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18 August, 2025
GLOBAL PHARMA AND BIOTECH SUMMIT - Embracing and industry reset
Biopharma is grappling with diverging policies between the US, EU, and Asia — including proposed drug pricing reforms in the US and new EU regulations taking effect this year. The need for strategic clarity has never been more urgent. Join us in London — in person and virtually — where we’re bringing together the industry’s most influential voices to chart a path forward.
top stories
1. Conflicts of interest among federal vaccine advisors were ‘historically low’ through 2024
2. Federal appeals court sends Vanda’s jet lag case back to FDA 
3. Draft MAHA Commission report outlines broader vaccine framework
4. GoodRx, Novo Nordisk partner to offer discounted GLP-1s at the pharmacy counter
5. Novo Nordisk’s Wegovy is the second drug approved in MASH
6. Genentech ends up to $2B cell therapy collab with Adaptive
7. Skyhawk's RNA mission gets another $2B lift via Merck KGaA
8. Updated: Reunion’s psychedelic approach in postpartum depression clears Phase 2 trial
more stories
 
Nicole DeFeudis
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Cases challenging Medicare negotiations under the IRA continue to make their way through the courts. On Aug. 7, the US Court of Appeals for the Second Circuit rejected a challenge brought by Boehringer Ingelheim. As Bristol Myers Squibb and Johnson & Johnson await decisions in the Third Circuit, they’ve filed responses arguing that certain analyses in the Boehringer case were flawed. Stay tuned as we look out for both decisions.

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Nicole DeFeudis
Editor, Endpoints News
@Nicole_DeFeudis
1
by Max Bayer

New re­search found that self-re­port­ed con­flicts of in­ter­est among fed­er­al vac­cine ad­vi­so­ry mem­bers were at their low­est lev­el in 25 years through 2024, coun­ter­ing an ar­gu­ment of po­lit­i­cal­ly-ap­point­ed health of­fi­cials who have sought to over­haul the com­mit­tees.

Re­searchers at the Uni­ver­si­ty of South­ern Cal­i­for­nia found that the av­er­age an­nu­al preva­lence of con­flicts of in­ter­est re­port­ed by mem­bers of the CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices de­clined from 42.8% in 2000 to 5.0% in 2024. For mem­bers of the FDA’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee, the av­er­age an­nu­al preva­lence dropped from 11.1% in 2000 to less than 4.0% since 2010.

The au­thors of the re­search let­ter that pub­lished Mon­day in JA­MA con­clud­ed that “re­port­ed COI preva­lence rates have de­clined for ACIP and VRB­PAC over the last 25 years and were at his­tor­i­cal­ly low lev­els through 2024.” They used pub­licly avail­able re­ports from ACIP mem­bers that were up­loaded ear­li­er this year and study waivers sub­mit­ted by VRB­PAC mem­bers.

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2025'S BREAKOUT STARTUPS. WHO'S ON THE LIST? - Endpoints 11
Endpoints News returns to Boston’s State Room to announce the 2025 class of biotechs worth watching. Join the live unveiling and see the industry’s next chapter come into focus. Which biotechs will make the leap? Join us.
2
by Nicole DeFeudis

Van­da Phar­ma­ceu­ti­cals’ jet lag treat­ment ap­pears to be head­ed back to the FDA fol­low­ing what the com­pa­ny is call­ing a “land­mark vic­to­ry” in a fed­er­al ap­peals court.

The US Court of Ap­peals for the DC Cir­cuit on Fri­day grant­ed Van­da’s pe­ti­tion for re­view in part, de­ter­min­ing that the agency’s de­ci­sion in 2024 to de­ny the com­pa­ny a hear­ing over its bid for a new in­di­ca­tion for its sleep dis­or­der drug Het­lioz was “ar­bi­trary and capri­cious.” The court re­mand­ed the case back to the FDA “for fu­ture pro­ceed­ings.”

Van­da has been in a years­long con­flict with the FDA over its ap­pli­ca­tion to mar­ket Het­lioz for jet lag dis­or­der. The drug was first ap­proved in 2014 to treat a chron­ic cir­ca­di­an rhythm dis­or­der called non-24-hour sleep-wake dis­or­der, and lat­er won a la­bel ex­pan­sion to treat night­time sleep dis­tur­bances in pa­tients with a rare neu­rode­vel­op­men­tal dis­or­der called Smith-Ma­ge­nis syn­drome.

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3
by Max Bayer

The White House’s MA­HA Com­mis­sion re­port in­cludes a broad vac­cine frame­work that will ad­dress the child­hood vac­ci­na­tion sched­ule and in­juries, ac­cord­ing to a draft ver­sion cit­ed by oth­er me­dia out­lets last week.

The draft, first pub­lished in full by Politi­co, pro­pos­es a frame­work de­vel­oped be­tween HHS and the White House­'s Do­mes­tic Pol­i­cy Coun­cil. Un­der HHS Sec­re­tary Robert F. Kennedy Jr., fed­er­al health agen­cies have al­ready start­ed to over­haul the gov­ern­ment’s vac­cine in­fra­struc­ture to fit the fo­cus of the pro­posed frame­work.

The draft re­port says that the vac­cine frame­work will fo­cus on the child­hood vac­cine sched­ule, in­juries, mod­ern­iz­ing vac­cines with “trans­par­ent, gold stan­dard sci­ence,” and re­mov­ing per­ceived con­flicts of in­ter­est. So far, pro­pos­als by Kennedy and oth­er top health of­fi­cials have sought to ad­dress all those pil­lars.

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4
by Shelby Livingston

GoodRx users will now be able to get all strengths of Ozem­pic and We­govy in­jec­tions at a cash price of $499 per month, thanks to a new col­lab­o­ra­tion be­tween the pre­scrip­tion drug dis­count com­pa­ny and phar­ma gi­ant No­vo Nordisk.

The part­ner­ship marks an­oth­er av­enue for pa­tients pay­ing with­out in­sur­ance to ac­cess the pop­u­lar GLP-1 med­i­cines, and it re­flects GoodRx’s re­cent push in­to work­ing with brand-name drug­mak­ers. It’s al­so the first time Ozem­pic, used to treat type 2 di­a­betes, is be­ing of­fered at the low­er cash price. No­vo said pa­tients can al­so ac­cess the Ozem­pic dis­count through its di­rect-to-con­sumer plat­form Novo­Care. The list price of the weight loss drug We­govy is $1,349, while Ozem­pic’s is $998.

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5
by Elizabeth Cairns

Af­ter se­cur­ing an ac­cel­er­at­ed ap­proval, No­vo Nordisk’s We­govy is the sec­ond drug to re­ceive a green light in the US to treat fat­ty liv­er dis­ease, or MASH.

The block­buster drug will join Madri­gal Phar­ma­ceu­ti­cals’ Rezd­if­fra on the mar­ket for the con­di­tion, and the ques­tion is how big a slice of the mar­ket No­vo’s drug can take, giv­en Rezd­if­fra’s first-mover ad­van­tage.

No­vo’s shares climbed 6% on the Copen­hagen ex­change on Mon­day morn­ing. Madri­gal’s MDGL were down 4% pre&s