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615 stories matching this filter · ← front page

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  • AI-focused biotech firms drive biopharma toward a 'fail-fast' drug development model
    AI is quickly becoming a central force in drug development as tech capital pours into biopharma, reshaping how new medicines are discovered. Tyrone Lam, chief business officer at GATC Health, says…
    BioSpace · 58m agoPositive↗ source
  • Insilico Medicine CEO touts billions in pipeline deals at BIO International Convention
    At the BIO International Convention in June, Insilico Medicine chief Alex Zhavoronkov made a high‑energy appearance that attracted considerable attention. Zhavoronkov handed out a postcard‑sized l…
    BioSpace · 16h agoDealPositive↗ source
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Infectious Disease302
  • Epicrispr and Infinimmune secure $165 million in venture funding for epigenetic and antibody programs
    Epicrispr Biotechnologies announced a $90 million Series C round to push its epigenetic therapy program for facioscapulohumeral muscular dystrophy (FSHD). The lead candidate, EPI-321, is in a firs…
    BioSpace · 16h agoDealPositive↗ source
  • AbCellera’s antibody ABCL635 cuts hot flash frequency in early trial, outperforms oral competitors
    AbCellera Biologics reported that its investigational antibody ABCL635 markedly reduced the number of moderate and severe hot flashes in post‑menopausal women during a Phase 1/2 study. At week four…
    BioSpace · 17h agoPositive readoutPositive↗ source
  • Vaderis raises $152M Series B to launch Phase 3 trial of engasertib for hereditary hemorrhagic telangiectasia
    Vaderis Therapeutics, a Swiss biotech, announced it has closed an oversubscribed $152 million Series B financing round. The new capital will fund the initiation of a Phase 3 study, named HEROIC, e…
    BioSpace · 17h agoDealPositive↗ source
  • Epicrispr secures $90M Series C to advance epigenetic therapy for rare muscle disease
    Epicrispr Biotechnologies announced a $90 million Series C financing round, led by Octagon Capital and Janus Henderson Investors, with participation from Sanofi Ventures and other investors. The c…
    Fierce Biotech · 19h agoDealPositive↗ source
  • FDA issues complete response letter rejecting ITM Isotope's radiopharma therapy over manufacturing concerns
    FDA sent a complete response letter rejecting the NDA for ITM Isotope's investigational radiopharmaceutical, citing manufacturing and third-party facility issues. The agency said there were no con…
    BioSpace · 15h agoCRLNeutral↗ source
  • Scholar Rock pulls Indiana fill-finish plant from SMA therapy filing after FDA flags violations
    Scholar Rock has removed Novo Nordisk's former Catalent fill‑finish facility in Bloomington, Indiana, from its regulatory filing for a spinal muscular atrophy therapy after the FDA classified the p…
    BioSpace · 15h agoRegulatoryNegative↗ source
  • Zydus Sentynl signs up to $475M deal to license Mereo's phase-3 ready rare lung disease drug alvelestat in U.S.
    Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, announced a licensing agreement with Mereo BioPharma for the U.S. rights to alvelestat, a neutrophil elastase inhibitor that has completed…
    Fierce Biotech · 19h agoDealPositive↗ source
  • Abbott partners with Google Health to add AI-driven insights to its Lingo glucose wearable
    Abbott and Google Health announced a partnership that will combine Abbott's Lingo consumer glucose wearable with Google Health's artificial‑intelligence platform. The integration will let Lingo us…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Amgen to open new R&D Science and Innovation Center in Hyderabad's Genome Valley by 2027
    Amgen announced plans to establish a Science and Innovation Center in Hyderabad's Genome Valley, a biotech hub in India. The facility is slated to open in 2027 and will become part of Amgen's globa…
    Fierce Biotech · 15h agoPositive↗ source
  • Aura Biosciences cuts 20% of staff and reshuffles C-suite to focus on ocular oncology
    Aura Biosciences announced it is eliminating about one-fifth of its workforce as part of a broader restructuring under its new chief executive officer, Natalie Holles, who took the helm in April.…
    Fierce Biotech · 20h agoLayoffsNeutral↗ source
  • Austria launches up to €100 million anchor investment for growth fund, aiming to channel half‑billion euros into biotech
    Austria's government announced a new national Startup & Scaleup Fund as part of the 2027/2028 budget, with an anchor investment of up to €100 million. The public money is designed to attract priva…
    BioSpace · 21h agoPositive↗ source
  • Henkel recalls Schwarzkopf Professional Osis Grip mousse in U.S. over packaging leak risk
    Henkel Corp announced a voluntary recall of its Schwarzkopf Professional Osis Grip mousse (6.76 fl oz/200 ml) sold in the United States. The recall is due to a potential packaging defect that coul…
    fda recalls · 13h agoCRLNegative↗ source
  • Silence causes uproar in rare blood cancer space as data sets high bar for competitors
    The mid-stage win of Silence Therapeutics’ siRNA drug in polycythemia vera validates the therapeutic approach of similar assets in development—but also sets a high standard for therapies from Taked…
    BioSpace · 17h 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 · 14h agoLayoffsNegative↗ source
  • FDA issues early alert after BD needle set defects linked to four deaths
    The FDA’s Center for Devices and Radiological Health released an early alert warning clinicians to stop using Becton Dickinson’s intraosseous vascular access needle sets after reports of serious in…
    Fierce Biotech · 1d agoRegulatoryNegative↗ source
  • Tenax Therapeutics' heart failure drug TNX-103 misses primary endpoint in Phase 3, shares plunge 85%
    Tenax Therapeutics announced that its investigational heart failure drug TNX-103 failed to meet the primary efficacy endpoint in the Phase 3 LEVEL trial. The trial, which enrolled patients with pu…
    BioSpace · 1d agoNegative readoutNegative↗ source
  • Sionna’s cystic fibrosis flop sends stock down 90%, but a ‘significant positive’ for Vertex
    Sionna Therapeutics has axed a cystic fibrosis add-on program after flunking a phase 2 trial, eliminating a would-be challenger to Vertex Pharmaceuticals’ empire. The biotech plans to “take actions…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Eli Lilly's $3.8 B acquisition of AtaiBeckley signals growing confidence in psychedelics for depression
    Psychedelics are being touted as a potential solution for patients who still struggle to find lasting relief from existing FDA‑approved psychiatric medicines. The article notes that many individual…
    BioSpace · 2d agoDealPositive↗ source
  • AbCellera's Phase 2 hot flash trial beats aggressive upside target, challenging Astellas and Bayer
    AbCellera announced that its Phase 2 study of ABCL635, an antibody that blocks the NK3R receptor, met its primary endpoint in postmenopausal women with hot flashes. The trial enrolled 92 participan…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Jazz Pharma to acquire Actio Biosciences for up to $1.3 billion, adding experimental KCNT1 epilepsy drug
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, paying $820 million in cash with up to $500 million in milestone payments. The deal is expected to close by the end of the year.…
    BioSpace · 1d agoDealPositive↗ source
  • Jazz Pharma to acquire Actio Biosciences for $820M, adding KCNT1+ epilepsy drug to its pipeline
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences for an upfront payment of $820 million, expanding its portfolio of epilepsy medicines. The deal brings Actio’s lead candidate, ABS…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Silence Therapeutics’ Phase 2 Trial Shows Strong Efficacy of divesiran in Polycythemia Vera
    Silence Therapeutics reported that its siRNA candidate divesiran met the primary endpoint in a phase 2 study of patients with polycythemia vera. The trial enrolled 48 participants and 88% of those…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • Biogen’s ALS drug shows symptom improvement in some patients three years after approval
    Biogen’s antisense therapy tofersen, marketed as Qalsody, received FDA approval three years ago as the first treatment to target a genetic form of ALS linked to the SOD1 gene. Since then, a number…
    BioSpace · 2d agoPositive readoutPositive↗ source