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2,193 stories matching this filter · ← front page

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  • 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
  • Pharma firms turn to outsourcing to boost value of aging drug portfolios
    For many years pharma companies treated legacy brands as low-maintenance cash generators, focusing only on steady but declining revenue once patents expired. With the largest patent cliff in histo…
    BioPharma Dive · 3mo agoPositive↗ source
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fda recalls67
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Infectious Disease444
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
  • 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
  • Regeneron immunotherapy combo comes up short in melanoma trial
    A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in marke…
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ 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
  • 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
  • Sun Pharma’s $12 billion Organon deal signals global push but India still faces R&D hurdles
    Sun Pharma is close to completing a nearly $12 billion purchase of Organon, which would lift the Indian group into the world’s top‑25 pharmaceutical companies and expand its footprint to about 150…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • FDA places clinical hold on Aardvark’s Prader-Willi drug amid heart safety concerns
    The Food and Drug Administration has issued a clinical hold on Aardvark Therapeutics' experimental treatment ARD-101 for Prader-Willi Syndrome after safety signals were identified. The hold follow…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Biotech execs push for Rick Pazdur as FDA chief while Takeda announces 4,500 layoffs
    Hundreds of biotechnology executives, investors and patient advocates have signed a petition urging President Trump to nominate Rick Pazdur as the next FDA commissioner. Pazdur, a longtime FDA vet…
    BioPharma Dive · 3mo agoLayoffsNeutral↗ 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
  • Supreme Court blocks lower court ruling, keeps mail-order access to abortion pill mifepristone
    The Supreme Court issued an indefinite stay that preserves mail-order access to the abortion medication mifepristone. The order maintains the ability for providers to prescribe the drug through pha…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ 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
  • UK election may reshape drug pricing while US urges Germany to pay more for medicines
    The upcoming political contest in the United Kingdom is being watched for its possible effects on how medicines are priced domestically. Analysts suggest that a change in government could lead to n…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Supreme Court temporarily restores telehealth access to mifepristone amid ongoing legal fight
    The Supreme Court on Thursday reversed a 5th Circuit order and allowed mifepristone to be prescribed and mailed through telehealth for the time being. The reversal follows a lawsuit brought by Lou…
    STAT · 3mo agoRegulatoryNeutral↗ source