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  • George Church departs AI startup as Ira Mellman advances immunotherapy efforts
    The latest Endpoints Weekly notes that geneticist George Church has left the artificial-intelligence startup he co-founded, signaling a shift in his focus. The newsletter also highlights that immu…
    Endpoints · 7h agoNeutral↗ source
  • 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 · 1d agoRegulatoryPositive↗ source
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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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 23h 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 · 1d 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 · 1d 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 · 1d 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 · 1d agoDealPositive↗ source
  • Charles River acquires two Frontage bioanalysis labs in Pennsylvania for $470 million
    Charles River Laboratories announced it has purchased two laboratory sites from Tigermed’s Frontage in Exton, Pennsylvania, paying $470 million upfront. The labs together span about 150,000 square…
    Fierce Biotech · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d agoLayoffsNegative↗ source
  • FDA issues warning letters to three Chinese API makers over record refusals and quality oversight lapses
    The U.S. Food and Drug Administration sent warning letters to three manufacturers of active pharmaceutical ingredients (APIs) based in China. Two of the companies were cited for refusing to provid…
    raps · 1d agoRegulatoryNegative↗ source
  • Medicaid work requirement enforcement delayed six months to July 2027
    The Trump administration announced that states will now have an additional six months before they must begin enforcing the new Medicaid work requirements, pushing the start date to July 1, 2027. T…
    STAT · 20h agoRegulatoryNeutral↗ 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 · 1d 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 · 1d 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 · 1d 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 · 1d agoRegulatoryNeutral↗ source
  • Democrats rally behind 'Medicare for More' and 'Medikids' health coverage proposals
    Democrats are aligning around two health-care proposals aimed at expanding coverage. The "Medicare for More" plan seeks to extend Medicare to a larger share of the population, potentially all Amer…
    STAT · 20h 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 · 1d agoNeutral↗ source