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1,957 stories matching this filter · ← front page

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  • 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 · 1d agoNegative readoutNegative↗ source
  • Silence Therapeutics moves siRNA drug for polycythemia vera to Phase 3 after Phase 2 success
    Silence Therapeutics announced that its siRNA candidate divesiran achieved its primary endpoint in a Phase 2 study in patients with polycythemia vera, a rare blood cancer. The trial results showed…
    Endpoints · 1d agoPositive readoutPositive↗ source
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  • 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 · 1d agoPositive readoutPositive↗ source
  • 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 · 1d agoNegative readoutNegative↗ 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 · 1d 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 · 1d 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 · 1d 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 · 1d agoRegulatoryNeutral↗ 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 · 1d agoPositive↗ 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 · 1d agoNegative↗ source
  • FDA issues warning letters to Indian OTC drugmaker over falsified logbooks and cites GMP lapses at two other firms
    The FDA sent warning letters to an over‑the‑counter drug manufacturer in India after discovering the company had submitted falsified production logbooks. The agency also cited two additional OTC m…
    raps · 1d agoRegulatoryNegative↗ source
  • FDA issues warning letters to Indian OTC drugmaker for falsified logbooks and to two others for GMP testing lapses
    The U.S. Food and Drug Administration sent a warning letter to an over‑the‑counter drugmaker in India after discovering that the company had submitted falsified logbooks to the agency. In addition…
    raps · 1d agoRegulatoryNegative↗ source
  • RevMed partners with BeOne for Asian rights to RAS drugs as MoonLake reports Phase 3 success
    RevMed and BeOne have entered a partnership granting BeOne rights to commercialize RevMed’s RAS pathway drugs in selected Asian markets. The agreement also includes collaboration on upcoming clini…
    Endpoints · 1d 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 · 1d 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 · 1d 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 · 1d agoDealNeutral↗ source
  • BioNTech veteran secures $25M seed round for virtual cancer surveillance startup
    A new virtual cancer surveillance company has closed a $25 million seed round, with the funding led by investors attracted to its novel approach to monitoring tumors. The company is headed by Ryan…
    Endpoints · 1d agoDealPositive↗ source
  • India tightens penalties for submitting false regulatory documents
    The Indian government has introduced stricter penalties for applicants who submit misleading, fake, or fabricated documents to regulatory authorities, prohibiting them from making further filing re…
    raps · 1d agoRegulatoryNeutral↗ source
  • Scholar Rock removes Indiana manufacturing site from SMA drug application after FDA cites deficiencies
    Scholar Rock, a Massachusetts biotech, announced it is withdrawing an Indiana manufacturing facility from its filing for a prospective spinal muscular atrophy (SMA) therapy. The decision follows a…
    Endpoints · 1d agoRegulatoryNegative↗ 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 · 1d 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 · 1d 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 · 1d 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 · 1d agoNeutral↗ 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 · 1d agoRegulatoryNegative↗ source
  • Weekly roundup: Experts debate China biotech work ethic and a stalled megamerger
    The Endpoints News team hosted a panel of industry experts in Cambridge, Massachusetts, to examine the future of biotech in China. Participants highlighted concerns about the country’s work ethic a…
    Endpoints · 3d agoNeutral↗ source