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  • Merck and Moderna vaccine data leak ahead of ESMO, Merck's sac-TMT cuts endometrial cancer deaths, BMS reports CAR-T death
    A data leak of the highly anticipated personalized cancer vaccine being developed by Merck and Moderna surfaced online before the European Society for Medical Oncology (ESMO) meeting. The premature…
    BioSpace · 13d agoNeutral↗ source
  • Biogen CEO says early-stage R&D now a priority after record five INDs this year
    Biogen's chief executive Chris Viehbacher told analysts that the company has shifted its strategy toward early-stage research and development. He highlighted that Biogen has filed five investigati…
    Fierce Biotech · 13d agoPositive↗ source
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Epic's data‑blocking tactics curb health‑tech innovation, investigation finds
A STAT investigation reveals that Epic Systems, the leading electronic health record vendor, is deliberately limiting access to patient data for competing software developers. This practice gives E…
STAT · 13d agoNegative↗ source
  • Former Novo and Sanofi staff describe mixed layoff experiences, citing severance benefits and poor communication
    Three former employees of large pharmaceutical companies, including Novo and Sanofi, spoke to BioSpace about how they were let go. Their accounts form part of a broader survey that collects layoff…
    BioSpace · 13d agoLayoffsNegative↗ source
  • Flagship launches Etcelera, an AI-driven biotech combining three platforms to predict drug effects
    Flagship Pioneering announced the formation of Etcelera, a new biotech emerging from stealth that will focus on AI-powered drug discovery. The company brings together the technologies of Cellarity…
    Fierce Biotech · 13d agoPositive↗ source
  • HHS adopts temporary policy to let compounding pharmacies produce six unapproved peptides
    HHS announced a temporary policy that grants enforcement discretion to state-licensed compounding pharmacies, federal facilities, and licensed physicians who compound six specific peptide products…
    STAT · 13d agoRegulatoryNeutral↗ source
  • GSK says UK restructuring will have limited impact on staff, focusing cuts on support roles
    GSK executives said the company's global restructuring will only modestly affect UK staff, mainly targeting support functions at headquarters. CEO Luke Miels explained during the Q3 earnings call…
    Fierce Biotech · 13d agoLayoffsNegative↗ source
  • Lawmaker asks GAO to examine TrumpRx claims of $700 million drug savings
    Representative Frank Pallone, the ranking member of the House Energy and Commerce Committee, sent a letter to the Government Accountability Office asking it to assess whether the TrumpRx website ha…
    STAT · 13d agoRegulatoryNegative↗ source
  • Epic’s dominance forces health-care AI firms to adapt, new STAT+ analysis finds
    The latest STAT+ AI Prognosis newsletter examines how Epic’s entrenched position in electronic health-record systems is shaping the strategies of health-care artificial-intelligence companies. The…
    STAT · 13d agoNeutral↗ source
  • GSK vaccine sales miss expectations amid falling demand from adults
    With pressure on GSK’s vaccine business, analysts predict the U.K. pharma will face challenges as it prepares for the loss of exclusivity on a key product.
    BioSpace · 13d agoRegulatoryNeutral↗ source
  • FDA issues draft guidance for electronic IDE submissions via eSTAR
    The U.S. Food and Drug Administration released draft guidance outlining how sponsors can submit investigational device exemption (IDE) applications using the electronic Submission Template and Reso…
    raps · 13d agoRegulatoryNeutral↗ source
  • U.S. overdose deaths fell 27% in 2024, with early 2025 data showing further decline
    U.S. overdose mortality dropped 27% in 2024 after years of steep increases, and preliminary figures for 2025 suggest the trend is continuing, though the overall death rate remains high. A Health a…
    STAT · 13d agoPositive↗ source
  • Pediatricians work to calm families and promote MMR vaccination amid Pennsylvania measles outbreak
    A pediatrician at the Children’s Hospital of Philadelphia describes a growing measles outbreak in Pennsylvania, noting more than 1,300 reported cases with roughly a third affecting children. Paren…
    STAT · 13d agoNeutral↗ source
  • Michigan Senate candidate Abdul El-Sayed vows to challenge RFK Jr. and push Medicare for All
    Abdul El‑Sayed, a Michigan Democrat and former public‑health official, is nearing the end of a contentious Senate campaign. He has announced he will aggressively question Robert F. Kennedy Jr., lab…
    STAT · 13d agoNeutral↗ source
  • Physician's personal egg-freezing story highlights systemic sexism in fertility industry
    In an opinion piece, NYU assistant professor Pooja Yerramilli reflects on her own egg-freezing experience after Democratic Representative Alexandria Ocasio-Cortez sparked a national conversation ab…
    STAT · 13d agoNegative↗ source
  • STAT seeks input on how Epic's practices affect hospital technology choices
    Epic is the largest electronic health records vendor in the United States, with its systems used by most large health systems and covering the health data of roughly eight in ten Americans. Indust…
    STAT · 13d agoNeutral↗ source
  • Biopharma leader urged to prioritize own job search after team layoffs
    A biopharma executive recently had to announce a downsizing of her team, and she described feeling guilt and grief for the impact on her direct reports. She said she would wait until every person…
    BioSpace · 13d agoLayoffsNeutral↗ source
  • Genmab’s cancer bispecific delivers early survival win in ‘exceedingly positive’ Phase 3 readout
    Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans.
    BioSpace · 13d ago↗ source
  • STAT+: Lilly’s triple-G drug beats Ozempic in head-to-head study
    Eli Lilly announced that its investigational drug retatrutide was more effective at lowering blood sugar and cutting weight than Novo Nordisk’s Ozempic in a large diabetes study.
    STAT · 13d ago↗ source
  • Lilly’s retatrutide trounces Novo’s Ozempic in diabetes, weight loss
    Eli Lilly’s next-gen weight loss drug retatrutide soundly beat Novo’s approved medicine Ozempic in weight loss and blood sugar reduction, padding the case for a regulatory application that’s expect…
    BioSpace · 13d ago↗ source
  • Phase 3 trial shows cancer vaccine intismeran autogene cuts recurrence risk by 42% versus Keytruda
    At the European Society for Medical Oncology Congress, a Phase 3 trial of the personalized cancer vaccine intismeran autogene reported a 42% reduction in risk of recurrence or death compared with p…
    STAT · 14d agoPositive readoutPositive↗ source
  • Incyte's KRAS G12D inhibitor shows 89% response rate in early pancreatic cancer trial
    In a Phase 1 study, Incyte tested its KRAS G12D inhibitor together with standard chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma carrying the G12D mutation. The combinati…
    BioSpace · 14d agoPositive readoutPositive↗ source
  • Novartis takes $1.9B write-down after Avidity's del-desiran fails Phase 3 but reaffirms confidence in $12B acquisition
    Novartis announced a $1.9 billion partial impairment after the Phase 3 HARBOR study of del-desiran, an antibody‑oligonucleotide conjugate from its Avidity Biosciences acquisition, did not meet its…
    BioSpace · 14d agoNegative readoutNeutral↗ source
  • Novartis CEO keeps faith in Avidity deal despite taking $1.9B hit from del-desiran fail
    Novartis CEO Vas Narasimhan has insisted that the phase 3 fail for del-desiran is just a “bump” in the Swiss pharma’s wider plans for the drug, despite costing the company an estimated $1.9 billion.
    Fierce Biotech · 14d agoNegative readoutNegative↗ source
  • GSK's B7-H3 ADC cuts osteosarcoma progression risk by 67% in Chinese phase 3 trial
    A phase 3 study in China evaluated GSK's B7-H3‑directed antibody‑drug conjugate, risvutatug rezetecan (ris‑rez), in patients with relapsed osteosarcoma. The trial met its primary endpoint, showing…
    Fierce Biotech · 14d agoPositive readoutPositive↗ source