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  • BioMarin drops BMN 401 after Phase 3 trial misses clinical endpoints, ending $270M Inozyme asset
    BioMarin announced it will stop development of BMN 401, an enzyme replacement therapy acquired in its $270 million purchase of Inozyme Pharma. The decision follows the Phase 3 ENERGY trial in pati…
    BioSpace · 10d agoNegative readoutNegative↗ source
  • FDA issues complete response letter rejecting ITM’s neuroendocrine tumor drug over manufacturing concerns
    The U.S. Food and Drug Administration sent a complete response letter to ITM Isotopes Technologies, refusing approval of its lead candidate for gastroenteropancreatic neuroendocrine tumors because…
    Fierce Biotech · 10d agoCRLNegative↗ source
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Infectious Disease353
  • Scholar Rock removes Novo Nordisk's Catalent plant from FDA filing for SMA drug apitegromab
    Scholar Rock announced it will no longer list Novo Nordisk’s legacy Catalent facility as a contract manufacturer in its FDA resubmission for apitegromab, its spinal muscular atrophy (SMA) candidate…
    Fierce Biotech · 10d agoRegulatoryNeutral↗ source
  • MoonLake reports all endpoints met in phase 3 trial of sonelokimab for psoriatic arthritis
    MoonLake Immunotherapeutics said its lead nanobody sonelokimab achieved positive topline results in a phase 3 study of patients with psoriatic arthritis. At week 16, 42.1% of participants reached…
    Fierce Biotech · 10d agoPositive readoutPositive↗ source
  • Global Ebola preparedness fixated on one strain, leaving other species vulnerable
    In an opinion piece, infectious-diseases physician Krutika Kuppalli and virologist Placide Mbala argue that the term "Ebola" masks several distinct virus species, each with different diagnostic and…
    STAT · 10d agoNegative↗ 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 · 10d agoNegative↗ source
  • Global Ebola preparedness fixated on one strain, leaving gaps for other species
    Krutika Kuppalli, a former WHO medical officer, and virologist Placide Mbala write that the world’s readiness for Ebola has been narrowly focused. They draw on Kuppalli’s experience in the 2014‑201…
    STAT · 10d agoNegative↗ source
  • China clamps down on investigator-initiated clinical trials, tightening oversight
    China has announced tighter oversight of investigator-initiated trials (ITTs), requiring these studies to obtain approval from the National Medical Products Administration before they can begin. Th…
    STAT · 10d agoRegulatoryNeutral↗ source
  • FDA approves Labcorp's BRAF melanoma companion diagnostic
    The FDA has granted approval to Labcorp's companion diagnostic for advanced melanoma patients with specific BRAF mutations. The test, called PGDx elio tissue complete CDx, uses next-generation seq…
    Fierce Biotech · 10d agoApprovalPositive↗ 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 · 10d agoPositive↗ source
  • Arpeggio Biosciences shuts down after Nrf2 drug program encounters off-target toxicity
    Arpeggio Biosciences, founded in 2018 in Boulder, Colorado, built its platform around a large nascent‑RNA sequence database and aimed to develop a small‑molecule degrader of the Nrf2 transcription…
    Fierce Biotech · 10d agoLayoffsNegative↗ source
  • aTyr Pharma cuts 60% of staff to fund second phase 3 trial of lung disease drug efzofitimod
    aTyr Pharma announced it will reduce its workforce by about 60%, leaving roughly 20 employees, to reallocate resources toward its lung disease program. The cut follows the company's previous phase…
    Fierce Biotech · 10d agoLayoffsNegative↗ source
  • BMS's Cobenfy faces market hurdles as side effects limit uptake, MapLight eyes opportunity
    The FDA approved Bristol Myers Squibb's Cobenfy in 2024, marking the first novel schizophrenia treatment in 35 years and raising hopes for a new therapeutic approach. Since its launch, the drug ha…
    BioSpace · 10d agoNegative↗ source
  • Regeneron Ventures leads $75 million Series A for eczema-focused antibody startup Infinimmune
    Infinimmune, a Bay Area biotech developing antibody therapies for eczema, announced a $75 million Series A financing round. The round was co-led by Regeneron Ventures and Playground Global, with p…
    Fierce Biotech · 10d agoDealPositive↗ source
  • FDA to require companies to notify agency of new food additives, creating public database
    The Health and Human Services Department announced a new policy that obligates manufacturers to inform the FDA when they introduce a new substance into human or animal food, and to explain how they…
    STAT · 10d agoRegulatoryNeutral↗ source
  • Calls to Ban Prior Authorizations Amid Hospital Job Cuts Highlight Health‑Care Policy Debate
    The Health Care Inc. newsletter from STAT highlighted a proposal to eliminate most prior authorizations, a requirement that insurers use to control drug spending. The suggestion comes from policy…
    STAT · 10d agoNeutral↗ 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 · 10d agoDealNeutral↗ source
  • Sobi pens $580M deal for Innate’s skin cancer drug ahead of phase 3 push
    Sobi has bought into Innate Pharma’s vision for lacutamab, handing the French biotech $75 million upfront for the rights to market the anti-KIR3DL2 antibody for an aggressive skin cancer.
    Fierce Biotech · 10d agoDealNeutral↗ source
  • Denali Therapeutics' Avlayah generates $3.6M in Q1, beating forecasts
    Denali Therapeutics reported that its newly launched Hunter syndrome therapy Avlayah earned $3.6 million in revenue during the first quarter after its April market entry. Analysts had projected ro…
    BioSpace · 10d agoPositive readoutPositive↗ source
  • States urged to use low-cost, scalable outreach for Medicaid enrollees facing 2027 eligibility changes
    States must begin notifying Medicaid beneficiaries about upcoming eligibility changes by September, as required by the One Big Beautiful Bill Act of 2025. The changes, set to take effect in 2027, i…
    STAT · 10d agoNeutral↗ source
  • Aspo Oyj announces upcoming leadership changes scheduled for August 10, 2026
    Aspo Oyj, a Finnish specialty chemicals company, issued a brief notice indicating that it will implement leadership transactions. The announcement specifies that the changes will take effect on Au…
    globenewswire health · 10d agoNeutral↗ source
  • Aspo Plc reports managers' transactions on August 10, 2026
    Aspo Plc disclosed that its managers executed transactions on August 10, 2026, as recorded in a filing. The filing does not provide details about the nature, size, or parties involved in the trans…
    globenewswire health · 10d agoNeutral↗ source
  • Novo Nordisk partners with Amazon Web Services to boost AI-driven drug discovery, opens London hub
    Novo Nordisk announced a partnership with Amazon Web Services aimed at using artificial intelligence to speed up the discovery of new medicines. The collaboration will see AWS become Novo Nordisk's…
    Fierce Biotech · 10d agoDealPositive↗ source
  • Sanofi reports shortages of Myozyme and Nexviazyme for Pompe disease after FDA manufacturing warning
    Sanofi has warned that supplies of two medicines used to treat Pompe disease are running low. The company notified patient groups and physicians in the United States and Europe that the shortage af…
    STAT · 10d agoRegulatoryNegative↗ source
  • Novo Nordisk CFO sees oral Wegovy rollout boosting outlook and remains upbeat on CagriSema
    Novo Nordisk's chief financial officer, Karsten Munk Knudsen, discussed the company's second‑quarter earnings and the progress of the oral Wegovy pill during a recent interview. He highlighted that…
    Fierce Biotech · 13d agoEarningsPositive↗ source