Pfizer Inc. has announced that a Phase 3 randomized withdrawal design study for Lyrica (pregabalin) in patients with inadequately treated painful diabetic peripheral neuropathy (pDPN) did not meet its primary efficacy endpoint, change in endpoint mean pain score relative to baseline. This follows an announcement regarding the failure...

The FDA has issued a complete response letter to Japanese drug-maker Takeda Pharmaceutical regarding New Drug Applications (NDAs) for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone. Recently, Takeda provided postmarketing data from outside the U.S., and has been in discussion with the FDA. The FDA has requested...

Kamada, announced positive preliminary interim results from a Phase I/II clinical trial of D1-AAT, which includes the Alpha 1 protein, for the treatment of type 1 diabetes. D1-AAT may slow the progression of the type 1 diabetes, and may greatly reduce or eliminate, the need for insulin. This would stabilize the condition of diabetics...

The European Commission has granted marketing authorization to Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and/or Actos® (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents. The EU approval was given...

A new study evaluating the efficacy and safety of adding dapagliflozin therapy to the treatment of type 2 diabetes patients whose blood glucose levels remain poorly controlled despite high doses of insulin was published today in the Annuls of Internal Medicine. The 24 week study conducted on 808 type 2 diabetes patients with...

Eli Lilly and Boehringer Ingelheim have announced Jentadueto tablets are now available by prescription in pharmacies across the U.S. Jentadueto is a new prescription medication for type 2 diabetes patients who need to control their blood sugar.  Jentadueto is a  twice daily medication combining two diabetes medicines — the dipeptidyl...

The newly approved type 2 diabetes drug  Bydureon, made by Amylin Pharmaceuticals and Alkermes plc, is now available by prescription in U.S. pharmacies. Bydureon is the first and only once-weekly treatment for type 2 diabetes.  It was approved by the US FDA on January 27th 2012 as an adjunct to diet and exercise to improve glycemic...

The FDA has approved Merck’s (MSD) new type 2 diabetes medication, JANUMET(R) XR (sitagliptin and metformin hydrochloride (HCl) extended-release) The new treatment combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.  Janumet targets three key defects of diabetes: insulin...

The FDA has approved Eli Lilly and Boehringer Ingelheim’s new type 2 diabetes treatment Jentadueto (linagliptin/metformin hydrochloride), which combines DPP-4 inhibitor, linagliptin (the active ingredient in Tradjenta™ (linagliptin) tablets), and metformin in a single tablet, taken twice-daily, to lower blood sugar in adults...

Amylin Pharmaceuticals, Inc. and Alkermes plc received FDA approval for Bydureon, a next generation once-weekly treatment for type 2 diabetes. The drug which received EU approval in June was turned down by the FDA twice during 2010, requesting further testing be conducted.    Bydureon, which is injected once a week, is due...