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  • Eli Lilly to acquire Merida Biosciences for up to $2.88 billion, adding autoimmune antibody-degrading pipeline
    Eli Lilly announced a transaction to purchase Merida Biosciences for up to $2.875 billion, combining an upfront cash payment with future milestone payments. Merida, which emerged from stealth last…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • FDA clears Protagonist-Takeda therapy for rare blood cancer as Lilly moves to buy Merida for up to $2.88 billion
    The U.S. Food and Drug Administration has granted approval to a collaborative therapy from Protagonist and Takeda aimed at treating a rare form of blood cancer. This regulatory decision adds a new…
    raps · 2mo agoDealPositive
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  • 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 · 2mo agoApprovalNeutral↗ source
  • 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 · 2mo 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 · 2mo agoDealPositive↗ source
  • Novartis and Bristol Myers pause multiple autoimmune CAR-T trials after serious immune adverse events
    Novartis and Bristol Myers Squibb announced a temporary halt to several CAR-T cell therapy trials targeting autoimmune diseases. The pause involves Novartis’s autologous CD19 CAR-T candidate rapca…
    Fierce Biotech · 2mo agoRegulatoryNegative↗ 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 · 2mo 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 · 2mo agoNegative↗ source
  • Analysts see opportunity for Alnylam’s RNAi therapy after AstraZeneca/Ionis ATTR-CM trial fails
    AstraZeneca and its partner Ionis reported a disappointing Phase 3 result for the antisense drug Wainua in transthyretin amyloid cardiomyopathy (ATTR-CM). The unexpected outcome was a focal point o…
    Fierce Biotech · 2mo agoNegative readoutNeutral↗ source
  • Electra Therapeutics files for Nasdaq IPO to fund phase 2/3 immunology and cancer programs
    Electra Therapeutics, based in South San Francisco, announced it has filed a registration statement to list its shares on the Nasdaq Global Select Market under the ticker ETRA. The company says th…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • AstraZeneca's oral relaxin agonist shows positive phase 2b results in chronic heart failure
    AstraZeneca presented phase 2b data from its Luminara trial at the European Society of Cardiology Congress in Munich. The study evaluated the oral relaxin agonist AZD5462 in patients with chronic h…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ 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 · 2mo agoPositive readoutPositive↗ 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 · 2mo agoRegulatoryNeutral↗ 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 · 2mo agoNeutral↗ source
  • Natera partners with Angiex to evaluate Signatera blood test in AGX101 cancer trial
    Natera announced a collaboration with biotech Angiex to assess its Signatera circulating tumor DNA blood test in the context of Angiex’s early‑stage clinical trial of AGX101. Angiex, based in Camb…
    Fierce Biotech · 2mo agoDealPositive↗ 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 · 2mo agoRegulatoryNeutral↗ 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoApprovalPositive↗ 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 · 2mo agoNeutral↗ source
  • Novartis IL-6 antibody pacibekitug cuts inflammation markers in Phase 2 study
    A Phase 2 trial called TRANQUILITY showed that pacibekitug, an IL-6‑targeting antibody acquired by Novartis, reduced several biomarkers of inflammation in participants. The reductions were sustain…
    STAT · 2mo agoPositive readoutPositive↗ source