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239 stories matching this filter · ← front page

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  • Spyre shares plunge as rheumatoid arthritis trial of SPY072 falls short of internal target
    Spyre Therapeutics reported that its antibody SPY072 did not meet the company’s internal criteria in a mid‑stage rheumatoid arthritis trial, despite showing some activity. The placebo‑controlled s…
    BioPharma Dive · 6h agoNegative readoutNegative↗ source
  • Study finds Lilly's obesity drug Zepbound may lower hospital and ER costs for older adults
    A real‑world analysis examined older patients with obesity or excess weight who were either treated with Eli Lilly’s drug Zepbound or not. The researchers tracked healthcare utilization over time t…
    BioPharma Dive · 8h agoPositive readoutPositive↗ source
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Infectious Disease381
  • Profit motive highlighted as key to advancing women’s health research and boosting economic productivity
    Experts say that turning to the profit motive could spur investment in under‑funded women’s health areas such as endometriosis, osteoporosis and autoimmune disorders. They note a long history of r…
    STAT · 14h agoNeutral↗ source
  • Oxford study finds Shingrix linked to lower risk of heart attacks, strokes and heart failure
    Researchers at Oxford University reported that receiving the newer shingles vaccine Shingrix was associated with a reduced risk of cardiovascular disease. The observation follows earlier work by t…
    STAT · 14h agoPositive readoutNeutral↗ source
  • JATT mastermind launches latest biotech-focused SPAC via $60M IPO
    Just two months after Someit Sidhu, M.D., succeeded in pairing off his second special purpose acquisition company (SPAC) with Talawar Therapeutics, the biotech entrepreneur is back at it again.
    Fierce Biotech · 13h ago↗ source
  • FDA greenlights Abbott’s wearable sensor for capturing diabetic ketoacidosis
    The FDA has approved Abbott’s first-of-its-kind bio-wearable sensor that can warn diabetics of increased ketones that can lead to diabetic ketoacidosis.
    Fierce Biotech · 14h ago↗ source
  • Spyre’s rheumatoid arthritis plan toppled by subpar TL1A data
    Phase 2 data on Spyre Therapeutics’ anti-TL1A antibody SPY072 in rheumatoid arthritis have fallen short of expectations, prompting the biotech to deprioritize monotherapy development in the indicat…
    Fierce Biotech · 17h ago↗ source
  • Sentivera secures up to $1.5 billion licensing deal for inflammatory disease candidate
    Sentivera, a biotech startup formed by investors behind Metsera, announced a licensing agreement with Shanghai-listed Haisco Pharmaceutical. Under the deal, Sentivera will pay Haisco $40 million u…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Senators say HHS Secretary RFK Jr.’s Gardasil stake explanation contradicts earlier testimony
    A group of U.S. senators have raised concerns about the explanation offered by Robert F. Kennedy Jr., the Health and Human Services secretary, regarding how he disposed of a financial interest tied…
    STAT · 1d agoRegulatoryNegative↗ source
  • Moderna’s melanoma vaccine trial success sparks $45 billion market value surge
    Moderna’s shares jumped more than 170% after the company announced that its experimental melanoma vaccine, intismeran, met its primary goals in a Phase 3 trial. The surge added roughly $45 billion…
    BioPharma Dive · 6d agoPositive readoutPositive↗ source
  • Merck and Moderna report positive late-stage melanoma vaccine results, adding to 2026 cancer breakthrough year
    Merck and Moderna announced that their personalized mRNA neoantigen vaccine achieved positive outcomes in a late-stage trial for melanoma patients. The data suggest the vaccine can stimulate an imm…
    STAT · 6d agoPositive readoutPositive↗ source
  • Neumora Therapeutics appoints Joshua Pinto as CEO and Doron Sagman as CMO ahead of IND filing
    Neumora Therapeutics announced leadership changes, naming Joshua Pinto, Ph.D., as its new chief executive officer. Pinto, who joined Neumora in 2021 as chief financial officer and most recently se…
    Fierce Biotech · 6d agoNeutral↗ source
  • Pheast Therapeutics sticks with open R&D despite competitor Antengene moving ahead with anti‑CD24 trials
    Pheast Therapeutics, a Redwood City biotech founded in 2021, builds on Irv Weissman’s 2019 Nature paper that highlighted the CD24 protein as a promising "don’t eat me" target for cancer immunothera…
    Fierce Biotech · 6d agoNeutral↗ source
  • Boehringer Ingelheim pauses phase 1 trial of BI 3031185 in Japan to investigate safety event
    Boehringer Ingelheim has placed a phase 1 study of its investigational oral small‑molecule candidate BI 3031185 on voluntary hold after a safety event was reported. The trial, which began in early…
    Fierce Biotech · 6d agoCRLNeutral↗ source
  • Moderna-Merck mRNA cancer vaccine shows landmark interim success in melanoma trial
    An interim analysis of a Phase 3 trial of an individualized mRNA cancer vaccine from Moderna and Merck showed the treatment met its primary goals. The vaccine, given together with Merck's immunothe…
    BioPharma Dive · 7d agoPositive readoutPositive↗ source
  • Tolerance Bio secures up to $260 M for thymus‑targeting fusion protein, moves into Phase 2 trials
    Tolerance Bio, a Philadelphia biotech founded in October 2024, has signed a licensing agreement to acquire rights to NeoImmuneTech’s long‑acting IL‑7 fusion protein, efineptakin alfa, for up to $26…
    Fierce Biotech · 7d agoDealPositive↗ source
  • Amgen ends $500M Crohn’s disease collaboration with TScan, but TScan says pipeline strategy stays on track
    Amgen has terminated its collaboration with TScan Therapeutics that was aimed at Crohn’s disease, ending a deal that could have delivered up to $500 million in milestones. The partnership began in…
    Fierce Biotech · 7d agoDealNeutral↗ source
  • Immunologist Liz Marnik, raised unvaccinated, now advocates for science and empathy in vaccine discussions
    Immunologist Liz Marnik grew up in a household that rejected vaccines, and she herself went without any immunizations into adulthood. At age 23 she visited a travel clinic and received all standar…
    STAT · 7d agoPositive↗ source
  • Merck and Moderna’s personalized mRNA vaccine shows longer recurrence-free survival in phase 3 melanoma trial
    Merck and Moderna reported that their individualized mRNA cancer vaccine, given together with Keytruda, extended the time patients remained free of melanoma recurrence in a late-stage study. The p…
    Fierce Biotech · 7d agoPositive readoutPositive↗ source
  • Argenx reports positive Phase 3 results for Vyvgart Hytrulo in myositis
    Argenx announced that its subcutaneous formulation of Vyvgart, named Vyvgart Hytrulo, met the primary endpoint in a late‑stage Phase 3 trial in patients with myositis. The trial combined participa…
    BioPharma Dive · 9d agoPositive readoutPositive↗ source
  • AstraZeneca halts Phase 3 lung cancer trial of bispecific antibody volrustomig after interim data miss survival goal
    AstraZeneca announced termination of the Phase 3 study of its experimental bispecific antibody volrustomig in non‑small cell lung cancer. An interim data review by trial monitors indicated the dru…
    BioPharma Dive · 9d agoNegative readoutNegative↗ source
  • AstraZeneca halts phase 3 lung cancer trial of bispecific antibody volrustomig after it falls short of Keytruda
    AstraZeneca stopped its phase 3 trial of the bispecific antibody volrustomig in metastatic non‑small cell lung cancer after interim data suggested the regimen would not meet the study's primary goa…
    Fierce Biotech · 9d agoNegative readoutNegative↗ source
  • Regeneron halts Phase 1/2a uveitis trial of anti-CD3 antibody after safety event
    Regeneron announced it is voluntarily ending the Phase 1/2a TITAN study of its anti‑CD3 monoclonal antibody, REGN7041, which was being evaluated for non‑infectious posterior uveitis. The decision…
    Fierce Biotech · 9d agoCRLNegative↗ source
  • Evaxion drops solid tumor vaccine program to prioritize brain cancer vaccine candidate
    Evaxion Biotech announced it has discontinued development of its next‑generation solid tumor vaccine, EVX‑03, and will redirect resources toward a brain cancer vaccine candidate developed with Duke…
    Fierce Biotech · 9d agoNeutral↗ source
  • FDA clears Bristol Myers' Zenbexus, first drug of a new class for advanced multiple myeloma
    The FDA announced approval of an oral therapy from Bristol Myers Squibb for patients with advanced multiple myeloma. The drug, iberdomide, will be marketed as Zenbexus and is intended to be used t…
    STAT · 12d agoApprovalPositive↗ source