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  • Moderna says it is ready to produce thousands of doses of its Merck-partnered cancer vaccine ahead of FDA filing
    Moderna announced that it is on track to manufacture large quantities of a cancer vaccine developed in partnership with Merck. The company says production facilities are prepared to produce thousa…
    Endpoints · 3h agoRegulatoryPositive↗ source
  • 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 · 5h agoApprovalPositive↗ source
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  • 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 · 5h agoRegulatoryPositive↗ source
  • 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 · 5h 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 · 18h agoDealPositive↗ source
  • Argenx CEO Karen Massey drives $3.4 billion of acquisitions to expand beyond Vyvgart
    Argenx, a rare‑disease biotech, announced that under its new CEO Karen Massey it has pursued two acquisitions. The deals together have a potential value of about $3.4 billion and are intended to b…
    Endpoints · 1h agoDealPositive↗ source
  • Milestone Pharmaceuticals trims 20% workforce after FDA approval as Q3 sales reach $1 million
    Milestone Pharmaceuticals announced it is reducing its headcount by about one‑fifth following the recent FDA approval of its heart‑arrhythmia therapy. The cut affects roughly 20% of the company’s s…
    Endpoints · 3h agoLayoffsNegative↗ source
  • HHS to allocate up to $4.9 million for ibogaine research targeting PTSD
    The U.S. Department of Health and Human Services announced it will provide up to $4.9 million to support research on ibogaine, a psychedelic compound. The funding is intended to explore ibogaine’s…
    STAT · 4h agoRegulatoryNeutral↗ 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 · 6h agoNegative readoutNegative↗ 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 · 10h agoDealNeutral↗ source
  • AstraZeneca withdraws EU filing for monoclonal antibody targeting amyloidosis subset
    AstraZeneca has announced that it is pulling its European marketing application for a monoclonal antibody intended for a specific subgroup of amyloidosis patients. The decision follows earlier fail…
    Endpoints · 1h agoRegulatoryNegative↗ source
  • Doctors question Boston Scientific's Watchman marketing after FDA approval
    Boston Scientific's Watchman cardiac implant has been placed in more than 800,000 patients worldwide. The device eventually secured FDA approval after a protracted review, but the clearance was li…
    STAT · 2h agoRegulatoryNegative↗ source
  • Windward Bio launches on Nasdaq after $175 million IPO, secures $50 million from Sanofi
    Windward Bio, a biotech developing drugs for respiratory diseases, completed its initial public offering and began trading on Nasdaq. The offering raised $175 million, with the stock opening at $1…
    Endpoints · 3h agoDealPositive↗ 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 · 5h agoRegulatoryNeutral↗ 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 · 5h 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 · 10h 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 · 7h 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 · 4h 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 · 10h agoNeutral↗ source
  • Regeneron posts mid-stage POTS data; Kyverna completes CAR-T filing
    Plus, news about Merck KGaA, Rezolute, Vir, Orakl and Cellectis. Regeneron’s mid-stage POTS data: The biotech’s monoclonal antibody, baloncibart, given at 450 mg led to an average 11.4-beat-per-min…
    Endpoints · 3h agoNeutral↗ source
  • Cerevance appoints Karl Kieburtz as new chief medical officer
    STAT+ runs a regular column that tracks personnel moves in the pharmaceutical sector. The piece highlights recent hires, promotions and transfers across companies. Cerevance announced that Karl Ki…
    STAT · 4h 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 · 10h 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 · 10h agoNegative↗ source
  • Scientists release detailed basal ganglia cell map, uncover new neuron linked to schizophrenia
    Scientists from a large international collaboration have created the most detailed map of the basal ganglia, a brain region that coordinates movement and emotion. The effort profiled over 25 millio…
    STAT · 1d agoPositive↗ source
  • FDA faces over 1,000 vacant positions as staffing shortage strains pharma oversight
    The FDA currently has more than a thousand open jobs, reflecting a deep staffing shortfall that began after a large wave of departures last year. The agency lost 1,343 employees at its CBER and CD…
    BioPharma Dive · 1d agoNegative↗ source