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  • EQT to acquire Qiagen in €10.8 billion deal
    EQT, a private‑equity firm, announced it will purchase Dutch molecular diagnostics company Qiagen in a transaction valued at €10.8 billion, including €1.1 billion of net debt. The deal follows a f…
    Fierce Biotech · 20d agoDealPositive↗ source
  • Roche's Genentech reports 43% reduction in kidney damage marker in phase 3 IgA nephropathy trial
    Roche Genentech disclosed detailed results from its phase 3 IMAgINATION trial of the antisense oligonucleotide sefaxersen in patients with IgA nephropathy. The trial showed a 43.1% greater reducti…
    Fierce Biotech · 20d agoPositive readoutPositive↗ source
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  • Takeda’s ADC arcotatug tavatecan shows survival benefit in phase 3 gastric cancer trial
    Takeda, together with Innovent Biologics, presented results from a late‑stage study of its next‑generation claudin‑18.2 antibody‑drug conjugate, arcotatug tavatecan (also known as IBI343 or TAK‑921…
    Fierce Biotech · 20d agoPositive readoutPositive↗ source
  • Lycia Therapeutics raises $318 million in IPO to fund protein degrader programs
    Lycia Therapeutics, a biotech focused on protein-degrading medicines, priced its initial public offering at about $318 million. The proceeds will be used to advance three LYTAC drug candidates, in…
    BioPharma Dive · 20d agoDealPositive↗ source
  • RNAi developers see surge in IPOs and funding as industry interest revives
    BioPharma Dive’s latest data‑visualization series highlights a rapid rise in interest and investment for companies developing RNA interference (RNAi) medicines. After a years‑long lull, more than…
    BioPharma Dive · 20d agoPositive↗ source
  • BMS reports patient death in MS CAR-T trial, cites septic pneumonia and pauses enrollment
    BMS disclosed details about a patient death that occurred in its investigational CAR-T therapy for multiple sclerosis. The autologous CD19-directed CAR-T, zolacabtagene autoleucel (zola-cel), had…
    Fierce Biotech · 20d agoNegative readoutNegative↗ source
  • Gilead agrees to pay $1.275 billion upfront for PepStar’s oral IL‑23 inhibitor, targeting J&J’s Icotyde
    Gilead Sciences has entered into a transaction to acquire PepStar Therapeutics' oral IL‑23 receptor inhibitor program. The deal is valued at $1.275 billion in upfront cash, roughly $1.3 billion as…
    Fierce Biotech · 20d agoDealPositive↗ source
  • Bolt Biotherapeutics to acquire Prana Therapies in reverse merger, secured $120M financing
    Bolt Biotherapeutics announced a stock‑for‑stock reverse merger with Prana Therapies. The transaction is supported by a $120 million financing package. The deal will bring Prana’s lead antibody in…
    Fierce Biotech · 20d agoDealPositive↗ source
  • Roche pays $55 million upfront to Zymeworks for global rights to trispecific antibody ZW209 targeting small-cell lung cancer
    Roche has agreed to pay Zymeworks an upfront sum of $55 million for worldwide rights to ZW209, a trispecific antibody being developed for small-cell lung cancer. ZW209 is designed to bind DLL3 on…
    Fierce Biotech · 20d agoDealNeutral↗ source
  • Star raises $200 million after successful spinouts of Electra and Vega Therapeutics
    Star, a biopharma company, announced it has secured $200 million in new funding. The capital follows the recent exits of its subsidiaries Electra Therapeutics and Vega Therapeutics, which were spu…
    BioPharma Dive · 20d agoDealPositive↗ source
  • Drug safety group petitions FDA to block marketing of unapproved compounded peptides; bipartisan bill seeks clinical trial reforms
    A drug safety advocacy group has filed a citizen petition with the FDA, asking the agency to stop the marketing of compounded peptide products that lack approval. A bipartisan group of lawmakers h…
    raps · 20d agoRegulatoryNeutral↗ source
  • Experts urge cultural shift and standards to unlock real-world evidence potential in medtech
    At The MedTech Conference in Boston, experts highlighted the need for a cultural shift to build trust between regulators and medtech firms when using real-world evidence (RWE) for device marketing.…
    raps · 20d agoNeutral↗ source
  • Moderna and Merck vaccine plus Keytruda cuts melanoma relapse risk by 42% in late-stage trial
    A late-stage adjuvant study of Moderna’s experimental melanoma vaccine, intismeran autogene, combined with Merck’s Keytruda showed a 42% reduction in the risk of relapse or death compared with Keyt…
    BioPharma Dive · 21d agoPositive readoutNeutral↗ source
  • Celltrion licenses Kaigene's preclinical antibody KG013 in deal worth up to $580.5 million
    Celltrion, a South Korean biotech, has entered into a licensing agreement with Maryland-based Kaigene for a preclinical monoclonal antibody known as KG013. KG013 is designed to block the prolifera…
    Fierce Biotech · 21d agoDealPositive↗ source
  • Menarini's Stemline signs $1.1 billion deal to license Georgiamune's preclinical cancer immunotherapy
    Georgiamune, a Maryland‑based immunology biotech, has granted Stemline Therapeutics, part of Italy's Menarini Group, exclusive worldwide rights to develop and commercialize its preclinical cancer c…
    Fierce Biotech · 21d agoDealPositive↗ source
  • FDA approves GSK hepatitis B drug; EQT to acquire Qiagen for $10.8 billion
    The U.S. Food and Drug Administration has granted approval to GlaxoSmithKline's new hepatitis B therapy, marking a regulatory milestone for the company. Private-equity firm EQT announced a definit…
    raps · 21d agoPositive↗ source
  • US Treasury proposes COINS Act rules that restrict biotech investment in China but leave big pharma licensing deals untouched
    The U.S. Treasury Department released draft regulations that add biotechnology to the Comprehensive Outbound Investment National Security (COINS) Act, labeling pharmaceutical compounds as prohibite…
    Fierce Biotech · 20d agoRegulatoryNeutral↗ source
  • FDA launches Neuroscience Advancement and Innovation Nexus to boost brain disorder drug development
    The U.S. Food and Drug Administration announced a new program called the Neuroscience Advancement and Innovation Nexus (NAIN) aimed at accelerating the development of medical products for brain and…
    fda press · 21d agoRegulatoryPositive↗ source
  • CSL appoints GSK veteran Deborah Waterhouse as new CEO to steer company through challenges
    CSL announced that Deborah Waterhouse, former head of GSK's HIV business ViiV Healthcare and former president of GSK Global Health, will become its new chief executive. Waterhouse joins CSL as the…
    Fierce Biotech · 21d agoNeutral↗ source
  • FDA accepts new submission for Biohaven’s Vyglxia, opening path to approval
    Biohaven announced that the FDA has accepted a refreshed application for its rare disease drug Vyglxia, which targets a nerve‑damaging disorder. Vyglxia is being developed for spinocerebellar atax…
    BioPharma Dive · 21d agoRegulatoryPositive↗ source
  • Compounding pharmacy recalls copycat version of Eli Lilly’s Zepbound amid safety concerns
    Apothecary Pharma, a compounding pharmacy, has voluntarily recalled its compounded tirzepatide product that mimics Eli Lilly's obesity drug Zepbound. The company said it could not guarantee the saf…
    BioPharma Dive · 21d agoCRLNegative↗ source
  • Roche reaffirms sales outlook despite weaker Xolair sales and looming generic competition
    Roche reported third-quarter group sales of 16.1 billion Swiss francs, about $19.6 billion, a 7% increase that beat analysts' consensus estimate of 15.8 billion francs. The beat was helped by a ne…
    BioPharma Dive · 21d agoEarningsNegative↗ source
  • Medrio aims to unify clinical trial tools to ease complexity for biotech firms
    Mike Novotny, founder and CEO of Medrio, says that funding cycles, growing study complexity and fragmented technology are slowing clinical research, especially for small and midsize life‑science co…
    Fierce Biotech · 21d agoPositive↗ source
  • Zentalis reports promising overall survival and response rates for oral WEE1 inhibitor azenosertib in platinum-resistant ovarian cancer
    Zentalis Pharmaceuticals presented early data from the phase 1b portion of its Denali study of azenosertib, an oral WEE1 tyrosine kinase inhibitor, in patients with platinum‑resistant ovarian cance…
    Fierce Biotech · 21d agoPositive readoutPositive↗ source
  • Researchers identify cellular stress trigger behind Angelman syndrome
    Researchers at Washington University School of Medicine in St. Louis reported a new mechanism linking loss of the maternal UBE3A gene to neuronal stress in Angelman syndrome. The study, published…
    Fierce Biotech · 21d agoPositive↗ source