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834 stories matching this filter · ← front page

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  • 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 · 19h agoApprovalPositive↗ source
  • Roche signs $15 billion ADC partnership with China's Hansoh Pharma
    Roche has re-entered a partnership with China's Hansoh Pharmaceutical, signing a $15 billion biobucks agreement. The deal covers a broad portfolio of antibody-drug conjugate programs, including tw…
    Fierce Biotech · 20h agoDealPositive↗ source
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  • FDA Grants Accelerated Approval for Jemperli Immunotherapy in Locally Advanced Rectal Cancer
    The U.S. Food and Drug Administration has granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab‑gxly). The approval applies to adults with previously untreated stage…
    fda press · 11h agoApprovalPositive↗ source
  • AbbVie’s combo of Skyrizi and trosunilimab shows higher remission than Skyrizi alone in phase 2 Crohn’s trial
    AbbVie tested a next‑generation Crohn’s disease regimen by randomizing 300 patients with moderate‑to‑severe disease to receive Skyrizi, the α4β7 inhibitor trosunilimab, or the two drugs together (c…
    Fierce Biotech · 22h 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 · 17h agoDealPositive↗ source
  • TCGX uses SPAC to take migraine biotech TriGemX public, securing $246M for phase-3 trial
    TCGX, a life‑sciences investment firm, announced it will merge its SPAC with TriGemX Bio, a biotech focused on migraine treatments. TriGemX, formerly known as Kallyope, is developing a TRPM8 chann…
    Fierce Biotech · 17h agoDealPositive↗ source
  • Gilead reports positive Phase 2 results for oral ulcerative colitis drug
    Gilead announced that its experimental oral therapy for ulcerative colitis achieved positive results in a Phase 2 trial. The study reported that patients receiving the drug showed measurable clini…
    Fierce Biotech · 18h agoPositive readoutPositive↗ source
  • Enlivex cuts 60% of staff, halts preclinical R&D and slashes exec salaries to fund osteoarthritis trial
    Enlivex, an Israeli biotech developing a cell‑based immunotherapy called allocetra for knee osteoarthritis, announced today that it is reducing its workforce by 60 percent. The cut reduces the sta…
    Fierce Biotech · 18h agoLayoffsNegative↗ 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 · 18h agoDealNeutral↗ source
  • Siemens Healthineers teams with Paradromics to develop multimodal imaging platform for brain-computer interfaces
    Siemens Healthineers and Paradromics announced a collaboration to build an advanced multimodal imaging system designed to support implantable brain‑computer interfaces (BCIs). The partnership combi…
    Fierce Biotech · 1d agoDealPositive↗ 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 · 1d agoDealPositive↗ source
  • China drafts policy to block foreign buyouts of key cell-gene therapy and siRNA platforms
    China’s government has released a draft amendment to its export blacklist that would prohibit or tightly control foreign purchases of certain biopharmaceutical platforms. The rule targets propriet…
    Fierce Biotech · 3d agoRegulatoryNegative↗ source
  • Nouscom secures €120M to advance off-the-shelf cancer vaccine for Lynch syndrome
    Swiss biotech Nouscom announced a €120 million (about $135 million) Series D financing round. The capital will fund a registration-enabling pivotal trial of its cancer-preventing vaccine candidate.…
    Fierce Biotech · 3d agoDealPositive↗ source
  • City Therapeutics completes $200 million IPO, earmarks funds for RNAi therapies
    City Therapeutics, based in Cambridge, Massachusetts, launched an IPO raising $200 million, exceeding its original target of 9.7 million shares at $17-$19 per share. The company sold 11.1 million…
    Fierce Biotech · 4d agoDealPositive↗ 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 · 4d agoPositive↗ source
  • FDA issues early alert for Edwards Lifesciences’ mitral valve delivery system after reported death, injury
    The FDA has issued an early alert for certain delivery systems used with Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement system amid serious safety concerns.
    Fierce Biotech · 4d ago↗ source
  • Vanda pauses social anxiety program after ex-Novartis asset flunks phase 3 study
    A phase 3 trial of Vanda Pharmaceuticals’ social anxiety disorder drug candidate has missed its primary endpoint, prompting the company to put the program on hold.
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • Estuary Biotherapeutics raises $103M to advance gene therapies for polycystic kidney disease
    Estuary Biotherapeutics announced it has exited stealth mode after securing $103 million in financing to move two gene‑therapy candidates into clinical testing for autosomal dominant polycystic kid…
    Fierce Biotech · 4d agoDealPositive↗ source
  • AstraZeneca signs $1.5B AI partnership with insitro to discover liver and heart disease targets
    AstraZeneca announced a partnership with insitro, a biotech that uses artificial intelligence, with an upfront payment of $40 million and potential milestones up to $1.46 billion. The collaboratio…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Iambic Therapeutics raises $150 million in IPO to fund oncology drug development
    Iambic Therapeutics, a San Diego-based AI biotech, completed an initial public offering that raised $150 million, exactly meeting its goal of selling 9.4 million shares at $16 each. The company sa…
    Fierce Biotech · 5d agoDealPositive↗ source
  • IQVIA urges early clinical insight in drug discovery to boost patient benefit
    IQVIA Laboratories' leaders argue that drug discovery and clinical development should be linked early to improve patient outcomes. They explain that decisions made during discovery affect later cl…
    Fierce Biotech · 4d agoPositive↗ source
  • OrbiMed raises $3 billion, its biggest Asian fund yet, to boost biotech investments worldwide
    OrbiMed announced it has closed a $3 billion fundraising round, the largest ever for its Asia‑focused vehicle. The capital will be used to make new growth‑equity and venture investments in biotech…
    Fierce Biotech · 4d agoDealPositive↗ source
  • SimBioSys receives FDA clearance for Nvidia-powered AI tool to predict breast cancer recurrence
    SimBioSys announced FDA clearance for its TumorSight Risk platform, an AI-driven tool that uses MRI, pathology and clinical data to assess the likelihood of breast cancer returning. The cloud-base…
    Fierce Biotech · 5d agoRegulatoryPositive↗ source
  • Osivax’s flu vaccine OVX836 misses primary efficacy goal in phase 2b trial
    Osivax announced that its influenza A vaccine candidate OVX836 failed to meet the primary efficacy endpoint in a phase 2b trial involving 2,850 healthy adults in Europe. The trial showed a vaccine…
    Fierce Biotech · 4d agoNegative readoutNegative↗ source
  • Bausch + Lomb CEO Brent Saunders exits again, interim CEO Thomas Appio appointed
    Bausch + Lomb announced that CEO Brent Saunders is leaving the eye health company for a second time, less than four years into his latest tenure. The departure was mutually agreed upon by Saunders…
    Fierce Biotech · 4d agoNeutral↗ source