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1. Trump asks 'very tough hombre' Dr. Oz to lead MFN talks
2. US warns drugmakers against misrepresenting cost of imported products
3. About 5% of CBER and CDER left after FDA staff cuts, analysis finds
4. Federal judge extends order blocking RFK Jr. from reorganizing HHS
5. CHMP clears path for GSK’s Blenrep relaunch, recommends four other drugs 
6. Gilead notches another Phase 3 win for Trodelvy in triple-negative breast cancer
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Geoffrey Porges exits Schrödinger with CFO swap; A new board seat for AstraZeneca's Pascal Soriot
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Alexis Kramer
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It's Memorial Day in the US on Monday, so we won't be sending newsletters then. Have a great long weekend!

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Alexis Kramer
Editor, Endpoints News
CMS Administrator Mehmet Oz at the podium with President Donald Trump on May 12, 2025 (Mark Schiefelbein/AP Images)
1
by Max Bayer

Pres­i­dent Don­ald Trump un­of­fi­cial­ly asked CMS Ad­min­is­tra­tor Mehmet Oz to lead the ad­min­is­tra­tion’s talks with drug­mak­ers to low­er prices, push­ing his "most fa­vored na­tion" pol­i­cy.

“I’d like to ask Oz in par­tic­u­lar, be­cause you and I know each oth­er,” Trump said. “He's a very tough hom­bre, this one, he's tough as hell. And so if you can lead the group — and it's not go­ing to be easy — you're go­ing to have to get in and you're go­ing to have to fight.”

The pres­i­dent’s com­ments came at the con­clu­sion of an event Thurs­day un­veil­ing the MA­HA com­mis­sion re­port on the rise of chron­ic dis­eases in the US. Trump be­gan to un­load on phar­ma­ceu­ti­cal com­pa­nies who re­ly on the US econ­o­my to buoy their rev­enue, in ad­di­tion to oth­er coun­tries that have kept low prices.

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2
by Drew Armstrong, Anna Brown

The US Cus­toms and Bor­der Pro­tec­tion warned drug­mak­ers against try­ing to evade im­port rules by mis­rep­re­sent­ing the val­ue of their prod­ucts, in what ap­pears to be an ef­fort to head off a tac­tic the in­dus­try is con­sid­er­ing ahead of the Trump ad­min­is­tra­tion's phar­ma­ceu­ti­cal tar­iffs.

In a state­ment Thurs­day, the agency said that "de­clar­ing in­cor­rect val­ue on im­port or ex­port doc­u­men­ta­tion sub­mit­ted to CBP is con­sid­ered trade eva­sion, and CBP will pur­sue any vi­o­la­tions to the fullest ex­tent pos­si­ble." The state­ment does­n't specif­i­cal­ly men­tion tar­iffs but ap­pears aimed at drug­mak­ers who might try to cir­cum­vent or lim­it them.

End­points News re­port­ed Thurs­day that drug de­vel­op­ers may be con­sid­er­ing us­ing a prin­ci­ple known as the "first sale" rule, which could let them de­crease the val­ue of a drug de­clared at the bor­der, low­er­ing any tar­iff du­ty they would have to pay.

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3
by Zachary Brennan

Near­ly one out of every 20 staff in the FDA of­fices that over­see drugs and bi­o­log­ics are gone af­ter the Trump ad­min­is­tra­tion cut thou­sands of agency roles and of­fered buy­outs, ac­cord­ing to an analy­sis by the in­vest­ment bank Bern­stein.

To con­duct the re­view, the bank down­loaded an on­line di­rec­to­ry of HHS staff from April 15, and a sec­ond copy from May 15, and com­pared list­ings of work­ers at CDER and CBER. It iden­ti­fied 456 CDER or CBER em­ploy­ees — 4% of CDER and 6% of CBER — who no longer ap­peared in the di­rec­to­ry and pre­sum­ably no longer work at the cen­ters.

"We be­lieve these ex­its will put fur­ther strain on an FDA that has al­ready shown signs of de­clin­ing pro­duc­tiv­i­ty," the Bern­stein an­a­lysts said, point­ing to missed PDU­FA dates (and sub­se­quent ap­provals) for both the No­vavax Covid-19 vac­cine and the Nu­cala COPD la­bel ex­pan­sion.

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4
by Alexis Kramer

The Trump ad­min­is­tra­tion has been barred from car­ry­ing out its sweep­ing plan to re­struc­ture and down­size the De­part­ment of Health and Hu­man Ser­vices, fol­low­ing a court or­der that al­so ap­plies to about 20 oth­er fed­er­al agen­cies.

The late Thurs­day de­ci­sion by a Cal­i­for­nia judge ex­tends an or­der halt­ing HHS Sec­re­tary Robert F. Kennedy Jr.’s plan, which called for con&s