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top stories
1. ‘This is unconscionable’: ACIP no longer recommends hepatitis B birth dose for all children
2. Bristol Myers expands Breyanzi approval to marginal zone lymphoma
3. Pinpointing the moment when biopharma sentiment finally turned
4. With backing from Pfizer and others, China startup raises $100M in new twist on licensing model
5. NICE adds further details on how the UK will pay more for drugs
6.
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Ex-Intercept CEO to take over at Altimmune; Carolyn Bertozzi leaves Alnylam's board
Drew Armstrong
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Max Bayer has been watching (and for better or worse, live-tweeting) ACIP's consideration of the hepatitis B birth dose, as well as the committee's broad debates about US vaccine policy. You can read his full story on the vote below.

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Drew Armstrong
Executive Editor, Endpoints News
@ArmstrongDrew
The ACIP panel votes on hepatitis B vaccine policy at the CDC headquarters on Dec. 5, 2025 (Ben Gray/AP Images)
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by Max Bayer

A pan­el of CDC vac­cine ad­vi­sors has stopped rec­om­mend­ing that all chil­dren re­ceive the he­pati­tis B vac­cine at birth, over­rul­ing sci­en­tif­ic con­sen­sus and pub­lic health of­fi­cials who plead­ed that there was no ground­ed ra­tio­nale for the move.

The ma­jor­i­ty of mem­bers of the Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices vot­ed on Fri­day that preg­nant women who test neg­a­tive for he­pati­tis B should con­sult a health­care provider be­fore giv­ing their new­born a shot. Eight mem­bers vot­ed in fa­vor of the change and three vot­ed against it. The rec­om­men­da­tion stops short of ex­plic­it­ly rec­om­mend­ing that some chil­dren not re­ceive the birth dose, in­stead putting the de­ci­sion on in­di­vid­u­als.

The com­mit­tee al­so vot­ed to rec­om­mend that par­ents con­sult a health­care provider to see if a child should get test­ed for their an­ti­body lev­els against he­pati­tis B be­fore re­ceiv­ing ad­di­tion­al dos­es in the vac­ci­na­tion se­ries.

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by Nicole DeFeudis

Bris­tol My­ers Squibb’s CAR-T ther­a­py Breyanzi has be­come the first such treat­ment ap­proved for pa­tients with a rare, slow-grow­ing type of non-Hodgkin lym­phoma.

The drug was ap­proved Thurs­day for third-line pa­tients with mar­gin­al zone lym­phoma, which oc­curs when white blood cells clump to­geth­er and form lumps in lymph nodes or or­gans. Pa­tients with mar­gin­al zone lym­phoma of­ten achieve re­mis­sion af­ter ini­tial treat­ment — but many re­lapse.

Vinay Prasad, di­rec­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, said in a news re­lease that the ap­proval “rep­re­sents a ma­jor ad­vance­ment in pre­ci­sion med­i­cine.”

Lynelle Hoch, pres­i­dent of Bris­tol My­ers’ cell ther­a­py unit, cham­pi­oned the breadth of Breyanzi’s la­bel in a sep­a­rate an­nounce­ment. The new in­di­ca­tion is Breyanzi’s fifth can­cer ap­proval, cov­er­ing what Hoch called “the broad­est range of B-cell ma­lig­nan­cies,” com­pared with oth­er CAR-Ts.

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by Tom Randall

In­side the two-week stretch that marked a re­ver­sal in bio­phar­ma sen­ti­ment.

Dur­ing the two weeks that our bio­phar­ma sen­ti­ment sur­vey was in the field in mid-Oc­to­ber, some­thing un­usu­al hap­pened: The mood of the in­dus­try ap­peared to snap out of its de­spair.

End­points Sig­nal sur­veyed more than 1,400 peo­ple for the Bio­phar­ma Sen­ti­ment In­dex (BP­SI) over that time. Com­ing in­to the sto­ry, many were still think­ing about 2025 as an­oth­er grind-it-out down year. At the start of our sur­vey, the sen­ti­ment read­ing hov­ered around 70, far be­low the neu­tral base­line of 100.

But over the next sev­er­al weeks, while the sur­vey was in the field, there was a sharp and con­sis­tent up­turn to­ward a much less neg­a­tive view­point.

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by Kyle LaHucik

A new biotech has raised $100 mil­lion to build a mix of as­sets from in­side and out­side Chi­na, while de­vel­op­ing its own drug can­di­dates.

The Shang­hai-based start­up, called OTR Ther­a­peu­tics, is a new twist on West­ern in­vestors that build new com­pa­nies around Chi­nese drug can­di­dates. The com­pa­ny wants to take ad­van­tage of the rapid de­vel­op­ment and clin­i­cal work avail­able in the re­gion, but with as­sets that can come from any­where.

That ap­proach has at­tract­ed a group of glob­al back­ers, in­clud­ing Pfiz­er Ven­tures, Lil­ly Asia Ven­tures, Temasek, True Light Cap­i­tal and Sirona Cap­i­tal.

OTR has al­ready ac­quired a pre­clin­i­cal neu­rol­o­gy drug can­di­date from an un­named Chi­nese biotech, CEO Zhui Chen said in a Fri­day morn­ing in­ter­view. And it's in late-stage dis­cus­sions about two or three oth­er as­sets to bring in.

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by Anna Brown

The UK’s Na­tion­al In­sti­tute for Health and Care Ex­cel­lence (NICE) told stake­hold­ers this week that pre­vi­ous­ly re­ject­ed drugs won’t au­to­mat­i­cal­ly fall un­der its new cost-ef­fec­tive­ness thresh­old.

Fur­ther, med­i­cines cur­rent­ly un­der re­view that would now be cov­ered by the new £35,000 lim­it will have their de­ci­sions de­layed un­til April, ac­cord­ing to a Thurs­day email seen by End­points News.

Af­ter on­go­ing ne­go­ti­a­tions with the US gov­ern­ment, the UK an­nounced last week it was rais­ing its cost-ef­fec­tive­ness thresh­old for drugs by 25%. Cur­rent­ly, the up­per thresh­old lim­it is £30,000, but this will be raised to £35,000, mean­ing an ad­di­tion­al three to five drugs or la­bel ex­pan­sions will be rec­om­mend­ed per year.

It’s cur­rent­ly un­clear which drugs would ben­e­fit from this fu­ture up­date, but meet­ings are ex­pect­ed to be set af­ter April.

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Peer Review: Weekly biopharma job report
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