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Morning! Today, we see a new synthetic biology startup, backed by Frances Arnold and Bob Langer. Plus, it’s still early, but Novo Nordisk already appears to be having a robust rollout of the Wegovy pill.
New FDA pathway brings promise, and concerns
Bioethicists including the University of Pennsylvania’s Holly Fernandez Lynch support the FDA’s push to create a new approval pathway for personalized gene-editing treatments like the one given to Baby KJ. But, in an interview with STAT’s Jason Mast, she warned that the “plausible mechanism” framework laid out by FDA Commissioner Marty Makary and CBER chief Vinay Prasad is legally murky — and could be dangerously open-ended.
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