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  • DOJ ramps up health-care fraud investigations, urges companies to self-report and reward remediation
    At the STAT Summit in Boston, DOJ officials announced a renewed focus on health-care fraud, especially targeting Medicare and Medicaid schemes. Deputy Assistant Attorney General Jacob Foster said…
    STAT · 25d agoRegulatoryNegative↗ source
  • Massachusetts Rep. Jake Auchincloss urges Congress to back U.S. biotech instead of targeting China
    At the STAT Summit in Boston, Rep. Jake Auchincloss (D-Mass.) told fellow lawmakers to back the U.S. biotechnology sector without hesitation. He urged Congress to champion biotech, criticize insur…
    STAT · 25d agoPositive↗ source
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  • Belgian startup Armed Cell Therapeutics acquires Galapagos-derived CAR-T assets for €8 million upfront
    Armed Cell Therapeutics, a new Belgian biotech chaired by former Galapagos CEO Paul Stoffels, has taken ownership of several cell therapy programs previously held by Lakefront Biotherapeutics. The…
    BioPharma Dive · 25d agoDealPositive↗ source
  • Melanoma patient shares hope after receiving Merck-Moderna mRNA cancer vaccine in trial
    A schoolteacher diagnosed with melanoma in 2019 participated in a late‑stage trial testing an mRNA cancer vaccine developed by Merck and Moderna. The trial added the vaccine to standard immunothera…
    STAT · 25d agoPositive↗ source
  • FDA unveils new rare disease framework to streamline evidence standards and speed therapies
    The FDA announced a new Rare Disease Framework Initiative aimed at standardizing how scientific evidence is evaluated for rare disease therapies. The framework seeks to apply consistent clinical t…
    BioSpace · 25d agoRegulatoryPositive↗ source
  • OrbiMed secures $3 billion for new life science funds, with over $1 billion earmarked for Asia
    OrbiMed, a leading global investor in life science companies, announced the closing of two new funds that together total about $3 billion. The capital will be deployed across a range of private equ…
    Endpoints · 25d agoDealPositive↗ source
  • Vanda halts Novartis-originated social anxiety drug after Phase 3 miss
    Vanda Pharmaceuticals announced it is suspending development of VQW-765, a social anxiety disorder candidate licensed from Novartis, after the drug failed to demonstrate a statistically significant…
    BioSpace · 25d agoNegative readoutNegative↗ source
  • Kenya confirms second Ebola case as Congo outbreak continues
    Kenya health officials have confirmed a second case of Ebola in the country, raising concerns about potential spread. The report comes as the neighboring Democratic Republic of Congo continues to…
    STAT · 25d agoNegative↗ source
  • Vanda pauses social anxiety program after Phase 3 trial misses endpoint in women
    Vanda Pharmaceuticals announced Wednesday that it is halting development of its social anxiety disorder candidate after a late-stage trial did not achieve its primary goal. The experimental drug,…
    Endpoints · 25d agoNegative readoutNegative↗ source
  • Nvidia-backed Iambic Therapeutics raises $150M in IPO, begins trading Thursday
    Iambic Therapeutics, a biotech focused on using artificial intelligence to develop cancer treatments, announced the completion of its initial public offering. The company sold 9.38 million shares…
    Endpoints · 26d agoDealPositive↗ source
  • Compass Pathways CEO says company will proceed cautiously as it readies psychedelic therapy for FDA review
    Compass Pathways chief executive Kabir Nath told reporters at the STAT Summit that the company will "go slow before we go fast," emphasizing that early negative experiences could hurt the emerging…
    STAT · 26d agoRegulatoryNeutral↗ source
  • FDA issues warning letters to manufacturers over CGMP and GLP violations
    The U.S. Food and Drug Administration has sent warning letters to multiple drug manufacturers for failing to meet current good manufacturing practice requirements. The agency highlighted problems e…
    raps · 26d agoRegulatoryNegative↗ source
  • Former FDA commissioners slam current HHS leadership over research cuts and regulatory challenges
    Former FDA commissioners Rob Califf, Scott Gottlieb and Ned Sharpless publicly criticized the officials running the agency, saying the current HHS leadership is failing the FDA. They highlighted m…
    STAT · 25d agoRegulatoryNegative↗ source
  • Verastem reports encouraging early data for KRAS G12D inhibitor in pancreatic cancer
    Verastem Oncology disclosed early clinical results for its KRAS G12D inhibitor, which is being evaluated in more than 200 patients with advanced solid tumors, including metastatic pancreatic ductal…
    STAT · 25d agoPositive readoutPositive↗ source
  • Advocates race to shape rules for AI sandboxes in health care
    The STAT Health Tech newsletter notes that AI sandboxes are becoming a popular mechanism for testing health‑care artificial intelligence under controlled conditions. A broad coalition of industry…
    STAT · 25d agoRegulatoryNeutral↗ source
  • Former Galapagos CEO Paul Stoffels aims to revive cell therapy projects at new biotech Armed Cell
    Paul Stoffels, who recently stepped down as chief executive of Belgian drug developer Galapagos, is turning his attention to cell‑based therapies. After leaving Galapagos last year, Stoffels has j…
    Endpoints · 25d agoDealPositive↗ source
  • Experts call for Congress to create a dedicated regulatory framework for AI models used in academic medical centers
    On Oct. 15, 2026, several health policy experts voiced support for a new regulatory approach specifically aimed at clinical artificial‑intelligence models that are developed and deployed in academi…
    raps · 26d agoRegulatoryNeutral↗ source
  • Osivax shifts to combination strategy after Phase 2b flu vaccine setback
    Osivax, a French biotech, reported that its lead influenza vaccine candidate did not meet primary endpoints in a Phase 2b study. The trial, which evaluated the vaccine as a standalone product, sho…
    Endpoints · 25d agoNegative readoutNegative↗ source
  • Webinar Explores How US Biotechs Can Compete and Collaborate with China’s Growing Industry
    BioSpace is hosting a webinar titled "The China question: Can US biotechs lead as investment heads east?" on October 15, 2026. The event will feature a panel of experts who will discuss how China i…
    BioSpace · 25d agoNeutral↗ source
  • AI tools push physicians to prioritize clinical reasoning over memorization, experts say
    During a recent Endpoints News panel, health‑tech experts highlighted how artificial‑intelligence applications are reshaping the competencies doctors need. They argued that AI can handle routine d…
    Endpoints · 25d agoPositive↗ source
  • U.S. Health Officials Push Policy to Let Specialty Pharmacies Make Certain Peptide Injections
    The Department of Health and Human Services has submitted an interim access policy for peptides to the White House, where it will be reviewed by the Office of Management and Budget. The proposal w…
    STAT · 25d agoRegulatoryNeutral↗ source
  • NorthStar Medical Technologies partners with Chinese CRO Quarkmed, while Lonza outlines mid-term guidance
    NorthStar Medical Technologies, a maker of radioisotopes, announced a new partnership with Beijing-based contract research organization Quarkmed. Under the agreement, Quarkmed will provide contrac…
    Endpoints · 25d agoDealNeutral↗ source
  • Cytiva podcast highlights decision confidence as key bottleneck in biopharma development
    In a recent episode of the Denatured podcast, hosted by BioSpace Insights director Jennifer Smith-Parker, the conversation focused on the challenges facing biopharma companies. The guest, Nicolas P…
    BioSpace · 25d agoNeutral↗ source
  • Personal tragedy highlights deeper flaws in nursing workforce and training gaps
    Lynne S. Moronski, a nurse researcher at the University of Pennsylvania, recounts the loss of her 21‑year‑old daughter, who died after a medication error by direct support professionals in a New Je…
    STAT · 26d agoNegative↗ source
  • Patients struggle to opt out of MyChart data sharing, facing notary and endless hurdles
    An opinion piece highlights how MyChart users who want to stop sharing their health information encounter a maze of requirements. The author describes needing a notary, multiple phone calls, unansw…
    STAT · 26d agoNegative↗ source