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506 stories matching this filter · ← front page

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  • Replimune secures FDA approval for RP1 therapy in advanced melanoma as Eli Lilly reports strong Q2 earnings
    Replimune announced that the FDA has granted market approval for its oncolytic immunotherapy RP1, aimed at treating advanced melanoma. The decision follows two earlier rejections and a contentious…
    BioSpace · 5h agoApprovalPositive↗ source
  • Study finds cancer patients now wait longer for treatment than a decade ago
    A new analysis of more than 2.7 million cancer cases shows that the interval between diagnosis and the start of therapy has grown over the past ten years. The researchers examined records from a na…
    STAT · 1h agoNegative↗ source
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Infectious Disease305
  • AI-focused biotech firms drive biopharma toward a 'fail-fast' drug development model
    AI is quickly becoming a central force in drug development as tech capital pours into biopharma, reshaping how new medicines are discovered. Tyrone Lam, chief business officer at GATC Health, says…
    BioSpace · 10h agoPositive↗ source
  • Climate change worsens symptoms for people with chronic illnesses, author reports from Chicago smoke events
    The author argues that climate change is already harming health, particularly for those living with chronic conditions, and that the impact is becoming more evident. She describes a recent summer…
    STAT · 7h agoNegative↗ source
  • Experts warn splitting MMR vaccine into separate shots could increase missed doses and illness
    The article notes that a recent executive order proposes separating the combined measles, mumps and rubella vaccine into three individual injections. The author argues that this change could lead t…
    STAT · 1d agoRegulatoryNegative↗ source
  • FDA issues complete response letter rejecting ITM Isotope's radiopharma therapy over manufacturing concerns
    FDA sent a complete response letter rejecting the NDA for ITM Isotope's investigational radiopharmaceutical, citing manufacturing and third-party facility issues. The agency said there were no con…
    BioSpace · 1d agoCRLNeutral↗ source
  • FDA rejects ITM Isotope's radiopharmaceutical therapy over manufacturing problems, halting potential competitor to Novartis
    The U.S. Food and Drug Administration has refused to approve a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich SE, citing manufacturing deficiencies. The therapy was desig…
    STAT · 1d agoRegulatoryNegative↗ source
  • Silence causes uproar in rare blood cancer space as data sets high bar for competitors
    The mid-stage win of Silence Therapeutics’ siRNA drug in polycythemia vera validates the therapeutic approach of similar assets in development—but also sets a high standard for therapies from Taked…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Nonprofit North Star Review Board offers independent model to fix IRB oversight issues
    Founders Stephen Rosenfeld and Patricia Seymour created the not‑for‑profit North Star Review Board after becoming disillusioned with the current system of institutional review boards (IRBs) that ov…
    STAT · 1d agoRegulatoryNeutral↗ source
  • MoonLake Immunotherapeutics’ vague data on its autoimmune candidate draws criticism
    Adam Feuerstein notes that MoonLake Immunotherapeutics announced "positive" results for its autoimmune drug candidate but released data that is difficult to interpret. He reminds readers that biot…
    STAT · 1d agoNegative↗ source
  • Drug makers and animal testing groups urge FDA to keep flexible guidance on animal studies for cancer drugs
    A coalition of drug developers, regulators and laboratory animal-testing organizations has asked the U.S. Food and Drug Administration to keep its guidance on cancer-drug safety studies flexible.…
    raps · 1d agoRegulatoryNeutral↗ 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 · 1d agoLayoffsNegative↗ source
  • FDA advisory panel set to review Grail’s multi-cancer Galleri screening test
    An FDA advisory committee is scheduled to evaluate Grail’s Galleri blood test, which is designed to detect a range of cancers at an early stage. The panel will examine the test’s clinical data, pe…
    STAT · 2d agoRegulatoryNeutral↗ source
  • Jazz Pharma to acquire Actio Biosciences for up to $1.3 billion, adding experimental KCNT1 epilepsy drug
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, paying $820 million in cash with up to $500 million in milestone payments. The deal is expected to close by the end of the year.…
    BioSpace · 2d agoDealPositive↗ source
  • Sionna's CF add-on pill fails to improve outcomes in Phase 2 trial with Trikafta
    Sionna Therapeutics reported that its experimental cystic fibrosis pill, SION-719, did not provide any additional benefit when combined with Vertex Pharmaceuticals' Trikafta in a Phase 2 study. Th…
    STAT · 2d agoNegative readoutNegative↗ source
  • FDA rejects ITM-11 radiopharmaceutical over manufacturing flaws, halting rival to Novartis therapy
    The U.S. Food and Drug Administration issued a rejection letter for ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich, citing manufacturing problems that prevent ap…
    STAT · 2d agoRegulatoryNegative↗ source
  • Tenax Therapeutics’ heart-failure drug misses primary goal in Phase 3 trial, shares tumble
    Tenax Therapeutics announced that its experimental oral levosimendan failed to meet the primary efficacy endpoint in the Phase 3 LEVEL study, which evaluated treatment for a form of heart failure l…
    STAT · 2d agoNegative readoutNegative↗ source
  • Silence Therapeutics’ divesiran shows 88% response in Phase 2 polycythemia vera trial, challenging Takeda’s upcoming drug
    Silence Therapeutics reported results from a Phase 2 study of its RNA-based therapy divesiran in patients with polycythemia vera, a rare blood cancer that causes excessive red blood cell production…
    STAT · 2d agoPositive readoutPositive↗ source
  • Safety concerns emerge as radiopharmaceuticals advance in cancer trials
    Radiopharmaceuticals are being hailed for their ability to deliver radiation directly to tumours, potentially sparing surrounding healthy tissue and improving cancer therapy. However, as more cand…
    STAT · 2d agoNegative↗ source
  • AGC Biologics targets in-vivo gene therapies with stable producer lines and next-gen purification
    The industry is moving from ex vivo to in vivo gene delivery, a change that forces viral vector manufacturers to rethink scale, purity, cell lines and analytical methods. In in vivo approaches the…
    BioSpace · 2d agoPositive↗ source
  • Latigo and BlossomHill file Nasdaq IPO plans to fund pain and cancer pipelines
    Latigo Biotherapeutics and BlossomHill Therapeutics, both based in California, have filed applications to list on the Nasdaq Global Select Market. Latigo aims to raise up to $285.2 million to advan…
    BioSpace · 2d agoDealNeutral↗ source
  • Replimune secures FDA approval for Tudriqev, eyes $1.3 bn peak sales in advanced melanoma
    Replimune announced FDA approval of its therapy Tudriqev for patients with advanced melanoma who have progressed after PD-1 treatment. Analysts at BMO Capital Markets project the drug could genera…
    BioSpace · 5d agoApprovalPositive↗ source
  • Replimune secures FDA accelerated approval for melanoma therapy Tudriqev
    Replimune announced that the FDA has granted accelerated approval to its melanoma therapy RP1, marketed as Tudriqev, after two earlier rejections and a third expedited review. The decision reflects…
    STAT · 5d agoApprovalPositive↗ source
  • FDA outlines inspection overhaul, proposes IND reforms, and greenlights a disputed cancer therapy
    FDA officials announced a plan to restructure the agency’s inspectional operations, aiming to make inspections more efficient and focused. The proposed changes include consolidating regional office…
    raps · 5d agoRegulatoryNeutral↗ source
  • EMA releases updated guidance on drug shortage prevention plans
    The European Medicines Agency has published a revised guideline aimed at helping marketing authorisation holders develop and keep drug shortage prevention plans for their products. The new guidanc…
    raps · 5d agoRegulatoryNeutral↗ source