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18 August, 2025 |
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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
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by Max Bayer
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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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by Nicole DeFeudis
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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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by Max Bayer
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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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by Shelby Livingston
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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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by Elizabeth Cairns
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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 |
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