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  • 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
  • Madrigal ex-clinical head sues, alleging liver-injury data cover-up for Rezdiffra
    Madrigal Pharmaceuticals is being sued by its former senior vice president and head of clinical development, Michael Charlton, who claims senior leaders suppressed serious liver‑injury data for the…
    Fierce Biotech · 5d agoRegulatoryNegative↗ source
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  • Minghui licenses sub-q TED drug to Japan's ASKA in up to $440 million deal
    Minghui Pharmaceutical of China has signed a licensing agreement with Japan's ASKA Pharmaceutical, granting exclusive rights to develop and sell its late‑stage thyroid eye disease (TED) candidate i…
    Fierce Biotech · 5d agoDealPositive↗ source
  • 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
  • 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 · 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
  • 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
  • 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 · 5d 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
  • Novo claims 80% share of oral GLP-1 market as rivalry with Lilly intensifies
    Novo's CEO Mike Maziar Doustdar said the company leads the oral GLP-1 market, stating the Wegovy pill holds about 80% of prescriptions since its launch in January. Eli Lilly, however, reported tha…
    BioSpace · 5d agoEarningsNeutral↗ 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
  • Pfizer targets Europe first for upcoming Lyme disease vaccine amid rising US cases
    Pfizer is planning to launch its Lyme disease vaccine in Europe first, leveraging its existing tick-borne encephalitis franchise in the region. The vaccine, developed with French partner Valneva,…
    BioSpace · 5d agoRegulatoryPositive↗ source
  • China targets five $1 billion blockbuster drugs by 2030, two already achieved
    China's latest five-year plan aims to develop five domestically created drugs that each generate over $1 billion in global sales by 2030. According to industry analysts, two drugs have already sur…
    BioSpace · 5d agoPositive↗ 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
  • Boehringer bets big on China, offering $7B biobucks for Sino cancer programs
    Boehringer Ingelheim is building up its China strategy, inking a deal to develop new cancer treatments with Sino Biopharmaceutical just weeks after opening an R&D facility in Shanghai.
    BioSpace · 5d agoDealNeutral↗ source
  • Amgen launches autoinjector study for GLP-1 candidate MariTide as Phase 3 readouts loom
    Amgen has begun a study of an autoinjector formulation of its GLP-1 drug candidate MariTide, as the company prepares for pivotal Phase 3 data expected next year. The candidate is marketed as havin…
    BioSpace · 5d agoNeutral↗ 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
  • Novo and Pfizer say MFN pricing agreements remain unchanged despite Democratic gains in Congress
    On their third‑quarter earnings calls, the CEOs of Novo Nordisk and Pfizer said the Most Favored Nation drug‑pricing contracts they signed under the previous administration are still in effect and…
    BioSpace · 5d 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