable to common stockholders of $4.8 million or $0.05 per share, narrower than $27.8 million or $0.30 per...
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Industry News Bytes: Delcath, Amylin and Access Pharma
Potash (POT) is poised to open trading at new highs after posting strong earnings and upping its guidance.Meanwhile, Yara International (YARIY.PK) has withdrawn its bid for Terra Industries (TRA), which will be acquired by CF Industries (CF). In addition,...
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Mo' Betta Byetta Stalls Out, but No New Trials Needed
Crystal-balling, punditry and guesswork over Byetta LAR ended Monday with news that the FDA had smacked a complete response letter on the compound, now branded Bydureon.It's far from the worst-case scenario, since regulators demanded no new testing and...
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Amylin: Shares Rise Despite Drug Approval Delay
The FDA recently issued a complete response letter delaying the approval of Amylin Pharmaceuticals, Inc.(AMLN), Eli Lilly and Co. (LLY) and Alkermes, Inc.s (ALKS) once weekly formulation of Byetta (exenatide). The companies are seeking to get ...
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Amylin Drug Approval Delayed - Analyst Blog
The US Food and Drug Administration (FDA) recently issued a complete response letter delaying the approval of Amylin Pharmaceuticals, Inc.( AMLN ), Eli Lilly and Co. ( LLY ) and Alkermes, Inc.s ( ALKS ) once weekly formulation of Byetta (exenatide)....
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FDA asks Amylin for more details but no new trials
Regulatory Last Updated: 2010-03-15 14:12:26 -0400 (Reuters Health) * FDA requests finalization of product labeling * FDA does not ask for additional trials * Amylin shares rise 13 pct in afternoon trading * Alkermes shares rise 12 pct By Toni Clarke BOSTON ...
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Clarification: Amylin FDA info request story
Share: Yahoo!Buzz Text tool name tool goes here The Associated Press SAN DIEGO -- In a story March 15, The Associated Press reported that Bydureon is the proposed trade name of exenatide, a diabetes treatment being developed by Amylin Pharmaceuticals Inc.,...
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Amylin Pharmaceuticals to Present at The Barclays Capital 2010 Global Healthcare Conference
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN) will be presenting at the Barclays Capital Global Healthcare Conference on Wednesday, March 24, 2010 at 11:15 a.m. ET / 8:15 a.m. PT in Miami. David Maggs, M.D., vice president,...
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Amylin Pharmaceuticals to Present at The Barclays Capital 2010 Global Healthcare Conference
Companies mentioned in this article: Amylin Pharmaceuticals, Inc.SAN DIEGO, March 16, 2010 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) will be presenting at the Barclays Capital Global Healthcare Conference on Wednesday, March 24,...
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Amylin Pharmaceuticals to Present at The Barclays Capital 2010
Amylin Pharmaceuticals, Inc.will be presenting at the Barclays Capital Global Healthcare Conference on Wednesday, March 24, 2010 at 11:15 a.m. ET / 8:15 a.m. PT inMiami.David Maggs, M.D., vice president, research and development strategic relations at...
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Amylin Pharmaceuticals to Present at The Barclays Capital 2010 Global Healthcare Conference
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN) will be presenting at the Barclays Capital Global Healthcare Conference on Wednesday, March 24, 2010 at 11:15 a.m. ET / 8:15 a.m. PT in Miami. David Maggs, M.D., vice president,...
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Amylin Pharmaceuticals to Present at The Barclays Capital 2010 Global Healthcare Conference
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN) will be presenting at the Barclays Capital Global Healthcare Conference on Wednesday, March 24, 2010 at 11:15 a.m. ET / 8:15 a.m. PT in Miami. David Maggs, M.D., vice president,...
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Amylin Pharmaceuticals to Present at The Barclays Capital 2010 Global Healthcare Conference
/PRNewswire-FirstCall/ Amylin Pharmaceuticals, Inc.(Nasdaq: AMLN) will be presenting at the Barclays Capital Global Healthcare Conference on Wednesday, March 24, 2010 at 11:15 a.m. ET / 8:15 a.m. PT in Miami. David Maggs, M.D., vice president, research...
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Amylin, Alkermes Find Relief in Benign FDA Response Letter to Diabetes Drug
The dreaded FDA complete response letter, so often seen as a major setback and perceived negatively by investors in afflicted companies, was Monday welcomed with open arms by shareholders in Amylin Pharmaceuticals (AMLN) and Alkermes (ALKS), sending shares in...
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FDA issues complete-response letter for Byetta LAR
_ FDA issues complete-response letter for Byetta LAR.
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Alkermes, others rise on Byetta news
SAN FRANCISCO Amylin Pharmaceuticals Inc.and Waltham, Mass.-based Alkermes Inc. Alkermes, others rise on Byetta news.
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Pharma News: Label Change to Bydureon, Inspire Trial Fails
The Food and Drug Administration is demanding clarifications on the labeling and manufacturing process for Bydureon, a new drug candidate of Amylin Pharmaceuticals (AMLN), Eli Lilly (LLY) and Alkermes (ALKS).The FDA would like changes made to clarify the...
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