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2,324 stories matching this filter · ← front page

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  • Sanofi requests removal of teplizumab from FDA fast-track voucher program after director dispute
    Sanofi has formally asked the Food and Drug Administration to withdraw its type 1 diabetes therapy, teplizumab, from the new speedy review voucher program overseen by Commissioner Marty Makary. Th…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Bayer to buy Perfuse for up to $2.45B, bolstering eye drug pipeline
    Centered around a glaucoma therapy in mid-stage testing, the deal is Bayer’s first drug company acquisition in several years and potentially its largest since it purchased AskBio in 2020.
    BioPharma Dive · 4mo agoDealNeutral↗ source
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  • Color Health expands into cancer treatment coordination with virtual tumor boards
    Color Health, a telehealth firm that currently coordinates cancer screening, is moving into providing and coordinating actual cancer care services. CEO Othman Laraki says the growing complexity of…
    STAT · 4mo agoPositive↗ source
  • FDA authorizes fruit-flavored vapes amid political pressure, sparking debate over youth risk and quitting aid
    The U.S. Food and Drug Administration granted its first authorization for fruit-flavored e-cigarettes on Tuesday, adding mango- and blueberry-tasting products from Los Angeles-based Glas to its app…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • PhRMA launches seven-figure ad campaign against 340B drug discount program
    PhRMA, the leading pharmaceutical lobbying group, announced a new advertising push aimed at the federal 340B drug discount program. The campaign, described as a seven-figure effort, is set to begi…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • STAT+: How a global effort to explore the ‘dark proteome’ is upending our understanding of human disease
    An international team has found thousands of mini-proteins, including some involved in cell division and DNA repair, as well as several unique to cancer cells.
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Health AI progress limited by bad data, newsletter notes
    The latest AI Prognosis newsletter highlights that the quality of health data is a major obstacle for building useful AI tools in medicine. The author explains that many existing datasets contain…
    STAT · 4mo agoNeutral↗ source
  • HHS focuses on overmedication as cruise ship hantavirus outbreak prompts port change
    The Health and Human Services department announced new efforts to curb excessive prescribing, highlighting concerns about overmedication in the United States. At the same time, a cruise ship ancho…
    STAT · 4mo agoNeutral↗ source
  • OpenAI’s health AI policy blueprint seen as reasonable yet self‑serving, experts say
    OpenAI has expanded its health‑focused AI tools, rolling out ChatGPT Health for consumers, a hospital‑oriented ChatGPT for Healthcare, and a version for clinicians. Alongside the clinician chatbot,…
    STAT · 4mo agoRegulatoryNegative↗ source
  • PeaceHealth abandons plan to outsource Oregon emergency doctors to ApolloMD after lawsuit and local opposition
    PeaceHealth, a nonprofit health system in Oregon, announced Wednesday that it will not move its emergency department staffing to the national physician staffing firm ApolloMD. The decision reverse…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Dementia care faces ambiguous loss, a unique grief that strains relationships
    Jason Karlawish, a professor of medicine and neurology at the University of Pennsylvania, wrote an opinion piece on the concept of ambiguous loss in dementia care. He reflects on a recent interview…
    STAT · 4mo agoNeutral↗ source
  • Dr. Glaucomflecken protests corporate staffing of PeaceHealth emergency department in Oregon
    Dr. Glaucomflecken, the online persona of physician Will Flanary, hosts the First Opinion Podcast where he blends humor with health‑care commentary. He has become a vocal critic of PeaceHealth’s p…
    STAT · 4mo agoNegative↗ source
  • Cytokinetics' Myqorzo meets primary goals in Phase 3 trial for non-obstructive hypertrophic cardiomyopathy
    Cytokinetics announced that its experimental therapy Myqorzo achieved its primary endpoints in a Phase 3 study of patients with non-obstructive hypertrophic cardiomyopathy (HCM). The trial showed…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Cytokinetics’ Myqorzo hits twin efficacy targets in genetic heart disease trial, while Viridian reports positive Phase 3 data for elegrobart
    Cytokinetics announced that its experimental heart‑failure drug Myqorzo achieved both primary efficacy endpoints in a study of patients with genetic cardiomyopathy, showing significant symptom impr…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Vertex Q1 revenue slightly below forecasts as key drug sales miss estimates, but Alyftrek revenue surges
    Vertex Pharmaceuticals reported first‑quarter revenue of about $3 billion, falling just short of Wall Street expectations. The modest miss left the stock largely unchanged on the day of the release…
    BioPharma Dive · 4mo agoEarningsNeutral↗ source
  • Cytokinetics' Myqorzo hits both primary endpoints in Phase 3 trial for non-obstructive hypertrophic cardiomyopathy
    Cytokinetics announced that its drug Myqorzo achieved the dual efficacy targets in the Phase 3 ACACIA trial, which evaluated patients with non-obstructive hypertrophic cardiomyopathy (HCM), an inhe…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Hantavirus outbreak on cruise ship highlights risks of U.S. exclusion from WHO
    Three passengers have died and seven others are ill after a suspected hantavirus infection was identified on a cruise vessel anchored off Cape Verde. The World Health Organization has taken the lea…
    STAT · 4mo agoRegulatoryNegative↗ source
  • J&J's IBD combo therapy misses statistical goal but will be tested in a focused patient subgroup
    Johnson & Johnson reported that its experimental combination of Tremfya and Simponi, called JNJ-4804, did not achieve a statistically significant improvement in a Phase 2b study of inflammatory bow…
    STAT · 4mo agoNegative readoutNegative↗ source
  • Viridian's elegrobart shows strong results in chronic thyroid eye disease trial, challenging Amgen's Tepezza
    Viridian Therapeutics announced that its injectable drug elegrobart met its primary goals in a late-stage study of patients with chronic thyroid eye disease. The trial reported response rates of 50…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Pharma's reputation among patient groups edges up to 57% but access and pricing concerns linger
    Patient groups surveyed by research firm PatientView gave drugmakers a 57% “good” or “excellent” reputation rating, the highest level since 2023. The survey covered more than 2,400 groups in 35 cou…
    STAT · 4mo agoNeutral↗ source
  • GOP Oversight Chair James Comer Targets AMA Billing Codes Over Fraud Concerns
    House Oversight Committee Chair James Comer, a Republican from Kentucky, is directing new scrutiny toward the American Medical Association's Current Procedural Terminology (CPT) billing codes, alle…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Cytospire secures $83 million to develop pan-gamma delta T-cell engagers
    Cytospire, a British biotechnology startup, announced it raised £61 million, about $83 million, to fund the development of a new type of T-cell engager therapy. The company is targeting a "pan-gam…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • STAT+ examines AI diagnostic claims, telehealth abortion access and Epic lawsuit in latest health tech newsletter
    STAT+ published a health‑tech newsletter that asks whether artificial intelligence has truly outperformed physicians in diagnosing disease, citing a high‑profile study on AI diagnostic performance.…
    STAT · 4mo agoNeutral↗ source
  • RFK Jr. proposes steps to curb SSRI prescriptions; J&J pushes IBD drug; French regulators fine Novo, Lilly over weight-loss ads
    U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced a set of initiatives aimed at reducing the prescribing of selective serotonin reuptake inhibitors, the most widely used clas…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • STAT+: Top lawmaker takes aim at doctor lobby, linking AMA’s billing codes to fraud fight
    A top Republican is asking if the AMA's codes are helping to fuel health care fraud.
    STAT · 4mo agoRegulatoryNeutral↗ source