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Pfizer says FDA may pull its Covid vaccine for young children Read in browser
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1. NIH backs away from mRNA research, claiming lack of public trust
2. CytomX discloses patient death in study of ADC in colorectal cancer
3. Pfizer says FDA may pull its Covid vaccine for young children
4. Vedanta's microbiome therapy fails Phase 2, company lays off 20%
5. US tariffs could undo generic drugmakers' efforts to be less reliant on Chinese raw materials, experts say
6. Autolus says it won’t make money from its cell therapy in Europe until 2027
7. Biotech industry goes six months without an IPO
8. The Endpoints Slack interview: AI bio backer Dylan Reid on techbio's original sin
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Alexis Kramer
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We’re still waiting for pharma tariffs to drop. But in the meantime, Anna Brown takes a look at how current US tariffs (which right now exempt pharma products) could cause some generic drugmakers to start sourcing their raw materials from China instead of India. Check out her piece here.

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Alexis Kramer
Editor, Endpoints News
NIH Director Jay Bhattacharya (Alex Brandon/AP Images)
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by Max Bayer

The NIH will step back from fund­ing mR­NA re­search, claim­ing that too many peo­ple don’t trust the tech­nol­o­gy plat­form, the di­rec­tor said in a new ed­i­to­r­i­al.

The move by NIH Di­rec­tor Jay Bhat­tacharya pig­gy-backs on last week’s an­nounce­ment by HHS that it would cut fund­ing for two dozen con­tracts in­volv­ing mR­NA vac­cines. In a Wash­ing­ton Post ed­i­to­r­i­al Tues­day, Bhat­tacharya said the NIH would al­so piv­ot away from the tech­nol­o­gy.

His rea­son­ing fo­cused on what he claimed is lack of pub­lic trust in the tech­nol­o­gy, cit­ing a 2024 Pew study in­di­cat­ing that the ma­jor­i­ty of Amer­i­cans did­n't plan to get an up­dat­ed Covid-19 vac­cine. Those sur­vey re­sults di­verge sharply by par­ty af­fil­i­a­tion, and less so by age group, with De­moc­rats and old­er peo­ple more like­ly to say they plan to get the shots.

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by Lei Lei Wu

Bay Area biotech Cy­tomX on Wednes­day dis­closed de­tails of a pa­tient death from its ex­per­i­men­tal col­orec­tal can­cer drug "to ad­dress cer­tain re­cent so­cial me­dia posts."

A user on X sug­gest­ed a day ear­li­er that a tox­i­c­i­ty is­sue was to blame for a dip in the com­pa­ny’s stock price. On Tues­day, Cy­tomX's shares CT­MX fell 15%.

Cy­tomX said the death was due to acute kid­ney in­jury re­lat­ed to treat­ment, not­ing the pa­tient had a “com­plex med­ical his­to­ry in­clud­ing hav­ing a soli­tary kid­ney.” The fa­tal kid­ney in­jury was like­ly caused by nau­sea, vom­it­ing and di­ar­rhea.

Cy­tomX de­clined to com­ment be­yond the press re­lease.

The col­orec­tal can­cer pa­tient was part of a Phase 1 tri­al study­ing Cy­tomX’s an­ti­body-drug con­ju­gate that tar­gets Ep­CAM, a pro­tein that helps cells stick to­geth­er but is over­ex­pressed in cer­tain can­cers.

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by Zachary Brennan

The FDA is con­sid­er­ing re­vok­ing Pfiz­er's emer­gency use au­tho­riza­tion for its Covid-19 vac­cine for chil­dren aged 6 months through 4 years, the com­pa­ny said in a state­ment to End­points News.

"We are cur­rent­ly in dis­cus­sions with the agency on po­ten­tial paths for­ward and have re­quest­ed that the EUA for this age group re­main in place for the 2025-2026 sea­son," a Pfiz­er spokesper­son said. "It is im­por­tant to note that these de­lib­er­a­tions are not re­lat­ed to the safe­ty and ef­fi­ca­cy of the vac­cine which con­tin­ues to demon­strate a fa­vor­able pro­file."

An HHS spokesper­son told End­points the com­pa­ny's com­ment was "pure spec­u­la­tion."

Po­ten­tial changes to who can get Pfiz­er and BioN­Tech's mR­NA-based Covid vac­cine, if they go through, would align with oth­er re­cent re­stric­tions for Covid-19 shots that HHS has put in place since Robert F. Kennedy Jr. took the helm of the agency in Feb­ru­ary.

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by Kyle LaHucik

An in­ves­ti­ga­tion­al cap­sule to treat ul­cer­a­tive col­i­tis failed a Phase 2 test, Vedan­ta Bio­sciences an­nounced Wednes­day, in an­oth­er set­back for the mi­cro­bio­me field.

Vedan­ta said that its oral ther­a­py, VE202, did­n't achieve the pri­ma­ry end­point of en­do­scop­ic re­sponse in a tri­al called COL­LEC­TiVE202. It won't move for­ward with the ex­per­i­men­tal ther­a­py and will cut 20% of its staff, or 23 em­ploy­ees, CEO Bernat Olle told End­points News in a phone in­ter­view on Wednes­day.

The place­bo-con­trolled study en­rolled 114 peo­ple with mild-to-mod­er­ate ul­cer­a­tive col­i­tis. The com­pa­ny said it will present more de­tails on bac­te­r­i­al col­o­niza­tion, his­to­log­i­cal find­ings and im­mune re­spons­es in "fu­ture sci­en­tif­ic fo­rums."

The VE202 cap­sules com­prised 16 strains of bac­te­ria found in "the nor­mal hu­man in­tes­tine," Vedan­ta has said. The goal was to re­store nor­mal bac­te­r­i­al bal­ance in the in­tes­tine and re­lieve in­flam­ma­to­ry bow­el dis­ease.

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