With an eye toward improving the combination product review process, the FDA is debuting an intercenter consult request (ICCR) pilot to encourage timely, efficient submission assessments. It marks the latest step taken by the agency this year aimed at helping both industry and the FDA staff members who review these products.

A new joint venture between London-based Glaxosmithkline plc. (GSK) and Google's parent company, Mountain View, Calif.-based Alphabet Inc., will evaluate bioelectronics medicine to combat chronic conditions, with Type 2 diabetes expected as a potential focus of initial research.

A new joint venture between Glaxosmithkline plc (GSK) and Google's parent company, Mountain View, Calif.-based Alphabet Inc., will evaluate bioelectronics medicine to combat chronic conditions, with type 2 diabetes expected as a potential focus of initial research.

York, Pa.-based Unilife Corp. started a new chapter this week by announcing John Ryan, who has served as interim CEO since March, will assume the position permanently. The company also disclosed in a SEC filing some of the details into the actions of former CEO Alan Shortall.

Acclarent, a Johnson & Johnson (J&J) unit, has agreed to pay $18 million to resolve allegations that it marketed a sinus spacer product as a drug delivery device without obtaining an FDA sign off for that use. As a result, health care providers submitted false claims to Medicare and other federal programs, the U.S. Department of Justice (DOJ) alleged.

Dexcom Inc. (NASDAQ:DXCM) was flying high Friday following a positive panel vote favoring a new indication for its G5 Mobile continuous glucose monitoring (CGM) system. The clinical chemistry and clinical toxicology devices panel of the medical devices advisory committee voted favorably Thursday on the proposed non-adjunctive indication for the mobile CGM system, which would allow it to replace fingerstick glucose testing for diabetes treatment decisions. (See Medical Device Daily, July 22, 2016.)

An FDA panel gave San Diego-based Dexcom Inc. good news Thursday, voting 8 to 2 that the benefits of its G5 continuous glucose monitor to replace fingerstick testing for diabetes management outweigh the risks. Members voted similarly on the question of safety (8 to 2) and efficacy (9 to 1).

Over the next several weeks, glioblastoma (GBM) patients in the U.S. will have a new choice after the FDA gave its blessing to Novocure Limited's second-generation Optune system. St. Helier, Jersey Isle-based Novocure reported the FDA's action last week.