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  • Opinion: Prolonged hospital stays can leave children isolated. It needs to change
    “The effects of isolation extend far beyond children’s time in the hospital,” writes medical student Anna Tsioulias.
    STAT · 1h ago↗ source
  • Opinion: The VA could help America win the biotechnology race with China
    “Together, HHS, the VA, and the DOD form a strong American innovation ecosystem — one that China and other competitors cannot easily replicate,” writes former VA Secretary David Shulkin.
    STAT · 1h ago↗ source
  • STAT+: In the biotech industry, a most-wanted fugitive was long hiding in plain sight
    Ronald Fischer, a most-wanted fugitive, was long hiding in the biotech industry in plain sight, and using an alias more extensively than has been previously reported.
    STAT · 1h ago
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↗ source
  • STAT+: Clinical chatbots are taking medicine by storm. Should doctors trust them?
    As LLMs compete for doctors' attention, some developers say the science of benchmarking their AI tools for safety and accuracy is flawed.
    STAT · 1h ago↗ source
  • Visa time limits on foreign Ph.D. students and postdocs will harm U.S. science, experts warn
    A Trump administration plan to limit visas for graduate student and postdocs to four years is fueling concerns that the U.S. could lose out on foreign scientists
    STAT · 16h agoApprovalPositive↗ source
  • STAT+: Preliminary trial results suggest a path to a safer Alzheimer’s treatment
    ProMIS Neurosciences is trying to design a safer amyloid-clearing drug for Alzheimer's. Early results suggest it might be on to something.
    STAT · 23h agoApprovalPositive↗ source
  • GSK prepares for patent cliff with $2.5B cost-cutting plan
    The pharma hasn’t yet revealed what kind of job cuts might be involved in the plan, which will help it absorb the coming loss of patents important to its HIV drug franchise.
    BioPharma Dive · 17h agoLayoffsNegative↗ source
  • Boston Scientific unveils major restructuring, plots job cuts amid savings drive
    Medical device maker Boston Scientific has been a prolific dealmaker this year but is now taking a step back as it looks to make changes internally.
    Fierce Biotech · 1d agoLayoffsNegative↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials
    Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
    raps · 1d agoRegulatoryNeutral↗ source
  • Six key issues we’re watching at Fauci’s hearing
    Sen. Rand Paul is forcing Fauci to appear before his Senate panel.
    STAT · 14h agoRegulatoryNeutral↗ source
  • FDA reminds investors about the risks of advisory panels
    Two days, two similar briefing documents and two companies with diving share prices. The FDA this week laid out its concerns with clinical data from both Capricor Therapeutics and
    Endpoints · 14h agoRegulatoryNeutral↗ source
  • FDA offers updated guidance for generics of weight loss blockbusters
    The FDA revised its draft guidance for generic companies looking to develop copycats of some of the world's best-selling weight loss drugs, including Eli Lilly's Zepbound and Novo Nordisk's Ozempic…
    Endpoints · 15h agoRegulatoryNeutral↗ source
  • STAT+: Bracing for another Fauci hearing
    Plus: Democrats take on Trump over IVF, and Trump's White House releases a new science funding blueprint.
    STAT · 16h agoRegulatoryNeutral↗ source
  • FDA staff say Replimune's melanoma trial failed to prove RP1 works
    FDA staff threw cold water on Replimune’s advanced melanoma drug ahead of a critical meeting with agency advisors, writing that the pivotal study design failed to prove its drug actually works. The…
    Endpoints · 18h agoRegulatoryNeutral↗ source
  • The future of gray-market peptides
    Two days’ worth of debate among FDA advisory committee members and agency staff over whether compounding pharmacies should be able to make seven different peptides left me with some big ...
    Endpoints · 19h agoRegulatoryNeutral↗ source
  • STAT+: GSK lays out plans to cut costs, pursue more late-stage drug trials
    New GSK CEO Luke Miels outlined his strategy to help the company navigate a patent cliff and get on a path toward long-term growth.
    STAT · 19h agoRegulatoryNeutral↗ source
  • STAT+: FDA staff reiterate concerns about Replimune skin cancer treatment
    Regulators at the FDA have reiterated concerns that Replimmune does not have adequate data to support an approval of its investigational skin cancer treatment.
    STAT · 19h agoRegulatoryNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about FDA views on a Duchenne drug, GSK cost savings, and more
    The FDA said a Capricor stem cell treatment for Duchenne muscular dystrophy did not meet a Phase 3 trial's objectives — contrary to company claims
    STAT · 20h agoRegulatoryNeutral↗ source
  • STAT+: Three questions with Whoop’s new CMO
    In this edition of STAT Health Tech: A chat with Whoop's new chief medical officer, an update on CMS health tech initiative, and more.
    STAT · 20h agoRegulatoryNeutral↗ source
  • An eye drug biotech banks $118M and stocks its executive suite
    Claris Bio has appointed veteran CEO Stephen Brady to lead advanced development of what it hopes to be the first drug therapy for a blinding condition called limbal stem cell deficiency.
    BioPharma Dive · 21h agoRegulatoryNeutral↗ source
  • The FDA was all in on AI. Will that change?
    High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.
    BioPharma Dive · 21h agoRegulatoryNeutral↗ source
  • Anthony Fauci’s pandemic-era diary entries
    New data on American substance use, concerns of a global HIV resurgence, and more health news from Morning Rounds
    STAT · 21h agoRegulatoryNeutral↗ source
  • After PCOS became PMOS, there’s hope for new awareness among Black and Latina women
    Growing awareness of a painful endocrine disorder now named PMOS is good news for women of color, who have high prevalence and low diagnosis.
    STAT · 1d agoRegulatoryNeutral↗ source
  • Opinion: STAT+: Dementia finally has a business model
    The big takeaway from the recent Alzheimer’s Association International Conference in London is an economic message: Dementia finally has a business model, writes Jason Karlawish.
    STAT · 1d agoRegulatoryNeutral↗ source