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  • Ionis secures FDA approval for zilganersen, a first treatment for Alexander disease
    Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration has approved its antisense drug zilganersen for the treatment of Alexander disease, an ultra‑rare neurodegenerative disord…
    Fierce Biotech · 10d agoApprovalPositive↗ source
  • Menarini to launch Gan & Lee’s GLP-1 drug bofanglutide across Europe in $771 M partnership
    Italian firm Menarini Group has entered a licensing agreement with Chinese insulin producer Gan & Lee Pharmaceuticals to bring the GLP-1 compound bofanglutide to Europe. The deal includes an upfro…
    Fierce Biotech · 10d agoDealPositive↗ source
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  • Novartis' Lp(a) drug pelacarsen fails to cut heart attack or stroke risk in phase 3 trial
    Novartis, in partnership with Ionis, completed the phase 3 Lp(a)Horizon trial of pelacarsen, an antisense oligonucleotide designed to lower lipoprotein(a) levels. The study enrolled more than 8,30…
    Fierce Biotech · 9d agoNegative readoutNegative↗ source
  • FDA issues guidance to prevent newborn nutrition supply gap
    The U.S. Food and Drug Administration announced it is taking action to address a potential supply gap of neonatal starter parenteral nutrition, which provides essential IV nutrients to premature an…
    fda press · 9d agoRegulatoryPositive↗ source
  • NeuShen Therapeutics raises over $80 million to advance three brain-health drug candidates
    NeuShen Therapeutics, a biotech with operations in Shanghai and Boston, announced it has closed a Series B financing round of more than $80 million. The capital will be used to move three clinical…
    Endpoints · 10d agoDealPositive↗ source
  • Truist sees biotech rebound as M&A hits $136B and XBI climbs 34% in H1
    Truist Securities says the biotech sector is regaining momentum after a prolonged post‑pandemic slowdown, driven by rising merger activity, returning venture capital and easing policy risks. The S…
    BioSpace · 10d agoPositive↗ source
  • Pfizer transfers Seagen ADC PF-08046031 to Medicus, adds $12M upfront payment amid acquisition doubts
    Pfizer has moved primary responsibility for an investigational antibody‑drug conjugate, PF‑08046031, to Medicus Pharma as part of its $43 billion Seagen acquisition. Under the license, Medicus wil…
    BioSpace · 10d agoDealNegative↗ source
  • Menarini secures European rights to Chinese GLP-1 obesity drug
    Menarini Group, a large family‑owned pharmaceutical company in Italy, has obtained the European commercial rights to a GLP‑1 agonist developed by China’s Gan & Lee. The agreement gives Menarini a…
    Endpoints · 10d agoDealPositive↗ source
  • Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapies
    Industry stakeholders have asked the U.S. Food and Drug Administration to expand the scope of its recent draft guidance on scientifically valid prior knowledge for gene therapies that involve genom…
    raps · 10d agoRegulatoryNeutral↗ source
  • MassBio and SCbio select 10 life science startups for Drive accelerator
    MassBio and SCbio announced that ten early‑stage life‑science companies have been chosen for the fall cohorts of the Drive accelerator program. The selection includes five biotech firms and five te…
    BioSpace · 10d agoPositive↗ source
  • Thiel-backed Lindus Therapeutics sells CRO division and shifts focus to acquiring drug assets
    Lindus Therapeutics, a transatlantic startup backed by Peter Thiel, announced the sale of its contract research organization (CRO) arm. The company, previously positioning itself as an “anti‑CRO,”…
    Endpoints · 10d agoDealNeutral↗ source
  • FDA approves Zanvastro, first therapy targeting protein buildup in Alexander disease
    The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in both pediatric and adult patients. Zanvastro is the first FDA-approve…
    fda press · 10d agoApprovalPositive↗ source
  • Ultragenyx’s Angelman therapy fails Phase 3, stock drops over 43% and company announces strategic review
    Ultragenyx reported that its investigational Angelman syndrome drug apazunersen did not meet the primary cognitive endpoints in a Phase 3 trial. The lack of efficacy means the therapy will not prov…
    BioSpace · 11d agoNegative readoutNegative↗ source
  • Akeso and Summit report ivonescimab meets overall survival endpoint in Phase 3 lung cancer trial
    Akeso and its partner Summit said the Phase 3 trial of ivonescimab, a PD-1xVEGF bispecific antibody, has met its overall survival endpoint in a selected group of lung cancer patients. The announcem…
    Endpoints · 11d agoPositive readoutPositive↗ source
  • AbbVie reports 60% reduction in progression risk for myeloma drug etentamig in Phase 3 trial
    AbbVie announced results from a Phase 3 study of its T cell engager etentamig in patients with multiple myeloma. The trial demonstrated a 60% relative reduction in the risk of disease progression…
    Endpoints · 11d agoPositive readoutPositive↗ source
  • Summit and Akeso's ivonescimab beats Merck's Keytruda in Chinese NSCLC trial
    Summit Therapeutics and Akeso reported that their bispecific PD-1/VEGF antibody ivonescimab outperformed Merck's Keytruda in a Phase 3 HARMONi-2 trial conducted in China. The study enrolled first‑l…
    BioSpace · 11d agoPositive readoutPositive↗ source
  • AbbVie’s bispecific T‑cell engager etentamig shows positive phase 3 results in relapsed/refractory multiple myeloma
    AbbVie reported that its bispecific T‑cell engager etentamig met its primary goals in the phase 3 Cervino trial for patients with relapsed or refractory multiple myeloma. The trial demonstrated hi…
    Fierce Biotech · 11d agoPositive readoutPositive↗ source
  • FDA approves Ionis’ Zanvastro as first disease-modifying therapy for Alexander disease
    The U.S. Food and Drug Administration has granted approval to Ionis Pharmaceuticals' antisense oligonucleotide Zanvastro, the first therapy that modifies disease progression for Alexander disease.…
    BioSpace · 10d agoApprovalPositive↗ source
  • Revolution Medicines' Rasonque shows 42% response and 16-month survival in NSCLC subgroup
    Data from a subgroup of an earlier trial, described by Truist Securities as the most relevant to Revolution Medicines' ongoing Phase 3 study, reported a 42% overall response rate and a median overa…
    BioSpace · 11d agoPositive readoutPositive↗ source
  • Pfizer sells Seagen-derived ADC to Medicus Pharma for $12 million upfront, potential $1 billion milestones
    Pfizer has transferred rights to an antibody‑drug conjugate it acquired in its Seagen purchase to Medicus Pharma. Medicus will pay $12 million upfront and $15 million a year later, and Pfizer coul…
    Fierce Biotech · 11d agoDealPositive↗ source
  • GSK licenses Hutchmed's KRAS-EGFR antibody-drug conjugate for $110 million upfront
    GSK announced it will pay $110 million upfront to obtain a license for a KRAS-EGFR antibody-drug conjugate developed by Chinese biopharma Hutchmed. The agreement also includes potential milestone p…
    Endpoints · 11d agoDealPositive↗ source
  • GSK agrees $1.3 billion deal with Hutchmed for early-stage KRAS-EGFR cancer candidate
    GSK will pay $110 million upfront to Hutchmed as part of a deal that could reach $1.295 billion, giving GSK worldwide rights to develop and commercialize a preclinical oncology asset. The asset, i…
    Fierce Biotech · 11d agoDealPositive↗ source
  • B. Braun recalls three lots of 0.9% Sodium Chloride injection due to zinc oxide particles
    B. Braun Medical Inc announced a voluntary recall of three lots of its 0.9% Sodium Chloride Injection USP, 100 mL, packaged in a 150 mL PAB® container. The recall was triggered after testing ident…
    fda medwatch · 11d agoCRLNegative↗ source
  • FDA alerts hospitals to purge cassette fault in Abiomed Impella controllers
    The FDA issued an Early Alert after identifying a problem with the purge cassette recognition in Abiomed’s Automated Impella Controllers, which could cause prolonged delays in mechanical circulator…
    fda medwatch · 11d agoRegulatoryNegative↗ source
  • Ultragenyx's Angelman gene therapy fails Phase 3, company to cut expenses
    Ultragenyx reported that its late‑stage Aspire trial of apazunersen in Angelman syndrome did not meet its primary or secondary endpoints. The primary goal of improving the Bayley‑4 cognitive raw sc…
    Fierce Biotech · 11d agoNegative readoutNegative↗ source