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21 November, 2025
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top stories
1. More drama surrounds FDA as top aide to Makary faces pushback from White House
2. AstraZeneca to onshore rare disease portfolio as part of its $50B pledge to the US
3. Teva loses IRA drug pricing challenge in DC federal court 
4. Novo, Lilly begin to sell obesity medications directly to employers
5.
peer review
Jeff Bluestone, Stephen Dilly talk CEO handoff, what’s next for Sonoma; Scott Gottlieb's next move
6. GSK, AnaptysBio enter legal battle over decade-old Jemperli licensing deal
7. Contineum's J&J-partnered drug fails Phase 2 multiple sclerosis trial
8. FDA investigates child death potentially related to Takeda's enzyme replacement therapy
9. Lilly becomes first $1 trillion pharma company
more stories
 
Alexis Kramer
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Merck was the first to file suit against Medicare drug price negotiations, and it may be the last to get a decision. Teva lost its IRA challenge in district court yesterday, so now Merck’s case (filed in 2023!) is the only one left at the lower court level. We’re also still waiting on the Fifth Circuit to decide on PhRMA’s appeal in a separate IRA case. It remains to be seen if the Supreme Court will wade into any of these lawsuits.

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Alexis Kramer
Editor, Endpoints News
1
by Max Bayer

A close con­fi­dant and aide of FDA Com­mis­sion­er Mar­ty Makary won't be forced to re­sign af­ter run­ning afoul of the White House, but al­so won't be pro­mot­ed in­to a se­nior role at the reg­u­la­tor.

Makary had planned to ap­point San­ju­la Jain-Nag­pal, who had been serv­ing as his di­rec­tor of pol­i­cy and re­search strat­e­gy, as his deputy chief of staff. Jain-Nag­pal used the new ti­tle dur­ing a Nov. 12 call with agency stake­hold­ers. But the White House had nev­er signed off, ac­cord­ing to a White House of­fi­cial, who spoke with End­points News Fri­day on con­di­tion of anonymi­ty.

That led to a per­cep­tion that she was be­ing in­sub­or­di­nate, and the White House asked for her res­ig­na­tion. It pulled back that de­mand, the of­fi­cial said, but it al­so de­nied Jain-Nag­pal's pro­mo­tion.

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AstraZeneca’s site that will be expanded in Frederick, MD (Courtesy AstraZeneca)
2
by Anna Brown

As­traZeneca will in­vest $2 bil­lion to ex­pand its pres­ence in Mary­land, its lat­est move to boost US man­u­fac­tur­ing as part of a larg­er $50 bil­lion pledge, the com­pa­ny an­nounced Fri­day.

The UK-based drug­mak­er will use the funds to on­shore its rare dis­ease port­fo­lio to the US for the first time. It plans to ex­pand its bi­o­log­ics fa­cil­i­ty in Fred­er­ick, MD, and near­ly dou­ble the fac­to­ry’s com­mer­cial ca­pac­i­ty.

As­traZeneca will al­so build a new fac­to­ry in Gaithers­burg, MD, which will man­u­fac­ture as­sets for clin­i­cal tri­als, the UK drug­mak­er said. Around 300 new jobs will be cre­at­ed across both the Gaithers­burg and Fred­er­ick sites.

The phar­ma gi­ant an­nounced its larg­er $50 bil­lion pledge in Ju­ly as part of the Trump ad­min­is­tra­tion’s on­shoring push.

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3
by Nicole DeFeudis

Te­va’s chal­lenge against Medicare ne­go­ti­a­tions fell flat in DC fed­er­al court, mark­ing an­oth­er loss for the phar­ma in­dus­try.

US Dis­trict Judge Sparkle Sook­nanan said Thurs­day that Te­va’s con­sti­tu­tion­al and statu­to­ry claims against the ne­go­ti­a­tion process “ei­ther fail on the mer­its or are un­ripe.”

Te­va has al­ready filed a no­tice of ap­peal, and a com­pa­ny spokesper­son said it “stands be­hind the mer­its” of the case.

Its chal­lenge will be one of two ap­peals cas­es left un­de­cid­ed in the phar­ma in­dus­try’s long-run­ning le­gal bat­tle against the In­fla­tion Re­duc­tion Act. A de­ci­sion could come any day for in­dus­try trade group PhRMA in the Fifth Cir­cuit. Mean­while, Mer­ck is still wait­ing on a de­ci­sion in DC dis­trict court, and As­traZeneca pe­ti­tioned its case to the US Supreme Court in Sep­tem­ber.

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4
by Lydia Ramsey Pflanzer

Build­ing on the grow­ing suc­cess of of­fer­ing cheap­er cash-pay prices to con­sumers for their GLP-1 weight loss drugs, No­vo Nordisk and Eli Lil­ly are set­ting up pro­grams to work di­rect­ly with em­ploy­ers.

Waltz Health, an Ever­sana com­pa­ny that brings pay­ors and phar­ma di­rect­ly to­geth­er, is work­ing with Lil­ly and No­vo to pow­er the ap­proach. Through Waltz, there will be a fixed price for the med­ica­tions, though the com­pa­nies haven’t shared what that price will be.

On­ly about 20% of em­ploy­ers with more than 200 em­ploy­ees in 2025 of­fer cov­er­age for GLP-1s for weight loss. Rather than cov­er­ing the med­ica­tions through the tra­di­tion­al phar­ma­cy ben­e­fit man­ag­er for­mu­la­ry, em­ploy­ers have been con­sid­er­ing al­ter­na­tive mod­els. That way, the em­ploy­er could of­fer some obe­si­ty med­i­cine ben­e­fits. Many Amer­i­cans get health ben­e­fits through their em­ploy­er.