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125 stories matching this filter · ← front page

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  • Merck and Moderna report 99% manufacturing success and 42% lower recurrence risk for personalized melanoma vaccine in Phase 3 trial
    Merck and Moderna announced that their personalized mRNA cancer vaccine, combined with Keytruda, was successfully manufactured for 99% of patients enrolled in a large Phase 3 study. The trial, call…
    BioSpace · 2d agoPositive readoutPositive↗ source
  • Moderna reports 29% revenue rise as COVID vaccine sales stay steady amid global uptake
    Moderna said its quarterly revenue jumped 29% to $1.3 billion, driven by continued demand for its COVID-19 shots. The company has generated $1.8 billion in revenue so far this year, according to CF…
    BioSpace · 2d agoEarningsPositive
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  • 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
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 2d agoLayoffsNegative↗ 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
  • Big pharma Q3 earnings roll out as FDA launches rare-disease initiative and uniQure's Huntington's gene therapy enters review
    Over the past week, a dozen major pharmaceutical companies reported third‑quarter results, including AstraZeneca, Biogen, GSK, Bristol Myers Squibb, Merck, Sanofi, AbbVie and Regeneron. Pfizer pos…
    BioSpace · 4d agoEarningsNeutral↗ source
  • Analysts predict biopharma gains as Democrats take Congress control
    Analysts say the biopharma sector is set to benefit from the recent shift in U.S. Congress, with Democrats now holding majorities in both the House and Senate. They note that drug‑pricing debates…
    BioPharma Dive · 4d agoPositive↗ source
  • Pfizer targets Europe first for upcoming Lyme disease vaccine amid rising US cases
    Pfizer is planning to launch its Lyme disease vaccine in Europe first, leveraging its existing tick-borne encephalitis franchise in the region. The vaccine, developed with French partner Valneva,…
    BioSpace · 4d agoRegulatoryPositive↗ source
  • Pfizer reports flat Q3 revenue as non-COVID sales rise 7% and acquired products grow 32%
    Pfizer posted third‑quarter revenue of $16.6 billion, essentially unchanged from $16.7 billion a year earlier. The flat top line reflects declines in its legacy Prevnar vaccine and COVID‑related pr…
    BioSpace · 5d agoEarningsNeutral↗ source
  • Five newly approved drugs achieve strong launches by offering superior efficacy, pricing and access
    Over the past year several newly approved therapies have entered the market with sales and uptake that far exceed analyst expectations, driven by strong clinical data, reasonable pricing and easy p…
    BioSpace · 12d agoPositive↗ source
  • GSK vaccine sales miss expectations amid falling demand from adults
    With pressure on GSK’s vaccine business, analysts predict the U.K. pharma will face challenges as it prepares for the loss of exclusivity on a key product.
    BioSpace · 11d agoRegulatoryNeutral↗ source
  • Merck and Moderna's mRNA melanoma vaccine shows 42% risk reduction in Phase 3 trial, easing analyst concerns
    At the European Society of Medical Oncology meeting, Merck and Moderna presented data from their Phase 3 INTerpath-001 trial of a personalized mRNA vaccine combined with Keytruda in resected melano…
    BioSpace · 13d agoPositive readoutPositive↗ source
  • US proposes new biotech investment limits on China, but licensing deals remain allowed
    The U.S. Treasury announced a proposal to curb outbound investments in Chinese biotechnology, citing national‑security concerns. The plan would limit U.S. persons from funding certain bio‑derived c…
    BioSpace · 16d agoRegulatoryNeutral↗ source
  • Moderna and Merck vaccine plus Keytruda cuts melanoma relapse risk by 42% in late-stage trial
    A late-stage adjuvant study of Moderna’s experimental melanoma vaccine, intismeran autogene, combined with Merck’s Keytruda showed a 42% reduction in the risk of relapse or death compared with Keyt…
    BioPharma Dive · 17d agoPositive readoutNeutral↗ source
  • Merck and Moderna cancer vaccine data leak shows modest benefit, shares slide
    A data leak ahead of the European Society of Medical Oncology meeting revealed early results for the personalized cancer vaccine intismeran autogene combined with Merck's Keytruda. The information…
    BioSpace · 17d agoNegative readoutNegative↗ source
  • GSK and Ionis receive FDA nod for Hibsago, a potential functional cure for chronic hepatitis B
    The U.S. Food and Drug Administration has cleared Hibsago, a collaborative product of GSK and Ionis, as the first therapy of its kind aimed at chronic hepatitis B. The medicine is to be added to s…
    BioPharma Dive · 18d agoApprovalPositive↗ source
  • Merck/Moderna vaccine and Summit/Akeso bispecific therapy among key highlights at ESMO 2026
    The European Society of Medical Oncology (ESMO) meeting in Madrid this weekend will showcase several high‑profile oncology programs. Among the most watched are Merck and Moderna’s personalized can…
    BioSpace · 21d agoNeutral↗ 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 over 1,200 jobs at Belgian sites as $2.5 bn restructuring continues
    GSK announced it will eliminate more than 1,200 positions across its Belgian facilities, following an earlier closure of a German vaccine plant that cut about 650 jobs. The reductions are part of…
    BioSpace · 25d agoLayoffsNegative↗ 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 · 26d agoNegative readoutNegative↗ source
  • GSK to invest $800 million in new biologics manufacturing hub in Pennsylvania
    GSK announced it will spend more than $800 million to expand its Upper Merion site near Philadelphia, adding biologics production capacity. The plan includes demolishing existing structures next y…
    BioSpace · 27d agoDealPositive↗ source
  • Novartis licenses Abogen’s mRNA CD19×CD3 engager in $575M upfront deal
    Abogen Biosciences saw its COVID vaccine miss the market, prompting questions about whether its mRNA platform could be leveraged for other therapies. Novartis agreed to pay $575 million up front f…
    BioSpace · 1mo agoDealPositive↗ source
  • HHS unveils new vaccine injury surveillance plan with NIH clinic and reporting reimbursements
    The Department of Health and Human Services announced a comprehensive initiative to improve monitoring of vaccine-related injuries. The plan includes opening a new clinic at the National Institute…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Vaxcyte's next-gen pneumococcal vaccine matches leading shots in Phase 3 trial
    Vaxcyte reported that its experimental pneumococcal vaccine, VAX-31, achieved its primary efficacy goals in the first of three Phase 3 studies. In adults aged 50 and older, the vaccine performed o…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Vaxcyte’s VAX-31 shows superior results in Phase 3, beating Pfizer and Merck’s pneumococcal vaccines and sparking $8 bn market hopes
    Vaxcyte reported that its investigational pneumococcal conjugate vaccine, VAX-31, met the co-primary endpoints in a Phase 3 trial, demonstrating non-inferiority to the existing shots from Pfizer an…
    BioSpace · 1mo agoPositive readoutPositive↗ source