Both an arm prosthesis and a device used in transcatheter valve replacement will be regulated via class II, FDA announced this week.

Recent progress on the US regulatory front is generating renewed interest in device-based glaucoma therapies, which potentially could grow to a multibillion-dollar industry. The list of companies targeting this space continues to expand, as does the variety of potential device-based solutions: the current pipeline includes several innovative and less invasive products and technologies designed to improve surgical outcomes, a growing number of advanced drug-delivery inserts to address the patient noncompliance issue that is so common in this arena, and some unique patient monitoring devices.

Our survey of news and notes from the second day of the BIO conference includes discussions of changes in the way pharma negotiates milestones, big ambitious projects to solve industry “dysfunction,” and a next-generation antibody developer pushing toward the clinic.

Merck, Lilly, Gilead and Celgene are among the companies striking deals that involve bispecific antibodies. The novel dual-acting drugs have been in development since the 1980s with little success, yet big pharma believes they may finally be coming of age.