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Health Canada approves ONGLYZA for the treatment of type 2 diabetes

13. November 2009 04:03
Bristol-Myers Squibb Canada and AstraZeneca Canada today announced that Health Canada has approved ONGLYZA(TM) (saxagliptin) which improves all three key measures of glycemic control - hemoglobin A1c (A1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG) - when taken in combination with other commonly used oral anti-diabetic agents (metformin or a sulfonylurea). [More]

FDA update on BYETTA injection: Amylin Pharmaceuticals and Eli Lilly respond

3. November 2009 03:07
Amylin Pharmaceuticals, Inc., and Eli Lilly and Company today issued the following statement in response to the U.S. Food and Drug Administration (FDA) update on BYETTA® (exenatide) injection. [More]

FDA approves an expanded indication for BYETTA injection

31. October 2009 00:31
Amylin Pharmaceuticals, Inc., and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. [More]

Positive results from Isis Pharmaceuticals' ISIS 113715 Phase 2 study in type 2 diabetes patients

22. October 2009 00:57
Isis Pharmaceuticals, Inc. today announced positive top-line results from a Phase 2 study evaluating the safety and efficacy of ISIS 113715 in patients with type 2 diabetes. ISIS 113715 is a novel insulin sensitizer that reduces the expression of protein tyrosine phosphatase-1B (PTP-1B). The study showed consistent and statistically significant reductions in multiple short and intermediate measures of glucose control. [More]

Study shows type 2 diabetes patients treated with ACTOplus met experience blood sugar reduction

15. October 2009 02:58
A study, published online in the journal Current Medical Research and Opinion, showed that a greater percentage of patients with type 2 diabetes treated with the fixed-dose combination ACTOplus met® (pioglitazone HCl and metformin HCl) as initial therapy reached the study goal of hemoglobin A1c (HbA1c) of less than or equal to 7 percent compared to either component alone. [More]

Merck Frosst Canada's JANUMET receives Notice of Compliance in Canada

13. October 2009 06:41
Merck Frosst Canada Ltd. announced today that its new diabetes treatment, JANUMET(TM) (sitagliptin/metformin HCI, MSD), has received Notice of Compliance (NoC) in Canada. [More]

Safety profiles of JANUVIA and JANUMET drugs established through clinical development program

28. September 2009 06:28
Merck has thoroughly reviewed the safety data for sitagliptin, and sitagliptin was not associated with an increase in the incidence of pancreatitis in preclinical studies or in clinical trials of up to two years in duration with more than 6,000 patients. [More]

European CHMP recommends Merck's JANUVIA and JANUMET as add-on to insulin

26. September 2009 01:23
Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme (MSD), has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for JANUVIA® tablets and JANUMET® tablets recommending their use as add-on to insulin for the treatment of type 2 diabetes. [More]

Takeda receives FDA response regarding NDA for fixed-dose combination of alogliptin and ACTOS

4. September 2009 05:06
Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl). [More]

NDA for Exenatide once weekly accepted for FDA review

7. July 2009 21:55
Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the U.S. Food and Drug Administration (FDA). [More]

Comprehensive review on sulfonylureas in the latest issue of Diabetic Hypoglycemia

4. June 2009 16:43
The latest issue of the online journal Diabetic Hypoglycemia features an authoritative review on sulfonylureas by Professor Ian Campbell, a leading expert in oral hypoglycemia therapy. [More]

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Drugs may be 'magic bullet' for infants born with rare form of diabetes

3. February 2009 19:51
Infants born with a rare form of inherited diabetes might avoid irreversible damage to their pancreases if they are treated immediately with sulfonylurea drugs rather than insulin, according to a new report in the February 4th issue of Cell Metabolism , a Cell Press publication. [More]

Amylin, Lilly update on FDA review of Byetta (exenatide) injection monotherapy submission

8. December 2008 21:25
Amylin Pharmaceuticals, Inc. and Eli Lilly and Company have announced that the U.S. Food and Drug Administration (FDA) is continuing with its review of the regulatory application for use of Byetta (exenatide) injection as stand-alone therapy (monotherapy) in people with type 2 diabetes who are not achieving acceptable blood sugar control. [More]

GlaxoSmithKline believes there is no liver safety issue with Avandia (rosiglitazone maleate)

31. October 2008 05:25
GlaxoSmithKline today issued the following response to a petition filed by Public Citizen to the U.S. Food and Drug Administration (FDA) on Avandia (rosiglitazone maleate), a highly effective therapy for treating type 2 diabetes when used in the appropriate patient population. [More]

FDA continues review of Takeda's NDA for Alogliptin

12. October 2008 18:27
Takeda Pharmaceutical Company Limited has announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008. [More]
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