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  • Revolution Medicines' Rasonge receives second-line pancreatic cancer nod, could drive $2.3B sales by 2028
    Revolution Medicines announced that its RAS inhibitor Rasonge earned a second-line indication for pancreatic ductal adenocarcinoma, marking the first regulatory step in the company's PDAC strategy.…
    BioSpace · 13d agoApprovalPositive↗ source
  • Moderna and Merck report late-stage success for personalized mRNA cancer vaccine
    Moderna and Merck announced that their personalized cancer vaccine achieved its primary goals in a late-stage clinical trial, sparking enthusiasm across the biotech community. The experimental the…
    STAT · 13d agoPositive readoutPositive↗ source
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  • Obesity drug market surges as Lilly, Novo Nordisk lead and rivals chase $200B opportunity
    Eli Lilly and Novo Nordisk continue to dominate the early market for obesity treatments, expanding their prescription bases with new oral products. Meanwhile, a range of larger and smaller compani…
    BioSpace · 13d agoPositive↗ source
  • AstraZeneca and Amgen’s Tezspire shows positive results in Phase 3 eosinophilic esophagitis trial
    AstraZeneca and Amgen continue to co‑develop and co‑commercialize Tezspire, an anti‑inflammatory therapy already approved for asthma and chronic rhinosinusitis. The partners are preparing another F…
    BioSpace · 13d agoPositive readoutPositive↗ source
  • Hospitals Mobilize to Challenge $1 Trillion Medicaid Funding Cuts
    Hospital leaders are reacting to a law that will cut nearly $1 trillion in Medicaid funding over the next ten years, prompting a rapid re‑evaluation of their financial models. Lobbyists and execut…
    STAT · 13d agoRegulatoryNegative↗ source
  • CEPI pledges up to $16.5M to advance Egyptian biotech's Ebola vaccine candidate
    CEPI has committed up to $16.5 million to help bring Minapharm’s Bundibugyo Ebola vaccine candidate into clinical testing. The funding will support preclinical work and an early-stage human trial…
    Fierce Biotech · 13d agoDealPositive↗ source
  • Senator Cassidy's report blames FDA for lax oversight of abortion pill manufacturers
    Senator Bill Cassidy released a report accusing the Food and Drug Administration of failing to tighten restrictions on the abortion pill mifepristone and of lacking transparency in its oversight.…
    STAT · 13d agoRegulatoryNegative↗ source
  • Alnylam’s heart drug outlook dimmed as rival eplontersen fails at ESC Congress
    The European Society of Cardiology Congress in Munich is a focal point for Alnylam Pharmaceuticals as it seeks clarity on the future of its two ATTR-CM programs. Data presented by AstraZeneca and…
    STAT · 13d agoNegative readoutNegative↗ source
  • Roche receives expanded FDA clearance for HER2 diagnostic tests linked to Jazz’s Ziihera cancer drug
    Roche announced that the U.S. Food and Drug Administration has broadened the clearance for two of its HER2 diagnostic assays, allowing their use in metastatic gastroesophageal adenocarcinoma. The…
    Fierce Biotech · 13d agoCRLPositive↗ source
  • FDA approves Roivant's brepocitinib for rare autoimmune disease dermatomyositis
    On Thursday the U.S. Food and Drug Administration gave its nod to a new therapy from Roivant Sciences and its subsidiary Priovant. The oral medication, brepocitinib, will be sold under the brand na…
    STAT · 13d agoApprovalPositive↗ source
  • Hospitals Prepare Lobbying Effort to Counter $1 Trillion Health Care Funding Cuts
    Hospitals are gearing up to lobby Congress after a projected $1 trillion reduction in health‑care spending, which was part of recent tax‑cut legislation. Hospital leaders say they will seek higher…
    STAT · 13d agoRegulatoryNegative↗ source
  • UK reduces drug rebate rate to 14.5% after a year of pharma pull-back, following US trade deal
    In September 2025, relations between the UK government and major pharmaceutical companies hit a low point when the government announced a steep increase in the share of sales of new branded medicin…
    Fierce Biotech · 13d agoRegulatoryNeutral↗ source
  • Vivace Therapeutics appoints Craig Gibbs as CEO and Ellen Lubman as chief business officer ahead of phase 3 mesothelioma trial
    Vivace Therapeutics announced two senior leadership appointments. Craig Gibbs, Ph.D., will serve as the company’s president and chief executive officer, while Ellen Lubman joins as chief business a…
    Fierce Biotech · 13d agoPositive↗ source
  • Osivax licenses GC Biopharma seasonal flu vaccine to develop combined OVX836-GC FLU shot
    Osivax has secured a non-exclusive license from GC Biopharma for its seasonal influenza vaccine, GC FLU, to pair with Osivax’s mid-phase candidate OVX836. OVX836 targets the conserved nucleoprotei…
    Fierce Biotech · 13d agoDealPositive↗ source
  • Proposed Biotech Investment National Security Act may protect US firms but contains loophole aiding Chinese competition
    A bipartisan bill called the Biotech Investment National Security Act (BINSA) has been introduced in Congress to expand federal oversight of biotechnology activities, from drug development to biolo…
    STAT · 13d agoRegulatoryNegative↗ source
  • Long-term unemployment pushes many biopharma professionals to quit job searches
    A recent BioSpace LinkedIn poll shows that about one-quarter of biopharma workers who have been unemployed for six months or more have stopped looking for new positions, and a similar share are con…
    BioSpace · 13d agoNegative↗ source
  • Scaling delivery is key for CAR T therapies to succeed in autoimmune diseases
    Biopharma companies are exploring CAR T cell therapies as a potential cure for autoimmune disorders, a market that could be twice the size of oncology. While current treatments manage symptoms, the…
    BioSpace · 13d agoNeutral↗ source
  • DEA moves on kratom substances as FDA greenlights new pancreatic drug
    The Drug Enforcement Administration is taking new steps concerning substances associated with kratom, signaling a shift in how the agency handles the plant-derived compounds. In a separate develop…
    STAT · 13d agoRegulatoryNeutral↗ source
  • CMS to host launch event for ACCESS, its new Medicare chronic care pilot
    CMS announced it will hold a launch event for ACCESS, a pilot program aimed at chronic care management for Medicare beneficiaries. The pilot is intended to test new care coordination models and pa…
    STAT · 13d agoRegulatoryNeutral↗ source
  • Generate Bio drops as data accidentally leaked ahead of European conference
    Phase 1 data from Generate Biomedicines’ ongoing chronic obstructive pulmonary disease study demonstrated “rapid and sustained reductions” across four disease biomarkers.
    BioSpace · 13d agoRegulatoryNeutral↗ source
  • FDA review highlights expanding role of manufacturing process models in drug applications
    The FDA released a review outlining how manufacturers can incorporate process modeling into their regulatory submissions. Process models are described as a growing scientific area and are being us…
    raps · 13d agoRegulatoryNeutral↗ source
  • Reddit reveals menopause symptoms often misdiagnosed, urging researchers to listen
    A University of Maryland researcher examined discussions on Reddit where women described perimenopause and menopause experiences that were frequently dismissed or misdiagnosed by clinicians. The on…
    STAT · 13d agoNeutral↗ source
  • Louisiana directs 20% of opioid settlement funds to sheriffs, who spend millions on police equipment
    KFF Health News investigated how Louisiana sheriffs used their share of opioid settlement money. The state allocated 20% of the settlement payouts to the 64 elected sheriffs, the largest law‑enfor…
    STAT · 13d agoNegative↗ source
  • Experts discuss hurdles and prospects for the first approved Fragile X therapy
    In a recent episode of BioSpace's "Denatured" podcast, Hilary Rosselot of the National Fragile X Foundation and Jordi Fàbrega, co‑founder and CEO of CONNECTA Therapeutics, talked about the current…
    BioSpace · 13d agoNeutral↗ source
  • Biopharma hiring gaps: experts cite four key mismatches between companies and candidates
    Recruiting specialists highlighted persistent disconnects between biopharma employers and job seekers, noting that misaligned expectations can slow hiring and discourage talent. One major issue st…
    BioSpace · 13d agoNeutral↗ source