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  • 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
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  • 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
  • Spyre Therapeutics reports SPY072 fails psoriatic arthritis trial as Ideaya halts eye cancer study
    Spyre Therapeutics announced that its long‑acting anti‑TL1A candidate, SPY072, did not meet the primary endpoints in a psoriatic arthritis trial. The result adds to recent setbacks for Spyre in ot…
    Endpoints · 5d agoNegative readoutNegative↗ 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
  • Sanofi halts development of Nurix's STAT6 degrader program
    Sanofi announced it will stop work on an experimental drug that targets STAT6, a protein involved in immune signaling. The compound, known as SAR448272 and developed in partnership with Nurix, was…
    Endpoints · 5d agoNegative↗ source
  • Novo says launch of obesity drug CagriSema in Europe delayed by a couple of years
    Novo Nordisk announced it will not bring its obesity candidate CagriSema to European markets for the next few years. The statement came from the company's outgoing chief financial officer, Karsten…
    Endpoints · 5d agoNeutral↗ source
  • Kamau Therapeutics presents first clinical data from its updated sickle-cell gene-editing program
    Kamau Therapeutics, a biotech company that entered the scene in 2023, has released clinical data from its reengineered sickle‑cell gene‑editing program for the first time. The disclosure marks the…
    Endpoints · 5d agoNeutral↗ 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
  • Servier’s $1.55 billion Becker muscular dystrophy drug fails pivotal Phase 3 trial
    Servier announced that its experimental drug for Becker muscular dystrophy did not meet its primary endpoint in a Phase 3 trial called GRAND CANYON. The drug, sevasemten, was acquired from Edgewis…
    STAT · 6d agoNegative readoutNegative↗ source
  • Pfizer raises 2026 outlook as oncology and migraine growth balances Covid product decline
    Pfizer announced it has increased its financial guidance for 2026, citing stronger performance in its cancer and migraine divisions. The company said sales of its Covid-19 related products have fa…
    Endpoints · 6d agoEarningsPositive↗ source
  • Servier’s $1.5 billion muscular dystrophy drug sevasemten fails pivotal trial
    Servier announced that its experimental muscular dystrophy therapy sevasemten did not meet its goals in a pivotal Phase III study. The trial, named GRAND CANYON, evaluated the drug’s ability to im…
    Endpoints · 6d agoNegative readoutNegative↗ source
  • Medicare Part D premiums expected to rise 50% on average in 2027, KFF warns seniors to compare plans
    KFF analysis shows average monthly premiums for Medicare Part D standalone plans will jump from $34 to $51 in 2027, a 50% increase if seniors stay in their current plans. Premiums vary widely acro…
    BioPharma Dive · 6d agoRegulatoryNegative↗ source
  • Scientists question safety and benefits of three-parent IVF as new UK data raise concerns
    The mitochondrial replacement technique, often called three‑parent IVF, was hailed after the United Kingdom reported the birth of eight healthy children whose mothers carried disease‑causing mitoch…
    STAT · 6d agoRegulatoryNegative↗ source
  • Ultragenyx cuts 20% of workforce and abandons Wilson disease gene therapy after mixed Q3 results
    Ultragenyx said it will cut about 20% of its workforce, marking a second round of layoffs this year. The reductions will affect roughly a fifth of the company's employees. At the same time, the fi…
    Endpoints · 6d agoLayoffsNegative↗ source
  • MGB CEO's vague email on financial challenges fuels anxiety after recent layoffs
    Mass General Brigham chief executive Dr. Anne Klibanski emailed the system’s roughly 85,000 staff late Monday, warning of urgent financial challenges and a need to improve performance. The message…
    STAT · 6d agoLayoffsNegative↗ source
  • Live discussion to assess how US midterm elections could reshape biopharma policy
    Drew Armstrong, executive editor of PharmaFDA+, announced a live webcast at 1:30 pm ET on November 3, 2026 to discuss the impact of the US midterm elections on biotech and pharma. The program will…
    Endpoints · 6d agoNeutral↗ source
  • FDA grants tentative approval for Dr. Reddy’s generic HIV prevention shot, expanding access in low- and middle-income countries
    The U.S. Food and Drug Administration has issued a tentative approval for Dr. Reddy’s Laboratories to produce a generic version of a leading HIV prevention medicine. This decision follows months of…
    STAT · 6d agoApprovalPositive↗ source
  • New York records first measles death in three decades as vaccination rates slip
    A child in rural northern New York died after contracting measles, marking the first measles-related death in the state in 30 years, officials said. The death comes as U.S. vaccination coverage ha…
    STAT · 6d agoNegative↗ source
  • UniQure slated for FDA decision by May 1 as analysts see potential for first Huntington’s disease therapy
    UniQure said the Food and Drug Administration has set a decision date for its Huntington's disease gene therapy and is likely to hold an advisory committee meeting. The agency indicated a faster‑th…
    BioPharma Dive · 6d agoRegulatoryNeutral↗ source
  • First U.S. bird flu death of 2026 reported in Washington state after cattle exposure
    A person in Washington state died from complications of avian influenza, according to the Associated Press. It is the first bird flu death in the United States this year. The case follows recent r…
    STAT · 6d agoNegative↗ source