New review model’s elements, including the mid-cycle communication and late-cycle meeting, helped make for a smoother advisory committee process for Janssen’s Olysio and Bayer’s Adempas. The sponsors and FDA review staff were able to reach agreement on labeling and other review issues in advance, narrowing the scope of matters requiring vetting by the expert panels.

After FDA abruptly cancelled an advisory committee meeting on the anesthesia injection product in July to review trial site inspection results for a hypersensitivity study, it issues a “complete response” letter indicating site “operational” concerns.

The big pharma will establish a new oncology unit focused on bringing its anti-PD-1 immunotherapy MK-3475 to market as part of a massive R&D overhaul aimed at lowering costs while driving innovation. Merck isn’t one of the industry’s leading oncology players and may not have as much R&D expertise in the area as rivals, but it might not ultimately matter – as long as MK-3475 gets to market.