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  • Study finds Merck’s Ervebo may protect against Bundibugyo Ebola strain, prompting calls for DRC testing
    New data from a human study published in the New England Journal of Medicine suggests Merck's Ervebo vaccine, licensed for the Zaire ebolavirus, may also offer protection against the Bundibugyo spe…
    STAT · 28d agoPositive readoutPositive↗ source
  • Pharma pushes back on China restrictions as AI VC raises $800M and Merck unveils cholesterol pill; Celldex reports trial setback
    Pharma companies are working to ease the impact of broad new restrictions in China, seeking ways to maintain market access amid tighter regulatory scrutiny. An AI‑focused venture capital firm anno…
    STAT · 28d agoNeutral↗ source
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  • Hospital AI oversight lagging; senior leaders must take daily responsibility
    AI tools are now common in U.S. hospitals, handling tasks such as drafting clinical notes, flagging sepsis, screening imaging, processing prior authorizations, and responding to patient messages.…
    STAT · 29d agoNeutral↗ source
  • Celldex halts skin disease program after barzolvolimab fails phase 2 trial
    Celldex Therapeutics announced it is discontinuing development of its anti‑KIT antibody barzolvolimab for chronic skin disorders after the drug failed to meet its primary endpoint in a phase 2 stud…
    Fierce Biotech · 29d agoNegative readoutNegative↗ source
  • Summit and Akeso sharpen case for ivonescimab with new Western data
    Summit Therapeutics and Akeso are answering questions raised about ivonescimab’s ability to translate to Western populations, though the partners have yet to share if the new findings are statistic…
    BioSpace · 28d agoRegulatoryNeutral↗ source
  • Study finds rising job dissatisfaction and health‑care access uncertainty among U.S. workers
    A new study shows increasing levels of job dissatisfaction and uncertainty about health‑care access among U.S. workers. The research, funded by AHRQ, surveyed a national sample and found that a gr…
    STAT · 28d agoNegative↗ source
  • AHRQ cuts $109 million in health services research grants, ending 78 projects early
    AHRQ announced that dozens of health services research grants will stop early, affecting about $109 million still to be spent. The agency said it is reshaping its discretionary award portfolio to…
    STAT · 29d agoRegulatoryNegative↗ source
  • Why moving from Big Pharma to a midsize specialty firm can boost impact and leadership
    Thomas Kolaras, formerly with large pharmaceutical companies, now works at SERB Pharmaceuticals and reflects on the benefits and constraints of big‑pharma environments. He highlights the rigorous p…
    BioSpace · 29d agoPositive↗ source
  • Webinar Highlights Emerging Recovery in Biopharma Hiring and Talent Strategies for Commercial Growth
    The BioSpace webinar "From Clinical to Commercial: Talent Strategies for Biopharma Growth" examined recent hiring activity across the biopharma sector and offered guidance for companies preparing t…
    BioSpace · 28d agoPositive↗ source
  • Cambridge biopharma job postings surge 120% as six firms ramp up hiring
    Job listings for biopharma positions in Cambridge, Massachusetts, have jumped 120% year over year on the BioSpace platform. The upward trend began in February, saw a brief dip in May, and accelerat…
    BioSpace · 28d agoPositive↗ source
  • Novartis drops mid-stage radioligand therapy 177Lu-NeoB after weak early data
    Novartis has discontinued its mid-stage radioligand therapy 177Lu-NeoB, which was being tested for breast cancer and other solid tumors. The company said early clinical data did not show enough ef…
    BioSpace · 28d agoNeutral↗ source
  • Nabla executive Alex LeBrun discusses ‘world model’ AI as an alternative to large language models
    Brittany Trang of STAT’s AI Prognosis newsletter interviewed Alex LeBrun, the executive chairman of AI scribe company Nabla, to explore a concept called a “world model.” LeBrun described a world m…
    STAT · 28d agoNeutral↗ source
  • Argentina’s World Cup defeat offers a cautionary lesson for U.S. hospitals on avoiding complacency
    Opinion writer Basel Tarab, a physician and hospital administrator, reflects on Argentina’s recent World Cup loss as a metaphor for American health‑care systems. He recalls Argentina’s 2022 triump…
    STAT · 28d agoNeutral↗ source
  • FDA revokes Orange B color additive and proposes to drop Citrus Red No. 2 from food approvals
    The U.S. Food and Drug Administration issued a final order that revokes the authorized use of Orange B as a food color additive. The agency also proposed revoking Citrus Red No. 2, a pigment autho…
    fda press · 28d agoRegulatoryNeutral↗ source
  • Dyne Therapeutics receives early 2027 FDA decision date for Duchenne therapy, analysts anticipate smooth review
    Dyne Therapeutics' investigational Duchenne muscular dystrophy therapy, zeleciment rostudirsen, has had its BLA accepted by the FDA with a target action date of Jan 21, 2027. Analysts at Oppenheim…
    BioSpace · 29d agoRegulatoryPositive↗ source
  • Samsung Biologics proposes $1.8B acquisition of PolyPeptide to enter fast-growing obesity peptide market
    Samsung Biologics, a South Korean contract development and manufacturing organization, announced an offer to acquire Swiss CDMO PolyPeptide for CHF 1.46 billion (about $1.8 billion). PolyPeptide s…
    BioSpace · 29d agoDealPositive↗ source
  • Novartis says it will keep seeking sub-$2 billion bolt-on deals worldwide, staying geography-agnostic
    Novartis CEO Vas Narasimhan told investors on the second‑quarter earnings call that the company will continue to pursue bolt‑on acquisitions below $2 billion and has no plans to overhaul its busine…
    BioSpace · 29d agoDealNeutral↗ source
  • Agios halts sickle cell drug program after disappointing phase 2 results
    Agios announced it is stopping development of its next‑generation pyruvate kinase activator, tebapivat, for sickle cell disease after a phase 2 trial failed to meet expectations. The study enrolle…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Biotech firms rally to defend FDA's mifepristone approval in Louisiana lawsuit
    Biotech companies, executives and investors filed an amicus brief supporting the FDA in the Louisiana case that seeks to limit access to the abortion pill mifepristone. The brief is signed by 61 e…
    Fierce Biotech · 29d agoRegulatoryPositive↗ source
  • Agios drops next-gen sickle cell drug after Phase 2 data show no advantage over Novo’s candidate
    Agios Pharmaceuticals said it is halting development of its next‑generation pyruvate kinase activator, tebapivat, for sickle cell disease after a mid‑stage trial failed to demonstrate a benefit ove…
    BioSpace · 29d agoNegative readoutNegative↗ source
  • Broad Institute, Boston Children’s Hospital and Jackson Laboratory launch nonprofit to advance affordable gene therapies for rare diseases
    The Broad Institute, Boston Children’s Hospital and Maine’s Jackson Laboratory announced a new collaboration to develop gene‑based treatments for rare genetic disorders. The three institutions will…
    STAT · 29d agoDealPositive↗ source
  • Anthropic expands rare disease collaborations as Novo sues Lilly and Agios halts sickle cell drug
    Anthropic, a biotech firm, announced it is expanding its partnership portfolio focused on rare disease therapeutics, deepening collaborations with several companies to advance pipeline candidates.…
    STAT · 29d agoDealNeutral↗ source
  • Novo Nordisk sues Eli Lilly over allegedly deceptive obesity and diabetes ads
    Novo Nordisk has filed a federal lawsuit against Eli Lilly, accusing the rival of running misleading advertisements for its obesity and diabetes medicines. The company claims Lilly's ads rely on ou…
    STAT · 29d agoRegulatoryNegative↗ source
  • FDA’s 505(b)(2) pathway offers faster, cheaper drug development and commercial gains
    The FDA’s 505(b)(2) regulatory route lets drug sponsors build on existing safety and efficacy data while proposing meaningful changes to a known product. By leveraging prior findings, companies can…
    BioSpace · 29d agoRegulatoryPositive↗ source
  • Novo Nordisk sues Eli Lilly, alleging deceptive ads that misrepresent GLP-1 drug efficacy
    Novo Nordisk filed a lawsuit in federal court in New Jersey accusing Eli Lilly of running a deceptive advertising campaign. The complaint says Lilly’s ads compare the highest doses of its weight‑l…
    STAT · 29d agoRegulatoryNegative↗ source