FDA user fee reauthorization eliminates limits on waivers, which may ease the burden on FDA to fill open seats on its advisory committees. Vacancy rates have been as high as 24% in FY 2012.

Companies presented data at ADA that could give patients options other than Lantus, but Sanofi is fighting back with a strategy to retain them.

Sanofi and Lilly, latecomers to the rising class of GLP-1 diabetes drugs, may not have much to differentiate their drugs from other offerings. But at investor forums at the American Diabetes Association meeting, they highlighted some possibilities, including hypertension data and combination therapies.

Five Phase III trials presented at ADA show J&J’s canagliflozin improves glycemic control over existing treatments and could offer a weight loss benefit to diabetes patients; they are part of a nine-study package that J&J submitted to FDA for approval May 31.