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77 stories matching this filter · ← front page

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STAT1748Endpoints1363BioSpace678Fierce Biotech677BioPharma Dive513raps227onclive165fda recalls110
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allOncology12165Rare Disease3133Immunology2826Cardiology2584Hematology2115Pulmonology2110Vaccines1771
  • Moderna posts first profit in two years, driven by Covid-19 vaccine sales, as it refocuses on cancer vaccines
    Moderna reported a modest profit for the quarter, marking its first earnings surplus in two years. The turnaround was driven primarily by continued sales of its international Covid-19 vaccine portf…
    Endpoints · 2d agoEarningsPositive↗ source
  • AAFP chief urges Congress to add oversight to CDC vaccine advisory panel
    Shawn Martin, CEO of the American Academy of Family Physicians, said the CDC’s Advisory Committee on Immunization Practices (ACIP) has faced more than a year of turmoil. He is urging Congress to e…
    Endpoints · 3d agoRegulatoryNeutral↗ source
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  • Sanofi eyes 'moonshot' drug acquisitions to offset upcoming Dupixent patent loss
    Sanofi's CFO Francois-Xavier Roger told Fierce that the company is looking at 'moonshot' treatments as potential acquisition targets to rebuild its pipeline. The push comes as the U.S. patent on D…
    Fierce Biotech · 10d agoDealNeutral↗ source
  • Merck says 2027 will focus on pipeline and new product launches despite recent trial wins
    Merck's chief financial officer said the company views 2027 as another year of investment, emphasizing its expanding pipeline and upcoming product launches rather than short‑term margin growth. Th…
    Fierce Biotech · 10d agoEarningsNeutral↗ source
  • GSK says UK restructuring will have limited impact on staff, focusing cuts on support roles
    GSK executives said the company's global restructuring will only modestly affect UK staff, mainly targeting support functions at headquarters. CEO Luke Miels explained during the Q3 earnings call…
    Fierce Biotech · 12d agoLayoffsNegative↗ source
  • Merck and Moderna disclose phase 3 cancer vaccine data early after leak, showing improved recurrence-free survival with Keytruda
    Merck & Co. and Moderna were forced to release their phase 3 trial results for the intismeran autogene cancer vaccine two days ahead of schedule after an unexpected leak of the data ahead of the ES…
    Fierce Biotech · 16d agoPositive readoutNeutral↗ 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 · 17d agoRegulatoryNeutral↗ source
  • Merck and Moderna release early phase 3 melanoma vaccine data showing primary endpoint success but weaker secondary results
    Merck and Moderna disclosed phase 3 data for their melanoma vaccine INTerpath-001 ahead of schedule after an embargo breach. The trial met its primary endpoint of recurrence‑free survival, with re…
    Fierce Biotech · 19d agoPositive readoutNeutral↗ source
  • Nouscom secures €120M to advance off-the-shelf cancer vaccine for Lynch syndrome
    Swiss biotech Nouscom announced a €120 million (about $135 million) Series D financing round. The capital will fund a registration-enabling pivotal trial of its cancer-preventing vaccine candidate.…
    Fierce Biotech · 24d agoDealPositive↗ source
  • 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 · 25d agoNegative readoutNegative↗ source
  • CDC removes pregnancy-specific Covid-19 vaccine guidance page after online backlash
    The CDC briefly posted a webpage that clearly endorsed Covid-19 vaccination for individuals planning to become pregnant. The page was later taken down and now redirects to another section of the C…
    Endpoints · 24d agoRegulatoryNeutral↗ source
  • GSK to cut up to 1,217 jobs in Belgium as cost-saving plan accelerates
    GSK announced it will lay off up to 1,217 employees in Belgium as part of its global cost-saving program. The cuts will affect R&D, manufacturing and support functions across the company's three m…
    Fierce Biotech · 26d agoLayoffsNegative↗ source
  • Saudi Arabia signs 46 biotech agreements at Riyadh summit, targeting $1.5 bn investment
    The fourth Riyadh Global Medical Biotechnology Summit wrapped up on September 16, with 46 agreements signed among local and international participants. The disclosed agreements represent about 5.5…
    Fierce Biotech · 26d agoDealPositive↗ source
  • CBER Director Karim Mikhail Aims to Restore Stability After Turbulent Leadership Changes
    The FDA's Center for Biologics Evaluation and Research (CBER) is working to regain stability after a period of rapid leadership turnover. Karim Mikhail, who was confirmed as the permanent director…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • MimiVax’s cancer vaccine fails phase 2 glioblastoma study, but CEO still sees data as ‘inspiring’
    MimiVax has reports a phase 2b miss in newly diagnosed glioblastoma patients, but remains positive about a significant survival benefit in a subset of patients 65 years and under.
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Vaxcyte’s 31-valent pneumococcal vaccine shows non-inferior immunity to Pfizer and Merck shots in Phase 3, shares surge
    Vaxcyte’s 31-valent pneumococcal candidate, VAX-31, was compared head‑to‑head with Pfizer’s Prevnar 20 and Merck’s Capvaxive in the late‑stage Opus‑1 study aimed at preventing invasive pneumococcal…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • FDA nominee Heidi Overton affirms safety of vaccines and mifepristone in Senate hearing
    Heidi Overton, the Trump administration’s pick for FDA commissioner, appeared before the Senate Health, Education, Labor and Pensions Committee to answer questions about her views on key public‑hea…
    Fierce Biotech · 1mo agoRegulatoryNeutral↗ source
  • Trump's Department of War bets $47M on Flagship biotechs to develop countermeasures
    The Department of War has awarded Flagship Pioneering $47 million to develop medical countermeasure technologies against emerging threats.
    Fierce Biotech · 1mo agoNeutral↗ source
  • Lexeo Therapeutics acquires Mantle Therapeutics for $8.3M to expand Friedreich ataxia pipeline
    Lexeo Therapeutics announced it will acquire Mantle Therapeutics for an upfront payment of $8.3 million, aiming to broaden its Friedreich ataxia pipeline. The transaction could rise to $21.3 milli…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • China unveils new five-year plan to boost biotech and pharma and compete globally
    China's government released its latest five-year plan aimed at expanding the country's biotech and pharmaceutical sectors. The document outlines a strategy to strengthen research, development and m…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • ARPA-H launches SPECTRA program to advance autism diagnosis and precision care
    ARPA-H announced the launch of the Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program, a new effort aimed at transforming autism diagnosis and precisio…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Gilead signs HIV PrEP partnership with PAHO in Latin America
    Gilead Sciences announced a new agreement with the Pan American Health Organization to expand access to HIV pre‑exposure prophylaxis across Latin American markets. The partnership aims to leverage…
    Endpoints · 1mo agoDealPositive↗ source
  • GSK to close German vaccine plant and cut 650 jobs as flu vaccine demand falls
    GSK announced it will wind down its vaccine manufacturing site in Germany, ending operations at the facility. The decision follows a rigorous review and reflects a decline in demand for egg‑based…
    Endpoints · 1mo agoLayoffsNegative↗ source
  • Evommune gives up hope for MRGPRX2 antagonist to treat itch after latest phase 2 fail
    Evommune’s MRGPRX2 antagonist has flunked another phase 2 trial, wiping out the biotech’s last hopes of developing the therapy for any itch-related conditions.
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • FDA appoints permanent heads for CDER and CBER amid pending commissioner confirmation
    The Department of Health and Human Services announced that Michael Davis, MD, PhD, and Karim Mikhail will become the permanent directors of the Centers for Drugs Evaluation and Research and the Cen…
    Fierce Biotech · 2mo agoRegulatoryNeutral↗ source