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top stories
1. Trump hints at tariff grace period for pharma companies to bring manufacturing to US
2. Trump's tax cut law expands orphan drug exclusions, could upend 340B program
3. Trump’s CDC nominee Monarez advances to full Senate
4. FDA chief calls for 'meaningful' reduction of animal testing for new drugs
5. In first half of 2025, novel drug approvals are in line with previous years
6. Despite delay, KalVista wins FDA approval after Makary's short-lived attempt to intervene
7. FDA reviewers advised broad label for Moderna’s next-gen Covid vaccine. Prasad overruled them
8. Supreme Court halts California order that blocked RFK Jr. from reorganizing HHS
9. Clinician groups sue RFK Jr. and HHS over Covid-19 vaccine recommendation changes
10. The Supreme Court passed on a state PBM case. Lawyers say a broader legal fight is brewing
Zachary Brennan
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President Donald Trump's pharma-specific tariffs are back in the spotlight, with his continued push to drive home foreign manufacturing. But analysts seem to think the tariffs won't take effect anytime soon. And earlier today, the Senate HELP Committee advanced Susan Monarez, Trump's selection to run the CDC (see more below).

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Zachary Brennan
Senior Editor, Endpoints News
@ZacharyBrennan
President Donald Trump at a Cabinet meeting on July 8, 2025 (Evan Vucci/AP Images)
1
by Max Bayer

Pres­i­dent Don­ald Trump said phar­ma­ceu­ti­cal com­pa­nies will have a grace pe­ri­od of at least a year to move their man­u­fac­tur­ing to the US be­fore fac­ing tar­iffs on their drugs.

The new de­tail dis­closed Tues­day by Trump came as he promised the tar­iffs on drug­mak­ers, which have been in de­vel­op­ment since ear­ly this year, would come "very soon." Trump has re­peat­ed­ly said over the last few months that the tar­iffs were com­ing short­ly.

A grace pe­ri­od would give com­pa­nies at least some time to shift man­u­fac­tur­ing — though it of­ten takes years to build and bring new drug plants on­line, far longer than Trump is propos­ing.

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2
by Zachary Brennan

Pres­i­dent Don­ald Trump on Ju­ly 4 signed in­to law his wide-rang­ing tax cuts and rec­on­cil­i­a­tion pack­age, in­clud­ing an ex­pan­sion of or­phan drug pro­tec­tions from Medicare ne­go­ti­a­tions, and near­ly $1 tril­lion in Med­ic­aid cuts that could up­end the op­er­a­tions of hos­pi­tals that pro­vide cheap­er drugs and care un­der the 340B fed­er­al pro­gram.

The or­phan drug pro­vi­sion is a sig­nif­i­cant win for the drug in­dus­try. Un­der the law, which is for­mal­ly called the One Big Beau­ti­ful Bill Act, any or­phan or rare dis­ease drugs, po­ten­tial­ly in­clud­ing block­busters with mul­ti­ple or­phan in­di­ca­tions, won't face Medicare price ne­go­ti­a­tions un­der the In­fla­tion Re­duc­tion Act.

Nei­ther of the first two rounds of drugs se­lect­ed for ne­go­ti­a­tion in­clud­ed or­phan drugs. But the phar­ma in­dus­try raised con­cerns that the way the IRA was writ­ten could lim­it the ex­clu­sion to on­ly drugs with one rare dis­ease in­di­ca­tion.

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Susan Monarez (Photo by Kayla Bartkowski/Getty Images)
3
by Alexis Kramer

Su­san Monarez's nom­i­na­tion for CDC di­rec­tor cleared the Sen­ate health com­mit­tee on Wednes­day, putting her one step clos­er to lead­ing the agency af­ter an up­heaval of its vac­cine ad­vis­ers.

If con­firmed by the full cham­ber, Monarez will be tasked with over­see­ing a new­ly re­built Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices (ACIP) and help­ing to re­store pub­lic trust in the agency’s de­ci­sion-mak­ing. The Sen­ate Com­mit­tee on Health, Ed­u­ca­tion, La­bor and Pen­sions vot­ed 12-11 in Monarez’s fa­vor.

Monarez “is com­mit­ted to im­prov­ing trans­paren­cy at the CDC and prop­er­ly com­mu­ni­cat­ing health guid­ance to the Amer­i­can peo­ple,” Sen. Bill Cas­sidy (R-LA) said in a state­ment be­fore the vote.

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4
by Zachary Brennan

FDA Com­mis­sion­er Mar­ty Makary pledged to "mean­ing­ful­ly re­duce" un­nec­es­sary an­i­mal test­ing that's cur­rent­ly used to bring new drugs to mar­ket and to test them in ear­ly de­vel­op­men­tal stages.

While Makary's pro­pos­al is light on specifics, a re­duc­tion of an­i­mal test­ing could low­er R&D costs, speed up drug de­vel­op­ment, and "po­ten­tial­ly even trans­late in­to low­er drug prices," Makary said at an FDA-NIH work­shop at the FDA's head­quar­ters on Mon­day.

"One of our biggest goals is to re­duce an­i­mal test­ing in a way that's mean­ing­ful and con­tin­ues to pro­tect against pub­lic safe­ty," he added.

Makary's FDA in April said an­i­mal test­ing re­quire­ments, which vary de­pend­ing on the type of drug in de­vel­op­ment, will be "re­duced, re­fined, or po­ten­tial­ly re­placed" via "a range of ap­proach­es, in­clud­ing AI-based com­pu­ta­tion­al mod­els of tox­i­c­i­ty and cell lines and organoid tox­i­c­i­ty test­ing in a lab­o­ra­to­ry set­ting."

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5
by Zachary Brennan

Thou­sands of FDA staff de­par­tures since April have sparked con­cerns with­in the phar­ma in­dus­try that nov­el drug ap­proval dead­lines might slip.

But in the first six months of 2025, the ap­proval num­bers re­main gen­er­al­ly aligned with pre­vi­ous years, even as FDA of­fi­cials warn that the full ex­tent of the staff cuts has yet to be re­al­ized.

As of Ju­ly 2, the FDA has ap­proved 24 new drugs and bi­o­log­ics so far in 2025, com­pared with 36 nov­el prod­ucts ap­proved by CDER and CBER over the same time pe­ri­od in 2024, and 40 in 2023. Ap­proval num­bers may vary year-to-year, de­pend­ing on pre­vi­ous years' sub­mis­sions, and of­ten serve more as a sign of in­dus­try pro­duc­tiv­i­ty and FDA's work­load.

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