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Merck CEO says he’s confident in growth despite Gardasil ‘headwind’ Read in browser
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4 February, 2025
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top stories
1. We’re about to find out which RFK Jr. will show up at HHS
2. Pfizer says it has at least $10B available for deals in 2025, with a focus on pipeline
3. Merck CEO says he’s confident in growth despite Gardasil ‘headwind’
4. J&J asks court for quick decision in 340B rebate model fight
5. After relaunch, FDA approves Roche's ocular implant in diabetic macular edema
6. Illumina added to China's blacklist following Biosecure Act, tariffs
7. FDA approves Supernus’ Parkinson’s drug-device after two rejections
8. Bavarian Nordic’s stock sinks after 2024 revenues underwhelm
9. Regeneron will start delivering quarterly dividends 37 years into its existence
10. Astellas shakes up management despite impressive nine-month earnings
11. Updated: RFK Jr. advances out of Senate committee with Cassidy’s support
more stories
 
Zachary Brennan
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A new executive order from President Trump mandates that anytime a federal agency (like the FDA) promulgates a new rule, regulation or guidance, it must identify at least 10 existing ones to repeal. That could significantly curtail the agency's ability to issue guidance for the pharma industry on various topics from clinical trials to new endpoints. When the first Trump administration required two existing regulations to be pulled for every new one promulgated, and guidance documents were also included in the mix, the FDA had to reconsider when to issue guidance documents in lieu of regulations.

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Zachary Brennan
Senior Editor, Endpoints News
@ZacharyBrennan
1
by Drew Armstrong

Robert F. Kennedy Jr. is head­ed for Sen­ate con­fir­ma­tion fol­low­ing Tues­day’s com­mit­tee vote and a state­ment of sup­port from the GOP’s biggest skep­tic.

But it’s still very, very un­clear which Kennedy Amer­i­cans are like­ly to end up with — the an­ti-vac­cine cru­sad­er, or a more mod­er­ate ver­sion who made (vague) promis­es last week that he would let in­de­pen­dent sci­ence lead.

In the space of just a few min­utes on Tues­day, that ques­tion got even mud­di­er. Just ahead of the Sen­ate Fi­nance vote, Trump post­ed on so­cial me­dia that “20 years ago, Autism in chil­dren was 1 in 10,000. NOW IT’S 1 in 34. WOW! Some­thing’s re­al­ly wrong. We need BOB­BY!!!”

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Albert Bourla, Pfizer CEO (Eric Risberg/AP Images)
2
by Max Bayer

Pfiz­er's next deals are like­ly to be longer-term ef­forts to re­load its R&D work rather than big-tick­et, late-stage as­sets, the com­pa­ny's top ex­ec­u­tives said Tues­day.

“Look­ing for­ward, we are look­ing at more strate­gic op­por­tu­ni­ties right now, which will en­hance the pipeline in ar­eas that we would like to play, rather than near-term rev­enues,” CEO Al­bert Bourla told in­vestors Tues­day.

The com­pa­ny has about $10 bil­lion to $15 bil­lion it could put to­ward M&A this year, ac­cord­ing to CFO Dave Den­ton. He pre­vi­ous­ly guid­ed that while there’s al­ways “a lit­tle flex­i­bil­i­ty to do BD,” large trans­ac­tions would like­ly be kicked to 2026 or be­yond. Pfiz­er has made de-lev­er­ing a pri­or­i­ty, with bil­lions in cost cuts ini­ti­at­ed and ex­e­cut­ed, and bil­lions more raised by sell­ing off stakes in Ha­le­on, a con­sumer health wing co-run with GSK.

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Rob Davis, Merck CEO (Jeenah Moon/Bloomberg via Getty Images)
3
by Nicole DeFeudis

De­spite un­cer­tain­ty around HPV vac­cine sales in Chi­na, Mer­ck CEO Rob Davis said he’s con­fi­dent the com­pa­ny can “de­liv­er strong growth” and nav­i­gate Keytru­da’s im­pend­ing patent cliff.

Davis called the Chi­nese mar­ket chal­lenges a “short-term head­wind” for Mer­ck. Low­er-than-ex­pect­ed de­mand for Gar­dasil led the com­pa­ny to pause ship­ments to Chi­na on Tues­day and drove its stock MRK down 10%. But when it comes to long-term sales ex­pec­ta­tions, Davis said Mer­ck was “nev­er count­ing on Gar­dasil as a growth dri­ver.”

“We al­ways had an ex­pec­ta­tion that even­tu­al­ly it would start to plateau,” he said dur­ing Mer­ck’s fourth-quar­ter earn­ings call on Tues­day. Davis tout­ed high­er de­mand for Gar­dasil out­side of Chi­na, and said “over­all busi­ness is healthy and grow­ing.”

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4
by Nicole DeFeudis

John­son & John­son has asked a fed­er­al dis­trict court to ex­pe­dite its de­ci­sion in a case over the com­pa­ny’s pro­posed 340B re­bate mod­el, cit­ing up­com­ing dead­lines for com­ply­ing with the In­fla­tion Re­duc­tion Ac­t's drug pric­ing pro­vi­sions.

The com­pa­ny has un­til Sept. 1 to sub­mit a writ­ten plan to CMS with its "in­tend­ed pro­ce­dures" for meet­ing its oblig­a­tions un­der the IRA's drug price ne­go­ti­a­tion pro­gram. But J&J said it faces "sig­nif­i­cant ob­sta­cles" to com­ply­ing with a key re­quire­ment: pre­vent­ing du­pli­cate dis­counts un­der the IRA and 340B.

The law­suit stems from the fed­er­al gov­ern­men­t's re­jec­tion of J&J's pro­posed re­bate mod­el, which the com­pa­ny says would help curb du­pli­cate dis­counts and re­duce fraud and abuse with­in the 340B pro­gram. J&J on Mon­day asked the US Dis­trict Court for the Dis­trict of Co­lum­bia for a rul­ing by Ju­ly 1.

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