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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.
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September 15, 2014
07:26 EDTLLYPiper Jaffray to hold a conference
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September 12, 2014
08:02 EDTLLYEli Lilly announces Cyramza Phase III cancer trial meets primary endpoint
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08:01 EDTLLYEli Lilly announces Cyramza Phase III cancer trial meets primary endpoint
Eli Lilly announced that the RAISE trial, a Phase III study of ramucirumab in combination with chemotherapy in patients with metastatic colorectal cancer, met its primary endpoint of overall survival. The global, randomized, double-blind study compared ramucirumab plus FOLFIRI to placebo plus FOLFIRI as a second-line treatment in patients with mCRC after treatment with bevacizumab, oxaliplatin and a fluoropyrimidine in the first-line setting. RAISE showed a statistically significant improvement in overall survival in patients treated with ramucirumab plus FOLFIRI compared to placebo plus FOLFIRI. The study also showed a statistically significant improvement in progression-free survival in the ramucirumab-plus-FOLFIRI arm compared to the placebo-plus-FOLFIRI arm.
September 10, 2014
07:04 EDTLLYEU grants marketing authorization for Eli Lilly's insulin glargine product
The European Commission granted marketing authorization for Eli Lilly and Boehringer Ingelheim's insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged 2 years and above. Lilly/Boehringer Ingelheim's insulin glargine product is the first insulin treatment approved through the European Medicines Agency's biosimilar pathway and the fourth diabetes product approved in the EU from the Lilly-Boehringer Ingelheim alliance. It received a positive recommendation from the Committee for Medicinal Products for Human Use on June 26. The marketing authorisation for the alliance's insulin glargine product is based upon a comprehensive clinical data program. The application included results from pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in patients with type 1 and type 2 diabetes.
September 8, 2014
07:15 EDTLLYIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
07:01 EDTLLYIgnyta names Robert Wild as Chief Scientific Officer
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September 4, 2014
08:11 EDTLLYEli Lilly's insulin peglispro for diabetes shows positive Phase III results
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