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2,334 stories matching this filter · ← front page

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  • 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 · 14d 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 · 14d 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…
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Endpoints · 15d ago
Positive 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 · 15d 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 · 15d 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 · 15d 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 · 15d 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
  • Shionogi to acquire Texas-based IntraBio for $2 billion, adding marketed rare-disease drug Aqneursa
    Shionogi announced Monday it will buy IntraBio, a Texas biotech, for $2 billion in cash, making IntraBio a wholly owned subsidiary of its U.S. division. The deal gives Shionogi ownership of Aqneur…
    BioPharma Dive · 15d agoDealPositive↗ source
  • Lilly adds $870M to Gate Bioscience partnership to pursue new drug targets
    Eli Lilly is expanding its collaboration with Gate Bioscience, adding a new financial commitment of more than $870 million. The original July 2025 agreement gave Lilly access to Gate’s "Molecular…
    BioSpace · 15d agoDealPositive↗ source
  • Shionogi agrees $2 billion upfront purchase of IntraBio, adding oral rare-disease drug Aqneursa to its portfolio
    Shionogi announced it will acquire Austin-based biotech IntraBio for $2 billion paid upfront. The deal brings IntraBio’s oral therapy Aqneursa into Shionogi’s rare‑disease pipeline, expanding its…
    Endpoints · 15d agoDealPositive↗ source
  • AI drives faster drug development and reshapes biopharma manufacturing facilities
    AI is speeding up the identification of drug candidates, turning years of laboratory work into months by analyzing large biological datasets and accelerating early‑stage development. This accelera…
    BioPharma Dive · 16d agoPositive↗ source
  • Leerink analyst downgrades Bristol Myers over pipeline concerns
    A Leerink analyst signaled new bearishness on Bristol Myers Squibb, downgrading the company's stock rating. Analyst David Risinger moved the rating from outperform to a lower stance, saying he is…
    Endpoints · 15d agoNegative↗ source
  • Viking Therapeutics jumps 24% after Phase 1 obesity data, Longeveron falls 64% on mid-stage setback
    In September biotech stocks showed wide swings, with Viking Therapeutics gaining 24% and Longeveron dropping 64% as investors reacted to clinical data and trial setbacks. Viking reported Phase 1 r…
    BioSpace · 15d agoPositive readoutNeutral↗ source
  • Genmab reports 45.9% response rate for FRα‑directed ADC in platinum‑resistant ovarian cancer; Lilly expands Jaypirca label
    Genmab presented new data on its FRα‑targeted antibody‑drug conjugate Rina‑S in patients with platinum‑resistant ovarian cancer. In the trial, the ADC achieved an objective response rate of 45.9%,…
    Endpoints · 15d agoPositive readoutPositive↗ source
  • Roche signs $100 million upfront deal with Alector to advance Parkinson's research
    Roche announced a partnership with biotech Alector focused on neuroscience and Parkinson's disease, providing an upfront cash payment of $100 million. The agreement aims to combine Roche's resourc…
    Endpoints · 15d agoDealPositive↗ source
  • Biogen's litifilimab shows clear or almost clear skin in cutaneous lupus after one year
    Biogen reported that its experimental antibody litifilimab produced clear or almost clear skin in patients with cutaneous lupus erythematosus after one year of treatment in a mid‑stage study. The r…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • Nobel prize honors scientists who pioneered light-activated gene therapy technology
    Three researchers received this year’s Nobel Prize in medicine for creating optogenetics, a technique that uses light to steer nerve activity. The award recognizes their foundational work that has…
    Endpoints · 15d agoPositive↗ source
  • Sensible Bio raises $47 million Series A to build mRNA therapy manufacturing platform
    Sensible Biotechnologies announced it has closed a $47 million Series A financing round. The capital will be used to develop its proprietary manufacturing platform for mRNA based therapies. The fu…
    Endpoints · 15d agoDealPositive↗ source
  • Epicrispr reports encouraging early data from EPI-321 in 12 patients with FSHD
    Epicrispr Biotechnologies released updated data on its epigenetic editing therapy EPI-321 aimed at treating facioscapulohumeral muscular dystrophy (FSHD). The company has now dosed twelve particip…
    Endpoints · 15d agoPositive readoutPositive↗ source
  • Kyverna Therapeutics reports encouraging data for first CAR-T therapy targeting autoimmune disease
    Kyverna Therapeutics released new data that strengthens its case for bringing the first CAR‑T treatment for an autoimmune condition to market. The results come after recent safety setbacks in simil…
    BioSpace · 16d agoPositive readoutNeutral↗ source
  • Roivant Sciences launches first solo drug, Lisraya, after FDA approval for dermatomyositis
    Roivant Sciences, which operates a hub-and-spoke subsidiary model, is stepping into the commercial arena with its inaugural solo product launch. The FDA has granted approval to the oral TYK2/JAK i…
    BioSpace · 16d agoApprovalPositive↗ source
  • CSL agrees $355M upfront deal to co-develop Alentis anti-fibrosis drug for kidney and liver
    CSL, an Australian drugmaker, announced a partnership with Alentis Therapeutics that includes a $355 million upfront payment. Under the agreement, CSL will co-develop Alentis's anti-fibrosis candi…
    Endpoints · 16d agoDealNeutral↗ source
  • FDA delays review of Novo's hemophilia A drug denecimig over factory issues
    US regulators have extended the review of Novo's hemophilia A injection, denecimig, because of problems at an unnamed manufacturing facility. The FDA said ongoing remediation activities observed d…
    Endpoints · 15d agoRegulatoryNegative↗ source
  • CSL strikes up to $1.6B deal with Alentis for autoimmune drug with broad potential
    CSL will co-develop and co-promote Alentis Therapeutics' anti-claudin-1 therapy lixudebart for kidney and liver conditions, including primary sclerosing cholangitis and a systemic autoimmune diseas…
    BioSpace · 15d agoDealNeutral↗ source