Intarcia and Lexicon fail to convince FDA's Center for Drug Evaluation and Research to grant hearings after complete response letters. Intarcia contends that kidney injury with its diabetes drug implant is similar to Novo Nordisk’s Wegovy, while Lexicon argues that CDER did not adequately consider a REMS when reviewing its SGLT2 inhibitor.

Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.

With Intarcia's request, the rarely used mechanism could now produce two hearings this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.

Stock-and-cash deal valued at $229m brings AzurRx rights to niclosamide in additional indications. Boehringer Ingelheim partners with Twist on therapeutic antibody discovery.