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831 stories matching this filter · ← front page

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  • Osivax’s flu vaccine OVX836 misses primary efficacy goal in phase 2b trial
    Osivax announced that its influenza A vaccine candidate OVX836 failed to meet the primary efficacy endpoint in a phase 2b trial involving 2,850 healthy adults in Europe. The trial showed a vaccine…
    Fierce Biotech · 10d agoNegative readoutNegative↗ source
  • Osivax shifts to combination strategy after Phase 2b flu vaccine setback
    Osivax, a French biotech, reported that its lead influenza vaccine candidate did not meet primary endpoints in a Phase 2b study. The trial, which evaluated the vaccine as a standalone product, sho…
    Endpoints · 9d agoNegative readoutNegative↗ source
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  • Lakefront Biotherapeutics sells its cell therapy pipeline to Belgian biotech Armed Cell Therapeutics
    Lakefront Biotherapeutics, formerly known as Galapagos Therapeutics, announced that it has sold its cell therapy pipeline to fellow Belgian biotech Armed Cell Therapeutics. The transferred assets…
    Fierce Biotech · 10d agoDealNeutral↗ source
  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 10d agoApprovalPositive↗ source
  • Gilead invests up to $1.87 B in Vir Biotechnology for three T-cell engagers
    Gilead Sciences announced a licensing agreement with Vir Biotechnology that includes an equity investment and potential milestone payments totalling up to $1.87 billion. The upfront component is $…
    BioSpace · 10d agoDealPositive↗ source
  • Johnson & Johnson shares drop 6% after earnings meet forecasts but show weak medical device outlook
    Johnson & Johnson reported third‑quarter results that met Wall Street expectations and raised its 2026 financial guidance, yet the stock fell about 6% on the day. Analysts highlighted an underwhel…
    BioPharma Dive · 11d agoEarningsNegative↗ source
  • J&J Q3 earnings fall short of expectations as stock slides, BMS reports mixed trial outcomes and RevMed highlights subgroup data
    Johnson & Johnson reported third‑quarter results that met analyst forecasts, driven by its innovative medicines segment, but the company’s stock dropped about 4% as the med‑tech division lagged beh…
    BioSpace · 11d agoEarningsNegative↗ source
  • Zealand Pharma partners with Generate Biomedicines on multispecific obesity proteins in $1.2B deal
    Zealand Pharma has agreed to pay Generate Biomedicines $30 million up front to start work on multispecific protein drug candidates aimed at obesity and other metabolic disorders. The agreement inc…
    Fierce Biotech · 11d agoDealPositive↗ source
  • Study finds almost 40% of FDA advisory committee meetings in past two decades included members with active industry ties
    Researchers examined FDA advisory committee meetings spanning the last 20 years and discovered that nearly 40% of those sessions featured a patient or consumer representative who had active ties to…
    STAT · 11d agoRegulatoryNeutral↗ source
  • OMass Therapeutics secures $310M Series C, eyes status as Britain’s leading biotech
    OMass Therapeutics, an Oxford‑based biotech still in pre‑clinical stage, announced a new financing round that brings in $310 million. The series C, co‑led by Bain Capital Life Sciences, Forbion an…
    Fierce Biotech · 11d agoDealPositive↗ source
  • Immune Boost Capital backs Orthrus Therapeutics to advance antigen-specific immune tolerance for rheumatoid arthritis
    Immune Boost Capital, the venture arm of the Arthritis National Research Foundation, announced an investment in Orthrus Therapeutics, a biotech focused on precision therapies for autoimmune disease…
    Fierce Biotech · 11d agoDealPositive↗ source
  • Early-life gut microbiome may influence lifelong brain health, experts say
    The authors argue that the composition of a baby’s gut microbiome could play a pivotal role in shaping brain development and later cognitive health. They suggest that understanding this link may he…
    STAT · 11d agoNeutral↗ source
  • Gilead signs $1.9 billion deal with Vir Biotechnology to license dual-masked T-cell engagers for oncology
    Gilead Sciences announced a licensing agreement with Vir Biotechnology to access Vir's dual-masked PRO-XTEN T-cell engager platform for oncology. Under the deal, Vir will discover, design and opti…
    Fierce Biotech · 11d agoDealPositive↗ source
  • iOnctura’s roginolisib shows encouraging phase 1 results in metastatic uveal melanoma
    iOnctura, a spinout of Merck KGaA, reported data from a two‑part phase 1 trial of its PI3K delta inhibitor roginolisib in patients with advanced solid and hematologic cancers, including a cohort of…
    Fierce Biotech · 11d agoPositive readoutPositive↗ source
  • BioNTech’s mRNA cancer vaccine misses key endpoint in head-and-neck trial, study to continue
    BioNTech reported that its mRNA cancer immunotherapy BNT113 did not improve progression‑free survival when added to Keytruda in patients with HPV16‑positive head and neck squamous cell carcinoma. T…
    Fierce Biotech · 12d agoNegative readoutNegative↗ source
  • BioNTech's head and neck cancer mRNA vaccine fails to extend progression-free survival in Phase 3 trial
    BioNTech reported that its experimental mRNA immunotherapy BNT113 did not meet its primary endpoint in a Phase 3 trial for a specific head and neck cancer, failing to improve progression-free survi…
    BioSpace · 11d agoNegative readoutNegative↗ source
  • Syndax halts Niktimvo trial for idiopathic pulmonary fibrosis after mid-stage failure
    Syndax announced it will stop testing Niktimvo (axatilimab) in idiopathic pulmonary fibrosis after the Phase 2 MAXPIRe trial failed to meet its primary endpoint. The study enrolled 145 patients an…
    BioSpace · 12d agoNegative readoutNegative↗ source
  • Safety concerns rise as Neurocrine's Prader-Willi drug linked to deaths and hospitalizations
    Patient advocates and several experts are voicing increasing alarm over the safety profile of Neurocrine Biosciences' therapy for Prader-Willi syndrome. The drug, Vykat XR, received approval 18 mo…
    STAT · 12d agoRegulatoryNegative↗ source
  • Paragon spinout Velaris Therapeutics goes public via reverse merger with Alaunos, raising $350 million
    Paragon Labs, a biotechnology incubator, announced that its latest spinout, Velaris Therapeutics, became a public company through a reverse merger with Alaunos Therapeutics. The transaction places…
    BioPharma Dive · 11d agoDealPositive↗ source
  • J&J’s innovative medicines carried Q3 as medtech disappoints, but newer medicines absent
    While innovative medicine supported Johnson & Johnson’s “in line” earnings for the third quarter of 2026, investors were disappointed to see older medicines carrying the bag.
    BioSpace · 11d agoEarningsNeutral↗ source
  • Nurix halts development of BTK degrader zelebrudomide after phase 1 review
    Nurix announced it will discontinue clinical development of its BTK degrader zelebrudomide, also known as NX-2127, following completion of enrollment in a phase 1 trial for aggressive non‑Hodgkin l…
    Fierce Biotech · 12d agoNegative↗ source
  • Pharma faces $500B risk as patents expire, with Merck most exposed by 2028
    More than $500 billion in global prescription sales could be threatened by generic competition between 2026 and 2032, according to Norstella data cited by Evaluate. Merck is the most immediately e…
    BioPharma Dive · 13d agoNeutral↗ source
  • Aspen Neuroscience files for Nasdaq IPO to fund Parkinson’s cell therapy program
    Aspen Neuroscience, founded in 2018, announced plans to list on Nasdaq, aiming to raise additional capital for its Parkinson’s disease cell therapy program. The company's lead candidate, sasinepro…
    BioPharma Dive · 12d agoDealNeutral↗ source
  • First Tracks reports positive early-stage results for celiac drug ANB033
    First Tracks Biotherapeutics announced that its experimental celiac disease drug ANB033 showed statistically significant improvement in a six‑week early‑stage trial compared with placebo. The trial…
    BioPharma Dive · 12d agoPositive readoutPositive↗ source
  • Bausch + Lomb appoints board chair Thomas Appio as interim CEO after Brent Saunders departs
    Bausch + Lomb announced that board chair Thomas Appio will serve as interim chief executive, taking over immediately from Brent Saunders, who is leaving the role. Appio, who has held several leade…
    BioPharma Dive · 13d agoNeutral↗ source