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  • MimiVax’s cancer vaccine fails phase 2 glioblastoma study, but CEO still sees data as ‘inspiring’
    MimiVax has reports a phase 2b miss in newly diagnosed glioblastoma patients, but remains positive about a significant survival benefit in a subset of patients 65 years and under.
    Fierce Biotech · 15d agoNegative readoutNegative↗ source
  • GE HealthCare to buy Sofie Biosciences for $945 million, boosting U.S. PET radiopharma capacity
    GE HealthCare announced it will acquire Sofie Biosciences for $945 million in cash, aiming to broaden its radiopharmaceutical manufacturing and distribution in the United States. Sofie Biosciences…
    BioPharma Dive · 15d agoDealPositive↗ source
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  • Forbion raises record €2.3 billion to back 30 European biotech firms
    Forbion Capital Partners announced it has closed two new funds, the Growth Opportunities Fund IV and Ventures Fund VIII, together raising €2.3 billion, a record for the European life‑sciences ventu…
    Fierce Biotech · 15d agoDealPositive↗ source
  • TRex Bio targets $111M IPO as Retension and Lycia also prepare public listings
    TRex Bio, backed by Eli Lilly, filed with the SEC to raise about $111.3 million by offering 8.3 million shares priced between $14 and $16. If the midpoint price is achieved, the company expects net…
    Fierce Biotech · 15d agoDealNeutral↗ source
  • UK regulator to shift from one-off checks to continuous monitoring of AI medical devices
    The UK’s Medicines and Healthcare products Regulatory Agency announced a new policy that will require continuous monitoring of AI‑driven medical devices, replacing the current one‑time review model…
    Fierce Biotech · 15d agoRegulatoryPositive↗ source
  • Caribou Biosciences halts pipeline and announces major workforce cut
    Caribou Biosciences, a Bay Area biotech that develops off-the-shelf CAR-T cell therapies, said it will stop all clinical development and begin a substantial workforce reduction. The company, which…
    Fierce Biotech · 15d agoLayoffsNegative↗ source
  • Forbion raises $2.6 billion for two European biotech venture funds
    Forbion announced it has secured 2.3 billion euros ($2.6 billion) across two new venture funds, its largest raise to date. The funds, called Forbion Growth Opportunities IV and Forbion Ventures Fu…
    BioPharma Dive · 15d agoDealPositive↗ source
  • ArriVent shares tumble as lung cancer trial of furmonertinib misses primary goal
    ArriVent BioPharma reported that its late-stage study of furmonertinib in patients with EGFR exon 20 insertion-mutated non-small cell lung cancer did not achieve its primary endpoint. The trial, w…
    BioPharma Dive · 15d agoNegative readoutNegative↗ source
  • Compliance worries keep AI adoption in drug manufacturing low, survey finds
    A new survey of more than 400 research and manufacturing professionals shows that over 90% of drugmakers have not committed to expanding AI use in regulated drug production. While AI is widely em…
    BioSpace · 15d agoRegulatoryNegative↗ source
  • ArriVent’s phase 3 EGFR inhibitor trial misses primary endpoint, shares plunge 57%
    ArriVent BioPharma reported results from its phase 3 Furvent trial, which evaluated firmonertinib, a brain-penetrant EGFR inhibitor, in patients with exon 20 insertion-mutated non-small cell lung c…
    Fierce Biotech · 15d agoNegative readoutNegative↗ source
  • Kairos pushes prostate cancer drug ENV-105 into earlier treatment line after promising mid-phase data
    Kairos Pharma announced a change to its phase 2 trial of ENV-105, a prostate cancer candidate, moving it to an earlier line of therapy. The modified protocol will enroll patients whose PSA rises a…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • Abbott receives FDA clearance for CardioMEMS HF System updates enabling home pressure monitoring via smartphone app
    Abbott announced that the U.S. Food and Drug Administration has cleared updated software for its CardioMEMS HF System. The changes add a patient facing component through the CardioGuide HF mobile a…
    Fierce Biotech · 15d agoApprovalPositive↗ source
  • AstraZeneca opens 570,000-sq-ft Kendall Square R&D hub to boost cancer and biotech research
    AstraZeneca inaugurated a 570,000-square-foot research and development facility in Kendall Square, Cambridge, Massachusetts. The 18-story building will host roughly 2,000 scientists working on chr…
    Fierce Biotech · 15d agoPositive↗ source
  • BioSpace honors 40 emerging leaders shaping biopharma with breakthroughs in mRNA, gene and cell therapies
    BioSpace announced its latest 40 Under 40 cohort, recognizing young professionals who have made notable contributions across biopharma. The honorees span a range of roles, from scientific innovator…
    BioSpace · 15d agoPositive↗ source
  • UK regulator adopts AI framework for medical devices and launches third AI Airlock phase
    The Medicines and Healthcare products Regulatory Agency (MHRA) announced that the UK government has adopted a set of recommendations on the use of artificial intelligence in medical devices. These…
    raps · 15d agoRegulatoryNeutral↗ source
  • UK regulator adopts AI framework for medical devices, launches next phase of AI sandbox
    The Medicines and Healthcare products Regulatory Agency announced that the UK government has accepted a set of recommendations on using artificial intelligence in medical devices. These recommendat…
    raps · 15d agoRegulatoryPositive↗ source
  • Key Biopharma Conferences to Watch in 2027 Highlight Industry Trends
    The article lists major medical meetings slated for 2027 that serve as platforms for companies to present clinical data and network. Highlights include the J.P. Morgan Healthcare Conference in ear…
    BioPharma Dive · 15d agoNeutral↗ source
  • WHO releases updated draft guideline to strengthen quality risk management for manufacturers and regulators
    The World Health Organization has issued an updated draft guideline designed to help manufacturers establish effective quality risk management systems and to aid regulators in planning inspections.…
    raps · 15d agoRegulatoryNeutral↗ source
  • Nuvig Therapeutics pauses CIDP trial of NVG-2089, cites enrollment and cost challenges
    Nuvig Therapeutics, backed by major pharmaceutical partners, announced it is stopping development of its lead fusion protein NVG-2089 for chronic inflammatory demyelinating polyradiculoneuropathy (…
    Fierce Biotech · 15d agoNegative↗ source
  • Season 2 of The Progress Profile podcast spotlights Alzheimer’s research and patient-centered trial design
    The Progress Profile: Alzheimer’s Research in Focus returns for a second season, offering conversations about Alzheimer’s disease and brain health. In the premiere episode, Dr. John Harrison, Dr.…
    BioPharma Dive · 15d agoNeutral↗ source
  • Shionogi makes $2B rare disease play with IntraBio buy
    With its acquisition of IntraBio, Shionogi will gain ownership over Aqneursa, which could hit peak global sales of $1 billion across its two indications in Niemann-Pick disease type C and ataxia-te…
    BioSpace · 15d ago↗ source
  • FDA extends review of Novo’s hemophilia A drug, citing manufacturing issues
    Despite the regulatory delay, Novo is still expecting a 2027 launch for its hemophilia A drug denecimig.
    BioSpace · 15d ago↗ source
  • Vaxcyte's next-gen pneumococcal vaccine matches leading shots in Phase 3 trial
    Vaxcyte reported that its experimental pneumococcal vaccine, VAX-31, achieved its primary efficacy goals in the first of three Phase 3 studies. In adults aged 50 and older, the vaccine performed o…
    BioPharma Dive · 16d agoPositive readoutPositive↗ source
  • Vaxcyte’s VAX-31 shows superior results in Phase 3, beating Pfizer and Merck’s pneumococcal vaccines and sparking $8 bn market hopes
    Vaxcyte reported that its investigational pneumococcal conjugate vaccine, VAX-31, met the co-primary endpoints in a Phase 3 trial, demonstrating non-inferiority to the existing shots from Pfizer an…
    BioSpace · 16d agoPositive readoutPositive↗ source
  • Genentech signs up to develop Alector’s preclinical blood-brain barrier therapy in $1.27 billion deal
    Genentech, a Roche subsidiary, announced a deal with Alector to obtain exclusive rights to its preclinical blood-brain barrier delivery asset, AL050. The agreement provides $100 million upfront an…
    BioSpace · 16d agoDealPositive↗ source