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We’re observing the Fourth of July tomorrow, so we won’t be sending newsletters then. Enjoy the long weekend! |
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Alexis Kramer |
Editor, Endpoints News
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by Alexis Kramer
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The Trump administration's actions to remove a broad swath of HHS webpages in late January were arbitrary and not the “product of reasoned decisionmaking,” a federal district court ruled Thursday. The decision hands a victory to a nonprofit doctors group that challenged a “gender ideology” executive order and resulting federal guidance. The group claimed that those directives led the federal health agencies to purge “numerous webpages” used daily by physicians to diagnose and treat their patients. “The defendants’ actions were ill-conceived from the beginning,” Judge John Bates wrote in his opinion in the US District Court for DC. Rather than take a “measured approach” to harmonize the HHS websites with the
executive order, “the defendants instead adopted policies of ‘remove first and assess later’ that failed to consider multiple important aspects of the situation," he said. |
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by Max Gelman
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Novartis faced a setback in its ambition to expand its blockbuster drug Cosentyx and compete in an autoimmune condition with products from Roche and AbbVie. The company said Thursday that the drug flopped a Phase 3 study in giant cell arteritis, an inflammatory disorder primarily occurring in older adults where blood vessels
become inflamed and restrict blood flow. Novartis did not report specific data, but said Cosentyx when combined with a tapering of steroids did not show significant sustained remission after one year compared to placebo. Relative to other inflammatory and immunological conditions, giant cell arteritis is not a particularly large market. The prevalence is estimated to be about 1 in 10,000
adults older than 50. |
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by Shelby Livingston
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In June, HHS Secretary Robert F. Kennedy Jr. said at a congressional hearing that his agency is poised to launch a major ad campaign to encourage Americans to use wearables so “people can take control of their own health, they can take responsibility, they can see as you know
what food is doing to their glucose levels,” among other metrics. He revealed his vision of every American using a wearable within four years, going so far as to suggest the devices can produce benefits on par with popular GLP-1 obesity and diabetes drugs. While Kennedy wasn’t specific about the type of wearable, it’s likely he was referring to continuous glucose monitors — small biosensors worn on the arm to provide a measure of the sugar levels in a person’s blood. The sensors are often
paired with an app that shows trends in glucose levels and provides lifestyle and nutrition recommendations based on the data collected. |
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by Alex Hoffman, Kathy Wong, Lei Lei Wu
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Bluebird bio rolled out three new executive hires on Tuesday: Brian Riley as president and chief technical officer, Joanne Lager as chief medical officer and Adrian
Chaisson as chief of staff. The new additions come after two private equity firms — Carlyle and SK Capital — took the biotech private in early June after bluebird had struggled for years to build a sustainable business from selling cell and gene therapies. Bluebird has three approved therapies: Zynteglo for beta thalassemia, Skysona for a rare disease called cerebral adrenoleukodystrophy, and Lyfgenia for sickle cell disease. In June, Former Mirati CEO David Meek joined to lead bluebird as part of the private equity deal, replacing Andrew Obenshain. |
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by Elizabeth Cairns
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Dizal said that its EGFR inhibitor sunvozertinib has been approved by the FDA for certain types of lung cancer. The pill, now branded as Zegfrovy, gained accelerated approval in the US for locally advanced or metastatic non-small cell lung cancer in patients with exon 20 insertion mutations in the EGFR gene. Patients must have relapsed after treatment with
platinum-based chemotherapy. Exon 20 insertion mutations are the third-most common type of EGFR mutation in NSCLC. Dizal is a Shanghai-based biotech that was spun out of AstraZeneca in 2017. The drug was approved in China for the same use in 2023. Making a commercial mark in the US might be challenging, however. Johnso |
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