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2,826 stories matching this filter · ← front page

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  • Blackstone Life Sciences and Boston Scientific launch $455 million partnership to develop next-generation heart pump
    Blackstone Life Sciences has entered a collaboration with Boston Scientific, committing $455 million to co‑fund development of a next‑generation miniature heart pump system. The device, called the…
    Fierce Biotech · 5d agoDealPositive↗ source
  • AbbVie pays $100M upfront in $1.4B deal for Nxera's phase-1 IBD candidate
    AbbVie has agreed to pay $100 million upfront for the worldwide rights to Nxera's oral EP4 receptor agonist, designated NXE0033744, with the total deal value potentially reaching $1.4 billion throu…
    Fierce Biotech · 5d agoDealPositive↗ source
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  • Ultragenyx to cut 20% of staff and halve R&D budget as it pivots to commercial sales
    Ultragenyx announced it will reduce its workforce by about 20%, bringing headcount down to roughly 1,000 employees. The cuts follow an earlier 10% reduction announced in February and are part of a…
    Fierce Biotech · 5d agoLayoffsNegative↗ 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
  • 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
  • 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 · 4d 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 · 4d 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 · 4d agoDealNeutral↗ source
  • Charles River partners with Ipsen to employ virtual control groups in toxicology studies
    Charles River Laboratories and French biopharma Ipsen announced a collaboration to use Charles River’s virtual control group (VCG) database in an upcoming toxicology study. The VCG approach aims t…
    Fierce Biotech · 4d agoDealPositive↗ 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 · 4d 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 · 4d agoRegulatoryNeutral↗ source
  • nPhase secures $30M Series D to grow AI-driven clinical data platform
    CRO nPhase announced it has closed a $30 million Series D financing round. The capital will be directed toward expanding its AI-native clinical data platform that debuted in September, which aims t…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Smith+Nephew ends talks with J&J on orthopedics merger as growth stalls
    Smith+Nephew announced that discussions with Johnson & Johnson’s DePuy Synthes about a possible orthopedics combination have ended. The talks were disclosed in the company’s third‑quarter release;…
    Fierce Biotech · 5d agoDealNegative↗ 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 Nurix STAT6 degrader program two months after phase-1 start
    Sanofi announced it is ending its collaboration with Nurix on a STAT6 degrader, just two months after the drug entered a phase-1 study. The two companies have worked together since 2019, with Sano…
    Fierce Biotech · 5d agoDealNegative↗ 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
  • MiniMed appoints diabetes and digital health veteran David Segal as chief medical officer
    MiniMed, the insulin pump maker that spun off from Medtronic, announced the appointment of Dr. David Segal as its new chief medical officer. Segal replaces Dr. Robert Vigersky, who has served as C…
    Fierce Biotech · 5d agoPositive↗ 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 · 4d 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 · 4d 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 · 5d agoNegative readoutNegative↗ source