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8 July, 2025
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1. In first half of 2025, novel drug approvals are in line with previous years
2. Trump hints at tariff grace period for pharma companies to bring manufacturing to US
3. 'CRISPR Cures' center launches with $20M to make customized gene editing therapies
4. Otsuka’s Taiho reports Phase 3 fail for Duchenne muscular dystrophy drug
5. Novartis maps launch of malaria drug for newborns after Swiss approval
6. Shell company Concentra has found its rhythm, with Cargo Therapeutics as its latest buyout target
7. ProKidney's stock shoots higher after mixed Phase 2 data
8. Exclusive: Startup raises $45M for universal flu vaccines made with mRNA
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Alexis Kramer
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Be sure to check out Ryan Cross’ story on a startup that’s raised $45 million to work on a universal flu vaccine. Centivax plans to rely on mRNA for its shot despite the Trump administration’s skepticism of the technology, and investors aren’t too worried about politics getting in the way.

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Alexis Kramer
Editor, Endpoints News
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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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Manufacturing Day 2025
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President Donald Trump at a Cabinet meeting on July 8, 2025 (Evan Vucci/AP Images)
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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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by Ryan Cross

Sci­en­tists seek­ing to make per­son­al­ized gene edit­ing ther­a­pies a re­al­i­ty for more peo­ple have launched a new ini­tia­tive to de­vel­op cures for the rarest of dis­eases left be­hind by drug com­pa­nies.

The Cen­ter for Pe­di­atric CRISPR Cures, an­nounced Tues­day by the Chan Zucker­berg Ini­tia­tive, will make cus­tom treat­ments for chil­dren with in­her­it­ed im­mune con­di­tions or meta­bol­ic dis­eases. The cen­ter is part of the In­no­v­a­tive Ge­nomics In­sti­tute (IGI) at Uni­ver­si­ty of Cal­i­for­nia, Berke­ley and is sup­port­ed by a $20 mil­lion grant from the CZI.

The ef­fort builds on the re­cent suc­cess that sci­en­tists had in de­vel­op­ing a cus­tom CRISPR ther­a­py for one in­fant’s de­bil­i­tat­ing meta­bol­ic dis­ease in un­der sev­en months, Fy­o­dor Urnov, a gene edit­ing sci­en­tist at the IGI who is lead­ing the new cen­ter, told End­points News. He de­scribed that suc­cess as a “yes we can” mo­ment for the field.

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by Nicole DeFeudis

An Ot­su­ka sub­sidiary said Tues­day that its ex­per­i­men­tal ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy has failed its Phase 3 pri­ma­ry end­point in a group of am­bu­la­to­ry pa­tients in Japan.

Tai­ho Phar­ma­ceu­ti­cal said the study showed “no sig­nif­i­cant dif­fer­ence” over 52 weeks in pa­tients’ mean change from base­line in the time it takes to rise from the floor, miss­ing the pri­ma­ry end­point for a co­hort of pa­tients who can walk in­de­pen­dent­ly. Duchenne is a rare and dev­as­tat­ing ge­net­ic mus­cle dis­ease that pri­mar­i­ly af­fects boys and men.

The am­bu­la­to­ry co­hort en­rolled male Duchenne pa­tients 5 years and old­er who re­ceived ei­ther Tai­ho’s oral drug TAS-205 or a place­bo twice dai­ly for 52 weeks. Tai­ho hasn’t re­leased the full dataset, but said that “de­tailed re­sults” will be pre­sent­ed at a fu­ture aca­d­e­m­ic con­fer­ence. The com­pa­ny al­so set out to test TAS-205’s safe­ty in a non-am­bu­la­to­ry co­hort, ac­cord­ing to the US’ clin­i­cal tri­als reg­istry, but didn’t share in­for­ma­tion from that group on Tues­day.

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