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  • Supreme Court Declines to Hear Lawsuits Against Medicare Drug Price Negotiation Program
    The U.S. Supreme Court on Monday refused to hear challenges to the Medicare drug price negotiation program, delivering a setback to the pharmaceutical industry's legal effort. The Court declined t…
    STAT · 3mo agoRegulatoryNegative↗ source
  • US biotech faces internal split over reliance on Chinese-developed drug candidates
    Ed Silverman's Pharmalittle column notes that US biotech firms are wrestling with how to treat Chinese partners, with some seeing them as collaborators and others as competitors. The column highli…
    STAT · 3mo agoNegative↗ source
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  • Regeneron's LAG-3 inhibitor fianlimab fails Phase 3 skin cancer trial
    Regeneron announced that its experimental LAG-3 inhibitor fianlimab did not meet its primary endpoint in a late-stage trial for a skin cancer indication. The Phase 3 study was designed to evaluate…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Experts debate testing Merck’s Ervebo vaccine for DRC Ebola outbreak amid lack of approved shot
    The Democratic Republic of the Congo confirmed a new Ebola outbreak at the end of May, making it the fourth largest on record. The virus is spreading in a conflict-affected region, complicating con…
    STAT · 3mo agoNegative↗ source
  • Design Therapeutics reports early Friedreich's ataxia trial shows 6.4-point improvement; Vincentage reports Chinese obesity data
    Design Therapeutics disclosed Phase 1/2 results for its Friedreich's ataxia candidate DT-216P2. The trial administered a 1 mg/kg dose and reported an average 6.4-point improvement on the study endp…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Supreme Court declines to hear pharma challenges to Medicare drug price negotiations
    The U.S. Supreme Court has refused to review several lawsuits filed by drug makers contesting the Medicare drug price negotiation provisions of the Inflation Reduction Act. The cases, brought by co…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Trump administration cuts childhood vaccine schedule, citing personal autonomy
    The opinion argues that the concept of patient autonomy does not apply to childhood vaccination because infants cannot refuse shots; the decision rests with parents. In January, the Department of…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Goodman urges five reforms to restore trust in CDC vaccine advisory committee
    Jesse Goodman, a former director of the FDA's Center for Biologics Evaluation and Research and former chief scientist, wrote an opinion piece calling for major changes to the CDC's Advisory Committ…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Texas launches clinic to support individuals seeking detransition services
    Texas health officials announced the opening of a clinic dedicated to people who want to reverse a gender transition, marking a new service in the state. The facility will provide counseling, medi…
    STAT · 3mo agoNeutral↗ source
  • WHO declares Ebola outbreak in DRC an international public health emergency
    The World Health Organization announced on Saturday that the Ebola outbreak first identified in the Democratic Republic of the Congo has been declared an international public health emergency. The…
    STAT · 3mo agoNegative↗ source
  • UK advocacy groups threaten legal action over pharma trade deal provision on medicine cost-effectiveness
    Two UK advocacy groups are demanding that the government reverse regulations embedded in a newly finalised pharma trade agreement with the United States. They argue the provision could let external…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Americans in Congo May Have Been Exposed to Ebola; One Shows Possible Symptoms, Tests Pending
    Several Americans traveling in the Democratic Republic of the Congo are believed to have had high risk exposure to suspected Ebola cases, according to sources familiar with the situation. At least…
    STAT · 3mo agoNeutral↗ source
  • Conflicting guidelines leave women unsure when to start routine mammograms
    Deciding when to begin routine mammograms is confusing because major health groups recommend different starting ages-some say 40, others 45, and a recent recommendation pushes the start to 50. They…
    STAT · 3mo agoNeutral↗ source
  • Senator Bill Cassidy loses Louisiana primary, paving way for Trump-backed Julia Letlow
    Senator Bill Cassidy, a leading Republican on health issues, finished third in Louisiana’s Senate primary with about 24.8% of the vote. State treasurer John Fleming received roughly 28%, while Rep.…
    STAT · 3mo agoNeutral↗ source
  • Hantavirus outbreak on cruise sparks Covid-era conspiracy chatter, officials say risk remains low
    A rare strain of hantavirus infected several passengers on a cruise ship, prompting health authorities to investigate the outbreak and issue public updates. Officials emphasized that, unlike Covid…
    STAT · 3mo agoNeutral↗ source
  • FDA Commissioner Marty Makary Resigns, Prompting Concerns Over Agency Direction
    FDA Commissioner Marty Makary stepped down on Tuesday, leaving the agency without a permanent leader as it already faces turnover in its drug and biologics divisions. Makary had recently appeared…
    STAT · 3mo agoNegative↗ source
  • FDA Commissioner Marty Makary resigns as Biogen unveils new Alzheimer’s data
    Marty Makary announced his resignation from the role of FDA commissioner, ending his tenure amid recent political developments. Biogen disclosed fresh data from its Alzheimer’s disease program, ad…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Trump backs challenger as Louisiana Senate incumbent Bill Cassidy faces primary showdown
    Senator Bill Cassidy, a physician who chairs the Senate health committee, is defending his seat in a Louisiana Republican primary. President Donald Trump has thrown his support behind Rep. Julia L…
    STAT · 3mo agoNegative↗ source
  • Podcast interview challenges the scientific basis of blue zones after 25 years of hype
    In a recent First Opinion podcast, Eric Topol and Shelley Wood discuss the rise of the blue zone concept over the past quarter century. They note that the idea began with isolated communities said…
    STAT · 3mo agoNeutral↗ source
  • Ebola surge in DRC and hantavirus cases on cruise ship highlight gaps in global outbreak preparedness
    Recent reports from the Democratic Republic of Congo describe an Ebola outbreak in Ituri province with 246 suspected cases and 65 deaths, and early testing points to a non‑Zaire ebolavirus strain.…
    STAT · 3mo agoNegative↗ source
  • FDA drug center acting director Tracy Beth Høeg resigns amid leadership vacuum
    Tracy Beth Høeg, the acting director of the FDA’s Center for Drug Evaluation and Research, is leaving the agency, according to three sources familiar with the matter. Her departure follows the res…
    STAT · 3mo agoRegulatoryNegative↗ source
  • FDA drug division chief Tracy Beth Høeg expected to depart amid leadership shakeup
    Tracy Beth Høeg, who leads the FDA’s Center for Drug Evaluation and Research, is reported to be leaving the agency. Her exit comes shortly after former Commissioner Marty Makary stepped down, sugg…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Candel Therapeutics shares 20-month follow-up data for its prostate cancer candidate ahead of FDA filing
    Candel Therapeutics announced that it has completed a long-term follow‑up study of patients treated with its prostate cancer drug. The data extend to about 20 months after treatment and are intende…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • FDA Commissioner Marty Makary Resigns After Turbulent Tenure
    Marty Makary stepped down as commissioner of the U.S. Food and Drug Administration on Tuesday, ending a period marked by controversy and intense scrutiny. His resignation follows a series of publi…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Ebola outbreak confirmed in Congo's Ituri province, 65 deaths among 246 suspected cases
    Africa CDC announced a new Ebola outbreak in the remote Ituri province of the Democratic Republic of Congo, noting 246 suspected infections and 65 fatalities. Most of the reported cases and deaths…
    STAT · 3mo agoNegative↗ source