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241 stories matching this filter · ← front page

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  • Roivant's brepocitinib cuts steroid use in non-infectious uveitis in Phase 3 trials
    Roivant Sciences and its subsidiary Priovant reported that their TYK2/JAK inhibitor brepocitinib met all primary and secondary endpoints in two identical Phase 3 studies (Clarity‑1 and Clarity‑2) i…
    BioSpace · 4h agoPositive readoutPositive↗ source
  • Menarini's Stemline signs $1.1 billion deal to license Georgiamune's preclinical cancer immunotherapy
    Georgiamune, a Maryland‑based immunology biotech, has granted Stemline Therapeutics, part of Italy's Menarini Group, exclusive worldwide rights to develop and commercialize its preclinical cancer c…
    Fierce Biotech · 5h agoDealPositive↗ source
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Nephrology654
  • Rebranded Rezera plans IPO to fund phase 3 trial of NLRP3 inhibitor ruvonoflast for peripheral artery disease
    Rezera, which rebranded from NodThera last month, announced plans for an initial public offering to raise capital for its lead candidate, ruvonoflast, a brain‑penetrant NLRP3 inhibitor. The compan…
    Fierce Biotech · 9h agoDealPositive↗ source
  • Roche CEO says stance on $1.5B Poseida acquisition unchanged despite dropping one CAR-T program
    Roche bought Poseida in 2024 for $1.5 billion to secure its off-the-shelf CAR-T platform and strengthen its cell-therapy portfolio. During the third-quarter earnings call, the company said it has…
    Fierce Biotech · 10h agoDealNeutral↗ source
  • Merck to showcase three late-stage TROP2 ADC trials at ESMO 2026, VP says payload is in the "Goldilocks zone"
    At the European Society for Medical Oncology meeting in 2026, Merck will present three late-stage trials of its TROP2‑directed antibody‑drug conjugate sac‑TMT, developed in partnership with Kelun‑B…
    BioSpace · 11h agoPositive↗ source
  • Roche’s pipeline trim claims Poseida’s off-the-shelf CAR T asset
    Aside from RG6540, Roche also discontinued a host of other early-stage assets, including an antisense oligonucleotide for Alzheimer’s disease and a small-molecule candidate for geographic atrophy.
    BioSpace · 1h agoRegulatoryNeutral↗ 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 · 18m agoLayoffsNegative↗ source
  • FDA approves GSK‑Ionis hepatitis B functional cure, Hibsago, targeting undetectable virus after six months
    The FDA has approved bepirovirsen, an antisense oligonucleotide from GSK and Ionis, for chronic hepatitis B infection. It will be sold under the brand name Hibsago. The therapy is described as a f…
    BioSpace · 1d agoApprovalPositive↗ source
  • Eight biopharma companies posting dozens of remote job openings
    BioSpace compiled a list of eight biopharma firms currently advertising remote positions for life‑science professionals. The companies together have roughly 300 openings, ranging from strategic ac…
    BioSpace · 1d agoNeutral↗ source
  • Alnylam shares tumble to $250 after cutting full-year revenue guidance for its TTR franchise
    Alnylam Pharmaceuticals saw its share price slide to about $250 after the company lowered its full-year revenue outlook for its transthyretin (TTR) franchise. The guidance cut, announced in July, f…
    BioSpace · 2d agoEarningsNegative↗ source
  • Pfizer halts phase 2 trial of CXCR5 antibody for immune thrombocytopenia
    Pfizer announced it is ending a phase 2 study of its CXCR5-targeting antibody PF-06835375 in patients with primary immune thrombocytopenia (ITP). The decision was described as a business decision a…
    Fierce Biotech · 2d agoCRLNegative↗ source
  • Cardinal Health issues updated instructions for Presource kits containing recalled BD Alaris infusion sets
    The FDA CDRH issued an Early Alert to inform the public of a potentially high‑risk device issue involving Cardinal Health Presource kits that may contain BD Alaris Pump Infusion Sets linked to a re…
    fda medwatch · 2d agoRegulatoryNegative↗ source
  • Nova Biomedical pulls Gen 2.0 StatStrip hospital glucose meters over patient ID software flaw
    Nova Biomedical has issued a recall of its StatStrip Glucose Hospital Meter System Gen 2.0 model after discovering a software issue that could assign glucose results to the wrong patient. The FDA…
    fda medwatch · 2d agoCRLNegative↗ source
  • Disc spins past FDA rejection with ‘overwhelmingly positive’ phase 3 data for rare disease drug
    A phase 3 trial of Disc Medicine’s bitopertin has hit both co-primary endpoints and all secondary endpoints, positioning the biotech to refile for approval of the once-rejected rare disease drug ca…
    Fierce Biotech · 3d agoApprovalPositive↗ source
  • Merck KGaA to acquire Silence Therapeutics for $1.1 billion, gaining Phase 3 PV siRNA asset
    Merck KGaA announced it will buy Silence Therapeutics for about $1.1 billion, giving the German group a foothold in hematology. Silence, a UK-based RNA specialist, develops short interfering RNA m…
    BioSpace · 2d agoDealPositive↗ source
  • Disc Medicine reports positive Phase 3 results for bitopertin in erythropoietic protoporphyria, setting stage for FDA resubmission
    Disc Medicine's bitopertin, being developed for erythropoietic protoporphyria (EPP), a rare blood disorder that causes painful light sensitivity, had its accelerated FDA application rejected in Feb…
    BioSpace · 3d agoPositive readoutPositive↗ source
  • Eli Lilly teams with Hong Kong's Metis TechBio in up to $1.1 billion AI nanoparticle partnership
    Eli Lilly has entered a partnership with Hong Kong‑based Metis TechBio to access an artificial‑intelligence driven platform for designing lipid nanoparticles that can improve drug delivery. The co…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Merck KGaA buys Silence in $1.3B deal after siRNA drug's phase 2 blood cancer win
    Germany’s Merck KGaA has picked up Silence Therapeutics to the tune of $1.3 billion in the wake of the British biotech’s mid-stage success for its challenger to Takeda’s Mimrylo.
    Fierce Biotech · 3d agoDealNeutral↗ source
  • Experts tout amylin as promising, potentially gentler obesity target as new combo therapies near FDA review
    While GLP-1 medicines dominate the weight‑loss market, some observers argue that amylin would have been the logical primary target for obesity treatment a decade ago. Novo Nordisk’s amylin/GLP‑1 c…
    BioSpace · 3d agoPositive↗ source
  • Novartis halts Phase 2 lupus nephritis trial of Fabhalta, cites strategic reasons
    Novartis has stopped a Phase 2 study of its complement blocker Fabhalta (iptacopan) in patients with lupus nephritis, a kidney involving form of the disease. The company said the decision was base…
    BioSpace · 3d agoNeutral↗ source
  • Sino Biological offers validated cytokines to improve organoid culture and research
    Organoids are three-dimensional cell models that mimic key features of real tissues, and they rely on specific signaling molecules to grow and differentiate. Key cytokines such as R-spondin 1, EGF…
    BioSpace · 3d agoNeutral↗ source
  • Disc’s rebuffed rare disease drug sets up FDA redo after ‘clean’ Phase 3 sweep
    Disc Medicine’s bitopertin—rejected by the FDA in February—significantly reduced levels of a key disease biomarker and significantly increased the time patients with erythropoietic protoporphyria w…
    BioSpace · 3d ago↗ source
  • Labcorp to acquire BioReference Health assets for $722M cash
    Labcorp and OPKO Health announced an agreement in which Labcorp will purchase select assets of BioReference Health, a subsidiary of OPKO. The assets include laboratory testing businesses focused o…
    Fierce Biotech · 4d agoDealPositive↗ source
  • Induced pluripotent stem cells gain momentum as new methods and clinical successes drive drug development
    Induced pluripotent stem cells (iPSCs) are moving from a research curiosity to a practical tool in drug development. After years of steady progress, recent advances are bringing iPSCs into the spot…
    BioSpace · 6d agoPositive↗ source
  • Labcorp teams with Thrive Global to launch Thrive 5 home health test
    Labcorp has introduced the Thrive 5 Health Test in partnership with Arianna Huffington's company, Thrive Global. The test is sold through Labcorp's OnDemand home testing service and pairs laborato…
    Fierce Biotech · 6d agoPositive↗ source