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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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November 17, 2014
16:04 EDTLLYEli Lilly says empagliflozin tablets reduced A1C, body weight and abdominal fat
Empagliflozin tablets reduced hemoglobin A1C (a measure of average blood sugar over the past two to three months), body weight and several markers of abdominal fat in adults with type 2 diabetes, according to a new retrospective analysis of clinical trial data presented on behalf of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company at the 2014 Scientific Sessions of the American Heart Association in Chicago. Abdominal fat, also known as visceral fat, sits on or near vital organs. The study presented at AHA included analyses of two sets of adults with T2D treated with either empagliflozin or placebo. The first group consisted of 823 adults with high blood pressure who were treated for 12 weeks, while the second examined a pool of 2,476 adults from four different trials who were treated for 24 weeks. These randomized studies compared empagliflozin with placebo as an add-on to existing therapy, including metformin, metformin plus sulfonylurea, or pioglitazone with or without metformin. In both groups, treatment with empagliflozin significantly reduced A1C, body weight and several markers of abdominal fat compared with placebo. Changes in estimated total body fat did not reach statistical significance.
11:06 EDTLLYLeerink biotech analysts hold an analyst/industry conference call
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November 14, 2014
14:53 EDTLLYCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
November 13, 2014
13:32 EDTLLYLeerink biotech analysts hold an analyst/industry conference call
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13:29 EDTLLYLeerink biotech analysts hold an analyst/industry conference call
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13:26 EDTLLYLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including Leukemia/MDS on an Analyst/Industry conference call to be held on November 20 at 10 am.
November 11, 2014
16:14 EDTLLYLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including JAK inhibitors, novel Jakafi combinations for Myelofibrosis and developing compounds on an Analyst/Industry conference call to be held on November 17 at 10 am.

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