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At FDA, ‘caretaker mode’ is better than power trip mode

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UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?

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Denali sells FDA voucher for $195M to support neurodegenerative pipeline

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Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.

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US launches investigation into German drug pricing, citing unfair R&D burden

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The U.S. government has argued that it pays too much of biopharma R&D costs, demanding that other high-income countries contribute fairly to global innovation efforts.

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STAT+: Up and down the ladder: The latest comings and goings

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that Protego Biopharma hired Jae Kim as chief medical officer. Previously, he held the same roles at Septerna and Design Therapeutics.

But all work and no play can make for a dull chief medical officer.

Continue to STAT+ to read the full story…

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