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  • Experts urge streamlined EU AI framework and higher regulatory literacy for healthcare products
    Experts speaking at the RAPS AI in Regulatory Conference in Barcelona called for a more streamlined artificial intelligence framework for healthcare products across Europe. They said the current r…
    raps · 4d agoRegulatoryNeutral↗ source
  • FDA official says midterm elections unlikely to delay user fee reauthorization for FY 2028-2032
    A senior FDA official indicated that the recent midterm election results are not expected to interfere with the upcoming renewal of the agency’s user fee contracts covering fiscal years 2028 throug…
    raps · 4d agoRegulatoryNeutral↗ source
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  • AAFP chief urges Congress to add oversight to CDC vaccine advisory panel
    Shawn Martin, CEO of the American Academy of Family Physicians, said the CDC’s Advisory Committee on Immunization Practices (ACIP) has faced more than a year of turmoil. He is urging Congress to e…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • STAT+: Beyond statins, one drug lowered heart attack risk by 20%
    A new study could help doctors figure out what medicine to prescribe for cholesterol when statins don't cut it: It's “answering a really challenging clinical question."
    STAT · 3d agoRegulatoryNeutral↗ source
  • Trump administration ends contracts with two No Surprises Act arbitrators over performance failures
    The federal government announced that two organizations that handle disputes under the No Surprises Act will no longer be allowed to accept new cases, saying they failed to meet required performanc…
    STAT · 3d agoRegulatoryNegative↗ source
  • Ellipsis Health acquires Kouper Health to expand AI voice call capabilities
    Ellipsis Health, a startup that builds voice-based artificial intelligence tools for healthcare, announced it has purchased Kouper Health. The deal reflects growing interest in AI systems that can…
    Endpoints · 3d agoDealNeutral↗ source
  • Medicare postpones controversial rule that bars hospitals from using third-party remote patient monitoring services
    Medicare announced it will finalize a proposal that delays an update to its remote patient monitoring (RPM) rule, despite strong opposition. The rule would prohibit hospitals and other providers f…
    STAT · 4d agoRegulatoryNegative↗ source
  • Podcast explores how intratumoral injections may spark systemic cancer immunity
    In a recent episode of BioSpace's Denatured podcast, host Jennifer C. Smith-Parker spoke with Lewis Bender, CEO of Intensity Therapeutics, and Paul-Peter Tak, president and CEO of Candel Therapeuti…
    BioSpace · 4d agoNeutral↗ source
  • BioSpace lists top 12 biopharma employers hiring in July 2026
    BioSpace released a list of the twelve biopharma firms with the most job postings in July 2026. The list includes AbbVie, Regeneron, Amgen, Eli Lilly, Sanofi, Novo Nordisk, Moderna, Insmed, Freder…
    BioSpace · 4d agoNeutral↗ source
  • Ballot measures on abortion, marijuana and transgender youth care highlight political divides in 2026 midterms
    Voters in the 2026 midterm elections faced a slate of state health policy ballot measures that addressed abortion rights, marijuana legalization, science funding bonds and care for transgender yout…
    STAT · 3d agoNeutral↗ source
  • MAHA movement faces electoral defeat as its political influence wanes
    The opinion piece declares that the original MAHA initiative, dubbed MAHA 1.0, has effectively ended after recent midterm elections, and suggests a new phase, MAHA 2.0, may emerge. At least eleven…
    STAT · 3d agoNegative↗ source
  • Neurosurgeon reflects on the difference between pain and suffering in chronic back pain patients
    Stephen Doran, a neurosurgeon and author, writes an opinion piece about how pain and suffering are distinct experiences for patients. He recounts a recent visit with a 60‑plus veteran who had endu…
    STAT · 4d agoNeutral↗ source
  • Seven new tumor cases reported among patients on Novartis' Zolgensma gene therapy
    Nine patients who have received Novartis' spinal muscular atrophy gene therapy Zolgensma have developed tumors following their treatment, the company confirmed Thursday. Seven of those cases were d…
    Endpoints · 3d ago↗ source
  • Child dies of measles in Wisconsin’s first such death since 1990
    An infant in southwestern Wisconsin has died after contracting measles, the state’s first death from the disease in 36 years.
    STAT · 3d ago↗ source
  • STAT+: Novartis cites cases of previously unknown tumors possibly tied to its SMA gene therapy
    Novartis has acknowledged seven previously unknown instances in which tumors were found in children who were treated with its spinal muscular atrophy therapy, Zolgensma.
    STAT · 3d ago↗ source
  • Novartis confirms 9 reported cases of tumors in patients treated with Zolgensma
    Advocates are sounding the alarm on social media as they learn from their doctors that Novartis has received reports of tumors in patients who have been treated with the spinal muscular atrophy gen…
    BioSpace · 3d ago↗ source
  • STAT+: What the midterms could mean for the future of health AI
    The midterms highlighted the negative sentiment around AI across the U.S. How will those attitudes trickle down to legislating AI use in health care?
    STAT · 4d ago↗ source
  • Recon: Sino, Boehringer ink cancer drug deal worth $7B; CVS to split pharmacy business from insurance
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 4d ago↗ source
  • Boehringer Ingelheim partners with Sino Biopharma on $7 billion cancer drug deal
    Boehringer Ingelheim announced a partnership with China's Sino Biopharmaceutical to co-develop cancer therapies. The agreement targets antibody-drug conjugates and T-cell engager platforms, with a…
    Endpoints · 4d agoDealPositive↗ source
  • CVS Health to split into two publicly traded companies amid regulatory scrutiny of its pharmacy‑insurer integration
    CVS Health announced it will separate into two independent, publicly traded companies. The move undoes years of acquisitions that combined a pharmacy chain, a pharmacy‑benefit manager and an insura…
    STAT · 4d agoNeutral↗ source
  • CVS Health to split into two publicly traded companies, separating pharmacy and insurance units
    CVS Health announced a plan to divide the company into two separate publicly listed entities. One entity will keep the CVS Health name and encompass the pharmacy retail and pharmacy benefit manage…
    Endpoints · 4d agoDealNeutral↗ source
  • Big pharma Q3 earnings roll out as FDA launches rare-disease initiative and uniQure's Huntington's gene therapy enters review
    Over the past week, a dozen major pharmaceutical companies reported third‑quarter results, including AstraZeneca, Biogen, GSK, Bristol Myers Squibb, Merck, Sanofi, AbbVie and Regeneron. Pfizer pos…
    BioSpace · 5d agoEarningsNeutral↗ source
  • Bernie Sanders poised to steer FDA user fee renewal, could push for reforms
    Democrats' midterm victory may shape the upcoming negotiations on the Prescription Drug User Fee Act, which funds the FDA's review of medicines. Senator Bernie Sanders, a longtime critic of the us…
    STAT · 4d agoRegulatoryNeutral↗ source
  • Novo falls behind Eli Lilly in market race as investors react to Q3 results
    A year ago the competition between Eli Lilly and Novo was described as the fiercest in the industry. Recent commentary suggests the rivalry has become increasingly one‑sided, with Novo struggling t…
    Endpoints · 4d agoNegative↗ source
  • Democratic doctors and scientists win key Senate and gubernatorial races, boosting health policy influence
    Democratic candidates with medical and scientific backgrounds secured several high‑profile victories in the recent midterm elections, contributing to the party’s regain of congressional control. A…
    STAT · 4d agoPositive↗ source