Ep. 383 - Moderna, Genentech obesity deal, Trump's FDA pick

Moderna and Merck’s Phase III success with personalized neoantigen vaccines marks a significant shift for mRNA therapies beyond infectious diseases, though questions remain regarding manufacturing burdens and broader clinical applicability in non-melanoma tumors. South Korea’s biotech sector continues to attract Western investment, exemplified by Genentech’s $190 million upfront deal with Hanmi for a uricortin-2 analog targeting obesity, designed to reduce fat while sparing lean muscle mass. Meanwhile, the nomination of Heidi Overton as FDA commissioner raises concerns regarding the agency's future independence and its alignment with the MAHA agenda, particularly following past regulatory friction. BioCentury’s annual "Back to School" report highlights the urgent need to expedite first-in-human trials, identifying Australia and China as key regions currently setting global standards for clinical development speed and regulatory risk tolerance.