Tandem Diabetes Care : FDA Clearance of the t:slim™ Insulin Delivery System

November 16, 2011 - Tandem Diabetes Care Announces FDA Clearance of the t:slim™ Insulin Delivery System -


Smallest Insulin Pump System and First-Ever with a Touch Screen -

Tandem Diabetes Care, Inc. announced that the U.S. Food and Drug Administration has granted the Company clearance to market the t:slim™ Insulin Delivery System.—

Tandem Diabetes Care, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to market the t:slim™ Insulin Delivery System (t:slim). This new full-featured pump is the first-ever with a color touch screen, and is the smallest insulin pump system currently available. The t:slim is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative.

“With the clearance of t:slim, Tandem Diabetes Care has an opportunity to set a new standard in insulin infusion therapy,” said Kim Blickenstaff, president and CEO, Tandem Diabetes Care. “In creating t:slim, we spoke with more than 4,000 healthcare professionals and people with diabetes, and the clear message we heard was, ‘make it cool and make it uncomplicated to use. Give us access to the most advanced features without extra effort.’ The t:slim’s touch screen interface has been proven in extensive user studies to be easy to learn and to use by new and experienced pump users alike.”

Of approximately 1.5 million people in the U.S. with type 1 diabetes,1 industry estimates indicate that only 20 to 30 percent use an insulin pump, despite clinical evidence that pump use can improve glycemic control and quality of life2. Tandem Diabetes Care believes that enhanced ease of use and attractive design will encourage more patients to consider the clinical benefits of insulin pump therapy... Tandem Diabetes Care's Press Release -

Servier : Type 2 Diabetes partnership with Canadian firm Prognomix Inc.

Nov. 8, 2011 - Les Laboratoires Servier, France (Servier) and Prognomix Inc., Canada (Prognomix) announced that they have entered into a research and development agreement aimed at identifying novel targets as part of programs meant to develop innovative type 2 diabetes and metabolic disease treatment.

This collaboration will rest on the discovery platform developed by Prognomix. This platform comprises genomic and bioinformatic technologies, a database of phenotypic and genotypic data and an assembly of results of the analysis of these data that are at the foundation of a knowledge base that will be exploited by the partners. This knowledge base was developed using, among other, the data collected during ADVANCE, the largest clinical study ever conducted on Type 2 diabetes and of which Servier was the main sponsor.

As part of the agreement, Servier will make a contract signature fee payment and will be granted options to obtain rights to use the results of the collaboration.

According to Dr. Pavel Hamet, President of Prognomix, « Closing of this agreement represents an important step in the development of Prognomix and confirms the value of the knowledge base that we have developed. We are happy to initiate this collaboration with Servier, a well known and very innovative pharmaceutical company and we are excited by the opportunities it represents ».

According to Dr. Emmanuel Canet, President of Research and Development at Servier, « This partnership confirms Servier interest for well validated biomarkers, allowing for the identification of the patients who will benefit the most from Servier therapeutic innovations »... [PDF] Prognomix's Press Release - Servier's Press Releases -

Poxel : New Clinical Results for an Anti-Diabetic Compound in Development

LYON, FRANCE - Oct. 26, 2011 - Poxel's Novel Compound Imeglimin Shows Significant Benefits in Type 2 Diabetes When Added to Metformin -

Poxel SA announced that Imeglimin, a novel compound in development for Type 2 diabetes, showed incremental efficacy as an add-on therapy to metformin, the reference first-line treatment, in patients inadequately controlled by metformin monotherapy. The study achieved its primary endpoint of superiority in HbA1c reduction versus placebo (p<0.001), and the decrease in FPG (Fasting Plasma Glucose) was also statistically significant (p<0.001). Reduction in HbA1c and FPG are two important measure of diabetes control.

Data from this Phase II trial assessing the clinical benefit of adding imeglimin to metformin demonstrate that in 12 weeks, patients in the imeglimin-metformin treatment group experience a -0.65 % reduction in HbA1c versus baseline. Moreover, the initial results indicated a trend towards reduced BMI (body mass index) and waist circumference, further indications of diabetes control. The overall safety and tolerability profile in the Imeglimin-metformin group was good.

Professor Valdis Pirags, Principal Investigator, commented, "I am pleased to see how positive these findings are. The results are exciting and we wait to further contribute to the development of this compound."

"The results from this add-on study are extremely encouraging, and I am confident that further development trials will reinforce the conclusion that Imeglimin is a safe and efficacious treatment option for diabetic people. There is still a need for new medications to control their disease," said Professor Harold Lebovitz, a distinguished member of Poxel's scientific advisory board... [PDF] Poxel's Press Release -