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1,836 stories matching this filter · ← front page

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  • Tiziana's lower-dose foralumab cuts neuroinflammation in SPMS, but higher dose fails
    Tiziana Life Sciences reported that its intranasal anti‑CD3 antibody, foralumab, lowered a neuroinflammation biomarker in patients with non‑active secondary progressive multiple sclerosis when give…
    BioSpace · 7d agoNegative readoutNegative↗ source
  • FDA accepts review of Biohaven’s ataxia drug, boosting shares as ArriVent’s lung cancer trial miss drags its stock down
    Biohaven saw its shares jump after the FDA agreed to review its rare‑disease drug for spinocerebellar ataxia. The regulator’s decision lifted the stock by roughly 25% in late October, offering the…
    BioSpace · 7d agoRegulatoryNeutral↗ source
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  • Karyopharm files Chapter 11 and taps Irish biotech Ayrmid as lead bidder for merger
    Karyopharm Therapeutics, a Massachusetts-based biopharma, entered Chapter 11 bankruptcy as part of a plan to merge with Irish hematology biotech Ayrmid. The move follows a cash crisis revealed in…
    Fierce Biotech · 7d agoDealNegative↗ source
  • Biossil Labs acquires Theriva's antibiotic-degrader portfolio in up to $91 million deal
    Biossil Labs, a Canadian biotech backed by OpenAI, announced a deal to acquire Theriva Biologics' early- to mid-stage portfolio of antibiotic‑degrading enzymes for a total potential value of up to…
    Fierce Biotech · 7d agoDealNeutral↗ source
  • FDA places partial hold on Bright Minds' seizure trial over mouse toxicity concerns
    The FDA issued a partial clinical hold on Bright Minds Biosciences' planned phase 2 trial of BMB-101 in patients with developmental and epileptic encephalopathies. The hold was triggered by precli…
    Fierce Biotech · 7d agoRegulatoryNegative↗ source
  • Top pharma firms line up for Summit Therapeutics' ivonescimab after strong China Phase 3 data
    Several major biopharma companies, including AstraZeneca, Pfizer and Revolution Medicines, are expressing strong interest in Summit Therapeutics' Akeso-partnered bispecific antibody ivonescimab. Th…
    BioSpace · 8d agoDealPositive↗ source
  • Saudi Arabia pushes ahead with biotech hub despite regional instability
    Saudi Arabia is constructing a regulatory framework, partnership networks and intellectual property structures to nurture a biotech ecosystem, even as regional political tensions persist. Experts…
    BioSpace · 8d agoPositive↗ source
  • BridgeBio eyes first FDA approval for limb-girdle muscular dystrophy therapy
    BridgeBio Pharma is preparing for a potential launch of its experimental drug BBP-418 aimed at treating limb-girdle muscular dystrophy type 2I/R9, pending FDA decision. The agency has set a review…
    BioSpace · 8d agoRegulatoryPositive↗ source
  • Teva halts phase 2 trial of emrusolmin for multiple system atrophy after futility analysis
    Teva Pharmaceuticals announced it is stopping a phase 2 study of its experimental small‑molecule drug emrusolmin, which was being tested in patients with the rare neurodegenerative condition multip…
    Fierce Biotech · 7d agoNegative readoutNegative↗ source
  • Tiziana's intranasal MS drug shows lower dose cuts neuroinflammation, higher dose falls short in Phase 2a trial
    Tiziana Life Sciences reported results from its mid‑stage Inform‑MS trial, a Phase 2a study that enrolled 48 patients with non‑active secondary progressive multiple sclerosis. Participants received…
    Fierce Biotech · 7d agoPositive readoutNeutral↗ source
  • FDA approves generic lenacapavir for low-income markets; EMA to review Lundbeck's Deanxit over safety concerns
    The U.S. Food and Drug Administration has granted approval for a generic version of lenacapavir, a drug aimed at treating HIV, with the intention of making it available to lower-income countries.…
    raps · 8d agoApprovalNeutral↗ source
  • U.S. bioscience jobs up 7% from 2021 to 2025: Report
    Bioscience employment rose in 41 states, though not in California, according to a new report from the Biotechnology Innovation Organization and the Council of State Bioscience Associations.
    BioSpace · 7d agoRegulatoryNeutral↗ source
  • Study finds patient agreement forms match knowledge surveys, urging greater transparency in FDA’s mifepristone REMS
    A randomized controlled trial published in JAMA Internal Medicine examined how well patients understood medication abortion when they signed the FDA’s risk evaluation and mitigation strategy (REMS)…
    raps · 8d agoRegulatoryNeutral↗ source
  • Australian regulator opens consultation on clinical trial data sharing and ICH GCP guidance
    The Therapeutic Goods Administration (TGA) in Australia has launched a public consultation seeking input on how clinical trial information should be shared under existing schemes. The consultation…
    raps · 8d agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
    The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
    fda press · 10d agoApprovalPositive↗ source
  • Regeneron posts $5.1 billion Q3 revenue, beating forecasts and highlighting strong sales of Dupixent, Eylea HD and Libtayo
    Regeneron reported third‑quarter revenue of $5.1 billion, well above the consensus range of $4.61‑$4.65 billion and representing a 36% increase from the same period last year. The company attribut…
    BioSpace · 10d agoEarningsPositive↗ source
  • AbbVie beats Q3 expectations, lifts full-year EPS outlook as immunology and neuroscience drive growth
    AbbVie reported third-quarter results that exceeded analysts' sales and earnings per share forecasts. The company posted $17.4 billion in revenue, driven largely by its immunology franchise which…
    BioSpace · 10d agoEarningsPositive↗ source
  • Alnylam shares tumble 25% as analysts flag uncertainties in its transthyretin franchise
    Alnylam Therapeutics saw its stock fall about a quarter on Thursday, closing near $174 after analysts highlighted a trio of uncertainties surrounding its transthyretin (TTR) franchise. The TTR fra…
    BioSpace · 10d agoEarningsNegative↗ source
  • Early-stage data show promise for targeting Wnt/β-catenin pathway across cancers
    Early-stage clinical results from the company and several peers indicate that the Wnt/β-catenin signaling pathway could become a viable target for treating a range of tumor types. The pathway has…
    BioSpace · 10d agoPositive readoutPositive↗ source
  • Sanofi eyes 'moonshot' drug acquisitions to offset upcoming Dupixent patent loss
    Sanofi's CFO Francois-Xavier Roger told Fierce that the company is looking at 'moonshot' treatments as potential acquisition targets to rebuild its pipeline. The push comes as the U.S. patent on D…
    Fierce Biotech · 11d agoDealNeutral↗ source
  • AstraZeneca launches $1.5 billion cost-saving plan to fund growth, says no layoffs expected
    AstraZeneca announced a three-year cost‑saving initiative worth $1.5 billion during its third‑quarter earnings call. The program, called Reshaping for Sustainable Growth, aims to redeploy resource…
    BioSpace · 10d agoEarningsPositive↗ source
  • Sanofi eyes late-stage and commercial acquisitions to counter upcoming Dupixent revenue drop
    Sanofi said on its third‑quarter earnings call that it is looking to acquire late‑stage and commercial medicines to sustain growth after Dupixent loses exclusivity. CEO Belén Garijo highlighted th…
    BioSpace · 10d agoDealPositive↗ source
  • Setara Biosciences raises $90 million Series A to advance Jazz-spun rare disease programs
    Setara Biosciences has been created to focus on a set of rare-disease assets that Jazz Pharmaceuticals retained after acquiring Actio Biosciences. The new company secured $90 million in Series A f…
    BioSpace · 10d agoDealPositive↗ source
  • Bracco to invest $230M in new US contrast media plant, creating 200 jobs
    Bracco Diagnostics announced a $230 million investment to build its first U.S. manufacturing facility for injectable contrast media in Sanford, North Carolina. The plant is slated to create about…
    Fierce Biotech · 11d agoDealPositive↗ source
  • Molecular Partners to cut up to 44% of staff as it shifts focus to radiotherapy pipeline
    Molecular Partners announced it will lay off up to 44% of its workforce, affecting as many as 55 positions, as the Swiss biotech redirects its limited cash toward a radiotherapeutic program. The c…
    Fierce Biotech · 11d agoLayoffsNegative↗ source