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1,273 stories matching this filter · ← front page

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  • 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 · 22d agoDealPositive↗ source
  • Israeli biotech's inhaled exosome therapy cuts respiratory failure and mortality in ARDS phase 2b trial
    Nano24, an Israeli biotech company, tested its inhaled exosome product EXO‑CD24 in a mid‑stage study involving 90 patients with acute respiratory distress syndrome. The trial compared the therapy,…
    Fierce Biotech · 22d agoPositive readoutPositive↗ 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 · 22d agoApprovalPositive↗ source
  • Pathos AI partners with BMS and Tempus to use AI for Alzheimer’s drug development
    Pathos AI announced two collaborations aimed at accelerating drug development for neurological disorders, including Alzheimer’s disease. The agreement with Bristol Myers Squibb gives the pharma co…
    Fierce Biotech · 22d agoDealPositive↗ 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 · 22d agoPositive readoutPositive↗ source
  • Lilly reports 79% response rate for FRα-directed ADC in platinum-sensitive ovarian cancer
    Lilly presented phase 1 data on its FRα‑directed antibody‑drug conjugate, sofetabart mipitecan (Sofe-M), combined with bevacizumab in patients whose ovarian cancer had progressed after platinum the…
    Fierce Biotech · 22d agoPositive readoutPositive↗ source
  • Merck acquires Silence Therapeutics for $1.3B; Hansoh Pharma signs $15B deal with Roche
    German Merck announced the acquisition of Silence Therapeutics in a transaction valued at $1.3 billion. In China, Hansoh Pharma disclosed a partnership with Roche that involves a $15 billion drug…
    raps · 23d agoDealNeutral↗ 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 · 22d 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 · 22d 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 · 22d 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 · 22d 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 · 22d 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 · 22d agoDealPositive↗ source
  • Japan’s PMDA releases guidance on evaluating generative AI-enabled medical devices
    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a set of review points aimed at medical devices that incorporate generative artificial intelligence. The guidance outlines th…
    raps · 23d agoRegulatoryNeutral↗ source
  • Philips issues updated use instructions for Lumify ultrasound systems after software glitch risk
    Philips Ultrasound has sent a letter to customers of its Lumify diagnostic ultrasound system, advising that the devices require updated use instructions. The update addresses a software applicatio…
    fda medwatch · 22d agoCRLNegative↗ source
  • MedTech firms grow more comfortable with FDA's Quality Management System Regulation amid inspection concerns
    At The MedTech Conference in Boston, a senior industry executive reported that the medtech sector is gradually accepting the new Quality Management System Regulation (QMSR) despite early worries.…
    raps · 23d agoRegulatoryNeutral↗ 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 · 23d 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 · 25d 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 · 25d agoDealPositive↗ source
  • FDA issues warning letters to drug makers over CGMP lapses and highlights patient rep ties to industry-backed groups
    The FDA has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practice requirements, citing problems with ensuring product sterility and meeting sp…
    raps · 26d agoRegulatoryNegative↗ source
  • Ambrose Healthcare acquires AM-Pharma for up to €161 million
    Ambrose Healthcare, a British rare‑disease specialist, announced it has completed the acquisition of Dutch biotech AM‑Pharma. The deal values the company at up to 161 million euros (about $181 mill…
    Fierce Biotech · 25d agoDealNeutral↗ 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 · 25d agoDealPositive↗ source
  • FDA issues warning letters to drug makers and a lab over CGMP and GLP violations
    FDA sent warning letters to several drug manufacturers for not meeting current good manufacturing practice (CGMP) requirements. The letters point to issues such as ensuring final product sterility…
    raps · 26d agoRegulatoryNegative↗ 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 · 25d 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 · 25d ago↗ source