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  • Novo files US and EU approval for etavopivat, its $1B acquired sickle-cell therapy
    Novo submitted regulatory applications in the United States and Europe for etavopivat, a sickle cell disease therapy it bought from Forma Therapeutics in a $1 billion transaction. The company says…
    BioPharma Dive · 1h agoApprovalPositive↗ source
  • Takeda narcolepsy pill receives DEA clearance as Oura-Lilly deal raises conflict concerns and Pfizer exits Canadian Premarin market
    Takeda announced that its experimental narcolepsy medication has been cleared by the U.S. Drug Enforcement Administration, marking the first regulatory nod for a therapy aimed at treating excessive…
    STAT · 1h agoRegulatoryPositive↗ source
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  • Neuroscience startups attract $450M in recent funding, Oyster Therapeutics secures $60M Series A
    Venture capital activity around neuroscience has picked up again, with five neurology-focused startups collectively raising about $450 million in the past few weeks. Data from BioPharma Dive show…
    BioPharma Dive · 2h agoDealPositive↗ source
  • Windward Bio raises $225 million in IPO to fund Chinese-sourced respiratory drug program
    Windward Bio, backed by Sanofi, completed its initial public offering at the $225 million target, selling 10.3 million shares at $17 each. The proceeds will be used to advance two respiratory drug…
    Fierce Biotech · 12h agoDealPositive↗ source
  • Swiss biotech Windward Bio raises $175 million in IPO to fund lung-drug development and test Tezspire competitor
    Windward Bio, a Swiss immune‑drug developer, completed a $175 million initial public offering, selling about 10.3 million shares at $17 each. The company began trading on the exchange under the tic…
    BioPharma Dive · 14h agoDealPositive↗ source
  • Regeneron's POTS antibody shows heart-rate reduction in Phase 2, paving way for Phase 3 trial
    Regeneron reported results from its Phase 2 Pinnacle trial of a monoclonal antibody targeting postural orthostatic tachycardia syndrome (POTS), a disorder with no approved therapies. The trial enr…
    BioSpace · 2h agoPositive readoutPositive↗ source
  • Setbacks in two heart disease trials raise questions about future cardiovascular drug research
    A recent episode of The Readout LOUD highlighted the disappointing results of two high-profile heart disease drugs, noting that both failed to demonstrate benefit in recent studies. The failures w…
    STAT · 2h agoNegative readoutNegative↗ source
  • Gate Bioscience eyes clinic trials with molecular gate drugs, backed by expanded $870M Lilly partnership
    Gate Bioscience is developing small-molecule drugs that block the Sec61 channel, preventing disease-causing proteins from entering cells and leading to their degradation. The company's first discl…
    Fierce Biotech · 6h agoDealPositive↗ source
  • Rezolute’s phase 3 trial of ersodetug meets primary endpoint in tumor hyperinsulinism
    Rezolute reported that its phase 3 Uplift study of ersodetug in tumor hyperinsulinism achieved its primary endpoint. The trial required at least nine of 16 patients to show a 50% or greater reduct…
    Fierce Biotech · 6h agoPositive readoutPositive↗ source
  • Oura to acquire telehealth firm Counsel Health, raising conflict-of-interest concerns for Eli Lilly
    Oura, known for its smart rings, announced it will purchase Counsel Health, a telehealth startup that connects patients with clinicians for GLP-1 prescriptions. The acquisition will give Counsel c…
    STAT · 6h agoDealNeutral↗ source
  • Virtuoso Surgical receives FDA De Novo clearance for robotic bladder lesion removal system
    Virtuoso Surgical's Virtuoso Endoscopy System received FDA De Novo authorization, marking the first device in a new classification for electromechanical surgical technologies that use robotic instr…
    Fierce Biotech · 12h agoApprovalPositive↗ source
  • Cellectis to cut 70% of staff as it shifts focus from allogeneic CAR-T to in vivo gene editing
    Cellectis announced that roughly seven out of ten employees will be let go as the Paris‑based biotech restructures its operations. The company previously abandoned its two clinical‑stage allogenei…
    Fierce Biotech · 12h agoLayoffsNegative↗ source
  • Senators propose bill to limit conflicts of interest on preventive services task force
    Two senators, Angus King of Maine and Elizabeth Warren of Massachusetts, announced legislation aimed at tightening conflict‑of‑interest rules for the U.S. Preventive Services Task Force, the panel…
    STAT · 2h agoRegulatoryNeutral↗ source
  • ObesityWeek 2026 to showcase amylin pathway and emerging weight-loss mechanisms
    ObesityWeek 2026 starts Saturday in Washington, DC, gathering weight-loss experts and biopharma companies with metabolic assets. The meeting will highlight the amylin pathway and other emerging me…
    BioSpace · 2h agoNeutral↗ source
  • Synchron pauses second-generation brain-computer interface trial, says pause not safety related
    Synchron, a brain-implant startup, announced it is pausing enrollment in its second-generation brain-computer interface trial. Company officials emphasized the decision is operational and not driv…
    STAT · 1h agoNeutral↗ source
  • Investigation reveals U.S. fertility clinics offering unproven three-parent IVF to older women despite safety concerns
    The probe began after a British couple reported that they had paid a U.S.-based firm, International Fertility Group, large sums to travel abroad for an experimental fertility method that is not per…
    STAT · 6h agoNegative↗ source
  • Gubra appoints ex-HHS official Brett Giroir as co-CEO after sudden exit of Markus Rohrwild
    Gubra, the Danish obesity partner of AbbVie and Boehringer Ingelheim, announced a leadership change following the abrupt departure of its CEO, Markus Rohrwild. The company will operate under a co…
    Endpoints · 4h agoNeutral↗ source
  • New organ donation rules criticized for pressuring grieving families
    A neurologist at Oregon Health & Science University recounts the case of a 22-year-old woman who was declared brain dead after a traffic accident and became a donor. He describes the intensive moni…
    STAT · 1h agoRegulatoryNegative↗ source
  • Senator-elect Abdul El-Sayed vows to rebuild trust in science amid rising measles and other health threats
    Senator-elect Abdul El‑Sayed is set to become the first epidemiologist to serve in the U.S. Senate, a timing that coincides with a series of public‑health challenges across the country. More than…
    STAT · 6h agoNeutral↗ source
  • New Alzheimer’s biomarker tests raise existential concerns for people without symptoms
    Jason Karlawish, a professor of medicine and neurology at the University of Pennsylvania, reflects on the personal impact of learning one may develop Alzheimer’s before any symptoms appear. He fram…
    STAT · 6h agoNeutral↗ source
  • Regeneron posts positive phase 2 data for baloncibart in nervous system disorder, eyes pivotal trial
    Regeneron has posted positive phase 2 data on baloncibart in postural orthostatic tachycardia syndrome, teeing the biotech up to start a potentially pivotal trial in the first half of 2027.
    Fierce Biotech · 12h agoNeutral↗ source
  • Local schools launch experiments to curb teen phone addiction
    A teacher in Milwaukee asked her digital journalism class to write about their relationship with devices, uncovering disturbing accounts of constant phone use and online abuse. The students descri…
    STAT · 6h agoNegative↗ source
  • Arrowhead’s Ionis problem, Kyverna’s next-gen end and more biotech earnings
    When Ionis Pharmaceuticals’ Tryngolza undersold, investors immediately looked to Arrowhead Pharmaceuticals’ executives for answers on how they will navigate a launch in the same market.
    BioSpace · 18m ago↗ source
  • STAT+: Up and down the ladder: The latest comings and goings
    From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
    STAT · 22m ago↗ source
  • HHS pumps up to $25M into ibogaine, other psychotropic drugs on Veteran’s Day
    Ibogaine, which operates via a “matrix pharmacology,” has long been a focus of Health Secretary Robert F. Kennedy Jr. and the Trump administration.
    BioSpace · 33m ago↗ source