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4,262 stories matching this filter · ← front page

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  • 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
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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
  • 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 · 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
  • 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
  • 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
  • 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
  • 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 · 4d 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
  • 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
  • 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 · 5d agoNegative readoutNegative↗ source
  • T-Therapeutics secures $133M Series B to advance TCR-CD3 bispecifics with major pharma investors
    T-Therapeutics announced a $133 million Series B financing round backed by several of the world’s largest drug developers, including Eli Lilly, Johnson & Johnson, Merck KGaA and Sanofi, along with…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Rhythm Pharmaceuticals expands LG Chem obesity drug license, total payout up to $855 million
    Rhythm Pharmaceuticals and LG Chem have revised their licensing agreement for the oral obesity and hyperphagia drug bivamelagon, increasing the total scheduled payments. The new terms raise the po…
    Fierce Biotech · 6d agoDealPositive↗ 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