In draft guidance published on 31 January 2013, the UK's health technologies assessment body, the National Institute of Health and Clinical Excellence (NICE), does not recommend the use of dapagliflozin (Forxiga, Bristol-Myers Squibb and Astra Zeneca) in combination therapy for the treatment of type 2 diabetes. Dapagliflozin promotes excretion of excess glucose in the urine by blocking glucose reabsorption of in the kidneys. It is authorized in the UK for use in adults...

The US Food and Drug Administration (FDA) has been ordered to immediately approve an abbreviated new drug application (ANDA) submitted to the agency by Watson Pharmaceuticals, marking what some analysts are calling a rare defeat for the agency's regulatory discretion. The case, decided by US District Court of Washington, DC, Judge Amy Berman Jackson, regarded the diabetes medication Actos (pioglitazone), one of the most prescribed drugs in the US. Watson, a generics manu...

A new pediatric addendum from the European Medicines Agency (EMA) is aimed at highlighting unique challenges facing the development of treatments for pediatric patients with lipid disorders. Primary, or familial, lipid disorders are characterized by an excess amount of lipids or lipoproteins, which can lead to organ-the heart in particular-and tissue damage in the absence of adequate treatment. In children with familial lipid disorders, this damage starts occurring fro...

The US Food and Drug Administration (FDA) is allowing GI Dynamics (GID) to move directly into pivotal clinical trials with its diabetes treatment device, according to a story from Mass High Tech. President and CEO Stuart Randle told the website his company's device, Endobarrier, has been approved and is marketed already in Australia, Chile and several European countries. He said Endobarrier has completed 13 clinical trials around the world, giving FDA "confidence" in le...

Generics manufacturer Watson Pharmaceuticals has filed a lawsuit against the US Food and Drug Administration (FDA) in an attempt to compel the agency to grant it 180-day generic marketing exclusivity for its generic version of anti-diabetes drug Actos (pioglitazone). Under a 2010 settlement between Actos' manufacturer, Takeda Pharmaceuticals of Japan, Watson, Mylan Inc and Ranbaxy Laboratories all received what Watson referred to as "shared exclusivity." Under normal c...

The European Medicines Agency (EMA) has released a new guideline aimed at assisting sponsors in the development of products to treat or prevent diabetes mellitus. The guideline makes important changes to how the agency plans to assess the cardiovascular risk of diabetes products and its "high-level" approach to emerging diabetes products. The new guideline, On Clinical Investigation of Medicinal Products in the Treatment or Prevention of Diabetes Mellitus , updates a pr...

The US Food and Drug Administration (FDA) is planning an upcoming meeting to discuss the challenges of designing and implementing clinical trial designs for glucose sensors, as well as ways to improve industry efficiency when conducting such trials. "The feedback may increase communication and collaboration within the stakeholder community, and, ultimately, help overcome some of the current challenges associated with designing clinical studies and generating clinical per...

The watchdog group Public Citizen is calling on the US Food and Drug Administration (FDA) to yank Novo Nordisk's diabetes drug Victoza (liraglutide) off the market for safety risks it says "outweigh any documented clinical benefits." After being approved, "the watchdog group says a review of the FDA adverse event database found 200 patients were diagnosed with acute pancreatitis during the first 17 months that Victoza was available, suggesting a larger number of [thyroid...

The Canadian Agency for Drugs and Technologies in Health (CADTH) Rapid Response Report found in patients with type II diabetes no statistically significant difference between two self-monitoring strategies, urine and blood testing, in glycemic control, measured by HbA1c levels, or in the proportion of patients reaching target HbA1c.  It concluded that findings from large randomized controlled trials comparing benefits of the two monitoring strategies and economic ...