
Biotech mergers and acquisitions are accelerating, with 33 deals valued over $1 billion recorded in the first half of the year as companies scramble to address looming patent cliffs and growth targets. Eli Lilly remains a dominant force, recently expanding into the hair loss market and drawing scrutiny for granting a single patient early access to its obesity candidate, retatrutide, through the Compassionate Use Program. Meanwhile, the FDA is signaling a shift in regulatory philosophy, moving away from restrictive policies established under previous leadership to favor greater flexibility for rare disease gene therapies. These changes, coupled with efforts to streamline clinical trial requirements, reflect a broader attempt to modernize the U.S. drug development landscape. Gilead Sciences and Kite are simultaneously advancing oncology through a dual-platform approach, integrating antibody-drug conjugates and CAR T-cell therapies to address complex, high-unmet-need cancers.
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