Exenatide News and Research

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Exenatide (marketed as Byetta) is one of a new class of medications (incretin mimetics) approved for the treatment of diabetes mellitus type 2.

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA (exenatide) injection added to Lantus (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

28 Jun 2010

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

Ipsen a global biopharmaceutical group, today announced that its partner Roche disclosed results of five Phase III 24-week studies for taspoglutide for type 2 diabetes at the American Diabetes Association's (ADA) 70th Annual Scientific Sessions. Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence, originating from Ipsen's research is developed by Roche. This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.

28 Jun 2010

Data on BYETTA and SYMLIN injections, BYDUREON drug candidate to be presented at ADA 2010

Amylin Pharmaceuticals, Inc. today announced that the Company will present data for its FDA-approved diabetes drugs, BYETTA (exenatide) injection and SYMLIN (pramlintide acetate) injection, and its investigational diabetes drug candidate BYDUREON (exenatide extended-release for injectable suspension) at the American Diabetes Association's 70th Annual Scientific Sessions being held in Orlando, FL from June 25 to June 29.

18 Jun 2010

DURATION-4 study tests superiority of BYDUREON as compared to other type 2 diabetes medications

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of BYDUREON (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications.

18 Jun 2010

Roche implements risk mitigation plan in taspoglutide Phase III programme

Ipsen, a global biopharmaceutical group, today announced that its partner Roche today announced the implementation of a risk mitigation plan in the taspoglutide Phase III programme. Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence, originating from Ipsen's research is developed by Roche. This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.

18 Jun 2010

Health Canada approves Victoza for treatment of adults with type 2 diabetes

Diabetes is growing at an alarming rate in Canada, with an estimated 3.7 million people expected to be diagnosed by 2020. It is a progressive disease that, if not properly monitored and managed over time, will lead to serious long term complications. Canadians now have a novel treatment available to help them maintain optimal blood glucose levels. Health Canada has approved Victoza (liraglutide), the first GLP-1 analogue, for once-daily administration for the treatment of adults with type 2 diabetes to improve glycemic control in combination with metformin or metformin and a sulfonylurea.

27 May 2010

FDA assigns BYDUREON new PDUFA action date of October 22, 2010

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has classified the BYDUREON™ (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.

6 May 2010

Roche announces results of phase III T-emerge 3 study of taspoglutide in diabetics

Ipsen, a global biopharmaceutical group, today announced that its partner Roche has disclosed results of the phase III T-emerge 3 study in patients with diabetes with taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence. Taspoglutide originating from Ipsen's research is developed by Roche.

29 Apr 2010

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON™ (exenatide for extended-release injectable suspension).

23 Apr 2010

Amylin Pharmaceuticals announces $174.1M total revenue for first-quarter 2010

Amylin Pharmaceuticals, Inc. today reported financial results for the quarter ended March 31, 2010. The Company reported total revenue of $174.1 million for the quarter ended March 31, 2010, which includes net product sales of $172.3 million. Non-GAAP operating loss was $3.8 million for the quarter ended March 31, 2010, compared to $19.9 million for the same period in 2009.

19 Apr 2010

Biotech reports record financial results for 2010 first quarter

Biotech racked up impressive gains for both the month of March and the first quarter of 2010. The Burrill Biotech Select Index posted a 3.7 percent jump in value in March and an 8 percent overall gain for Q1 '10.

2 Apr 2010

Patients switching to Victoza experience further reductions in A1c and weight loss

Diabetes Care published online the results of the Novo Nordisk LEAD™ 6 extension study, which evaluated the efficacy and safety of switching from exenatide, which is taken twice a day, to once-daily Victoza®. Results show that when added to oral antidiabetes drugs, patients who switched from exenatide to Victoza experienced further reductions in A1c and weight loss.

31 Mar 2010

QRxPharma initiates Phase 1 trial for evaluating PK profiles of morphine, oxycodone CR formulations

QRxPharma announced today initiation of the Company's first Phase 1 trial to evaluate the pharmacokinetic (PK) profiles of experimental controlled-release (CR) morphine and oxycodone formulations that will be incorporated into MoxDuo®CR. MoxDuo®CR contains a fixed 3:2 morphine:oxycodone combination and is intended to be dosed twice daily in patients experiencing chronic pain, an approximately US$7 billion dollar market worldwide.

31 Mar 2010

NDA for BYDUREON: FDA issues complete response letter

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the New Drug Application for BYDUREON™ (exenatide for extended-release injectable suspension).

15 Mar 2010

FDA sets new PDUFA action date for exenatide once weekly NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) action date of March 12 for its review of the exenatide once weekly new drug application (NDA).

25 Feb 2010

Amylin Pharmaceuticals and Takeda Pharmaceutical to advance pramlintide/metreleptin combination therapy development

Amylin Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited announced today that the companies have selected the combination treatment of pramlintide, an analog of the natural hormone amylin, and metreleptin, an analog of the natural hormone leptin, for advancement toward Phase 3 development. The decision to advance the program followed encouraging results from a 52-week blinded, placebo-controlled Phase 2 extension study. The pramlintide/metreleptin combination met the key target criteria of sustained and robust weight loss.

23 Feb 2010

Roche discloses results of two of eight taspoglutide T-emerge phase III studies in diabetes patients

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced that its partner Roche has disclosed headline results of the fourth and fifth of eight T-emerge phase III studies in patients with diabetes for taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence.

17 Dec 2009

Positive results from study comparing exenatide once weekly to BYETTA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to BYETTA® (exenatide) injection taken twice daily, in patients with type 2 diabetes.

15 Dec 2009

Eli Lilly provides financial guidance for 2010

At its annual meeting today with the investment community, Eli Lilly and Company highlighted how its innovation-based strategy will enable it to better serve patients and compete effectively in a challenging health care environment. The company also detailed the progress being made in its labs and across its five new business units on an expanding pipeline of innovative molecules and marketed medicines, and provided investors with the company's financial guidance for 2010.

10 Dec 2009

Roche announces results of phase III taspoglutide study in diabetes patients

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced that its partner Roche has disclosed the results of the second and third of eight T-emerge phase III studies in patients with diabetes for taspoglutide, the first human once weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen’s research and developed by Roche.

2 Dec 2009

Exenatide News and Research

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

Data on BYETTA and SYMLIN injections, BYDUREON drug candidate to be presented at ADA 2010

DURATION-4 study tests superiority of BYDUREON as compared to other type 2 diabetes medications

Roche implements risk mitigation plan in taspoglutide Phase III programme

Health Canada approves Victoza for treatment of adults with type 2 diabetes

FDA assigns BYDUREON new PDUFA action date of October 22, 2010

Roche announces results of phase III T-emerge 3 study of taspoglutide in diabetics

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Amylin Pharmaceuticals announces $174.1M total revenue for first-quarter 2010

Biotech reports record financial results for 2010 first quarter

Patients switching to Victoza experience further reductions in A1c and weight loss

QRxPharma initiates Phase 1 trial for evaluating PK profiles of morphine, oxycodone CR formulations

NDA for BYDUREON: FDA issues complete response letter

FDA sets new PDUFA action date for exenatide once weekly NDA

Amylin Pharmaceuticals and Takeda Pharmaceutical to advance pramlintide/metreleptin combination therapy development

Roche discloses results of two of eight taspoglutide T-emerge phase III studies in diabetes patients

Positive results from study comparing exenatide once weekly to BYETTA

Eli Lilly provides financial guidance for 2010

Roche announces results of phase III taspoglutide study in diabetes patients

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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