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The company, which was built by Bain Capital, has now raised more than $426 million in its quest to advance a portfolio of Bristol Myers drugs.

Following Vijay Kumar’s exit, acting CBER Director Karim Mikhail will also oversee a review office that has become a battleground for debates on FDA flexibility.

There’s never been a higher bar for innovation than right now. Almost any promising molecule quickly has a horde of copycats. Development costs keep rising. Investors are leaning on seemingly safer…