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  • FDA accepts first Keytruda biosimilar application as Merck faces looming patent cliff
    The U.S. Food and Drug Administration has accepted the first publicly announced filing for a Keytruda biosimilar, identified as FYB206, which could receive approval as early as the third quarter of…
    BioPharma Dive · 7d agoRegulatoryNeutral↗ source
  • Woman travels to Albania for experimental mitochondrial replacement therapy amid global fertility industry concerns
    A STAT reporter detailed a case of a woman named Heidy Willis who, after multiple failed IVF cycles, sought an experimental fertility option abroad. Willis traveled to Albania to undergo mitochond…
    STAT · 8d agoNegative↗ source
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  • Karyopharm files Chapter 11 and taps Irish biotech Ayrmid as lead bidder for merger
    Karyopharm Therapeutics, a Massachusetts-based biopharma, entered Chapter 11 bankruptcy as part of a plan to merge with Irish hematology biotech Ayrmid. The move follows a cash crisis revealed in…
    Fierce Biotech · 8d agoDealNegative↗ source
  • Pharma leaders turn to integrated scenario modeling as US MFN pricing reshapes global launch strategies
    The article explains that integrated scenario modeling is becoming a key tool for pharmaceutical executives facing pricing uncertainty and the complexities of worldwide product launches. It refere…
    BioPharma Dive · 8d agoNeutral↗ source
  • Biossil Labs acquires Theriva's antibiotic-degrader portfolio in up to $91 million deal
    Biossil Labs, a Canadian biotech backed by OpenAI, announced a deal to acquire Theriva Biologics' early- to mid-stage portfolio of antibiotic‑degrading enzymes for a total potential value of up to…
    Fierce Biotech · 8d agoDealNeutral↗ source
  • Women travel abroad for unproven three-parent IVF marketed to older patients
    STAT investigators found that women are journeying thousands of miles to undergo a mitochondrial‑replacement IVF procedure that is promoted as a fertility option for older patients, even though the…
    STAT · 8d agoNegative↗ source
  • FDA places partial hold on Bright Minds' seizure trial over mouse toxicity concerns
    The FDA issued a partial clinical hold on Bright Minds Biosciences' planned phase 2 trial of BMB-101 in patients with developmental and epileptic encephalopathies. The hold was triggered by precli…
    Fierce Biotech · 8d agoRegulatoryNegative↗ source
  • Teva halts phase 2 trial of emrusolmin for multiple system atrophy after futility analysis
    Teva Pharmaceuticals announced it is stopping a phase 2 study of its experimental small‑molecule drug emrusolmin, which was being tested in patients with the rare neurodegenerative condition multip…
    Fierce Biotech · 8d agoNegative readoutNegative↗ source
  • Tiziana's intranasal MS drug shows lower dose cuts neuroinflammation, higher dose falls short in Phase 2a trial
    Tiziana Life Sciences reported results from its mid‑stage Inform‑MS trial, a Phase 2a study that enrolled 48 patients with non‑active secondary progressive multiple sclerosis. Participants received…
    Fierce Biotech · 8d agoPositive readoutNeutral↗ source
  • Midterm voters weigh health-care costs as urgent-care visits billed like ERs
    The upcoming midterm elections will see tens of millions of voters consider health‑care affordability, especially those whose coverage comes through their employers. The article points out that ri…
    STAT · 7d agoNegative↗ source
  • Study finds psilocybin does not produce lasting anxiety or depression relief in mice
    Five Bay Area laboratories joined forces to examine whether a single dose of psilocybin could produce lasting reductions in anxiety and depression-like behavior in mice. The study measured behavior…
    STAT · 7d agoNegative readoutNegative↗ source
  • Cancer can be treated safely during pregnancy, says maternal-fetal specialist
    Elyce Cardonick, a maternal-fetal medicine physician and founder of the Cancer and Pregnancy Registry, argues that pregnant cancer patients are often urged to terminate their pregnancies even thoug…
    STAT · 8d agoPositive↗ source
  • STAT calls for input on mitochondrial replacement therapy used in fertility tourism
    STAT is asking patients and clinicians to share their experiences with mitochondrial replacement techniques (MRT), sometimes called three-parent IVF, which are being marketed as a fertility option…
    STAT · 8d agoNeutral↗ source
  • Midterm election outcomes could reshape U.S. health policy, experts say
    The article notes that regardless of the results, the upcoming midterm elections will have broad effects on the U.S. health system, according to more than two dozen policymakers, lobbyists and expe…
    STAT · 10d agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
    The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
    fda press · 10d agoApprovalPositive↗ source
  • Moderna and Merck’s individualized cancer vaccine shows promising melanoma results but shares tumble after ESMO presentation
    Investors closely watched the European Society for Medical Oncology (ESMO) meeting for updates on an individualized neoantigen cancer vaccine being co‑developed by Moderna and Merck. The therapy, c…
    BioPharma Dive · 10d agoPositive readoutNeutral↗ source
  • Lilly beats forecasts and raises outlook as Novartis steadies and GSK faces investor pressure
    Lilly reported third‑quarter revenue that exceeded analysts' expectations by about 8%, driven by strong demand for its diabetes and obesity treatments Mounjaro and Zepbound. The company also lifted…
    BioPharma Dive · 11d agoEarningsPositive↗ source
  • Setara Biosciences launches with $90 million to pursue Charcot-Marie-Tooth and other rare-disease therapies
    Setara Biosciences announced its formation on Friday, backed by $90 million of financing to advance a pipeline of experimental medicines. The company’s first candidate targets the genetic disorder…
    BioPharma Dive · 11d agoDealPositive↗ source
  • Sanofi eyes 'moonshot' drug acquisitions to offset upcoming Dupixent patent loss
    Sanofi's CFO Francois-Xavier Roger told Fierce that the company is looking at 'moonshot' treatments as potential acquisition targets to rebuild its pipeline. The push comes as the U.S. patent on D…
    Fierce Biotech · 11d agoDealNeutral↗ source
  • Aspen Neuroscience raises $140M IPO to advance Parkinson’s cell therapy
    Aspen Neuroscience, a San Diego biotechnology company, completed an initial public offering, selling roughly 9.4 million shares at $15 each and raising about $140.6 million. The capital will be di…
    BioPharma Dive · 11d agoDealPositive↗ source
  • Podcast examines Merck and Moderna’s mRNA cancer vaccine data presented at ESMO
    The latest episode of STAT’s biotech podcast "The Readout LOUD" focused on the mRNA cancer vaccine being co‑developed by Merck and Moderna, using data shown at the European Society for Medical Onco…
    STAT · 11d agoNeutral↗ source
  • Congress must restore independence of scientific advisory panels after controversial firings
    The authors note the recent dismissal of two vice chairs of the U.S. Preventive Services Task Force by HHS Secretary Robert F. Kennedy Jr., stressing the panel’s role in reviewing evidence to guide…
    STAT · 11d agoRegulatoryNegative↗ source
  • STAT reporters outline how upcoming midterms could reshape US vaccine, drug policy and the MAHA movement
    STAT's weekly video series STATus Report aired from Boston, the historic heart of American democracy, as the nation heads toward the midterm elections. The episode features reporters from the D.C.…
    STAT · 11d agoNeutral↗ source
  • FDA and CMS work to prevent regulatory clash as states move to test clinical AI
    Officials at the FDA and CMS are working behind the scenes to avoid a regulatory clash as more states plan to test artificial intelligence tools that perform clinical tasks. The tension arises fro…
    STAT · 11d agoRegulatoryNeutral↗ source
  • Bracco to invest $230M in new US contrast media plant, creating 200 jobs
    Bracco Diagnostics announced a $230 million investment to build its first U.S. manufacturing facility for injectable contrast media in Sanford, North Carolina. The plant is slated to create about…
    Fierce Biotech · 11d agoDealPositive↗ source