Posts Tagged ‘FDA’

Was the reaction to kill sibutramine after a cardiovascular safety study in 2010 a mistake? A new study in the International Journal of Obesity raises that question with new data. Joseph Hayes and colleagues found found little risk of cardiovascular events in a cohort of more than 23,927 people receiving sibutramine, except in those people with […]

Investment in obesity research and development is a scarce resource. There’s no supply of money to burn. So the news of the termination of a large, expensive cardiovascular outcomes trial of naltrexone/bupropion (Contrave) is sad news indeed. This was the inevitable result of a mistake involving premature release of interim data from this study. As […]

If you’re looking for a clue to why the definition of “healthy eating” is such a tricky subject, just take a look at the fight about disclosing added sugar on nutrition labels. Yesterday, Mars — the makers of M&M’s — announced that they support FDA’s proposal for added sugar labeling. Meanwhile, the yogurt industry is […]

By twisting the obvious, reporters for MedPage Today and the Milwaukee Journal Sentinel  have published remarkably biased reports this week on new treatments for obesity. In fact, they barely even mention obesity, instead choosing to trivialize serious medicines for obesity as “diet pills.” The obvious facts that these reporters have chosen to twist are straightforward and […]

It gets harder and harder every day to be sure what foods are kinda healthy. This week, the FDA smacked the makers of the KIND brand of snack bars for labeling some of their products as “healthy” and for putting a plus sign on their products to designate that they have some extra good stuff in […]

Even knowing the complicated history of dietary supplements for weight loss, current reports of FDA foot dragging on dangerous supplements are nothing short of shocking. In an academic journal this week, a group of scientists revealed that dietary supplements containing an amphetamine isomer are still on the market — two years after FDA first knew […]

Dangerous crosscurrents remain in the regulatory environment for obesity medicines, even though progress has been considerable over the last five years. You need look no further than headlines of the last week. In just one news cycle Orexigen — the originators of Contrave — made both good and bad news for themselves when they disclosed […]

The first drug for binge eating disorder may be nearing approval at FDA. Shire’s application for lisdexamfetamine (brand name Vyvanse®) for the treatment of binge eating disorder was accepted at the end of September, which means that the FDA is due to rule on their application by February 1. FDA granted a priority review for […]

Let’s just say it. European regulators were spooked by obesity drugs for quite a few years. So news that first buproprion/naltrexone (Contrave U.S./Mysimba EU) and now liraglutide (Saxenda) have been recommended for approval in Europe is good news indeed. What spooked the Europeans was the experience with rimonobant. The European  Commission (EC) granted Sanofi approval for this obesity treatment in 2006, […]

The birthday of Scotland’s beloved poet, Robert Burns, is upon us. Kilts, Scotch, and haggis will be the centerpiece of celebrations in Scotland — but the haggis will be hard to find in the U.S. Lord McColl of Dulwich sees this as a compound problem. The retired professor of surgery and Conservative member the British House of […]