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CDC adopts advisors' recommendation for Merck’s infant RSV antibody Read in browser
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7 August, 2025
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1. Kennedy's mRNA cuts challenge Trump's Warp Speed achievements
2. Appeals court rejects Boehringer Ingelheim’s constitutional arguments against IRA 
3. CDC adopts advisors' recommendation for Merck’s infant RSV antibody
4. New FDA program aims to speed up construction of US manufacturing sites 
5. Dewpoint downsizes while in 'final stages' of getting more funds for first trial
6. Merck KGaA joins other drugmakers in considering direct-to-patient US sales 
7. FDA removes hold on Valneva’s chikungunya vaccine in those over 60, adjusts product label
8. Strand Therapeutics nabs $153M to test mRNA cancer therapies
9. Scholar Rock expects September PDUFA for spinal muscular atrophy drug to stay unchanged despite CDMO woes 
10. Chinese biotech Minghui raises $131M to advance its PD-1xVEGF bispecific
11. Updated: Lilly CEO pushes back on Trump’s drug price plan, as obesity data overshadow revenue beat
12. Novo keeps the lead in obesity pill battle against Lilly
more stories
 
 
Alexis Kramer
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We’ve gotten two appellate decisions in a row this week on the validity of the Inflation Reduction Act’s drug pricing provisions, both in the government’s favor. Today’s decision by the Second Circuit rejected Boehringer Ingelheim’s constitutional claims and noted, multiple times, that participation in Medicare price negotiations is voluntary.

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Alexis Kramer
Editor, Endpoints News
President Donald Trump (AP Photo/Alex Brandon)
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by Zachary Brennan, Max Bayer

Pres­i­dent Don­ald Trump is mov­ing on from his Op­er­a­tion Warp Speed lega­cy.

Dur­ing his first ad­min­is­tra­tion, Trump’s health­care of­fi­cials led the spend­ing of bil­lions of dol­lars to get mR­NA vac­cines up and run­ning as fast as pos­si­ble in re­sponse to the Covid-19 pan­dem­ic, bring­ing a pow­er­ful new med­ical tech­nol­o­gy in­to the main­stream and like­ly sav­ing mil­lions of lives.

Five years lat­er, his health de­part­ment un­der HHS Sec­re­tary Robert F. Kennedy Jr. is slash­ing funds and turn­ing its back on the tech­nol­o­gy, not just for Covid but for fu­ture ap­pli­ca­tions as well.

When asked about Kennedy’s mR­NA cuts at the White House on Wednes­day, Trump praised the work of Op­er­a­tion Warp Speed as “amaz­ing,” but added, “you know that was a long time ago, and we’re on to oth­er things.”

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by Nicole DeFeudis

For the sec­ond time this week, the gov­ern­ment de­feat­ed a le­gal chal­lenge against Medicare drug price ne­go­ti­a­tions, af­ter an ap­peals court af­firmed that the pro­gram is vol­un­tary and didn’t vi­o­late Ger­man phar­ma Boehringer In­gel­heim’s con­sti­tu­tion­al rights.

Drug­mak­ers have suf­fered a string of loss­es in court as they try to de­rail the ne­go­ti­a­tions. The new prices will take hold for the first time in Jan­u­ary. Like oth­er re­cent court opin­ions in the gov­ern­ment’s fa­vor, the Thurs­day rul­ing from the US Court of Ap­peals for the Sec­ond Cir­cuit fo­cused on the “vol­un­tari­ness” of the ne­go­ti­a­tion process.

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by Max Bayer

The CDC now rec­om­mends the use of Mer­ck’s re­cent­ly-ap­proved RSV an­ti­body in in­fants, af­ter ad­vi­sors to the agency vot­ed in fa­vor of the prod­uct in June.

CDC Di­rec­tor Su­san Monarez adopt­ed the rec­om­men­da­tion of the Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices on Mon­day af­ter tak­ing the helm of the agency last week.

Mer­ck­'s En­flon­sia was ap­proved by the FDA ear­li­er in June to pre­vent RSV low­er res­pi­ra­to­ry tract dis­ease in in­fants en­ter­ing their first res­pi­ra­to­ry virus sea­son. In­clu­sion of the an­ti­body in CDC’s guide­lines was the fi­nal step for Mer­ck as it chal­lenges Sanofi and As­traZeneca’s Bey­for­tus in the mar­ket. Bey­for­tus raked in al­most $2 bil­lion in sales in 2024 af­ter be­ing ap­proved in 2023.

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