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1,823 stories matching this filter · ← front page

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  • Akeso's ivonescimab shows survival advantage over Keytruda in Chinese lung cancer trial
    A new data cut from a study comparing ivonescimab, a bispecific antibody from China-based Akeso, with Merck's Keytruda in patients with non-small cell lung cancer was released. The interim results…
    BioPharma Dive · 8d agoPositive readoutPositive↗ source
  • Superluminal Medicines raises $60M Series B to launch Phase 1 trial of genetic obesity therapy
    Superluminal Medicines, a Boston‑based biotech, announced it has closed a $60 million Series B financing round. The capital will fund the company’s first‑in‑human study of its genetic obesity candi…
    Endpoints · 8d agoDealNeutral↗ source
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Infectious Disease456
  • Ultragenyx's Angelman syndrome drug fails Phase 3 trial, halting development
    Ultragenyx reported that its experimental antisense oligonucleotide designed for Angelman syndrome did not meet primary endpoints in a Phase 3 study. The trial, which enrolled patients with the ra…
    Endpoints · 9d agoNegative readoutNegative↗ source
  • Invivyd appoints chairman Marc Elia as CEO ahead of COVID antibody readout
    Invivyd, an infectious-disease biotech, announced that its chairman Marc Elia will also serve as chief executive officer. Elia, who joined the board in 2022 and helped shape the company's scientif…
    Fierce Biotech · 8d agoNeutral↗ source
  • Pfizer grants Medicus co-development rights to CD228-targeted ADC PF-08046031
    Pfizer announced it is transferring co-development rights for its CD228-targeted antibody-drug conjugate, PF-08046031, to Medicus Pharma. The ADC, originally discovered by Seagen, will now be adva…
    Endpoints · 8d agoDealNeutral↗ source
  • Novartis licenses Alteogen’s hyaluronidase enzyme ALT-B4 in new drug delivery partnership
    Novartis announced a licensing agreement with South Korean biotech Alteogen to use its hyaluronidase enzyme ALT-B4 for drug delivery applications. The enzyme will be produced using Alteogen’s prop…
    Endpoints · 8d agoDealNeutral↗ source
  • Psilocybin prevents chemotherapy-induced neuropathy in mouse study, effects last up to eight months
    Researchers at MD Anderson reported that a single dose of psilocybin given before chemotherapy blocked the development of pain hypersensitivity in mice. The protective effect persisted for up to ei…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
  • Deaths of two Chinese children receiving CRISPR therapy spark safety debate
    Two children in China died after receiving experimental CRISPR-based gene therapies, according to a recent report. The fatalities have unsettled researchers in the United States who are developing…
    Endpoints · 9d agoRegulatoryNegative↗ source
  • Novartis signs up to $3.2 billion deal with Korea's Alteogen for subcutaneous drug delivery technology
    Novartis has entered an option and license agreement with Korean biotech Alteogen to use its ALT-B4 subcutaneous delivery platform, a partnership that could be worth up to $3.2 billion if all optio…
    Fierce Biotech · 9d agoDealPositive↗ source
  • Novartis CAR-T trial deaths spark safety concerns for autoimmune applications
    Novartis disclosed that three participants in its CAR-T cell therapy trials for autoimmune disease have died. The company said the deaths were reported to health authorities and are under investiga…
    Endpoints · 9d agoRegulatoryNegative↗ source
  • Novartis and Bristol Myers pause autoimmune CAR-T trials after serious safety events
    Novartis and Bristol Myers Squibb announced the suspension of several autoimmune CAR‑T studies after encountering serious safety problems. In Novartis' trials, three participants died from a severe…
    BioPharma Dive · 9d agoNegative readoutNegative↗ source
  • FDA CBER director overrides review team to grant accelerated approval for Replimune's melanoma therapy Tudriqev
    A senior official at the FDA's Center for Biologics Evaluation and Research stepped in to reverse a prior rejection by the agency's review panel. The director of the office of clinical evaluation a…
    Endpoints · 9d agoApprovalPositive↗ source
  • UniQure files FDA priority review request for Huntington’s gene therapy AMT-130
    UniQure, a Dutch biotech, announced on Wednesday that it has submitted applications to the U.S. Food and Drug Administration seeking a priority review for its gene therapy AMT-130, which targets th…
    BioPharma Dive · 9d agoRegulatoryNeutral↗ source
  • FDA vows tighter review of foreign clinical trial data amid rising Chinese influence
    Top FDA officials announced that the agency will intensify its oversight of clinical trial data generated outside the United States. The move is aimed at ensuring that foreign data meet the same st…
    Endpoints · 9d agoRegulatoryNeutral↗ source
  • H1 partners with Novo Nordisk to build AI-driven data foundation for clinical development
    Clinical trials are becoming more complex and data‑heavy, but decision‑making processes have not kept pace. H1 and Novo Nordisk are collaborating to address this gap. Novo Nordisk’s StudyHub links…
    Fierce Biotech · 9d agoDealPositive↗ source
  • UK regulator suspends Tavneos sales as MHRA follows EMA decision; UniQure files for Huntington's gene therapy approval
    The UK Medicines and Healthcare products Regulatory Agency has ordered a halt to the sale of the drug Tavneos, citing concerns that align with a recent decision by the European Medicines Agency. T…
    Endpoints · 9d agoRegulatoryNegative↗ source
  • Teva's experimental antibody cuts intestinal damage in celiac patients after gluten challenge
    Teva reported that a single injection of an experimental antibody markedly lowered intestinal damage in participants with celiac disease who continued to consume gluten daily. The study was a glut…
    Endpoints · 9d agoPositive readoutPositive↗ source
  • Fortrea acquires Worldwide Clinical Trials' early-phase division for $45 million
    Fortrea announced it will purchase the early-phase services division of Worldwide Clinical Trials for $45 million. The transaction gives Fortrea control of Worldwide's clinical pharmacology unit,…
    Fierce Biotech · 9d agoDealPositive↗ source
  • Teva reports positive mid-stage results for celiac disease antibody, BioMarin settles patent fight with Ascendis
    Teva said its experimental antibody TEV-408 showed statistically significant and clinically meaningful reduction in gluten-induced intestinal damage in a mid-stage trial for celiac disease. The tr…
    BioPharma Dive · 9d agoPositive readoutPositive↗ source
  • Novartis to cut about 130 jobs in Switzerland as it reshapes biologics production in Basel
    Novartis announced it will eliminate roughly 130 positions in Switzerland as part of a reorganization of its biologics technical development and manufacturing footprint in Basel. The company plans…
    Fierce Biotech · 9d agoLayoffsNegative↗ source
  • Typewriter secures $56M to advance jumping-gene platform and in vivo CAR-T therapies
    Typewriter, a biotech startup, announced it has closed a $56 million financing round. The capital will be used to develop its jumping-gene platform, which seeks to deliver full genes without viral…
    Endpoints · 9d agoDealPositive↗ source
  • Teva's anti-IL-15 antibody meets primary endpoint in phase 2a celiac disease trial
    Teva Pharmaceuticals reported that its anti‑interleukin‑15 antibody, TEV‑408, achieved the primary endpoint in a phase 2a study of 50 adults with celiac disease. Participants received a single dose…
    Fierce Biotech · 9d agoPositive readoutPositive↗ source
  • SEC and FDA sign three-year info-sharing pact to boost market integrity and public-health oversight
    The U.S. Securities and Exchange Commission and the Food and Drug Administration have entered into a three-year memorandum of understanding to expand cooperation and share information. The MOU is…
    Fierce Biotech · 9d agoRegulatoryPositive↗ source
  • TScan Therapeutics cuts 75% of staff to focus on preclinical solid tumor programs
    TScan Therapeutics said it will cut about three quarters of its workforce after pausing its hematological and autoimmune programs. The company will shift resources to its preclinical solid tumor p…
    Fierce Biotech · 9d agoLayoffsNegative↗ source
  • Moderna and Merck's mRNA cancer vaccine extends survival in phase 3 melanoma trial
    Merck and Moderna reported that their personalized mRNA cancer vaccine improved patient outcomes in a late-stage study. The phase 3 INTerpath-001 trial enrolled 1,137 patients who had surgery to r…
    Fierce Biotech · 10d agoPositive readoutPositive↗ source