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  • Eli Lilly to acquire Merida Biosciences in up to $2.9 billion deal for precision antibody-degrading therapies
    Eli Lilly announced it will purchase Massachusetts‑based Merida Biosciences, adding a platform that can selectively degrade disease‑causing antibodies. The transaction could total up to $2.875 bil…
    BioSpace · 12d agoDealPositive↗ source
  • FDA approves Takeda/Protagonist cancer drug Mimrylo as White House readies new drug pricing deals, BioNTech ends colon vaccine trial
    The U.S. Food and Drug Administration gave approval to a weekly injection called Mimrylo, developed by Takeda and partner Protagonist Therapeutics, for treatment of a slow‑growing cancer. The agenc…
    STAT · 12d agoApprovalNeutral↗ source
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  • New American Headache Society guidelines highlight expanded migraine prevention options
    The American Headache Society and the American Academy of Neurology released updated guidance on migraine prevention, the first revision since 2012. The new recommendations note that the FDA has a…
    STAT · 12d agoRegulatoryPositive↗ source
  • Trump announces nine new drug pricing agreements to align U.S. prices with peer nations
    President Trump announced a new round of voluntary pricing agreements with nine additional pharmaceutical companies, adding to the 17 firms that have previously signed similar deals. The companies…
    STAT · 12d agoDealPositive↗ source
  • Amgen faces FTC-backed lawsuit over patent-application purchase amid insurer dispute
    Amgen and a large health insurer are locked in a court fight over whether purchasing a drug patent application can be used to extend a monopoly on a medicine. The case is drawing attention because…
    STAT · 12d agoRegulatoryNegative↗ source
  • GLP-1 drugs push employers to rethink worker health-care costs
    GLP-1 medications are prompting many employers to reexamine how they fund employee health care. Rising prescription use and associated costs are forcing companies to consider new benefit designs an…
    STAT · 12d agoNegative↗ source
  • Sanofi-backed Electra Therapeutics files for Nasdaq IPO to fund Phase 2/3 immunology program
    Electra Therapeutics announced it has filed with securities regulators to begin trading on the Nasdaq shortly after the Labor Day holiday. The Sanofi-backed biotech aims to raise capital through t…
    Endpoints · 12d agoDealPositive↗ source
  • Arrowhead’s plozasiran shows favorable safety in severe hypertriglyceridemia late-stage trials
    Arrowhead presented late-stage data for its RNA interference therapy plozasiran, marketed as Redemplo, in severe hypertriglyceridemia at the European Society of Cardiology 2026 meeting in Munich.…
    BioSpace · 12d agoPositive readoutNeutral↗ source
  • Personalized mRNA melanoma vaccine shows clinical success, reviving optimism for the platform
    Moderna and Merck reported positive results from a personalized mRNA vaccine designed to treat melanoma in a recent clinical study. The outcome is being hailed as a boost for mRNA technology, whic…
    STAT · 12d agoPositive readoutPositive↗ source
  • BMS leverages Celgene merger to revive neuroscience pipeline amid delayed readouts
    Bristol Myers Squibb, long recognized for its oncology work, is re‑investing in neurological and psychiatric disease programs, a move rooted in assets gained from its 2019 $74 billion Celgene merge…
    BioSpace · 12d agoNeutral↗ source
  • Experts urge FDA to boost transparency of complete response letters and refine master protocol guidance
    A recent paper in the Journal of Law and the Biosciences outlines ways the FDA could better disclose complete response letters to the public, aiming to increase transparency for stakeholders. Indu…
    raps · 12d agoRegulatoryNeutral↗ source
  • Trump announces nine voluntary drug pricing agreements with mid-size biotech firms
    On August 31, 2026, the White House announced that President Donald Trump has secured nine new voluntary drug-pricing agreements with mid-size biotechnology companies. The companies entered the de…
    Endpoints · 12d agoDealNeutral↗ source
  • Radiopharmaceutical experts urge pharma to adopt bolder dosing despite safety concerns
    Louise Emmett and a group of radiopharmaceutical specialists argue that these modern radiation‑based drugs could dramatically improve cancer outcomes if used more aggressively. They say the therapi…
    STAT · 12d agoNeutral↗ source
  • Crystal Temptations Issues Allergy Alert on Undeclared Milk in Chocolatey Eyeballs
    Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run th…
    fda recalls · 12d agoRegulatoryNeutral↗ source
  • Industry insiders invited to take Q3 BioPharma Sentiment Survey
    Signal's Endpoints team is launching the third quarterly BioPharma Sentiment Index (BPSI) survey, a three minute questionnaire that captures industry views. The survey asks participants to share p…
    Endpoints · 12d agoNeutral↗ source
  • Pregnancy hormone explored as possible guide for cardiovascular drug development
    The STAT+ newsletter preview highlights a discussion about whether a hormone that regulates pregnancy could be leveraged to direct a new cardiovascular therapy. The piece also notes that researche…
    STAT · 12d agoNeutral↗ source
  • Industry and patient groups urge FDA to revise master protocol guidance
    Industry groups and patient advocacy organizations have written to the U.S. Food and Drug Administration asking for several revisions to its recently updated draft guidance on master protocols for…
    raps · 12d agoRegulatoryNeutral↗ source
  • Highlights from the European Society of Cardiology meeting and updates on radiopharmaceutical research
    The newsletter reports that the European Society of Cardiology convened in Munich, with Europe correspondent Andrew Joseph providing coverage of the event. The author contrasts the ESC’s rotating…
    STAT · 12d agoNeutral↗ source
  • India streamlines regulations for outsourced medical device sterilization
    The Indian government announced a simplification of the regulatory framework governing outsourced sterilization of medical devices. The move is part of a broader effort to make it easier for busine…
    raps · 12d agoRegulatoryPositive↗ source
  • Kofinas Olive Oil voluntarily recalls garlic-infused extra virgin olive oil over unapproved essential oil
    LMSI LLC/Kofinas Olive Oil announced a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil because it contains a garlic essential oil not approved for culinary use. The pro…
    fda recalls · 12d agoCRLNeutral↗ source
  • Study reports up to 25% of sampled NFL players had CTE at death, sparking calls for league-wide action
    Researchers in the Boston area examined the brains of a sample of former NFL players and found that about one quarter showed signs of chronic traumatic encephalopathy at death. The authors noted th…
    STAT · 12d agoNegative↗ source
  • FDA approves Mimrylo, a weekly injection for polycythemia vera, developed by Protagonist and sold by Takeda
    The Food and Drug Administration has approved a new therapy for polycythemia vera, a rare blood cancer that causes an overproduction of red blood cells. The drug, known as rusfertide, will be mark…
    STAT · 13d agoApprovalPositive↗ source
  • AstraZeneca’s oral relaxin drug shows partial success in mid-stage heart-failure trial
    AstraZeneca reported that its oral relaxin agonist improved cardiac function in a subset of patients enrolled in a mid-stage heart‑failure study. The trial demonstrated measurable benefits for some…
    Endpoints · 13d agoPositive readoutPositive↗ source
  • Alnylam defends its heart failure silencers after AstraZeneca's ATTR-CM trial miss
    AstraZeneca reported that its experimental drug Wainua failed to meet its primary endpoints in a study of transthyretin amyloid cardiomyopathy (ATTR-CM). The setback raised concerns about the thera…
    STAT · 13d agoNeutral↗ source
  • Arrowhead's RNAi drug Redemplo shows safety advantage over Ionis in late-stage triglyceride trials
    At the European Society of Cardiology meeting in Munich, Arrowhead Pharmaceuticals presented new data on its RNA interference candidate Redemplo. Redemplo was evaluated in two late-stage studies i…
    Endpoints · 13d agoPositive readoutPositive↗ source