Tag: pharmaceuticals

  • STAT+: HHS announces new efforts to speed up, expand clinical trials with AI

    STAT+: HHS announces new efforts to speed up, expand clinical trials with AI

    WASHINGTON — The Department of Health and Human Services announced a set of new initiatives aimed at speeding up clinical trials by incorporating more artificial intelligence and computational models and moving away from sharply delineated trial phases. 

    The centerpiece five-year program, dubbed SURPASS — “Simulation-augmented, Real-time Platform Adaptive Seamless Trials” — will kick off later this fall by accepting “ground-breaking ideas from cross-disciplinary teams in statistics, AI, and clinical trial design, operations, and regulation,” reads a website about the program. 

    HHS is launching the program through the Advanced Research Projects Agency for Health. The initial announcement did not note how much funding was designated for the new initiatives, nor did it provide details on whether participants would be offered more flexibility or resources.  

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  • STAT+: Will House delay Trump plan to politicize NIH grants? 

    STAT+: Will House delay Trump plan to politicize NIH grants? 

    You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays.

    A New York bar sells a spritz in a Hermès-esque glass purse, while in Baltimore you can get a spritz made with Miller High Life beer. Way to keep it real, guys. Send news tips and your favorite cocktail of the Deadliest Drug to [email protected] or John_Wilkerson.07 on Signal.

    The need-to-know this week

    • The House returns for one week and will vote on the Senate’s stopgap funding bill that temporarily blocks the White House’s proposal to give political appointees control over federal research grants. The House will use a fast-track process that requires two-thirds support for passage, signaling that House GOP leadership believes the Senate bill will pass. The House vote is expected Tuesday evening, according to Punchbowl News. Were it to fail, lawmakers would have to wait until the Senate returns on Sept. 14 to work out differences between the two chambers’ bills.
    • Congressional Medicare advisers kick off their annual public meeting cycle on Thursday. This cycle, the Medicare Payment Advisory Commission will analyze the Part D benefit redesign. The redesign reduced cost sharing for beneficiaries and gave insurers more reason to manage costs, but it has probably also contributed to more spending. MedPAC also will study clinician quality measurements, and commissioners will continue their work on Medicare Advantage.

    Nine, or 10, more MFN deals

    President Trump announced nine more deals to set drug prices in Medicaid on par with prices available in peer countries, Daniel Payne and Elaine Chen report. But it seems they missed one.

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  • STAT+: After a rough stretch, mRNA gets a boost — at least for now

    STAT+: After a rough stretch, mRNA gets a boost — at least for now

    Angus reports on the basic research, clinical science, and drug development that may transform survival and quality of life for patients, as well as developments affecting the cancer community. You can reach Angus on Signal at angus.08.

    The mRNA technology that built Moderna and BioNTech’s Covid-19 vaccines and is now being used to build cancer vaccines has been through political whiplash. But now, with clinical success from Moderna and Merck on using a personalized mRNA vaccine for melanoma, experts are hoping for a more stable future for the field. 

    “I don’t know how this will be received among parts of our society that have become suspicious of the word ‘vaccine.’ There’s a possibility that people will say, ‘Oh, if we can vaccinate against cancer, that’s good,’” said Ryan Sullivan, a Mass General Brigham melanoma physician and immunologist who has worked with Moderna. “Maybe that will thaw some of the stigma around vaccines. I don’t think it’ll fix all of it, but maybe just a little bit helps us think of ‘vaccine’ not as a dirty word, ‘mRNA’ as not a four-letter word.”

    mRNA technology allows scientists to instruct cells to construct practically any protein or protein pieces by simply rewriting the mRNA’s genetic code. That is one of the technology’s greatest strengths, and what made it possible for scientists to develop Covid vaccines in under a year. It was also possible in part thanks to Operation Warp Speed, which helped fund and push the vaccine’s development. President Trump still calls it a “monumental national achievement” of his first term. 

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