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  • Epic’s annual meeting offers limited AI updates, highlights new customers and quirky song choices
    At Epic’s annual meeting, the company touched on artificial intelligence but provided few concrete details about its strategy or new tools. During the session, Epic staff announced a roster of new…
    STAT · 1d agoNeutral↗ source
  • Prince Bakery recalls several breads over undeclared milk and sesame allergens
    Prince Bakery Inc. of Bronx, New York announced a recall of multiple Prince brand breads because they may contain undeclared milk or sesame. The recall covers Sesame Italian Bread, Large Italian B…
    fda recalls · 1d agoRegulatoryNegative↗ source
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  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 1d agoLayoffsNegative↗ source
  • Immunologist Liz Marnik, raised unvaccinated, now advocates for science and empathy in vaccine discussions
    Immunologist Liz Marnik grew up in a household that rejected vaccines, and she herself went without any immunizations into adulthood. At age 23 she visited a travel clinic and received all standar…
    STAT · 1d agoPositive↗ source
  • Eyepoint’s Phase 3 trial for age‑related blindness treatment fails primary endpoint, jeopardizing approval plans
    Eyepoint announced that its Phase 3 trial of the experimental drug Duravyu for a common cause of age‑related blindness did not meet its primary endpoint. Patients receiving the investigational ther…
    STAT · 2d agoNegative readoutNegative↗ source
  • Amylyx avexitide cuts serious low blood sugar events by 55% in Phase 3 trial for post bariatric hypoglycemia
    Amylyx Pharmaceuticals reported that its experimental drug avexitide significantly reduced the frequency of serious low blood sugar episodes in a Phase 3 study of patients with post‑bariatric hypog…
    STAT · 2d agoPositive readoutPositive↗ source
  • Academic groups sue DHS over new four-year visa limit for foreign graduate students and postdocs
    Groups representing universities and educators filed a lawsuit in U.S. District Court in Massachusetts against the Department of Homeland Security. The suit challenges a new DHS rule that would re…
    STAT · 2d agoRegulatoryNegative↗ source
  • Amylyx reports positive pivotal trial results for drug targeting post-bariatric hypoglycemia
    Amylyx announced that its experimental therapy achieved statistically significant improvement in patients who experience severe hypoglycemia after bariatric surgery. The company said the pivotal t…
    STAT · 2d agoPositive readoutPositive↗ source
  • Municipalities and States Grapple with Rising Health-Insurance Costs and Upcoming Medicaid Drug Pricing Deadline
    Municipalities across the country are reporting that the cost of providing health insurance to their employees is becoming increasingly unsustainable, putting pressure on local budgets. States are…
    STAT · 2d agoRegulatoryNegative↗ source
  • LEO Pharma spends $435 million to acquire rare-disease skin drug dersimelagon
    LEO Pharma announced it will pay $435 million to buy the rights to dersimelagon, an oral MC1R agonist originally developed by Tanabe Pharma. The drug has completed Phase 3 trials for two rare phot…
    BioSpace · 2d agoDealPositive↗ source
  • GenBio AI launches AIDO Cell, a virtual model that simulates whole-cell behavior
    GenBio AI, a Palo Alto startup, unveiled AIDO Cell, a virtual cell platform that lets researchers view a cell’s interior like a map. The system visualizes proteins, RNA and DNA and can simulate gen…
    STAT · 2d agoPositive↗ source
  • Biotech funding rebound set to boost CDMO demand by early 2027
    Analysts note that demand for pharma services has historically lagged behind biotech funding, but a recent surge in venture capital is expected to drive activity for contract development and manufa…
    BioSpace · 2d agoPositive↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial after safety concerns
    Regeneron announced termination of a Phase 1/2 study of its investigational anti-inflammatory antibody REGN7041, which was being evaluated for non-infectious uveitis. The company said the decision…
    BioSpace · 2d agoNegative↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial over unfavorable risk-benefit profile
    Regeneron has stopped a Phase 1/2 study of its anti‑inflammatory antibody REGN7041 in non‑infectious uveitis, citing an unfavorable benefit‑risk assessment. The antibody targets CD3 on immune cell…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • Amylyx to seek FDA approval for avexitide after Phase 3 success in post-bariatric hypoglycemia
    Amylyx announced plans to file a new drug application for avexitide, a GLP-1 receptor antagonist, after a Phase 3 trial showed reduction in serious hypoglycemia in patients who had gastric bypass s…
    BioSpace · 2d agoRegulatoryPositive↗ source
  • Enveda reports promising Phase 1 data for oral drug that mimics exercise to preserve muscle during weight loss
    Enveda, a biotech based in Boulder, Colorado, announced Phase 1 results for its oral candidate ENV-308, a chemically engineered version of the metabolite lactate phenylalanine (lac-phe). The metabo…
    STAT · 2d agoPositive readoutPositive↗ source
  • Study shows antibiotic overuse is concentrated in high-income nations, while low-income countries struggle with shortages
    Peter Beyer, deputy executive director of the Global Antibiotic Research & Development Partnership, writes an opinion piece highlighting a shift in how antimicrobial resistance is framed across the…
    STAT · 2d agoNeutral↗ source
  • FDA issues draft guidance for generative AI medical devices as industry calls for German drug pricing reform
    The U.S. Food and Drug Administration has published a draft guidance document that outlines the agency's expectations for medical devices that incorporate generative artificial intelligence. The dr…
    raps · 2d agoRegulatoryNeutral↗ source
  • Former NIAID adviser David Morens pleads guilty to concealing records and defrauding government
    David Morens, a former top National Institute of Allergy and Infectious Diseases official and longtime senior adviser to former NIAID leader Anthony Fauci, entered a guilty plea on Tuesday on charg…
    STAT · 2d agoRegulatoryNegative↗ source
  • Sandoz inks $322M Henlius deal for rights to as many as 10 biosimilars
    The initial batch of biosimilars includes copies of Amgen, Eli Lilly and GSK drugs that collectively generate billions of dollars in annual revenues.
    BioSpace · 2d agoDealNeutral↗ source
  • AI and data sharing essential for safer cell and gene therapies, says industry leader
    The author argues that keeping data secret in cell and gene therapy harms patients, and that a commitment to transparency and artificial intelligence is needed to make these treatments safer and mo…
    BioSpace · 2d agoPositive↗ source
  • FDA updates guidance to clarify ANDA and 505(b)(2) approval pathways
    The FDA released a draft guidance that updates a seven-year-old document on abbreviated drug approval pathways. The guidance clarifies the distinction between traditional Abbreviated New Drug Appl…
    raps · 2d agoRegulatoryNeutral↗ source
  • Study highlights limits of premarket evaluation for identifying recalls of high-risk medical devices
    More than one-third of high-risk therapeutic medical devices approved over the last decade were subject to serious recalls, but the lack of consistent characteristics of these recalled devices sugg…
    raps · 2d agoRegulatoryNeutral↗ source
  • White House touts record drug-price drop, but critics say the claim oversimplifies the data
    The administration highlighted a recent Consumer Price Index report showing prescription drug prices fell 3.1% over the 12 months ending in July, the steepest annual decline since 1963, and dropped…
    STAT · 2d agoRegulatoryNegative↗ source
  • Kindergarten vaccine exemptions rise as Doritos marketing sparks food-health debate
    A recent Morning Rounds briefing highlighted that exemptions for childhood vaccines are increasing in kindergarten classrooms, raising concerns among public health observers. The same report also…
    STAT · 2d agoNeutral↗ source