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FDA won't reorganize medical product centers, Makary says in interview Read in browser
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1. Pfizer CEO Bourla suggests pharma tariffs will focus on US adversaries, not allies
2. FDA won't reorganize medical product centers, Makary says in interview: 'I rejected that proposal'
3. Artios drug exploits ‘replication stress’ in cancer, shrinking subset of tumors in early study
4. Merck plans to bring Keytruda production to the US with $1B biologics factory
5. AstraZeneca, Novartis execute ‘US for US’ strategy as pharma tariffs near
6. AstraZeneca posts another Truqap study fail, says China import tax could triple
7. Novartis continues earnings winning streak as it raises 2025 sales expectations
8. Pfizer launches a new wave of cost cuts, expects $7.7B in total savings through 2027
9. Hims and Novo Nordisk partner to offer discounted Wegovy
10. With a new CEO, oligonucleotide biotech Creyon forges Eli Lilly partnership
11. FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts
12. FDA approves Abeona’s skin disease cell therapy
more stories
 
Alexis Kramer
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As US tariff policy rapidly evolves, Pfizer's CEO is "cautiously optimistic" that any pharma-specific levies would focus on countries that are genuine national security risks, as opposed to allies. His hope would be welcome news for many drugmakers. But a White House official told Endpoints that "any notion" that the investigation has been pre-judged and that the White House has decided resulting actions "is speculation."

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Alexis Kramer
Editor, Endpoints News
Albert Bourla, Pfizer CEO (Stefan Wermuth/Bloomberg via Getty Images)
1
by Max Bayer

With the Trump ad­min­is­tra­tion's planned phar­ma tar­iffs on the hori­zon, Pfiz­er CEO Al­bert Bourla gave an op­ti­mistic read on Tues­day when asked how he thought the trade levies might be im­ple­ment­ed.

Speak­ing dur­ing the com­pa­ny's quar­ter­ly earn­ings call, Bourla said he was “cau­tious­ly op­ti­mistic” that any find­ings from the White House’s on­go­ing Sec­tion 232 in­ves­ti­ga­tion in­to phar­ma­ceu­ti­cal prod­ucts would fo­cus on im­ports from coun­tries that are an ac­tu­al na­tion­al se­cu­ri­ty risk, as op­posed to al­lies. His read comes from con­ver­sa­tions with the White House and as­so­ci­at­ed staff, he told in­vestors.

“There is a very clear dis­tinc­tion in the way that they look at it, in terms of what prod­ucts they are talk­ing about. And there is a very clear dis­tinc­tion as to what comes from friend­ly coun­tries or what comes from ad­ver­sary coun­tries,” Bourla said.

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Marty Makary, FDA Commissioner (Bill Clark/CQ Roll Call via AP Images)
2
by Zachary Brennan

The FDA plans to con­sol­i­date some ad­min­is­tra­tive func­tions, but won't em­bark on a whole­sale re­or­ga­ni­za­tion of the re­view cen­ters that over­see drugs, bi­o­log­ics and med­ical de­vices, FDA Com­mis­sion­er Mar­ty Makary said in an in­ter­view pub­lished Tues­day.

"Yes, we are con­sol­i­dat­ing trav­el of­fices, IT, and some oth­er things that make sense for ef­fi­cien­cy, but noth­ing else is planned," Makary told Har­vard physi­cian Je­re­my Faust in an in­ter­view.

The agency and HHS had pre­vi­ous­ly con­sid­ered the idea of re­or­ga­niz­ing the agency in­to five shared ser­vices of­fices. The pro­pos­al, first re­port­ed by End­points News, fol­lowed sweep­ing job cuts tar­get­ing about 3,500 FDA em­ploy­ees. The Trump ad­min­is­tra­tion, in many cas­es led by Elon Musk's DOGE ini­tia­tive, has tar­get­ed sim­i­lar cuts across the gov­ern­ment.

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3
by Ryan Cross

Ar­tios Phar­ma, a start­up de­vel­op­ing drugs that weak­en a tu­mor’s abil­i­ty to main­tain its DNA, an­nounced pos­i­tive re­sults in a sub­set of pa­tients with ad­vanced can­cer. It’s the first big da­ta re­veal for the Cam­bridge, UK-based start­up, which has been rel­a­tive­ly qui­et since 2021, when it struck a drug dis­cov­ery part­ner­ship with No­var­tis and raised $153 mil­lion in Se­ries C fi­nanc­ing.

The com­pa­ny’s drug, called ART0380, in­hibits a DNA re­pair en­zyme called ATR. When ad­min­is­tered with a low dose of the chemother­a­py irinote­can, the drug shrank tu­mors in 37% of pa­tients whose can­cer was con­sid­ered “de­fi­cient” in an­oth­er DNA dam­age re­sponse pro­tein dubbed ATM, ac­cord­ing to da­ta from a Phase 1/2 study.

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4
by Anna Brown

Mer­ck is shift­ing man­u­fac­tur­ing for its block­buster drug Keytru­da to a new $1 bil­lion fac­to­ry in Delaware, dou­bling down on its plans to move pro­duc­tion to the US to mit­i­gate the im­pact of po­ten­tial phar­ma tar­iffs.

“By pro­duc­ing Keytru­da in the US, as well as nu­mer­ous fu­ture bi­o­log­ic prod­ucts, we are reaf­firm­ing our com­mit­ment to a strong US foot­print that sup­ports the Pres­i­dent’s eco­nom­ic agen­da,” the com­pa­ny said Tues­day.

With the threat of phar­ma-spe­cif­ic tar­iffs on the hori­zon, drug­mak­ers are rush­ing to show they are mov­ing man­u­fac­tur­ing to the US. On Tues­day morn­ing, No­var­tis re­it­er­at­ed it wish­es to have 100% of all its drug pro­duc­tion in the US in the next five years, and As­traZeneca said it's look­ing to shift man­u­fac­tur­ing from Eu­rope in­to the US. Mer­ck said it plans to con­tin­ue re­lo­cat­ing man­u­fac­tur­ing op­er­a­tions to the US, in­clud­ing Keytru­da pro­duc­tion in 2026.