Semaglutide News and Research

Latest Semaglutide News and Research

FDA assigns new PDUFA date for Takeda's investigational type 2 diabetes therapy, alogliptin

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., today announced that the company received notification from the U.S. Food and Drug Administration (FDA) that its review of investigational type 2 diabetes therapy alogliptin, and thus the fixed-dose combination therapy alogliptin/pioglitazone, will be delayed.

18 Nov 2011

Midatech receives Swissmedic approval to start trial of insulin-coated gold nanoparticle

Midatech Ltd., a global leader in the design, development, synthesis and manufacture of nanomedicines, announced today it has received Swissmedic approval to start the First-in-Human clinical trial with insulin-coated gold nanoparticles, which will be coordinated through its Swiss subsidiary PharMida AG.

15 Nov 2011

Amylin and Lilly terminate exenatide alliance, resolve litigation

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced an agreement to terminate their alliance for exenatide and resolve the outstanding litigation between the companies.

9 Nov 2011

Quintiles closes agreement to acquire Advion BioServices

Quintiles' ability to provide customers with actionable early-stage data to make better development decisions faster has taken a significant step forward with the closing of the previously announced agreement to acquire Advion BioServices, a premier U.S.-based bioanalytical laboratory.

From Advion 7 Nov 2011

Isis commences ISIS-GCGRRx and ISIS-GCCRRx Phase 1 studies for type 2 diabetes

Isis Pharmaceuticals, Inc. announced today that it has initiated Phase 1 clinical studies for ISIS-GCGRRx and ISIS-GCCRRx, antisense drugs Isis is developing for the treatment of type 2 diabetes.

2 Nov 2011

NPS announces new data from GATTEX Phase 3 study on short bowel syndrome

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced new data from STEPS 2, a long-term open-label study, showing that GATTEX (teduglutide) was associated with achieving and maintaining clinically meaningful reductions in parenteral nutrition (PN) and intravenous (IV) fluid volume in adult subjects with short bowel syndrome.

1 Nov 2011

Covance Shanghai facility receives OECD Good Laboratory Practice certification

Covance Inc. today announced that its early development facility located in Shanghai, China, has received Good Laboratory Practice (GLP) certification from the Belgian GLP Monitoring Authority, a member of the Organization for Economic Cooperation and Development (OECD). The Covance facility in Shanghai provides bioanalytical, toxicology, lead optimization toxicology, in-vivo PK screening, and metabolism services.

24 Oct 2011

Byetta combination with insulin glargine gets FDA nod in type 2 diabetes

The US Food and Drugs Administration (FDA) has approved Byetta (exenatide) injection as add-on treatment for use with insulin glargine, together with exercise and diet for diabetes type 2 patients who are not responding well enough to glargine alone. Byetta's add-on therapy is for those on glargine with metformin and/or a TZD (thiazolidinedione) or without.

20 Oct 2011

Two newer Type 2 diabetes drugs could be linked to increased risk of pancreatic cancer

Two newer drugs used to treat Type 2 diabetes could be linked to a significantly increased risk of developing pancreatitis and pancreatic cancer, and one could also be linked to an increased risk of thyroid cancer, according to a new UCLA study.

19 Sep 2011

New diabetes drugs linked to increased risk of pancreatitis and pancreatic cancer

17 Sep 2011

Enrollment commences in ConjuChem's CJC-1134-PC Phase 2 trial for Type 2 diabetes

ConjuChem, LLC, a biotechnology company dedicated to the discovery of novel therapeutics, today announced it has initiated patient enrollment for its Phase 2 clinical trial of its proprietary GLP-1 receptor agonist drug, CJC-1134-PC, in patients with Type 2 diabetes mellitus who are receiving metformin monotherapy.

15 Sep 2011

Lexicon's LX4211 clinical data presented at EASD annual meeting

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced today that the company is presenting clinical data this week at the European Association for the Study of Diabetes (EASD) annual meeting in Lisbon, Portugal.

14 Sep 2011

Sanofi's Lyxumia achieves primary efficacy endpoint in study of patients uncontrolled on metformin

Sanofi announced today that Lyxumia (lixisenatide), a once-daily GLP-1 receptor agonist under development for type 2 diabetes, achieved its primary efficacy endpoint of significant HbA1c reduction vs. placebo in patients uncontrolled on metformin.

12 Sep 2011

Lexicon's second quarter revenues decrease 55% to $0.6 million

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three and six months ended June 30, 2011.

9 Aug 2011

Femta files IND with FDA for FM101 monoclonal antibody against RA

Femta Pharmaceuticals announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a clinical development program for FM101, a high-affinity, humanized monoclonal antibody against Interleukin-6 (IL-6), in patients with rheumatoid arthritis (RA).

1 Aug 2011

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

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 in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.

28 Jul 2011

Roux-en-Y gastric bypass appears to reduce dietary fat intake

Roux-en-Y gastric bypass, the most common type of bariatric surgery in the United States, is currently considered the most effective therapy for morbid obesity.

28 Jul 2011

Roux-en-Y gastric bypass surgery can lead to effective weight loss

Imperial College London. The findings, published in the American Journal of Physiology—Regulatory, Integrative, and Comparative Physiology, suggest a new mechanism by which some types of bariatric surgery lead to long-term weight loss.

28 Jul 2011

Takeda resubmits alogliptin and fixed-dose combination therapy NDA to FDA

Takeda Pharmaceutical Company Limited announced today that Takeda Global Research & Development Center, Inc., resubmitted two New Drug Applications to the United States Food and Drug Administration for alogliptin and the fixed-dose combination therapy alogliptin/pioglitazone, which combines alogliptin with pioglitazone in a single tablet.

26 Jul 2011

Isis commences ISIS-PTP1BRx Phase 1 study in type 2 diabetes

Isis Pharmaceuticals, Inc. announced today that it has initiated a Phase 1 clinical study for ISIS-PTP1BRx, an antisense drug for the treatment of type 2 diabetes targeting protein tyrosine phosphatase-1B, PTP-1B.

21 Jul 2011