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Sanofi Says FDA Accepts Filing for New Diabetes Drug Toujeo

Posted by dlife on Tue, Jul 08, 14, 10:02 AM 0 Comment

July 8, 2014 (Reuters) -- Sanofi said on Tuesday the U.S. Food and Drug Administration had accepted for review the filing of a new drug application for its diabetes drug Toujeo.

"With the FDA's acceptance of our submission, we are anticipating the regulatory decision for marketing authorization for Toujeo in the U.S. in the first half of 2015." said Pierre Chancel, Senior Vice President, Globa

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Diabetes Drug Eyed as Obesity Treatment

Posted by dlife on Tue, May 27, 14, 01:06 PM 0 Comment

May 26, 2014 (Medscape) -- The glucose-lowering drug liraglutide (Victoza, Novo Nordisk) promotes weight loss in overweight and obese people who don't have diabetes, according to the results of the multinational SCALE — Obesity and Prediabetes trial, presented here at the American Association of Clinical En

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FDA Approves Tanzeum to Treat Type 2 Diabetes

Posted by dlife on Tue, Apr 15, 14, 01:23 PM 0 Comment

April 15, 2014 (FDA) —

The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

Type 2 diabetes affects approximately 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, a

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Takeda Loses First Federal Trial Over Actos Diabetes Drug

Posted by dlife on Tue, Apr 08, 14, 01:09 PM 0 Comment

April 7, 2014 (Bloomberg News) -- Takeda Pharmaceutical Co. (4502) lost the first federal court trial in the U.S. over claims it hid the cancer risks of its Actos diabetes medicine to protect billions of dollars in sales.

The jury in Lafayette, Louisiana, today awarded $1.5 million in compensatory damages and will consider a request for punitive damages.

Takeda, Asia's largest drugmaker, faces the Actos claims after it scrapped development o

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FDA alerts companies to stop illegal sale of treatments for diabetes

Posted by dlife on Tue, Jul 23, 13, 03:55 PM 0 Comment

July 23, 2013 (FDA) — The U.S. Food and Drug Administration is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications. The agency recently issued letters warning 15 companies that the sale of their illegally marketed diabetes products violates federal law. The letters were sent to foreign and domestic companies whose products were sold online and in retail st

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