Sulfonylurea News and Research

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Amylin to present data on investigational diabetes drug candidates at ADA annual meeting

Amylin Pharmaceuticals, Inc. today announced that the Company will present data for its two first-in-class diabetes drugs, BYETTA injection and SYMLIN injection, and its investigational diabetes drug candidates BYDUREON and exenatide once monthly at the 71st Scientific Sessions of the American Diabetes Association (ADA) being held in San Diego, CA from June 24 to June 28.

21 Jun 2011

Amylin disappointed with U.S. District Court's ruling in BYETTA preliminary injunction

Amylin Pharmaceuticals, Inc. today issued the following statement regarding the decision of the United States District Court for the Southern District of California to deny its motion for a preliminary injunction to enjoin Eli Lilly and Company from engaging in anticompetitive activity and breaching its diabetes collaboration agreement with Amylin.

10 Jun 2011

China's SFDA grants production license to TPI anti-diabetic drug Gliclazide

Tianyin Pharmaceutical Co., Inc., a pharmaceutical company that specializes in patented biopharmaceutical medicine, modernized traditional Chinese medicine, branded generics and other pharmaceuticals today announced TPI has received the production license for its anti-diabetic drug Gliclazide Tablets from China's State Food and Drug Administration.

1 Jun 2011

U.S. District Court grants temporary restraining order in Amylin's litigation against Lilly

Amylin Pharmaceuticals, Inc. today announced that the United States District Court for the Southern District of California issued a temporary restraining order (TRO) against Eli Lilly and Company relating to its litigation with respect to the Amylin / Lilly diabetes collaboration agreement.

26 May 2011

Eli Lilly responds to Amylin's exenatide lawsuit

Eli Lilly and Company has provided additional perspective in response to Amylin Pharmaceuticals, Inc.'s lawsuit filed in the United States District Court for the Southern District of California.

17 May 2011

Amylin files lawsuit against Eli Lilly for improper commercialization of exenatide

Amylin Pharmaceuticals, Inc. today announced that it has filed a lawsuit against Eli Lilly and Company in the United States District Court for the Southern District of California, alleging that Lilly is engaging in anticompetitive activity and breaching its strategic alliance agreements with Amylin to maximize commercialization of exenatide.

16 May 2011

China's SFDA approves TPI anti-diabetic drug Gliclazide

Tianyin Pharmaceutical Co., Inc., a pharmaceutical company that specializes in patented biopharmaceutical medicine, modernized traditional Chinese medicine, branded generics and other pharmaceuticals today announced that TPI has received the China's SFDA's approval for its anti-diabetic drug Gliclazide Tablets.

13 May 2011

Boehringer Ingelheim, Eli Lilly receive FDA approval for linagliptin to treat type 2 diabetes

Boehringer Ingelheim and Eli Lilly and Company today announced that the U.S. Food and Drug Administration has approved linagliptin tablets, a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

3 May 2011

Boehringer Ingelheim, Eli Lilly receive FDA approval for Tradjenta to treat type 2 diabetes

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the U.S. Food and Drug Administration approved Tradjenta tablets, a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

3 May 2011

Positive results from exenatide phase 2 study in patients with type 2 diabetes

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes.

10 Mar 2011

Takeda receives Japanese approval for additional indications for NESINA

Furiex Pharmaceuticals, Inc. today confirmed that Takeda Pharmaceutical Company Limited's applications for two additional indications for "NESINA®" (alogliptin), combination therapy with sulfonylurea and combination therapy with biguanide for type 2 diabetes, were approved by the Japanese Ministry of Health, Labour and Welfare.

25 Feb 2011

FDA approves ONGLYZA to treat type 2 diabetes patients with renal impairment

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration has approved the inclusion of data from two clinical studies in an update to the ONGLYZA U.S. Prescribing Information for adult type 2 diabetes patients.

24 Feb 2011

Health Canada approves Eli Lilly's BYETTA for treatment of adults with type 2 diabetes

Eli Lilly Canada is pleased to announce the Health Canada approval of BYETTATM for the treatment of adults with type 2 diabetes.

18 Jan 2011

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

12 Jan 2011

GLUMETZA tablets are now available to wholesalers and physicians

Santarus, and Depomed, today announced that supply of GLUMETZA® 500 mg to wholesalers and retailers has resumed. GLUMETZA is a once-daily, extended release formulation of metformin and is approved for use in adults with type 2 diabetes mellitus.

5 Jan 2011

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA"), have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications ("ANDAs") for generic ACTOS® (pioglitazone HCl), ACTOplus met® (pioglitazone HCl and metformin HCl), and duetact® (pioglitazone HCl and glimepiride).

22 Dec 2010

FDA issues complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension).

21 Oct 2010

En Ze Jia Shi Pharmaceuticals receives patent for controlled-release oral gliclazide

Lotus Pharmaceuticals, Inc.a fast-growing, profitable developer, manufacturer and seller of medicine and drugs in the People's Republic of China announced today that its wholly owned subsidiary, En Ze Jia Shi Pharmaceuticals, has been issued a patent by the State Intellectual Property Office of the People's Republic of China for controlled-release oral gliclazide. The patent covers the composition and preparation methods for the drug through 2030.

20 Oct 2010

Australian reimbursement committee is set to consider Novo Nordisk's type 2 diabetes treatment

In its November meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) will consider Novo Nordisk's second-to-market glucagon-like peptide-1 (GLP-1) agonist Victoza for reimbursement, which would be essential in order for the drug to compete effectively with Eli Lilly's Byetta. However, its chances of success are uncertain, considering that it took three years to get Byetta on the Pharmaceutical Benefits Scheme (PBS).

4 Oct 2010