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FDA’s new voucher program hints at broader policy agenda, making many ‘uncomfortable’

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While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Review voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.

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

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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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…

Read More

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Moderna’s mRNA flu shot wins unanimous support at FDA adcomm in rebuke of former leadership

Moderna’s mRNA flu shot wins unanimous support at FDA adcomm in rebuke of former leadership

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The FDA in February briefly refused to review Moderna’s flu vaccine, citing trial inadequacies, but reversed course a few days later. A verdict is expected by Aug. 5.​ ​Read More

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Memento brings home $93M series A souvenir, picks up bispecific for eye diseases

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Memento’s lead asset is a bispecific antibody that blocks VEGF and activates Tie2. The biotech plans to test the candidate in retinal conditions such as neovascular age-related macular degeneration and diabetic macular edema.

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