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513 stories matching this filter · ← front page

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  • FDA launches Rare Disease Framework Initiative to reshape drug development for small patient populations
    The FDA announced a new Rare Disease Framework Initiative aimed at overhauling how drugs and biologics for rare conditions are developed. The initiative will produce a tailored framework that refl…
    fda press · 8d agoRegulatoryPositive↗ 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 · 8d agoLayoffsNegative
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  • States could counter potential Trump administration vaccine shortages by producing vaccines themselves
    Joel Dodge, director of industrial policy at Vanderbilt Policy Accelerator, warns that the Trump administration is considering changes to the Vaccine Injury Compensation Program, a policy that has…
    STAT · 9d agoRegulatoryNegative↗ 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 · 9d agoLayoffsNegative↗ source
  • Former FDA leaders denounce agency layoffs as historic disaster
    Three former Food and Drug Administration commissioners publicly condemned the recent staffing reductions at the agency, calling the moves a major failure of policy. Rob Califf, who served as FDA…
    STAT · 8d agoLayoffsNegative↗ source
  • Sanofi avoids fine as EU ends antitrust probe over alleged disparagement of rival flu vaccine
    EU antitrust regulators have closed a probe into Sanofi after the company offered concessions, allowing it to avoid a monetary penalty. The investigation centered on a campaign that allegedly port…
    STAT · 8d agoRegulatoryNeutral↗ source
  • Study explores how GLP-1 weight-loss drugs affect criminal justice involvement, job prospects and housing stability
    A new research effort is looking at how GLP-1 based weight‑loss medications influence outcomes beyond health, specifically interactions with the criminal justice system, employment prospects and ho…
    STAT · 8d agoNeutral↗ 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 · 9d agoNegative readoutNegative↗ source
  • Par Health initiates voluntary recall of Argatroban injection after detecting particulate contaminants
    Par Health USA announced a voluntary nationwide recall of its Argatroban Injection 250 mg/2.5 mL product, affecting 22 lots that have been distributed to hospitals and users. The recall was trigge…
    fda recalls · 9d agoRegulatoryNegative↗ source
  • Trump administration proposes $70,000 fee to curb foreign student work authorizations
    The Department of Homeland Security announced a proposed $70,000 fee for a work authorization program that many foreign students and scholars use to gain professional experience in the United State…
    STAT · 9d agoRegulatoryNegative↗ 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 · 9d agoDealPositive↗ source
  • Veteran infectious disease journalist Helen Branswell dies at 69
    Helen Branswell, a veteran reporter covering infectious diseases, died on Tuesday at age 69. Her sister said the cause was complications from cancer. Branswell was known for clear, nuanced coverag…
    STAT · 9d agoNeutral↗ 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 · 10d agoDealPositive↗ source
  • Americans show higher trust in science than most countries, survey finds
    A new Wellcome Global Monitor survey of people in 140 countries found that 52% of Americans say they have a lot of trust in science, compared with just 26% globally. Only 40% of Americans reported…
    STAT · 12d agoNeutral↗ 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 · 13d agoDealPositive↗ source
  • Half-century after IL-2 discovery, its impact on HIV, cancer and blood safety is highlighted
    Robert Gallo marks the 50-year anniversary of the 1976 paper that described interleukin-2, one of the first cytokines identified and essential for T-cell growth. He notes that IL-2 enabled the dis…
    STAT · 14d agoPositive↗ 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 · 13d agoRegulatoryPositive↗ source
  • FDA week: HHS launches vaccine injury study, midterms may reshape oversight committees, and patent thickets threaten generics
    The Department of Health and Human Services announced a new agency‑wide effort to examine and address injuries that may be linked to vaccines. The initiative will coordinate research across FDA and…
    raps · 14d agoRegulatoryNeutral↗ 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 · 14d agoRegulatoryNeutral↗ 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 · 16d agoNegative readoutNegative↗ source
  • AstraZeneca launches $1 billion R&D hub in Boston’s Kendall Square
    AstraZeneca opened a new research and development site in Kendall Square, Boston, marking a $1 billion investment in the U.S. biotech corridor. The Boston location underscores the company’s commit…
    STAT · 16d agoNeutral↗ source
  • Experts warn FDA against approving Grail’s ineffective multicancer blood test
    Physician and cancer‑screening researcher H. Gilbert Welch argues that the FDA should not greenlight Grail’s multicancer blood test, noting the company’s trial of 140,000 participants used a weak s…
    STAT · 17d agoRegulatoryNegative↗ source
  • Trump proposes $90 monthly aid for seniors as stem cell therapies gain attention
    STAT's D.C. Diagnosis newsletter notes that stem cell treatments are being discussed as a possible next breakthrough in medicine, likening them to the rise of peptide therapies. President Trump an…
    STAT · 16d agoNeutral↗ source
  • Infectious disease expert urges calm over mysterious pneumonia case in Siberia
    A 28‑year‑old laboratory worker at a Siberian institute that studies plague died after developing severe pneumonia, prompting a quarantine of a nearby hospital and monitoring of roughly 200 contact…
    STAT · 16d agoNeutral↗ source
  • When to get your flu shot: key factors to consider
    The article addresses the question of the optimal timing for a flu vaccination. It notes that deciding when to receive the shot can depend on several practical considerations. Readers are encourag…
    STAT · 16d agoNeutral↗ source