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1. Updated: RFK Jr. advances out of Senate committee with Cassidy’s support
2. We’re about to find out which RFK Jr. will show up at HHS
3. RFK Jr. evades questions on vaccines and autism in written responses to senators
4. Updated: Drug prices likely to soar due to Trump tariffs, pharma bodies warn
5. Celltrion looks to buy US facilities to sidestep potential Trump tariffs 
6. Vertex's non-opioid pain drug is approved by FDA, bringing first of new class to market
7. After relaunch, Roche gets FDA approval for ocular implant in diabetic macular edema
8. J&J’s Rybrevant gets CHMP backing weeks after FDA rejection
9.
in focus
Drugmakers seize on biomarkers to test the FDA's rare disease shift
Zachary Brennan
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As all federal agencies are asking career employees if they want to resign, and offering some with pay through September, we've seen several more high-profile resignations and step-downs in recent weeks. Matthew Hepburn, former director of Covid vaccine development at Operation Warp Speed, stepped down several weeks ago after serving for about five months as the vaccine and therapeutics lead for the White House Office of Pandemic Preparedness and Response. Eric Pittman, an FDA veteran of 20+ years who most recently directed the Bioresearch Monitoring Division in the west, also said this week that he will step down but won't take the buyout from the Trump administration as he's headed to industry.

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Zachary Brennan
Senior Editor, Endpoints News
@ZacharyBrennan
Robert F. Kennedy Jr. (AP Photo/Julia Demaree Nikhinson)
1
by Max Bayer, Zachary Brennan

Sen. Bill Cas­sidy (R-LA) vot­ed to ad­vance Robert F. Kennedy Jr.’s nom­i­na­tion for HHS sec­re­tary to the full Sen­ate, a key show of sup­port from one of the nom­i­nee's most vo­cal crit­ics on the Re­pub­li­can side.

The 14-13 com­mit­tee vote along par­ty lines like­ly so­lid­i­fies Kennedy's con­fir­ma­tion in an up­com­ing Sen­ate floor vote. Fi­nance Com­mit­tee Chair­man Mike Crapo (R-ID) sig­naled last week that the larg­er Sen­ate vote could come at the end of this week.

"I’ve had very in­tense con­ver­sa­tions with Bob­by and the White House over the week­end and even this morn­ing," Cas­sidy tweet­ed ahead of the vote on Tues­day. "I want to thank VP JD specif­i­cal­ly for his hon­est coun­sel. With the se­ri­ous com­mit­ments I’ve re­ceived from the ad­min­is­tra­tion and the op­por­tu­ni­ty to make progress on the is­sues we agree on like healthy foods and a pro-Amer­i­can agen­da, I will vote yes."

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2
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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3
by Max Bayer

Robert F. Kennedy Jr.’s chances of be­com­ing HHS chief like­ly hinge on one of his more con­tro­ver­sial stances: that vac­cines con­tribute to the de­vel­op­ment of autism.

And in writ­ten re­spons­es to the Sen­ate Fi­nance Com­mit­tee, Kennedy con­tin­ued his re­fusal to walk back from that view.

When asked, “Yes or no, do you be­lieve vac­cines cause autism,” Kennedy evad­ed.

“If con­firmed, I will do noth­ing as HHS sec­re­tary that makes it dif­fi­cult or dis­cour­ages peo­ple from tak­ing vac­cines,” he wrote in a re­sponse. “As I tes­ti­fied to the Com­mit­tee, I am not an­ti-vac­ci­na­tion. I sup­port trans­paren­cy and sound da­ta for vac­cines.”

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4
by Anna Brown

Phar­ma­ceu­ti­cal in­dus­try groups cau­tion that Pres­i­dent Don­ald Trump’s tar­iffs on Chi­na, Mex­i­co and Cana­da will like­ly ex­ac­er­bate ex­ist­ing drug short­ages in the US, raise drug prices and put gener­ic man­u­fac­tur­ers out of the mar­ket.

The Trump ad­min­is­tra­tion im­posed a 25% tar­iff on im­ports from Mex­i­co and Cana­da and a 10% tar­iff on Chi­na on Sat­ur­day. The tax­es on Mex­i­co have since been de­layed by a month, un­der a deal be­tween Trump and Mex­i­co’s Pres­i­dent Clau­dia Shein­baum, both lead­ers an­nounced Mon­day on X.

The US re­lies on im­port­ing phar­ma­ceu­ti­cal prod­ucts glob­al­ly, in par­tic­u­lar from Chi­na, which is a large sup­pli­er of APIs.

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5
by Anna Brown

South Ko­re­an bio­phar­ma con­tract man­u­fac­tur­er Cell­tri­on is con­sid­er­ing ac­quir­ing US man­u­fac­tur­ing sites to mit­i­gate Pres­i­dent Don­ald Trump’s po­ten­tial tar­iffs on for­eign-made phar­ma­ceu­ti­cals.

Trump is con­sid­er­ing a va­ri­ety of glob­al tar­iffs to re­duce US re­liance on for­eign man­u­fac­tur­ing, in­clud­ing a 25% tar­iff on Cana­da and Mex­i­co and 10% on Chi­na, which could af­fect non-US phar­ma­ceu­ti­cal com­pa­nies and man­u­fac­tur­ers.

In­cheon-head­quar­tered Cell­tri­on al­ready has short- and long-term strate­gies in place in case the drug tar­iffs get im­ple­ment­ed, the com­pa­ny said in a state­ment to share­hold­ers on Thurs­day.

Cell­tri­on has six FDA-ap­proved biosim­i­lar prod­ucts avail­able in the US, as well as its sub­cu­ta­neous in­flix­imab in­jec­tion Zym­fen­tra, which is used to treat in­flam­ma­to­ry bow­el dis­ease. It has three plants in South Ko­rea, which are all cer­ti­fied by the FDA. The com­pa­ny al­so has a con­tract man­u­fac­tur­ing arm, dubbed Cell­tri­on Pharm, with a small mol­e­cule site in Cheongju, which ships prod­ucts to the US, and an oral sol­id dosage fac­to­ry lo­cat­ed in Jin­cheon for do­mes­tic sup­ply.

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