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  • 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
  • AI investments in healthcare delivering returns faster than executives anticipated
    A new report from Bessemer Venture Partners finds that artificial-intelligence projects in health-care are delivering benefits more quickly than industry leaders expected. The survey highlights th…
    Endpoints · 15d agoPositive↗ source
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  • 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
  • Lycia Therapeutics files for IPO to fund antibody degrader platform
    Lycia Therapeutics, a protein‑degradation startup built on research from Nobel laureate Carolyn Bertozzi, announced it has filed for an initial public offering. The filing is intended to raise cap…
    Endpoints · 15d agoDealNeutral↗ 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
  • Utah expands AI prescribing sandbox to boost health‑tech innovation
    Utah is positioning itself as a national leader in the use of artificial intelligence for healthcare, according to recent reporting. The state’s Office of AI Policy runs a regulatory sandbox that…
    Endpoints · 14d agoRegulatoryPositive↗ source
  • KymaThera secures $80M Series B to advance oral PI3Kα inhibitor K-1728 as biotech peers raise funds and go public
    KymaThera, a San Diego biotech, announced an $80 million Series B round to fund development of its pan-mutant selective PI3Kα inhibitor, K-1728. The oral candidate is planned to enter Phase 1 clin…
    Endpoints · 15d agoDealPositive↗ source
  • Leader Formulas recalls RAPTURE pre-workout supplement after FDA finds DMAA in product
    Leader Formulas, LLC of Tomball, Texas announced a voluntary nationwide recall of one lot of its RAPTURE pre‑workout powder after testing revealed the presence of the stimulant 1,3‑dimethylamylamin…
    fda recalls · 15d agoCRLNegative↗ 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
  • 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
  • Pacific Health Sciences recalls Baby Sleep Gripe Water over undeclared alcohols
    Pacific Health Sciences announced a voluntary recall of one lot of its Babies' Magic Tea brand Baby Sleep Gripe Water dietary supplement. FDA testing identified undeclared ethanol, methanol and is…
    fda recalls · 15d agoCRLNegative↗ 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
  • Secretive new issue links diverse groups, raises concerns for pharma industry
    The article, dated October 6, 2026, was written by senior reporter Max Bayer and carries the title “In DC, a secretive new thorn has appeared in pharma’s side.” It notes that the Seattle Latino Ch…
    Endpoints · 14d agoNegative↗ 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 experimental pneumococcal vaccine VAX-31 meets Phase 3 endpoints, shares jump 35%
    Vaxcyte announced that its experimental pneumococcal vaccine VAX-31 achieved its primary objectives in a Phase 3 trial involving adult participants. The trial results showed that the vaccine met t…
    Endpoints · 16d agoPositive readoutPositive↗ 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
  • Nobel Prize honors optogenetics pioneers; Roche licenses Alector’s Parkinson’s enzyme therapy
    The Nobel Committee awarded this year’s Physiology or Medicine prize to three scientists whose work created the field of optogenetics. Their discoveries of a light‑sensing protein in algae and its…
    BioPharma Dive · 16d agoDealPositive↗ source
  • FDA urged to boost US access to new and experimental drugs as trials shift to China
    The piece highlights that the FDA has taken steps such as launching Operation TrialBlazer and tightening review of foreign clinical data, but argues that further action is required to keep the Unit…
    BioSpace · 16d agoRegulatoryNegative↗ source
  • FDA approves first expandable pediatric pulmonary heart valve
    The FDA has cleared a new surgically implanted pulmonary valve designed for children with congenital pulmonary valve disease. The device, called the Autus Size-Adjustable Valve, was developed by E…
    Fierce Biotech · 16d agoApprovalPositive↗ source