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  • Early-life gut microbiome may influence lifelong brain health, experts say
    The authors argue that the composition of a baby’s gut microbiome could play a pivotal role in shaping brain development and later cognitive health. They suggest that understanding this link may he…
    STAT · 6d agoNeutral↗ source
  • BlackRock to acquire majority stake in Humana’s CenterWell clinics for $2.8 billion
    Humana announced that BlackRock will purchase Welsh Carson’s majority stake in the CenterWell Senior Primary Care network, a deal valued at $2.8 billion. The transaction covers roughly 150 Medicare…
    STAT · 6d agoDealPositive↗ source
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  • Study finds nearly 40% of FDA advisory panels include reps linked to pharma-funded advocacy groups
    A new analysis published in Health Affairs Scholar examined FDA advisory committee meetings over the past 20 years and found that almost 40% featured a patient or consumer representative with activ…
    STAT · 6d agoRegulatoryNegative↗ source
  • Study urges regulators to adopt cloud platforms to speed drug approvals
    A new study led by Nina Cauchon of Amgen and co-authors, published in the Journal of Pharmaceutical Sciences, calls for broader use of cloud-based platforms by regulatory agencies. The authors arg…
    raps · 7d agoRegulatoryPositive↗ source
  • Patient advocates and experts raise alarm over safety of Neurocrine Biosciences rare disease drug
    Two months after an open letter highlighted possible safety issues, patient advocacy groups and several experts are publicly voicing growing alarm about a rare disease therapy marketed by Neurocrin…
    STAT · 7d agoNegative↗ source
  • Trump administration proposes $70,000 fee to curb foreign student work authorizations
    The Department of Homeland Security announced a proposed $70,000 fee for a work authorization program that many foreign students and scholars use to gain professional experience in the United State…
    STAT · 7d agoRegulatoryNegative↗ source
  • Safety concerns rise as Neurocrine's Prader-Willi drug linked to deaths and hospitalizations
    Patient advocates and several experts are voicing increasing alarm over the safety profile of Neurocrine Biosciences' therapy for Prader-Willi syndrome. The drug, Vykat XR, received approval 18 mo…
    STAT · 7d agoRegulatoryNegative↗ source
  • Stakeholders urge FDA to adopt flexible approach for psychedelic drug regulation
    Various individuals and groups have submitted comments urging the U.S. Food and Drug Administration to be flexible in regulating psychedelic medicines that could treat major depressive disorder and…
    raps · 7d agoRegulatoryNeutral↗ source
  • Roche signs $1.2B partnership with China’s Rona for obesity drug as Stryker pours $400M into CMR Surgical
    Roche has entered a $1.2 billion agreement with Chinese firm Rona to advance an obesity treatment, targeting the growing market for weight‑loss therapies in China. The deal will combine Roche’s dr…
    raps · 7d agoDealPositive↗ source
  • Doctors donate heavily to fellow physicians running for office amid Medicare overhaul debate
    Doctors are contributing sizable amounts to political candidates who are also physicians, according to a STAT+ report. The donations come as Congress prepares its first major overhaul of Medicare…
    STAT · 7d agoNeutral↗ source
  • North Carolina public worker health plan faces court challenge over provider restrictions
    The latest Health Care Inc. newsletter highlights a growing dispute over a health plan that covers North Carolina’s public employees and retirees. Employers often try to reduce health care costs b…
    STAT · 7d agoRegulatoryNeutral↗ source
  • FTC and seven states seek contempt order against Martin Shkreli for breaching pharma work ban
    The FTC, joined by seven states, filed a petition with a federal court asking that Martin Shkreli be held in contempt for allegedly violating a court order that bars him from any involvement in the…
    STAT · 7d agoRegulatoryNegative↗ source
  • Lancet study assesses performance of Google’s diagnostic chatbot AMIE
    STAT’s Health Tech newsletter highlighted a recent evaluation of Google’s diagnostic chatbot AMIE that was published in The Lancet. The article notes that the study examined how well the chatbot c…
    STAT · 7d agoNeutral↗ source
  • Veteran infectious disease journalist Helen Branswell dies at 69
    Helen Branswell, a veteran reporter covering infectious diseases, died on Tuesday at age 69. Her sister said the cause was complications from cancer. Branswell was known for clear, nuanced coverag…
    STAT · 6d agoNeutral↗ source
  • Physicians Face Learned Helplessness From Training Culture, Says STAT+ Columnist
    Frances Mei Hardin, a former ENT surgeon, launches a new STAT+ column called Chief Complaint, where she examines challenges confronting doctors today. She highlights a striking example: some resid…
    STAT · 7d agoNegative↗ source
  • Botched lethal injection of Christa Pike raises questions about execution protocols
    An execution attempt on death-row inmate Christa Pike failed, leaving her alive after the lethal injection protocol was administered. The incident has been described as the most severe botched exec…
    STAT · 7d agoNegative↗ source
  • FDA approves new treatments for persistent herpes and schizophrenia; Steris to acquire Xodus Medical for $2.1 billion
    The U.S. Food and Drug Administration has granted approvals for two new drugs, one targeting persistent herpes infections and another for the treatment of schizophrenia. The herpes indication addr…
    raps · 8d agoApprovalPositive↗ source
  • FDA finalizes guidance aligning biosimilar post-approval manufacturing changes with global standards
    The U.S. Food and Drug Administration has issued its final guidance on how biosimilar manufacturers can implement post-approval changes to their production processes. The new recommendations bring…
    raps · 8d agoRegulatoryNeutral↗ source
  • Japan's PMDA Issues Guidance to Safeguard Participants in Generic Bioequivalence Trials
    The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has released new guidance aimed at protecting healthy adult volunteers who take part in generic bioequivalence studies. The document…
    raps · 8d agoRegulatoryNeutral↗ source
  • Europe’s share of clinical trials falls 13.5% as Asia’s research footprint expands
    The latest data show a 13.5% drop in the number of clinical trials authorized in the EU and EEA compared with pre-pandemic levels. At the same time, Asian countries have increased their share of g…
    raps · 8d agoNeutral↗ source
  • Americans show higher trust in science than most countries, survey finds
    A new Wellcome Global Monitor survey of people in 140 countries found that 52% of Americans say they have a lot of trust in science, compared with just 26% globally. Only 40% of Americans reported…
    STAT · 9d agoNeutral↗ source
  • Half-century after IL-2 discovery, its impact on HIV, cancer and blood safety is highlighted
    Robert Gallo marks the 50-year anniversary of the 1976 paper that described interleukin-2, one of the first cytokines identified and essential for T-cell growth. He notes that IL-2 enabled the dis…
    STAT · 11d agoPositive↗ source
  • FDA flags safety concern after four deaths in schizophrenia drug trial
    The U.S. Food and Drug Administration issued a warning after four participants died while receiving an experimental treatment for schizophrenia in a clinical study. The agency described the observ…
    STAT · 11d agoRegulatoryNegative↗ source
  • Hospitals file second lawsuit to block Trump admin's 340B rebate pilot
    The American Hospital Association (AHA) has filed another lawsuit against the federal government, challenging a new version of the 340B drug discount program proposed by the Trump administration.…
    STAT · 10d agoRegulatoryNegative↗ source
  • Pharma gifts and payments to doctors linked to higher inappropriate prescribing, study finds
    A Cochrane review of dozens of prior studies found that gifts and payments from drug makers to physicians lead to more inappropriate prescribing and a higher total number of prescriptions, which li…
    STAT · 11d agoNegative↗ source