The Latest

  • An illustrated image of clinical development for a BioPharma Dive 2021 outlook story
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    Kendall Davis/BioPharma Dive
    Deep Dive

    10 clinical trials to watch in the second half of 2022

    The biotech industry's downturn accelerated in the first half of the year. Important study readouts for Eisai, Gilead, Merck and Seagen, among others, could determine whether the slump endures.

  • Illustration of lung cancer
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    SciePro via Getty Images

    Fresh off Enhertu success, AstraZeneca and Daiichi claim progress for next cancer drug

    A treatment that AstraZeneca acquired for up to $6 billion in 2020 is showing early promise as a combination agent in lung cancer, where it’s being tested alongside Merck & Co.’s Keytruda.

  • A worker prepares ampoules of the Nuvaxovid vaccine against Covid-19 by Novavax in Berlin, Germany in February 2022.
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    Carsten Koall via Getty Images

    Novavax slashes revenue forecasts amid slow demand for COVID-19 vaccine

    The biotech now expects about $2 billion in revenue in 2022, less than half its previous estimates, after sales fell sharply in the second quarter.

  • A building framed through tree foliage is seen with a sign that reads "Lilly."
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    Kris Tripplaar/Sipa/Newscom

    Lilly criticizes Indiana abortion law, indicating it may look elsewhere to hire

    After Indiana’s governor signed a near-total abortion ban into law, the drugmaker said it will rethink future hiring in the state.

  • Image attribution tooltip
    National Cancer Institute, NIH

    Amgen data on KRAS cancer drug disappoints, opening door for rival Mirati

    Highly anticipated trial results for Lumakras combinations with immunotherapy fell short of expectations, showing significant liver toxicity that limited dosing.

  • 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.

    Amgen’s takeover of ChemoCentyx is the third largest biotech acquisition this year and, alongside a small buyout by Gilead also disclosed Thursday, adds to a recent pickup in dealmaking activity.

    Updated Aug. 4, 2022
  • A logo of Gilead Sciences
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    Permission granted by Gilead Sciences

    How a small UK biotech ended up in Gilead’s hands

    MiroBio, which was spun out of the University of Oxford three years ago, drew Gilead’s interest with its autoimmune disease research.

  • Breast Cancer under light microscopy zoom in different areas
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    jxfzsy via Getty Images

    FDA approves AstraZeneca, Daiichi drug in breast cancer first

    Enhertu is the first targeted therapy cleared for breast cancers that are ‘HER2 low,’ a new classification that could change how doctors treat the disease.

    FDA
  • Lilly takes long view on Alzheimer’s drug as FDA starts expedited review

    The pharma said Thursday the FDA had accepted its application for donanemab, starting a six month evaluation for potential accelerated approval.

  • Image attribution tooltip
    Sarah Silbiger via Getty Images

    Acadia turned back by FDA on second attempt to get psychosis drug approved

    The agency issued Acadia a complete response letter for pimavanserin, for which the company had sought to win an expanded clearance in Alzheimer’s disease psychosis.

  • 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.

    MAIA Biotechnology last week became the first biotech company to price an IPO since late May, and the fifth cancer drug developer to do so this year. 

    Updated July 28, 2022
  • A view of the Capitol Dome from below with an American flag waving in the wind on the left side and blue skies in the background.
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    iStock via Getty Images

    Pharma CEOs press case against drug price negotiation as bill gains support

    On earnings calls with investors, executives reiterated opposition to legislation advanced by Democrats that would curtail their pricing power in the U.S.

  • An outside view of an Amgen building.
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    Amgen Inc.

    Amgen bets almost $4B on a biotech and its inflammation drugs

    The deals hands Amgen a few clinical programs and a marketed therapy in Tavneos, which was approved last year to treat a group of autoimmune diseases.

  • Boston Children's Hospital doctor and laboratory director George Daley
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    Permission granted by Michael Goderre / Boston Children’s Hospital
    Emerging biotech

    ElevateBio, Boston Children’s launch startup to test new approach to ‘off-the-shelf’ cell therapy

    Spun out of a Boston Children’s research lab, the biotech is the first to emerge from a partnership ElevateBio and the hospital struck to create new cell and gene therapy companies.

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    Novo Nordisk

    Novo shares tumble after latest setbacks for closely watched obesity drug

    The Danish drugmaker lost tens of billions in market value after revealing a key clinical study for Wegovy won't be stopped early and production issues are still being ironed out.

  • Red human heart drawing on blue background
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    Jolygon via Getty Images

    Alnylam drug succeeds in key heart disease study, boosting company

    The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on a planned approval application.

  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland.
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    Sarah Silbiger via Getty Images

    Coherus wins FDA approval for second Lucentis biosimilar, its third drug

    The biotech company secured a valuable interchangeable designation for the copycat medicine, which it plans to launch later this year.

  • An employee handles product in Gilead's cell therapy unit.
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    Gilead Sciences Inc.

    Gilead, following cell therapy approval, impresses Wall Street with fast sales

    Together, the biotech’s two CAR-T therapies earned $368 million between April and June, a substantial jump over last year and above what analysts forecast.

  • 3D rendering of T cells attacking a cancer cell.
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    Meletios Verras via Getty Images

    Roche digs into off-the-shelf cell therapy with Poseida deal

    The pharma has now signed two alliances with allogeneic drug developers since September, signalling its interest in CAR-T treatment alternatives.

  • A white lab coat showing an AbCellera logo
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    Courtesy of AbCellera
    Emerging biotech

    AbCellera inks another venture partnership, this time with Atlas

    One week after striking a deal with Versant, the antibody specialist is teaming up with Atlas to provide drug candidates to an undisclosed startup backed by the biotech investor.

  • Strand Therapeutics CEO Jake Becraft
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    Courtesy of Strand Therapeutics
    Q&A // Emerging biotech

    Strand CEO on founder-led biotech, venture capital and the market’s retreat

    Jake Becraft, founder and current chief of mRNA startup Strand Therapeutics, argues biotech would be healthier if more scientists and researchers lead the companies they start.

  • Leaders of Belite Bio posing in front of Belite Bio Nasdaq stock market listing
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    Photography courtesy of Nasdaq, Inc.

    Emerging biotech

    How Belite Bio, a small, under-the-radar drugmaker, emerged as one of biotech’s best performing IPOs

    Belite's shares have risen nearly 500% from their IPO price at a time when many other newly public biotech companies are struggling to hold their value.

    Updated Aug. 2, 2022
  • Alexis Borisy
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    Courtesy of IDRx

    IDRx, a new biotech startup, raises $122M to develop better cancer drug combinations

    Founded by entrepreneur Alexis Borisy, the company comes equipped with two experimental medicines it licensed from Merck KGaA and Blueprint Medicines.

  • The outside of an AbbVie building, with the company's logo displayed.
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    AbbVie

    AbbVie, targeting a well-known protein family, expands a partnership into neuroscience

    It’s the second deal in as many years between AbbVie and Sosei Heptares, which together have been trying to develop drugs that target so-called G protein-coupled receptors.

  • Roche Pharmaceutical Group's office building in Shanghai, China
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    iStock via Getty Images

    With new data, Roche takes step toward more convenient cancer immunotherapy

    The pharma claimed Phase 3 study success for a subcutaneous version of its drug Tecentriq, a strategy it and rivals Merck and Bristol Myers could use to extend the market life of their lucrative drugs.