All GLG News Analyses Filed Under: Endocrinology

Kelly ClosePresidentClose Concerns

Novo Nordisk's Liraglutide Wins in Obesity Too

October 29, 2009

Analysis of:Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study | www.thelancet.com

Results from a 20-week study of the GLP-1 analog liraglutide in obese and overweight patients were recently published in The Lancet. In the trial, 564 patients were randomized to one of six groups: orlistat (120 mg, 3 times daily), placebo, and liraglutide 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg. The trial involved a three-week screening period,a two-week run-in period, a 20-week double blind study period, and a 84-week open label follow up.

Donny WongDirector, Metabolic DisordersDECISION RESOURCES, INC.

Improvements to CV risk factors, but magnitude very low

October 27, 2009

Analysis of:Arena: 2nd weight loss trial shows cardiac benefit | www.reuters.com

Arena presented data on lorcaserin at a series of presentations this week at the 2009 meeting of The Obesity Society in Washington DC. Data from both the BLOOM and BLOSSOM Phase III studies were presented, although BLOOM data had been released for some time already.

denosumab approval delayed

October 21, 2009

Analysis by: GLG Expert Contributor

Analysis of:denosumab approval delayed | www.pharmatimes.com

Amgen's osteoporosis drug denosumab is delayed fda approval.

Kelly ClosePresidentClose Concerns

Major Turnaround- NEJM VADT Correction Shows MVC Benefits of Intensive Control

October 19, 2009

Analysis of:Veterans Affairs Diabetes Trials- Corrections | content.nejm.org

The authors of the original Veterans Affairs Diabetes Trial (VADT) published a correction in the September 3, 2009 issue of the NEJM indicating that the rate of progression to microalbuminuria was misreported in the original trial publication. Updated numbers show a meaningful and statistically significant reduction of progression to albuminuria for the intensive treatment group.

Kelly ClosePresidentClose Concerns

LEAD-6 Extension Trial Results Announced-- Look Positive for Novo Nordisk

October 17, 2009

Analysis of:Switching From Exenatide to Liraglutide for Type 2 Diabetes Demonstrates Benefits: Presented at EASD | www.docguide.com

LEAD-6 was a randomized open label parallel group study conducted at 132 sites in the US and EU, comparing the use of liraglutide and exenatide in type 2 diabetes patients 18-80 years of age. In the extension arm of the study, patients on 1.8 mg of liraglutide continued on the drug for another 14 weeks while patients originally randomized to the exenatide treatment group were switched to 1.8 mg liraglutide therapy for 14 weeks. After 40 weeks,  both groups had identical A1c levels. 

Fresh Hope for Diabetes Patients

October 15, 2009

Analysis by: GLG Expert Contributor

Analysis of:ONGLYZA™ (saxagliptin) Receives Marketing Authorisation In Europe For The Treatment Of Type 2 Diabetes | www.pipelinereview.com

The success of ONGLYZA (saxagliptin) will largely depend on its long-term safety. Saxagliptin is the second drug from this class to be approved in Europe and the US - Merck's Januvia (sitagliptin) was the first. Saxagliptin has had to overcome several new regulatory hurdles as a result of major recent safety issues with other diabetes drugs including sitagliptin. Sceptical prescribers and heavy postmarketing scrutiny will likely mitigate a rapid uptake.    

Is the End of the Beginning of Diabetes Coming?

October 11, 2009

Analysis by: GLG Expert Contributor

Analysis of:Andromeda Biotech Consummates Deal with Teva for the Commercialization of DiaPep277, its Late Stage Development Drug for Type 1 Diabetes | www.pipelinereview.com

Teva's global operations and recognition in association with many generic drugs of different classes and for different indications across many speciaties will be immensely helpful in marketing DiaPep277 worldwide.

Third to market but any advantages?

October 11, 2009

Analysis by: GLG Expert Contributor

Analysis of:ONGLYZA™ (saxagliptin) Receives Marketing Authorisation In Europe For The Treatment Of Type 2 Diabetes | www.pipelinereview.com

With sitagliptin (Januvia, MRK) and vildagliptin (Galvus, NVS) already well established in the European market and the additional availability of the combination of these drugs with metformin, it seems unlikely that saxagliptin (Onglyza, BMS/AZ) will grab much of the market.

Saxagliptin - third gliptin on the EU market

October 8, 2009

Analysis by: GLG Expert Contributor

Analysis of:ONGLYZA™ (saxagliptin) Receives Marketing Authorisation In Europe For The Treatment Of Type 2 Diabetes | www.pipelinereview.com

Besides Sitagliptin and Vildagliptin there will be now a 3rd gliptin available in Europe. Whereas vildagliptin officially needs monitoring of the liver enzymes, at least according to the P.I., and there are new warnings for pancreatitis for sitagliptin no such limitations are known to me at the moment. I do not think that there will be major advantages for saxa compared with sita or vilda, however, we will have to wait and see.

Kelly ClosePresidentClose Concerns

Updates on Januvia

October 5, 2009

Analysis of:Januvia, Janumet to Note Pancreatitis Cases | diabetes.webmd.com

Merck and the FDA are working to revise the prescription guidelines for Januvia to reflect incidences of pancreatitis seen in association with Januvia. Also, post-hoc analysis presented at EASD showed that those completing two years of Januvia monotherapy had A1c drops from 8.4% to 6.9%. Lastly, Januvia therapy as an adjunct to insulin therapy received approval by the EMEA, making it likely to be adopted by the European Commission for this indication.

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