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top stories
1. Acting general counsel at HHS has left the department
2. New PDUFA deal allots money to rehire FDA reviewers, trade groups say
3. PhRMA sues Trump administration over GLOBE drug pricing demo program
4. Novartis gives infectious disease docs a boost with antibiotic approval
5. Ultragenyx sells PRV for $210M and still has another voucher it plans to monetize
6. Asahi Kasei lands approval for new HSV treatment
Max Bayer
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The FDA has announced a new rare disease initiative on Wednesday, meant to better engage drug developers and patients along the entire regulatory process. The Rare Disease Framework Initiative is expected to be a broader and a more encompassing program than the plausible mechanism pathway unveiled by previous agency leaders at the tail end of 2025. A late October meeting is planned to solicit feedback from industry and patient stakeholders, facilitated by the Reagan-Udall Foundation. 

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Max Bayer
Senior Reporter, Endpoints News
1
by Max Bayer

The act­ing gen­er­al coun­sel at HHS, Bob Fos­ter, is no longer at the agency.

When End­points Newscon­tact­ed Fos­ter through his gov­ern­ment email, it re­ceived...

Read the full story
2
by Max Bayer

Top phar­ma­ceu­ti­cal trade groups say the FDA will have a ded­i­cat­ed pool of mon­ey to re­plen­ish its sta­ble of re­view­ers as part of the new...

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3
by Max Bayer

The phar­ma in­dus­try is yet again tak­ing the gov­ern­ment to court over its lat­est ef­fort to con­trol US drug prices.

Last week, the Trump ad­min­is­tra­tion...

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4
by Max Bayer

There is some good news in the world of an­tibi­otics.

No­var­tis qui­et­ly snagged sup­ple­men­tal FDA ap­proval for its drug Lam­prene over the sum­mer, tran­si­tion­ing a decades-old...

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5
by Kyle LaHucik

Ul­tragenyx Phar­ma­ceu­ti­cal is sell­ing a pri­or­i­ty re­view vouch­er to an undis­closed buy­er for $210 mil­lion, mark­ing one of the rich­est sales of the speedy-ap­proval...

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6
by Max Bayer

Japan­ese phar­ma Asahi Ka­sei Ther­a­peu­tics has snagged FDA ap­proval for a her­pes treat­ment that it ac­quired ear­ly this year in an al­most $1 bil­lion deal...

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