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  • PharmaLogic acquires Lantheus radiopharma CDMO and New Jersey plant to launch transatlantic manufacturing platform
    PharmaLogic announced it will purchase Lantheus' radiopharmaceutical contract development and manufacturing organization (CDMO) along with a production plant in Springfield, New Jersey. Lantheus h…
    BioSpace · 1h agoDealNeutral↗ 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 · 4h agoRegulatoryPositive↗ source
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  • 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 · 16h 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 · 4h agoLayoffsNegative↗ source
  • Arrowhead faces challenges as Ionis's Tryngolza sales fall short, putting sHTG launch at risk
    Ionis Pharmaceuticals reported flat sales of its severe hypertriglyceridemia drug Tryngolza, generating only $9 million and cutting its annual revenue outlook to $50 million. The weak performance…
    BioSpace · 4h agoEarningsNegative↗ source
  • HHS commits up to $25M for ibogaine and other psychotropic drugs on Veteran's Day
    HHS announced an investment of up to $25 million for ibogaine and other rapid acting psychotropic medicines aimed at serious mental illnesses such as PTSD, unveiled on Veteran's Day. Up to $4.9 mi…
    BioSpace · 5h 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 · 6h agoPositive readoutPositive↗ 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 · 10h 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 · 10h 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 · 11h agoPositive readoutPositive↗ 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 · 16h 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 · 16h agoLayoffsNegative↗ 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 · 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 · 4h agoDealPositive↗ source
  • Windward Bio raises $175M in IPO, boosting 2026 biotech debut count to 35
    Windward Bio completed an initial public offering that raised about $175 million, selling roughly 10.3 million shares at $17 each on the Nasdaq. The proceeds are earmarked to advance its lead antib…
    BioSpace · 5h agoDealPositive↗ 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 · 7h agoNeutral↗ 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 · 8h 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 · 4h 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 · 17h agoNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 4h agoLayoffsNegative↗ source
  • American Cancer Society updates prostate cancer screening guidance
    For the first time in 16 years, the American Cancer Society (ACS) has updated its guideline for prostate cancer screening as it drives to boost detection of the disease before it spreads.
    Fierce Biotech · 12h ago↗ source
  • Eli Lilly’s Mounjaro and Merck’s oral PCSK9 inhibitor win FDA nod amid string of cardiovascular trial setbacks
    The cardiovascular drug development landscape entered the American Heart Association’s Scientific Sessions with a mix of optimism and disappointment. Recent months have seen several late‑stage tria…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Neurosterix raises $105M Series B to advance oral M4 schizophrenia drug and adds former Karuna leaders
    Neurosterix, a spinout from Addex Therapeutics, announced a $105 million Series B financing. The round was led by RTW Investments with participation from GV, Janus Henderson Investors and others. A…
    BioSpace · 1d agoDealPositive↗ source
  • Bristol Myers Squibb reshuffles R&D leadership as chief research officer departs and CMO takes over combined unit
    Bristol Myers Squibb announced a restructuring of its research and development organization, merging the separate research and development divisions into a single unit. The new combined R&D unit w…
    Fierce Biotech · 1d agoNeutral↗ source