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top stories
1. Teva beats Corcept in appeals fight over generic Cushing's syndrome drug
2. AbbVie, PhRMA can proceed with 340B case in Hawaii
3. Hims is buying an Australian telehealth company for $240M upfront
4. J&J pauses patient recruitment in mid-stage trial of AC Immune’s Alzheimer’s drug
5. Obesity biotech Verdiva gears up for a big year of data — and maybe deals too
6. Makary, Prasad set one pivotal trial policy via NEJM article
more stories
 
Max Bayer
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The upcoming meeting of the CDC’s vaccine advisors has been postponed, an HHS spokesperson confirmed to Endpoints News. ACIP was slated to meet next week for the first time since HHS officials overhauled the childhood vaccine schedule in January, without the panel’s input.

The timing of the meeting has been in flux as the government defends its vaccine decisions in court in a lawsuit brought by the American Academy of Pediatrics. It’s not immediately clear when the meeting will take place, although Bloomberg News reports it's been pushed to March.

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Max Bayer
Pharma Reporter, Endpoints News
1
by Alexis Kramer

Te­va scored a win af­ter a fed­er­al ap­peals court held that its gener­ic Cush­ing’s syn­drome drug doesn’t in­fringe Cor­cept Ther­a­peu­tic­s' patents.

The US Court of Ap­peals for the Fed­er­al Cir­cuit said Thurs­day there was “no clear er­ror” in the low­er court’s rul­ing, which found Cor­cept failed to prove di­rect or in­duced in­fringe­ment.

The patents cov­er meth­ods of ad­min­is­ter­ing Cor­cept’s Ko­r­lym with a CYP3A in­hibitor to treat Cush­ing’s syn­drome. Ko­r­lym was ap­proved in 2012 with a warn­ing la­bel about co-ad­min­is­tra­tion due to safe­ty con­cerns, and the la­bel was re­vised in 2019. Cor­cept sued Te­va af­ter it filed an ap­pli­ca­tion for a gener­ic ver­sion of the drug with a pro­posed la­bel iden­ti­cal to Cor­cept’s.

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2
by Nicole DeFeudis

A fed­er­al judge is al­low­ing Ab­b­Vie and PhRMA to pro­ceed with most of their claims against a Hawaii state law that reg­u­lates how 340B-dis­count­ed drugs are dis­trib­uted.

Thurs­day's de­ci­sion dealt an ear­ly win to Ab­b­Vie and the in­dus­try trade group, which had ar­gued that Hawaii’s state law is pre­empt­ed by the fed­er­al 340B statute. Ab­b­Vie sep­a­rate­ly brought a hand­ful of oth­er claims, in­clud­ing that the law, known as Act 143, is “un­con­sti­tu­tion­al­ly vague.”

US Dis­trict Judge Shan­lyn Park de­nied the state’s re­quests to dis­miss all but one of those chal­lenges, not­ing that “Ab­b­Vie has failed to plau­si­bly al­lege that Act 143 is un­con­sti­tu­tion­al­ly vague.” PhRMA did­n't bring a sim­i­lar claim about the law.

Ab­b­Vie and PhRMA weren't im­me­di­ate­ly avail­able for com­ment.

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3
by Ngai Yeung

In a bid to build out its glob­al pres­ence, Hims is buy­ing Aus­tralian dig­i­tal health com­pa­ny Eu­ca­lyp­tus in a deal worth $240 mil­lion up­front.

The deal an­nounced Thurs­day morn­ing would al­low Hims to launch in Aus­tralia and Japan and deep­en its pres­ence in Ger­many, Cana­da and the UK, as the com­pa­ny looks to ex­pand in­ter­na­tion­al­ly. Last year, Hims ac­quired Livewell, a Cana­di­an dig­i­tal health plat­form fo­cused on weight loss.

“We've shown the dif­fer­ence that makes in the US, and the log­i­cal next step is work­ing with more in­ter­na­tion­al ex­perts to make that dif­fer­ence abroad,” Hims CEO An­drew Dudum said in a news re­lease.

The ac­qui­si­tion is ex­pect­ed to close in the mid­dle of this year. Hims ex­pects to pay $240 mil­lion in cash at clos­ing, and the deal could be worth up to $1.15 bil­lion if cer­tain fi­nan­cial tar­gets are met in the 18 months af­ter clos­ing.

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4
by Elizabeth Cairns

John­son & John­son has paused en­roll­ment in the Phase 2b tri­al of its Alzheimer’s dis­ease can­di­date, and the stock ACIU of its part­ner AC Im­mune closed down about 10% on Wednes­day.

The as­set is an an­ti-pTau ther­a­peu­tic vac­cine known as ACI-35.030, or JNJ-2056. Pa­tient sign-up in the mid-stage study was tem­porar­i­ly halt­ed to al­low J&J to as­sess as­pects of the tri­al, in­clud­ing re­cruit­ment, a Tues­day SEC fil­ing shows. The tri­al it­self con­tin­ues. The pause was not re­lat­ed to new safe­ty find­ings, and the tri­al’s pre­spec­i­fied in­ter­im im­muno­genic­i­ty thresh­old was met, AC Im­mune said.

The study was test­ing the can­di­date in around 500 pa­tients with pre-symp­to­matic Alzheimer’s dis­ease, which means that the study par­tic­i­pants were cog­ni­tive­ly nor­mal but test­ed pos­i­tive for tau.

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5
by Elizabeth Cairns

Pfiz­er’s pur­chase of obe­si­ty biotech Met­sera last year threw the spot­light on long-act­ing weight loss drugs. And the launch of No­vo Nordisk’s We­govy pill in Jan­u­ary did the same for oral drugs. So a long-act­ing pill ought to be just the tick­et — pro­vid­ed there are da­ta that show it works.

This is where the UK biotech Ver­di­va Bio finds it­self. The com­pa­ny emerged in Jan­u­ary 2025 with $411 mil­lion and a plan to de­vel­op a week­ly oral form of a GLP-1 ag­o­nist it had li­censed from Chi­na-based com­pa­ny Sci­wind Bio­sciences.

That as­set, called ec­nog­lu­tide or VRB-101, en­tered Phase 2 late last year. A week­ly pill ap­pears to be a unique ap­proach, CEO Khurem Fa­rooq told End­points News, and in­ter­im da­ta from the tri­al could come in the next few months.

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