Sulfonylurea News and Research

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Positive top-line results from Phenomix' Phase 3 trial of dutogliptin for Type 2 diabetes mellitus

Phenomix Corporation today announced positive top-line results from a six-month Phase 3 study comparing dutogliptin 400mg and 200mg once daily as monotherapy versus placebo for the treatment of patients with Type 2 diabetes mellitus. Dutogliptin is Phenomix' internally-discovered dipeptidyl peptidase-4 (DPP-4) inhibitor.

20 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

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

Isis Pharmaceuticals reports revenues of $32.3M for fourth-quarter 2009

Isis Pharmaceuticals, Inc. today announced its 2009 financial results and reviewed the highlights of the year. Isis achieved its 2009 financial guidance with pro forma net income of $166.9 million and a pro forma net operating loss (NOL) of $14.2 million compared with its guidance for the year of pro forma net income of more than $145 million and a pro forma NOL in the low to mid $20 million range. Isis also achieved its cash guidance by ending 2009 with $574.3 million of cash, cash equivalents and short-term investments significantly in excess of the $550 million projected.

1 Mar 2010

Ipsen’s 2009 performance: Azzalure, Dysport and Decapeptyl approval, Adenuric partnership, drug sales up 7.6%

The Board of Directors of Ipsen, chaired by Jean-Luc Bélingard, met on 26 February 2010 to review the Group’s results for 2009, published today.

1 Mar 2010

GlaxoSmithKline responds to Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia

Today, GlaxoSmithKline responded to the recently released Senate Committee on Finance's January 2010 "Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia" (the "Staff Report").

25 Feb 2010

Ipsen reports consolidated group sales of €1,032.8M for 2009

Ipsen reported today its sales for the fourth quarter and full year 2009.

1 Feb 2010

Diabetes journal reviews the role of hypoglycemia in criminal behavior

Professor Vincent Marks, a leading authority on the forensic aspects of hypoglycemia and its role in criminal behavior, discusses how hypoglycemia-related neuroglycopenia can cause behavioral changes, which can bring people with diabetes into conflict with the law. "

31 Jan 2010

FDA approves Novo Nordisk's Victoza for type 2 diabetes

Novo Nordisk, a global healthcare company, announced today the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza® (liraglutide [rDNA origin] injection), the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

27 Jan 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

Health Canada approves ONGLYZA for type 2 diabetes treatment

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).

13 Nov 2009

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

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.

3 Nov 2009

FDA approves an expanded indication for BYETTA injection

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.

31 Oct 2009

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

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.

22 Oct 2009

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

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.

15 Oct 2009

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

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.

13 Oct 2009

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

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.

28 Sep 2009

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

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.

26 Sep 2009

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

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).

4 Sep 2009