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  • 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
  • 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
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  • 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
  • China rises on biotech risk list as US draft rules threaten Chinese biopharma investments
    A recent Signal Survey shows China moving up the biotech industry’s concern list even before the Treasury Department issued draft rules that could curb U.S. investment in Chinese biopharma. The pr…
    Endpoints · 4d agoRegulatoryNegative↗ 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
  • First wave of ASH 2026 abstracts released, featuring data from J&J, Servier and AstraZeneca
    The American Society of Hematology’s annual meeting is set for New Orleans, Louisiana, a little over a month away. The first batch of abstracts for the conference has been posted, showcasing early…
    Endpoints · 4d agoNeutral↗ 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
  • AbbVie licenses Nxera's EP4 gut-targeting IBD program for up to $1.47 billion
    AbbVie announced a licensing agreement with Nxera Pharma to acquire rights to its EP4 receptor agonist program aimed at inflammatory bowel disease. The deal includes an upfront payment of $100 mil…
    Endpoints · 5d agoDealPositive↗ source
  • Novo projects flat 2026 sales as CFO exits, marking an upgrade from prior expectations
    Novo announced that its 2026 sales outlook will be flat, a shift from earlier growth expectations. The drugmaker also disclosed that its chief financial officer will be leaving the company, and a…
    Endpoints · 5d agoNeutral↗ source
  • Minghui Pharma sells Japanese rights to its Phase 3 thyroid eye disease drug for $110 million upfront
    Minghui Pharmaceutical, a Shanghai‑based biotech, has agreed to transfer the Japanese commercial rights for its late‑stage thyroid eye disease candidate to a specialty pharmaceutical company. The…
    Endpoints · 5d agoDealPositive↗ 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
  • 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 · 4d 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 · 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 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 · 4d agoNegative↗ source