The Latest

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    Kendall Davis/BioPharma Dive
    Deep Dive

    10 clinical trials to watch in the first half of 2023

    Highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s, while a pair of high-priced acquisitions could be put to the test.

  • A micrograph of a myeloma neoplasm in a bone marrow biopsy.
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    OGphoto via Getty Images

    J&J, Legend’s cancer cell therapy has early success in key clinical trial

    The trial is an important test of Carvykti’s potential for earlier use in multiple myeloma and found treatment helped extend progression-free survival over standard regimens.

  • Pembrolizumab Keytruda molecular model
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    Dr_Microbe via Getty Images

    Merck gets a ‘surprise’ win for Keytruda in early lung cancer

    The FDA gave the top-selling immunotherapy a broad label in adjuvant lung cancer despite mixed results in the main supporting study, taking one Wall Street analyst by surprise. 

    FDA
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    Alvarez via Getty Images

    Celularity warns of layoffs for ‘substantial portion’ of its staff

    After a strategic review, the Celgene spinout said it won’t advance two experimental cancer therapies that use “natural killer” cells.

  • A pharmacist prepares to administer COVID-19 vaccine booster shots on September 09, 2022 in Chicago, Illinois.
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    Scott Olson via Getty Images

    FDA advisers back agency plan to simplify COVID-19 vaccination

    The expert committee supported making primary and booster shots the same composition, while recommending periodic updates to better match the vaccines to circulating variants.

    Updated Jan. 27, 2023
    FDA
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    ismagilov via Getty Images

    Magenta halts study of targeted conditioning drug after participant’s death

    The biotech said one patient died after receiving an experimental antibody drug designed to deplete certain blood and bone marrow cells before a transplant.

    Updated Jan. 26, 2023
  • A thumbnail illustration for BioPharma Dive's IPO tracker
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    Adeline Kon/BioPharma Dive
    Deep Dive

    After a record run, fewer biotechs are going public. Here’s how they’re performing.

    Obesity drug developer Structure Therapeutics set terms for what could be the first large biotech IPO of the year, if its offering prices as planned on Thursday.

    Updated 17 hours ago
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    Maddie Meyer via Getty Images

    Moderna draws more lawmaker criticism for COVID vaccine pricing plan

    Senators Warren and Welch urged the biotech to reconsider a planned price hike to between $110 and $130 a dose, and sought answers to a long list of questions.

  • Veteran biotech leader George Scangos to step down as Vir CEO

    The former Biogen head is retiring after taking Vir from a small startup to a publicly traded developer of infectious disease drugs. Bayer executive Marianne De Backer will succeed him.

  • A photograph of an infusion bag of Carvkyti, J&J and Legend Biotech's cancer cell therapy
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    Permission granted by Johnson & Johnson

    Sales of J&J, Legend cell therapy plateau amid production challenges

    Carvykti, which was approved a year ago for hard-to-treat multiple myeloma, generated $55 million in fourth-quarter sales, on par with the previous quarter.

  • The front entrance of the Food And Drug Administration headquarters building.
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    Sarah Silbiger via Getty Images

    FDA advisers back Cidara and Melinta’s antifungal treatment

    The drug, if approved, would be the first new treatment in more than a decade for two conditions that stem from Candida fungus.

    FDA
  • An illustration for BioPharma Dive's deals database
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    Adeline Kon/BioPharma Dive
    Deep Dive

    Biotech M&A is picking back up. Here are the latest deals.

    Four of the past five biotech acquisitions have featured contingent value rights agreements, suggesting a mismatch between buyers and sellers over what companies are worth.

    Updated Jan. 26, 2023
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    Marko Georgiev / Stringer via Getty Images

    Merck reports one success, one setback from late-stage Keytruda trials

    The top-selling immunotherapy bested chemo in treating bile duct cancer, but fell short in a study testing it with other drugs for metastatic prostate tumors.

  • A photograph of an empty laboratory.
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    gorodenkoff via Getty Images

    Finch to lay off 95% of staff, scrap microbiome drug study

    The company blamed a range of factors in its decision, including limited funding options, slow trial enrollment and “broader sector trends.”

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    Mario Tama via Getty Images

    J&J puts focus on cancer drugs in push to reach 2025 sales target

    The drugmaker reported fourth quarter revenue that fell short of forecasts, but reiterated confidence in reaching a $60 billion pharmaceutical sales goal.

    Updated Jan. 24, 2023
  • A horizontal headshot of Roivant Sciences chief executive officer Matt Gline.
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    Permission granted by Roivant Sciences
    Q&A // Emerging biotech

    Roivant’s Matt Gline on the hub-and-spoke biotech model and lessons learned from Axovant

    The year ahead could be turbulent for biotech as investors look for what the Roivant CEO described to BioPharma Dive as “safe harbors in a storm.”

  • Lilly to boost diabetes drug production with $450M factory investment

    The pharma aims to double its manufacturing capacity for drugs like Mounjaro and Trulicity as competition with rival Novo Nordisk heats up.

  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Jacob Bell / BioPharma Dive

    FDA to seek outside advice on Biogen’s ALS drug

    The agency plans to convene a panel of experts on March 22 to discuss the approval application for tofersen, a closely watched medicine Biogen submitted to the FDA despite its failure in a key clinical trial.

  • A sign showing the Takeda Oncology logo.
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    Jacob Bell

    Takeda pays $400M to buy into Hutchmed’s colorectal cancer drug

    The deal is the second big licensing deal Takeda has signed in as many months and gives the company rights to a drug Hutchmed began submitting to U.S. regulators in December.

  • A 3D illustration of human lungs.
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    yodiyim via Getty Images

    Pliant shares jump on new data for lung disease drug

    A high dose of the company’s experimental medicine appeared potent in patients with idiopathic pulmonary fibrosis, an elusive target for drugmakers. The results are from a small and short clinical trial, however.

  • A pharmacist prepares to administer COVID-19 vaccine booster shots on September 09, 2022 in Chicago, Illinois.
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    Scott Olson via Getty Images

    FDA weighs shift in COVID vaccination strategy

    Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens.

    FDA
  • A picture of the street sign stating "Wall Street." American flags drape over a nearby building
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    Kena Betancur via Getty Images

    Why Wall Street shrugged at Lilly’s Alzheimer’s setback

    Analysts argue the FDA’s choice to decline accelerated approval for donanemab, while surprising, is not the main factor that will determine whether it eventually becomes a commercial success.

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    Jonathan Gardner / BioPharma Dive

    BeiGene wins expanded approval for leukemia drug, intensifying battle with AbbVie, AstraZeneca

    The drugmaker hopes Brukinsa’s survival data will help its drug compete with Imbruvica and Calquence.

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    The image by Pixabay is licensed under CC BY 1.0

    FDA lifts hold on Astellas gene therapy for Pompe disease

    The regulator’s decision ends a seven-month study pause that followed a report of one participant experiencing mild symptoms of peripheral neuropathy.

    FDA
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    Sarah Silbiger via Getty Images

    FDA rejects Lilly Alzheimer’s drug, citing insufficient data

    The drugmaker had sought an accelerated approval based on data from a small mid-stage trial. Results from a larger study are due in the second quarter.