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3 July, 2025
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top stories
1. HHS actions to remove web content were arbitrary, 'poorly thought-through,' judge rules
2. Novartis' Cosentyx fails Phase 3 study for autoimmune disease
3. The Trump administration is promoting wearable health devices — with or without evidence
4.
peer review
Now private, bluebird bio continues leadership revamp; Roche R&D exec announces retirement
5. Dizal’s lung cancer pill approval sets up competition with J&J
6. Sage talked to 43 'counterparties' before inking Supernus deal
7. Structure in partnering talks for GLP-1 pill as mid-stage readout nears
8. Number of megarounds drop 38% in first half as biotechs struggle against worsening slump
more stories
 
Alexis Kramer
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We’re observing the Fourth of July tomorrow, so we won’t be sending newsletters then. Enjoy the long weekend!

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Alexis Kramer
Editor, Endpoints News
1
by Alexis Kramer

The Trump ad­min­is­tra­tion's ac­tions to re­move a broad swath of HHS web­pages in late Jan­u­ary were ar­bi­trary and not the “prod­uct of rea­soned de­ci­sion­mak­ing,” a fed­er­al dis­trict court ruled Thurs­day.

The de­ci­sion hands a vic­to­ry to a non­prof­it doc­tors group that chal­lenged a “gen­der ide­ol­o­gy” ex­ec­u­tive or­der and re­sult­ing fed­er­al guid­ance. The group claimed that those di­rec­tives led the fed­er­al health agen­cies to purge “nu­mer­ous web­pages” used dai­ly by physi­cians to di­ag­nose and treat their pa­tients.

“The de­fen­dants’ ac­tions were ill-con­ceived from the be­gin­ning,” Judge John Bates wrote in his opin­ion in the US Dis­trict Court for DC. Rather than take a “mea­sured ap­proach” to har­mo­nize the HHS web­sites with the ex­ec­u­tive or­der, “the de­fen­dants in­stead adopt­ed poli­cies of ‘re­move first and as­sess lat­er’ that failed to con­sid­er mul­ti­ple im­por­tant as­pects of the sit­u­a­tion," he said.

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POST-HOC DISPATCHES FROM THE NEWSROOM
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2
by Max Gelman

No­var­tis faced a set­back in its am­bi­tion to ex­pand its block­buster drug Cosen­tyx and com­pete in an au­toim­mune con­di­tion with prod­ucts from Roche and Ab­b­Vie.

The com­pa­ny said Thurs­day that the drug flopped a Phase 3 study in gi­ant cell ar­teri­tis, an in­flam­ma­to­ry dis­or­der pri­mar­i­ly oc­cur­ring in old­er adults where blood ves­sels be­come in­flamed and re­strict blood flow. No­var­tis did not re­port spe­cif­ic da­ta, but said Cosen­tyx when com­bined with a ta­per­ing of steroids did not show sig­nif­i­cant sus­tained re­mis­sion af­ter one year com­pared to place­bo.

Rel­a­tive to oth­er in­flam­ma­to­ry and im­muno­log­i­cal con­di­tions, gi­ant cell ar­teri­tis is not a par­tic­u­lar­ly large mar­ket. The preva­lence is es­ti­mat­ed to be about 1 in 10,000 adults old­er than 50.

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3
by Shelby Livingston

In June, HHS Sec­re­tary Robert F. Kennedy Jr. said at a con­gres­sion­al hear­ing that his agency is poised to launch a ma­jor ad cam­paign to en­cour­age Amer­i­cans to use wear­ables so “peo­ple can take con­trol of their own health, they can take re­spon­si­bil­i­ty, they can see as you know what food is do­ing to their glu­cose lev­els,” among oth­er met­rics.

He re­vealed his vi­sion of every Amer­i­can us­ing a wear­able with­in four years, go­ing so far as to sug­gest the de­vices can pro­duce ben­e­fits on par with pop­u­lar GLP-1 obe­si­ty and di­a­betes drugs.

While Kennedy wasn’t spe­cif­ic about the type of wear­able, it’s like­ly he was re­fer­ring to con­tin­u­ous glu­cose mon­i­tors — small biosen­sors worn on the arm to pro­vide a mea­sure of the sug­ar lev­els in a per­son’s blood. The sen­sors are of­ten paired with an app that shows trends in glu­cose lev­els and pro­vides lifestyle and nu­tri­tion rec­om­men­da­tions based on the da­ta col­lect­ed.

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Peer Review: Weekly biopharma job report
4
by Alex Hoffman, Kathy Wong, Lei Lei Wu

Blue­bird bio rolled out three new ex­ec­u­tive hires on Tues­day: Bri­an Ri­ley as pres­i­dent and chief tech­ni­cal of­fi­cer, Joanne Lager as chief med­ical of­fi­cer and Adri­an Chais­son as chief of staff.

The new ad­di­tions come af­ter two pri­vate eq­ui­ty firms — Car­lyle and SK Cap­i­tal — took the biotech pri­vate in ear­ly June af­ter blue­bird had strug­gled for years to build a sus­tain­able busi­ness from sell­ing cell and gene ther­a­pies. Blue­bird has three ap­proved ther­a­pies: Zyn­te­glo for be­ta tha­lassemia, Skysona for a rare dis­ease called cere­bral adrenoleukody­s­tro­phy, and Lyf­ge­nia for sick­le cell dis­ease.

In June, For­mer Mi­rati CEO David Meek joined to lead blue­bird as part of the pri­vate eq­ui­ty deal, re­plac­ing An­drew Oben­shain.

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5
by Elizabeth Cairns

Dizal said that its EGFR in­hibitor sun­voz­er­tinib has been ap­proved by the FDA for cer­tain types of lung can­cer.

The pill, now brand­ed as Zegfrovy, gained ac­cel­er­at­ed ap­proval in the US for lo­cal­ly ad­vanced or metasta­t­ic non-small cell lung can­cer in pa­tients with ex­on 20 in­ser­tion mu­ta­tions in the EGFR gene. Pa­tients must have re­lapsed af­ter treat­ment with plat­inum-based chemother­a­py. Ex­on 20 in­ser­tion mu­ta­tions are the third-most com­mon type of EGFR mu­ta­tion in NSCLC.

Dizal is a Shang­hai-based biotech that was spun out of As­traZeneca in 2017. The drug was ap­proved in Chi­na for the same use in 2023.

Mak­ing a com­mer­cial mark in the US might be chal­leng­ing, how­ev­er. John­so