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    Deep Dive

    10 clinical trials to watch in the second half of 2024

    Study results are expected for two closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.

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    Lexeo gene therapy shows signs of heart benefit in small study

    The biotech, which went public late last year, argued the results justify exploring an accelerated approval. But shares fell by double digits amid investor skepticism.

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    Revolution Medicines firms up Phase 3 trial plans with latest cancer drug data

    Updated results show the biotech's RAS inhibitor shrank pancreatic tumors in 20% to 25% of study participants, but with high rates of side effects like rash and nausea.

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    News roundup

    Leqembi sales inch higher; Spark’s pivot leads to layoffs

    Sales data suggest forecasts for the Alzheimer’s drug may be in reach. Elsewhere, a well-funded DNA sequencing startup landed one of the year’s larger private funding rounds.  

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    Bristol Myers’ leukemia blockbuster set to face generic rivals

    Patent litigation has opened the door to generic copies of Bristol Myers’ Sprycel arriving in the U.S. as soon as September.

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    Novo’s once-weekly insulin rejected by FDA

    The FDA’s decision to turn back the drugmaker’s new insulin product narrows Novo’s lead in the U.S. over Eli Lilly, which has a similar diabetes treatment in late-stage testing. 

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    Deep Dive // Emerging biotech

    Biotech IPOs are the industry’s lifeblood. Track how they’re performing.

    Twelve biotechs went public between January and June, surpassing 2023's total over the same period but falling short of the pace set in each of the previous five years.

    Updated 20 hours ago
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    Flagship raises $3.6B for biotech investing

    The latest round of funding comes as the biotech company creator adds executives and prepares to grow more life sciences startups.

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    Permission granted by Amylyx Pharmaceuticals
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    Amylyx, with GLP-1 buy, doubles down on blood sugar drugs

    Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.

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    FTC to sue three largest PBMs over drug price practices: WSJ

    Antitrust regulators are set to file suit against CVS Caremark, Express Scripts and Optum Rx over how they negotiate discounts for drugs, including insulin, per the report.

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    As GLP-1 drugs boom, other healthcare companies are cashing in

    With more Americans taking obesity medications, adjacent businesses are offering supportive services to offset side effects, collect data and document new health benefits.

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    Adeline Kon/BioPharma Dive
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    Deep Dive

    Biotech M&A is on the upswing. Track the latest deals here.

    Eli Lilly’s proposed $3.2 billion acquisition of Morphic Holdings extends the industry’s streak of dealmaking involving immune disease drugmakers.

    Updated July 8, 2024
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    News roundup

    AbbVie names new R&D head; Arcutis eczema cream approved

    Roopal Thakkar will succeed Tom Hudson as AbbVie’s top scientist. Elsewhere, Skyhawk is advancing its Huntington’s drug and Zevra is preparing for an FDA advisory committee meeting.

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    UniQure stock surges on data for Huntington’s gene therapy

    The biotech’s stock rose more than 60% as fresh data appeared to alleviate some investor concerns about the therapy’s effectiveness and reliability.

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    FTC criticizes PBM power over prescription drug market

    On Tuesday, regulators updated the public on their yearslong probe of PBM's business practices. The report faults PBMs for profiting at the expense of patients and independent pharmacists. 

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    Doucefleur via Getty Images
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    Emerging biotech

    SciRhom pulls in $70M for a new type of immune disease drug

    The Series A round will help the startup bring its lead candidate, an antibody aimed at the protein iRhom2, into human testing by the end of 2024.

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    Lilly to buy Morphic in $3B bet on inflammation drug

    The deal would hand Lilly an experimental pill that could one day rival Takeda's blockbuster medicine Entyvio as a treatment for inflammatory bowel disease.

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    HilleVax’s norovirus vaccine ineffective in large trial of infants

    Shares in HilleVax plummeted after the company reported its experimental shot failed to meet the primary and secondary goals of the Phase 2b study.

  • Myricx Bio co-founders Andrew Bell, Roberto Solari and Ed Tate, and CEO Robin Carr in a laboratory.
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    Permission granted by Myricx Bio
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    A London biotech raises $114M to hone a new ADC payload

    Myricx Bio is developing a type of payload that it thinks could work in tumors resistant to the toxins contained in ADCs like Enhertu and Trodelvy.

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    News roundup

    Ligand to buy Apeiron; Roche reports another TIGIT setback

    Acquiring Apeiron will hand Ligand royalty rights on the neuroblastoma drug Qarziba. Elsewhere, CSL reported the first commercial treatment of patients in Europe with its gene therapy Hemgenix.

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    CureVac cuts jobs, licenses out vaccines to GSK

    The mRNA specialist plans to eliminate 30% of its workforce as part of a restructuring that will prioritize “high-value” projects like its cancer vaccines.

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    Moderna gets US funding for bird flu vaccine development

    BARDA will provide Moderna with $176 million to advance late-stage testing of an H5 influenza shot, as health officials monitor animal outbreaks.

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    News roundup

    Beacon raises $170M for eye gene therapy; J&J confirms Carvykti survival benefit

    Forbion led the startup’s Series B round. Elsewhere, Vertex got an FDA decision date for its “vanza triple” and Dupixent won a marketing green light in Europe for COPD.

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    New Alzheimer's drugs

    Lilly drug for Alzheimer’s approved by FDA

    The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.

    Updated July 2, 2024
    FDA
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    Cartesian data add to progress, questions for CAR-T in autoimmune disease

    The company claimed Phase 2 study results prove the therapy’s promise treating myasthenia gravis. But shares lost more than a quarter of their value amid questions about the data.