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1,329 stories matching this filter · ← front page

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  • RNAi biotech ADARx raises $446 million in IPO, secures $89 million from AbbVie
    ADARx Pharmaceuticals priced its initial public offering at $17 per share, selling more than 26 million shares to raise about $446.3 million. The company also received an additional $89 million th…
    BioPharma Dive · 27d agoDealPositive↗ source
  • Biomanufacturers Redesign Processes to Blend Emergency Vaccine Readiness with Commercial Flexibility
    Manufacturers are overhauling their production methods to simultaneously improve rapid vaccine deployment for future health crises and maintain flexible, commercially viable manufacturing networks…
    BioSpace · 26d agoNeutral↗ source
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  • ADARx raises $446 million in one of 2026's largest biotech IPOs as City Therapeutics plans its own listing
    ADARx Pharmaceuticals completed an initial public offering that raised about $446.3 million, exceeding the company’s original target. The shares were priced at $17 each, with 26.25 million shares…
    BioSpace · 26d agoDealPositive↗ source
  • Novo signs €1.2 bn deal with Nanexa for long-acting injectables as Acadia’s Alzheimer trial misses target
    Novo has agreed to pay Nanexa up to about €1.165 bn for its PharmaShell delivery platform, which enables long-acting injectable medicines. The partnership will apply the technology to up to five c…
    BioPharma Dive · 26d agoDealNeutral↗ source
  • Jury awards Nektar $90 million in damages after lawsuit over broken rezpeg partnership with Eli Lilly
    A jury in a US court has ordered Eli Lilly to pay Nektar Therapeutics $90 million after finding the pharma giant breached their collaboration on the experimental autoimmune drug rezpeg. Nektar and…
    BioSpace · 26d agoNegative↗ source
  • FDA approves Eli Lilly’s weekly insulin Onswik for U.S. patients, expanding competition with Novo
    The U.S. Food and Drug Administration has cleared Eli Lilly’s weekly insulin product, Onswik, for use in American patients. This marks the drug’s fourth global approval after earlier clearances in…
    BioSpace · 27d agoApprovalPositive↗ source
  • Kyverna reports one-year mobility gains and safety for CAR-T miv-cel in stiff-person syndrome, bolstering FDA filing plans
    Kyverna Therapeutics presented data from its Phase 2 KYSA-8 trial of miv-cel, a CAR-T therapy aimed at stiff-person syndrome (SPS). The study followed 26 patients for one year. At the one-year mar…
    BioSpace · 27d agoPositive readoutPositive↗ source
  • FDA advisory panel finds Grail's Galleri multicancer blood test benefits outweigh risks
    A Food and Drug Administration advisory panel voted 7-2, with one abstention, to conclude that the probable benefits of Grail's Galleri multicancer blood test outweigh its risks. The panel unanimou…
    BioPharma Dive · 27d agoRegulatoryPositive↗ source
  • Roche signs up to $2 billion partnership with Atavistik to develop cardiometabolic drugs
    Roche announced a partnership with Atavistik Bio, a biotech focused on hematology, to pursue new small-molecule treatments for cardiovascular, renal and metabolic conditions. The agreement provide…
    BioSpace · 27d agoDealPositive↗ source
  • Eli Lilly earmarks up to $3.25 billion for partnership with InnoCare Pharma
    Eli Lilly announced an upfront payment of $100 million to Beijing‑based InnoCare Pharma to start work on drug candidates for five targets that have critical unmet medical needs. The agreement also…
    BioSpace · 27d agoDealNeutral↗ source
  • Radioligand therapy gains momentum as experts discuss expanding patient impact
    In a recent episode of the Denatured podcast presented by Curium, host Jennifer Smith-Parker spoke with Mike Patterson, CEO North America, and Sabine Brookman-May, Vice President and Head of Global…
    BioSpace · 27d agoPositive↗ source
  • FDA warns Houston compounding pharmacy of unsanitary GLP-1 production risking contamination
    FDA issued a warning letter to Empower Clinic Services, operating as Empower Pharmacy, after inspectors found unsanitary conditions at its Houston compounding site. Inspectors observed that the ph…
    BioSpace · 27d agoRegulatoryNegative↗ source
  • Merck's remigromig meets visual acuity goal in diabetic macular edema trial, safety signals noted
    Merck announced that its experimental eye drug remigromig achieved non‑inferiority to Roche’s Lucentis in a late‑stage trial for diabetic macular edema. The trial, called Brunello, measured visual…
    BioPharma Dive · 27d agoPositive readoutNeutral↗ source
  • Acadia’s Alzheimer’s psychosis drug misses primary goal but advances on secondary data
    Acadia Pharmaceuticals reported that its investigational drug remlifanserin failed to meet the primary endpoint in the Phase 2 portion of the RADIANT trial for Alzheimer’s disease psychosis. The t…
    BioSpace · 27d agoNegative readoutNeutral↗ source
  • Eli Lilly inks $3.35 B China partnership as Immunovant halts lupus drug trial
    Eli Lilly announced a new alliance with Beijing‑based InnoCare Pharma that could be worth up to $3.35 billion. The deal includes an upfront payment of $100 million and up to five target programs fo…
    BioPharma Dive · 27d agoDealNeutral↗ source
  • Merck’s eye-drug matches Lucentis in vision improvement but raises safety concerns
    Merck reported results from its Phase 2b/3 BRUNELLO trial of remigromig, a Wnt-pathway agonist for diabetic macular edema. The drug achieved non-inferior improvement in best-corrected visual acuit…
    BioSpace · 27d agoNegative readoutNegative↗ source
  • Basecamp Research secures $140 million Series C to accelerate AI-designed drug pipeline
    Basecamp Research announced closing a $140 million Series C financing round to further develop its AI-driven drug discovery platform. The round was led by venture firm S32 and included participati…
    BioSpace · 27d agoDealPositive↗ source
  • Senators question FDA nominee as agency issues rule to cut animal testing
    The latest FDA briefing highlighted two key developments: a Senate hearing on the agency’s next leader and a new regulation targeting animal testing. During the confirmation hearing, senators pres…
    raps · 28d agoRegulatoryNeutral↗ source
  • FDA signals need for GCP compliance to accept foreign clinical trial data for regulatory review
    The U.S. Food and Drug Administration says it will only consider clinical evidence generated outside the United States if the studies were conducted according to good clinical practice standards.…
    raps · 28d agoRegulatoryNeutral↗ source
  • Series B funded biotechs expand hiring, Tenpoint Therapeutics raises $85M for eye-health pipeline
    Companies that secured series B rounds this year are scaling up their staff, making them attractive targets for biopharma talent. Tenpoint Therapeutics, based in Warren, New Jersey, announced an $…
    BioSpace · 27d agoDealPositive↗ source
  • AI-driven interviews risk alienating biotech and pharma job seekers, experts warn
    AI interview tools are being introduced by biotech and pharma firms to speed up candidate screening, but they can create negative experiences for applicants. Candidates described frustrations such…
    BioSpace · 27d agoNegative↗ source
  • EMA leaders say single pivotal trial should not be default, decision must match evidence needed
    EMA chief Emer Cooke and other officials weighed in on the ongoing debate about the number of pivotal trials required for drug approval. They argued that requiring a single pivotal trial as a rigi…
    raps · 28d agoRegulatoryNeutral↗ source
  • Senators Question FDA Nominee Overton as Agency Issues New Rule to Cut Animal Testing
    Senators on the Senate Health Committee interrogated President Trump's nominee to lead the FDA, Dr. Janet Overton, during her confirmation hearing. Lawmakers focused on her views about the agency's…
    raps · 28d agoRegulatoryNeutral↗ source
  • Senate grills Trump’s FDA nominee Heidi Overton on agency priorities
    Heidi Overton, President Trump’s nominee to lead the U.S. Food and Drug Administration, appeared before the Senate for a confirmation hearing on September 24, 2026. Senators from both parties aske…
    raps · 28d agoRegulatoryNeutral↗ source
  • Galil Importing Corp recalls Lior ground cinnamon over elevated lead levels
    Galil Importing Corp of Hauppauge, New York announced a recall of its Lior Cinnamon Ground Seasoning because of potential elevated lead contamination. The product, distributed to retail outlets in…
    fda recalls · 27d agoRegulatoryNegative↗ source