FDA leadership overhaul follows firing of acting CDER director; 20 deaths linked to Amgen’s Tavneos in Japan

The FDA announced another leadership change, removing acting directors of its two main drug review centers. Tracy Beth Høeg, acting head of the Center for Drug Evaluation and Research (CDER), posted that she was fired, and Katherine Szarama also left. The changes come after commissioner Marty Makary’s sudden resignation and are described as a broader effort to install more traditional leadership. Michael Davis has been named acting head of CDER and Karim Mikhail is now acting director of the Center for Biologics Evaluation and Research (CBER).

In a separate safety issue, twenty patients in Japan have died after receiving Amgen’s rare-disease therapy Tavneos, which is supplied by partner Kissei Pharmaceuticals. The deaths were reported in the agency’s roundup, highlighting concerns about the drug’s safety profile in that market.

Meanwhile, biotech Parabilis Medicines announced a partnership with Regeneron to advance an obesity treatment that is moving toward regulatory approval in China. The collaboration aims to combine Parabilis’s platform with Regeneron’s development capabilities.