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December 12, 2012
06:56 EDTLLYEli Lilly provides update on next steps for Solanezumab
Eli Lilly provided an update on the next steps planned for solanezumab, its Phase 3 monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer's disease. Following discussions with regulators in the U.S., Europe and Canada, Lilly plans to conduct an additional Phase 3 study of solanezumab in patients with mild Alzheimer's disease. Additional details, including study design and length, are still being determined. Lilly expects to initiate this study no later than 3Q2013. Based on recent meetings with the FDA, Lilly does not intend to submit a Biologics License Application at this time in the U.S. based solely on the existing analyses of data from the Expedition studies. Lilly will continue to analyze and discuss the data from the two, Phase 3, double-blind, placebo-controlled solanezumab Expedition studies with regulators globally to determine the regulatory paths forward in different regions. It is possible that different courses of action could be taken in different jurisdictions.
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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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08:04 EDTLLYEli Lilly extends Evacetrapib Phase 3 trial by six months
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February 13, 2015
08:19 EDTLLYAckman noncommittal on McDonald's rumors, Bloomberg reports
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