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News Breaks
March 5, 2014
09:34 EDTLLYFDA issues complete response letter for Empagliflozin to Boehringer, Lilly
Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company announced the U.S. Food and Drug Administration has issued a complete response letter for the New Drug Application of the investigational sodium glucose co-transporter-2 inhibitor empagliflozin.The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA stated these deficiencies need to be resolved before the approval of the application. The FDA has not asked Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.Boehringer Ingelheim and Lilly are committed to working with the FDA to make empagliflozin available to adults with type 2 diabetes and submitting a response to the complete response letter as soon as possible. The U.S. NDA was based on results from one of the largest clinical registration programs in its class, comprised of more than 10 multinational clinical trials and more than 13,000 people with type 2 diabetes.
News For LLY From The Last 14 Days
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December 19, 2014
09:48 EDTLLYBiogen should be bought on weakness after Roche drug halted, says Evercore ISI
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08:53 EDTLLYBiogen drug, trial differs from Roche Alzheimer's drug, says RBC Capital
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05:39 EDTLLYEli Lilly, Adocia to co-develop BioChaperone Lispro
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December 16, 2014
14:48 EDTLLYEli Lilly's CYRAMZA receives third FDA approval
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December 15, 2014
16:33 EDTLLYEli Lilly raises quarterly dividend 2% to 50c per share
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December 12, 2014
12:52 EDTLLYEli Lilly: FDA expands approved use of Cyramza to treat lung cancer
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December 11, 2014
10:13 EDTLLYOn The Fly: Analyst Upgrade Summary
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08:40 EDTLLYEli Lilly upgraded at Morgan Stanley
As previously reported, Morgan Stanley upgraded Eli Lilly two notches to Overweight from Underweight. The firm has increased confidence in Eli Lilly's pipeline investments following recent external data in Alzheimer's and atherosclerosis and now expects potential evacetrapib peak sales of $3B and solanezumab peak sales of $10B. Price target raised to $85 from $60.
06:22 EDTLLYEli Lilly upgraded to Overweight from Underweight at Morgan Stanley
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December 9, 2014
07:44 EDTLLYAmerican Association for Cancer Research to hold a symposium
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07:11 EDTLLYEli Lilly and Incyte announce Phase 3 RA-BEACON study met primary endpoint
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December 8, 2014
08:10 EDTLLYLilly, Anthem, HealthCore form five-year research collaboration
Eli Lilly and Company (LLY), Anthem (ANTM) and HealthCore, Inc. announced that they have formed a five-year, real-world evidence research collaboration intended to improve health outcomes for patients. The companies will jointly develop and conduct research projects in health outcomes and real-world evidence in areas of mutual interest. Each party will bring distinct and valuable contributions to the collaboration, including the U.S. provider and patient environment, research capabilities, therapeutics and methods expertise, and integrated, researchable data. The collaboration allows the organizations to explore research opportunities across disease states and incorporate surveys and other information from providers and patients.

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