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  • 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 · 4d 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 · 4d 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
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  • 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
  • Novo Nordisk lifts 2026 profit outlook after Wegovy obesity pill beats forecasts
    Novo Nordisk announced on Wednesday that it is raising its full-year profit and sales guidance after the third-quarter results for its Wegovy obesity pill came in above analysts' expectations. The…
    BioPharma Dive · 5d agoEarningsPositive↗ source
  • CVS to split into two companies, separating Aetna and Caremark from its retail pharmacies
    CVS Health announced it will divide the business into two independent companies, one that will contain its insurance unit Aetna and pharmacy‑benefit manager Caremark, and another that will operate…
    BioPharma Dive · 5d agoNeutral↗ 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 · 5d agoNeutral↗ 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 · 5d agoRegulatoryNeutral↗ 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 · 5d agoPositive↗ source
  • Sanofi halts development of Nurix-partnered STAT6 degrader, triggering sharp drop in Nurix stock
    Sanofi announced it is ending work on SAR448272, an experimental oral drug that was intended to degrade the STAT6 protein, which is linked to inflammatory diseases. The biotech firm Nurix, which l…
    BioPharma Dive · 5d agoNegative↗ source
  • Analysts predict biopharma gains as Democrats take Congress control
    Analysts say the biopharma sector is set to benefit from the recent shift in U.S. Congress, with Democrats now holding majorities in both the House and Senate. They note that drug‑pricing debates…
    BioPharma Dive · 5d agoPositive↗ source
  • Democratic doctors gain ground as MAHA movement falters and Medicare for All resurfaces after midterms
    Democrats reclaimed control of both the Senate and the House in Tuesday night’s midterm results, adding four governorships and strengthening their capacity to challenge President Trump’s health‑car…
    STAT · 5d agoRegulatoryNeutral↗ source
  • Ultragenyx to lay off roughly 20% of staff as it halts two rare disease drug programs
    Ultragenyx announced it will cut about 20% of its workforce as it ends development of two rare disease drug candidates. The move follows a recent clinical study that failed to meet its primary end…
    STAT · 5d agoLayoffsNegative↗ source
  • CVS Health to split into two separate companies, separating insurance and pharmacy operations
    CVS Health announced that it will divide the business into two independent companies. One entity will house its insurance arm Aetna together with pharmacy‑benefit manager Caremark, while the other…
    STAT · 5d agoDealNeutral↗ source
  • Former Madrigal exec sues, alleging retaliation after flagging safety concerns on approved MASH drug
    A former senior vice president of clinical development at Madrigal Pharmaceuticals, Michael Charlton, has filed a federal lawsuit claiming he was forced to resign after raising internal safety conc…
    STAT · 5d agoNegative↗ source
  • Democrats win Congress and doctors secure key seats, shifting health policy direction
    The recent midterm elections gave Democrats control of both the House and the Senate. Voters also elected a number of doctors and scientists to key congressional positions. These outcomes signal a…
    STAT · 5d agoRegulatoryPositive↗ source
  • Democrats Gain Senate Control, Poised to Reverse Trump Health Care Policies
    Democrats secured a Senate majority with at least 51 seats after Tuesday's election, ending the Republican trifecta of power. The new majority equips Democrats with oversight tools and the ability…
    STAT · 5d agoRegulatoryNeutral↗ source
  • FDA urges biosimilar sponsors to use alternative efficacy studies while AI reshapes regulatory work
    AI is becoming common in regulatory work. Experts say it will not replace regulatory professionals but will help them work more efficiently and free up time for human interaction. They stress that…
    raps · 5d agoRegulatoryNeutral↗ source
  • Congress faces Dec. 11 deadline to fund government, shaping lame-duck session and health-care agenda
    Democrats have taken control of both the House and Senate, but Republicans will remain in power until the new Congress convenes in January. Lawmakers must pass a funding bill by Dec. 11 to avoid a…
    STAT · 5d agoRegulatoryNeutral↗ source
  • Democrats Wyden and Sanders poised to lead Finance and Health committees after Senate flip
    The Senate’s recent shift to Democratic control is set to place Sen. Ron Wyden of Oregon at the helm of the Finance Committee and Sen. Bernie Sanders of Vermont as the presumptive chair of the Heal…
    STAT · 5d agoRegulatoryNeutral↗ source
  • FDA urges biosimilar makers to adopt alternatives to clinical efficacy trials
    FDA's Office of Therapeutic Biologics and Biosimilars, led by director Sarah Yim, announced that the agency is working to help sponsors rely less on clinical efficacy studies when developing biosim…
    raps · 5d agoRegulatoryPositive↗ source
  • Biotech startups opt out of AI for drug discovery, say STAT
    The latest STAT AI Prognosis newsletter notes that a number of biotech startups are deliberately avoiding artificial intelligence in their drug discovery programs. These companies argue that AI ma…
    STAT · 5d agoNeutral↗ source
  • Massachusetts voters reject repeal of recreational cannabis sales, keeping industry open
    Voters in Massachusetts decisively rejected Question 8, a ballot initiative that sought to dismantle the state’s recreational cannabis industry. Approximately 76% of voters cast ballots against th…
    STAT · 5d agoRegulatoryPositive↗ source
  • MAHA movement faces uncertain future after midterm losses
    Midterm elections swept many of the Make America Healthy Again (MAHA) coalition’s allies out of office, leaving the group led by health secretary Robert F. Kennedy Jr. with a reduced political base…
    STAT · 5d agoNegative↗ source
  • American expatriate in Malta finds free health care but misses digital patient portal
    Mariska Breland, an American co‑founder of The Neuro Studio, moved to Malta seeking free health care and recounts her first visit to a local general practitioner. She describes a modest clinic wit…
    STAT · 5d agoNeutral↗ source