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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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March 4, 2015
09:07 EDTLLYFDA making testosterone product makers change labeling
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March 3, 2015
08:04 EDTLLYDenovo Biopharma licensed Pomaglumetad Methionil from Eli Lilly
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07:16 EDTLLYCowen to hold a conference
35th Annual Health Care Conference is being held in Boston on March 2-4 with webcasted company presentations to begin on March 3 at 8 am; not all company presentations may be webcasted. Webcast Link
March 2, 2015
08:53 EDTLLYNon-profit gives lukewarm review to MannKind inhaled insulin, TheStreet says
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February 24, 2015
06:34 EDTLLYEli Lilly CEO states company is not for sale, Financial Times says
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February 23, 2015
08:31 EDTLLYEli Lilly announces delay in submission of basal insulin peglispro beyond Q1
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07:06 EDTLLYEli Lilly and Incyte announces positive results for baricitinib
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February 19, 2015
08:04 EDTLLYEli Lilly extends Evacetrapib Phase 3 trial by six months
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