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  • A sign reading Food and Drug Administration is seen above a door to a government building.
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    Sarah Silbiger via Getty Images
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    FDA advisers back updating COVID shots to target JN.1 virus family

    The unanimous recommendation from the panel should help Novavax, which would have had difficulty adapting its shot in time if the committee picked a more specific subvariant.

    FDA
  • Seres Therapeutics' microbiome pill Vowst for recurrent C. diff. infections.
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    Courtesy of Seres Therapeutics
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    Seres, indebted and in need of cash, agrees to sell microbiome pill to Nestle

    Seres did not disclose financial details for the deal, but said it would help extend the company's cash runway by one year.

  • A 3D illustration showing amyloid plaques in brain tissue
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    Dr_Microbe via Getty Images
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    New Alzheimer's drugs

    In review of Lilly Alzheimer’s drug, FDA staff focus on safety, patient selection

    An advisory panel is meeting today to discuss whether donanemab is effective across different groups of Alzheimer's patients, and to give input on an unusual dosing strategy used by Lilly.

  • A white sign with the word Lilly written in red stands outside of an office.
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    Scott Olson via Getty Images
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    Lilly CFO leaves to join Alphabet

    Anat Ashkenazi is switching industries after a 23-year career at the Indianapolis drugmaker.

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    Daniel Tadevosyan via Getty Images
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    News roundup

    Lilly details MASH data for tirzepatide; Cytokinetics comments on past sale talks

    A study abstract shed more light on tirzepatide’s potential in MASH. Elsewhere, Cytokinetics CEO spoke on deal negotiations and AbbVie started a key multiple myeloma drug study.

  • A micrograph showing triglyceride fat accumulated inside liver cells.
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    Dr_Microbe via Getty Images
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    Viking says biopsy data confirm MASH drug’s benefit

    The company may look to license the experimental liver disease drug as it focuses on an obesity treatment that's shown early promise.

  • A sign reading Food and Drug Administration is seen above a door to a government building.
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    Sarah Silbiger via Getty Images
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    FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns

    “I just feel very convinced that I had to vote no,” said one member of the committee, which was unconvinced by Lykos Therapeutics’ data on MDMA-assisted treatment for post-traumatic stress disorder.

    Updated June 4, 2024
    FDA
  • A Grail employee in a white coat works in a lab.
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    Courtesy of Grail
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    Illumina board approves Grail spinoff

    One analyst said Grail, with a cash burn of $532 million in 2023, is likely to remain “a cautionary tale in diagnostics for years to come.”

  • A micrograph of an epiphyseal growth plate, stained in color to show layers of cartilage
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    Jose Luis Calvo Martin, Jose Enrique Garcia-Maurino Muzquiz via Getty Images
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    BridgeBio data show sustained benefit for achondroplasia drug

    Longer follow-up results from a mid-stage trial indicate the company’s treatment for a genetic cause of dwarfism may be competitive to an approved therapy from BioMarin Pharmaceutical.

  • An Eli Lilly logo is seen at the top of a building.
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    JHVEPhoto via Getty Images
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    ALS drug development

    Eli Lilly adds ALS drug prospect with QurAlis deal

    The alliance hands Lilly an RNA-based therapy in preclinical testing for ALS and frontotemporal dementia, and includes a research collaboration to develop other, similar medicines.

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    Spencer Platt via Getty Images
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    Obesity drugs

    Structure pill leads to competitive weight loss in obesity study

    Shares in the company soared by more than 50% as study data showed the pill led to similar levels of weight loss as a rival drug being developed by Eli Lilly.

  • Physicians, researchers and healthcare professionals attend ASCO's annual Meeting on June 2, 2023 in Chicago.
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    ASCO / Nick Agro

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    ASCO24

    ASCO24: Tagrisso in the spotlight, Caribou’s adjustment and Lilly’s KRAS competitor

    AstraZeneca’s therapy could see wider use after ASCO data. Elsewhere, Caribou sought to explain an alternative cell therapy strategy that will delay its study plans.

  • Physicians, researchers and healthcare professionals attend ASCO's annual Meeting on June 2, 2023 in Chicago.
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    ASCO / Nick Agro

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    ASCO24

    GSK builds case for return of multiple myeloma drug Blenrep

    Study results showed the antibody-drug conjugate helped stave off disease progression better than a standard treatment. But eye-related side effects remained common.

  • Enhertu
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    Permission granted by Daiichi Sankyo
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    ASCO24

    With new Enhertu data, an ADC could overtake chemo in breast cancer

    The results are a step forward for antibody-drug conjugates, which Enhertu makers AstraZeneca and Daiichi Sankyo see replacing chemo in many tumors.

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    Jonathan Gardner/BioPharma Dive
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    ASCO24

    AstraZeneca immunotherapy extends survival by two years in rarer type of lung cancer

    The findings, from a trial testing Imfinzi in limited-stage small cell lung cancer, could help AstraZeneca expand the drug's use.

    Updated June 2, 2024
  • A microscopic image of chronic myeloid leukemia cells, magnified 1000 times.
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    jarun011 via Getty Images
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    ASCO24

    Novartis study points to larger role for targeted leukemia drug

    Results from a trial called ASC4FIRST show Scemblix outperformed Gleevec and other drugs in treating newly diagnosed chronic myeloid leukemia.

    Updated June 3, 2024
  • A product image of Moderna's RSV shot mRESVIA in its packaged box with syringe in front of the box
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    Permission granted by Moderna
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    RSV vaccines

    Moderna wins FDA approval for RSV vaccine

    The OK for mResvia adds another option for preventing RSV-related disease in older adults, one year after the agency cleared shots from GSK and Pfizer.

    FDA
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    Justin Sullivan via Getty Images
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    Gilead’s Trodelvy misses goal in bladder cancer study

    Treatment didn’t significantly improve overall survival in the trial, a finding that one analyst described as a “meaningful setback” to Gilead’s oncology pipeline.

  • A sign for the Food and Drug Administration is seen on July 20, 2020 in Maryland.
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    Sarah Silbiger via Getty Images
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    FDA staff outline shortcomings of Lykos data for MDMA therapy

    A panel of expert advisers met Tuesday to discuss several sticking points in the clinical trial results backing Lykos’ treatment for PTSD.

    FDA
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    Daniel Tadevosyan via Getty Images
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    News roundup

    FDA delays decision on Dupixent in COPD; Summit makes a bold claim

    Regeneron and Sanofi now expect an FDA verdict in September. Elsewhere, Summit claimed victory over Keytruda and Neurocrine’s longtime CEO revealed plans to step down.

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    Stadtratte via Getty Images
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    Emerging biotech

    CinCor’s ‘hub-and-spoke’ parent nabs new funding to build its next biotechs

    The $73 million round for CinRx Pharma, which created a startup AstraZeneca bought last year, will help fund subsidiaries making drugs for obesity, irritable bowel syndrome and gastroparesis. 

  • Antibodies autoimmune disease
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    Getty Images via Getty Images
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    Immunovant changes up plans for closely watched autoimmune drugs

    The company is prioritizing development of an earlier so-called FcRn inhibitor, a type of medicine that’s shown promise treating multiple inflammatory conditions. 

  • Sanket Shah stands in front of a wood wall.
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    Permission granted by Otsuka Precision Health
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    Otsuka defies digital health downturn with new company

    With “no playbook out there” to fall back on, the new company is taking a long-term approach as it develops its portfolio, an Otsuka Precision Health exec told MedTech Dive.

  • J&J HQ
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    Mario Tama via Getty Images
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    J&J antidepressant eases symptoms, improves sleep in key trial

    The company has put high expectations on the drug, an orexin-2 antagonist called seltorexant, as a cornerstone of its neuropsychiatry pipeline.

  • A closeup of an eye with light reflecting off of it.
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    Zorica Nastasic via Getty Images
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    Merck to buy eye drug developer for $1.3B

    An acquisition of EyeBio will hand Merck a treatment for diabetic macular edema and age-related macular degeneration that’s ready for pivotal testing.