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  • FDA advisory panel backs Moderna seasonal mRNA flu vaccine after earlier controversy
    A Food and Drug Administration advisory committee unanimously endorsed Moderna’s seasonal mRNA flu vaccine on Thursday, after the product became the focus of controversy earlier this year when a se…
    STAT · 2mo agoRegulatoryPositive↗ source
  • Eli Lilly stops 340B discounts for hospitals that did not submit required claims data
    Eli Lilly has begun withdrawing the federally mandated 340B price discounts from a handful of hospitals that have failed to provide the comprehensive claims data the company requires. The move fol…
    STAT · 2mo agoRegulatoryNegative↗ source
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  • FDA lifts opposition to Huntington’s disease gene therapy, clearing path for development
    The Readout Loud podcast this week highlighted a regulatory shift for a gene therapy aimed at Huntington’s disease. The Food and Drug Administration reversed its earlier opposition, removing a key…
    STAT · 2mo agoRegulatoryPositive↗ source
  • Biogen to acquire RayThera in up to $1 billion deal for immunology pipeline
    Biogen announced it will acquire RayThera, a startup founded in 2023, in a deal valued at up to $1 billion. The acquisition gives Biogen access to RayThera’s immunology pipeline, which includes th…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Pfizer CFO Dave Denton to leave; Denali Therapeutics sells $195 million FDA priority review voucher
    Pfizer announced that its chief financial officer Dave Denton will depart on Aug. 15 to take a role outside the pharmaceutical sector. He has been CFO since May 2022. In the interim, finance chief…
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • Shingles vaccine linked to 24% lower dementia risk in nursing home residents, study shows
    A new study of elderly nursing home residents examined the effect of receiving at least one dose of the shingles vaccine Shingrix on dementia incidence over a four year period. The analysis found…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Biogen to acquire RayThera for up to $1 billion as J&J shifts focus away from obesity to cancer
    Biogen announced an agreement to purchase RayThera for as much as $1 billion, marking the company's second takeover this year. The deal expands Biogen's portfolio into RayThera's pipeline, though s…
    STAT · 2mo agoDealNeutral↗ source
  • New poll shows only half of U.S. adults can afford quality health care, with record-high concerns for next year
    A recent West Health-Gallup Affordability Index found that roughly 50% of American adults said they could pay for health care and still access quality services in the past year. The survey also re…
    STAT · 2mo agoNegative↗ source
  • Super-potent nitazene opioids linked to sharp rise in U.S. overdose deaths
    Synthetic opioids known as nitazenes, which can be up to forty times stronger than fentanyl, are increasingly being found mixed into other street drugs across the United States. The Centers for Di…
    STAT · 2mo agoNegative↗ source
  • Senate Democrats subpoena HHS for records on Trump-era vaccine policy overhaul
    Senate Democrats have launched an inquiry into the Trump administration’s overhaul of U.S. vaccine policy, asking the Department of Health and Human Services to turn over records by the following w…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Pfizer and Amgen target GLP-1 weight-loss market to rival Novo Nordisk and Eli Lilly
    The STATus Report video hosted by Alex Hogan discusses the growing GLP-1 weight-loss drug market. Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound have been on the market for a few years and are pop…
    STAT · 2mo agoNeutral↗ source
  • Cardiovascular biotech Kardigan raises $400M in IPO, fourth 2026 $400M+ offering
    Kardigan, a cardiovascular drug startup, priced a $400 million initial public offering on Wednesday, adding to a recent surge in large biotech offerings. The company becomes the fourth biotech in…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Eli Lilly stops 340B discounts for dozens of hospitals that did not submit claims data
    Eli Lilly has begun removing the federally mandated 340B price discounts for a few dozen hospitals that have not provided the required claims data. The company said the step follows a warning it is…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Former Senators Urge Congress to Prioritize Global Health as Strategic Diplomacy
    The authors, former U.S. senators, argue that improving global health must become a top priority for the United States, especially in light of recent outbreaks such as hantavirus and Ebola, which l…
    STAT · 2mo agoPositive↗ source
  • Patrick Soon-Shiong's pancreatic cancer claims lag behind reality, STAT reports
    STAT's Adam Feuerstein notes a wide gap between the outcomes promised by Patrick Soon-Shiong's pancreatic cancer therapies and the results that have actually been delivered. The columnist highlight…
    STAT · 2mo agoNegative↗ source
  • AI's rising electricity and water demand poses a public health risk, authors warn
    Two public-health scholars argue that the expanding use of artificial intelligence is creating a hidden strain on essential services such as electricity and water. They note that the massive data c…
    STAT · 2mo agoNegative↗ source
  • STAT Health Tech examines whether wearables benefit cardiovascular patients
    Mario Aguilar writes in a STAT Health Tech newsletter that the issue of wearables for people with cardiovascular disease is under review. The piece notes that researchers have been studying whether…
    STAT · 2mo agoNeutral↗ source
  • Cambrian’s experimental longevity drug shown to mimic exercise effects
    Cambrian Therapeutics reported early data on a new compound aimed at extending healthy lifespan by reproducing some benefits of physical activity. The preclinical studies described in the newslett…
    STAT · 2mo agoNeutral↗ source
  • Trump administration earmarks $700 million for mental health and addiction programs, experts say funds are existing grants
    The Trump administration announced a $700 million allocation for mental health and addiction initiatives. Health Secretary Robert F. Kennedy Jr. described the money as new investments, but behavio…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • FDA reverses stance, allows UniQure to file for accelerated approval of Huntington’s gene therapy AMT-130
    The Food and Drug Administration has changed its earlier position and now permits UniQure to submit a marketing application for its experimental Huntington’s disease gene therapy, AMT-130. The age…
    STAT · 2mo agoRegulatoryPositive↗ source
  • RFK Jr. announces $700 million mental-health funding, experts say money is from existing grants
    RFK Jr. announced a $700 million package aimed at mental health and addiction services, with a particular focus on addressing homelessness linked to severe, untreated mental illness. Behavioral he…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • DOJ settlement forces OhioHealth to change contracting, prompting hospitals to review payer agreements
    The Department of Justice and the Ohio attorney general announced a proposed antitrust settlement that requires nonprofit OhioHealth to stop using certain contracting practices that were said to ke…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • UniQure plans to file Huntington’s disease gene therapy with FDA after leadership shift eases data requirements
    UniQure, a Dutch biotech, announced it will seek FDA approval for its gene therapy targeting Huntington’s disease later this summer. The company said FDA staff indicated that three years of data f…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • Jazz partners with AbCellera on $4 billion deal to develop next-generation T-cell engagers for solid tumors
    Jazz Pharmaceuticals disclosed a collaboration with AbCellera aimed at creating next-generation T-cell-engaging antibodies for solid tumors. Under the agreement Jazz will pay $56 million up front…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • FDA signals openness to Moderna flu vaccine and clears UniQure's Huntington's therapy as Eli Lilly acquires 4E Therapeutics
    The U.S. Food and Drug Administration indicated it is receptive to Moderna's seasonal flu vaccine ahead of the upcoming advisory committee meeting, suggesting a smoother review path. UniQure repor…
    STAT · 2mo agoRegulatoryPositive↗ source