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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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  • 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 · 4d 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
  • 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
  • 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
  • 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
  • Sanofi drops Nurix STAT6 degrader program amid molecule-specific concerns
    Sanofi has halted development of an early‑stage STAT6 degrader program that it licensed from Nurix Therapeutics. The decision was announced after the asset entered Phase 1 trials for type 2 inflamm…
    BioSpace · 5d agoNeutral↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 5d agoNeutral↗ 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
  • Flagship partner Louisa Helms credits high-school librarian for sparking biotech career
    Louisa Helms, a BioSpace 40 Under 40 honoree and partner at Flagship Pioneering, reflects on a unique path into biotech. In high school she was mentored by librarian Tammy Carabello, who turned th…
    BioSpace · 5d agoPositive↗ 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
  • 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
  • AbbVie bets up to $1.47B for Nxera’s discarded IBD program
    AbbVie’s $100 million upfront cash payment will purchase global rights to Nxera’s deprioritized oral small molecule, which has already completed Phase 1 testing.
    BioSpace · 5d ago↗ 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
  • Neurocrine launches new safety study after another death linked to Prader-Willi drug Vykat
    Neurocrine Biosciences announced it will start a new study to evaluate dosing and safety of its rare disease drug Vykat in patients with Prader-Willi syndrome who have complex health issues. The m…
    BioSpace · 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