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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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January 30, 2015
09:29 EDTLLYEli Lilly sees ForEx to have a negative impact of 4c in 2015 EPS
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07:20 EDTLLYEli Lilly CEO Lechleiter says currency fluctuations hitting topline
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06:38 EDTLLYEli Lilly reports Q4 Cialis sales $622.4M vs. $588.3M last year
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06:30 EDTLLYEli Lilly FY15 EPS guidance does not include 12c potential charge
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06:28 EDTLLYEli Lilly backs FY15 EPS view of $3.10-$3.20, consensus $3.18
Lowers FY15 revenue guidance to $19.5B-$20B from $20.3B-$20.8B, consensus $20.67B.
06:26 EDTLLYEli Lilly reports Q4 EPS 75c, consensus 74c
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January 29, 2015
15:37 EDTLLYNotable companies reporting before tomorrow's open
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13:36 EDTLLYEli Lilly volatility elevated into Q4 and outlook
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13:29 EDTLLYEarnings Preview: Eli Lilly to report Q4 results amid new product launches
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12:00 EDTLLYLeerink biotech analysts hold an analyst/industry conference call
Biotech Analyst Schwartz discusses Biogen Idec BIIB037 and whether 2015 will be the year when Amyloid Beta is finally validated as a disease-modifying target in Alzheimer's Disease on an Analyst/Industry conference call to be held on February 3 at 2 pm.
January 21, 2015
10:16 EDTLLYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.

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