The Latest

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    Adeline Kon/BioPharma Dive
    Deep Dive

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

    Pfizer’s acquisition of Global Blood Therapeutics is the seventh biotech buyout this year valued at greater than $1 billion.

    Updated Aug. 10, 2022
  • A general view of AstraZeneca is seen during Prime Minister Scott Morrison's visit on August 19, 2020 in Sydney, Australia.
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    Lisa Maree Williams via Getty Images

    New Enhertu approval adds to growing role of well-known cancer target

    AstraZeneca and Daiichi Sankyo’s drug is the first medicine cleared for lung tumors with mutations to HER2, a gene known for its link to breast cancers.

    FDA
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    Jeenah Moon via Getty Images

    Pfizer’s new pneumococcal vaccine meets study goal in children

    Pfizer, which competes with Merck in this market, plans to ask the FDA for an expanded approval of its 20-valent shot later this year.

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    alvarez via Getty Images

    Shifting focus, ProQR to seek partners for stalled eye drugs

    The company will wind down five trials involving two drug candidates and lay off more staff, prioritizing instead its RNA-editing technology.

  • Alexis Borisy and Melanie Nallicheri of EQRx, at launch
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    Courtesy of EQRx

    EQRx, in bid to compete, takes on AstraZeneca’s top seller in head-to-head trial

    The study could be critical for a medicine EQRx plans to position as a competitor to Tagrisso. The drug is under review in the U.K., a first for EQRx.

  • 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.

  • A medical professional prepares a dose of the monkeypox vaccine on July 23, 2022 in London, England.
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    Hollie Adams via Getty Images

    US takes step to expand monkeypox vaccine supply

    The FDA authorized a new plan that could lead to a five-fold increase in available doses. European health officials may follow the agency's lead. 

    FDA
  • Disc Medicine CEO John Quisel
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    Permission granted by Disc Medicine

    Gemini’s fall gives Disc a way around biotech’s IPO slump

    The biotech’s failed attempt to develop an eye drug has ended in a reverse merger that gives startup Disc Medicine a fast path to the public markets.

  • Electron microscope image of T regulatory cells interacting with antigen-presenting cells
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    NIAID. (2019). "T Regulatory Cells" [Microscope image]. Retrieved from Flickr.

    GentiBio partners with Bristol Myers as cell therapy for immune disease gains momentum

    The deal, worth as much as $2 billion, is the latest sign of industry interest in treatments that harness regulatory T cells, an approach behind several recent biotech startups.

  • The Merck & Co. sign at the company's building in Summit, New Jersey.
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    Kena Betancur via Getty Images
    Emerging biotech

    A biotech startup gives Merck its next shot at treating Alzheimer’s

    Boston-based Cerevance is searching for new drug targets for neurological diseases like Alzheimer’s, although CEO Craig Thompson wouldn’t reveal what its work with Merck will take aim at.

  • 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
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    Mario Tama via Getty Images

    J&J’s head of R&D departs as pharma’s leadership turns over

    Mathai Mammen is leaving to “pursue other opportunities,” J&J said in an abrupt announcement. William Hait, currently head of external innovation, will take Mammen’s place in the interim.

  • 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.

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    Erik Karits via Getty Images

    Pfizer, Valneva take next step with Lyme disease shot, starting large trial

    The experimental vaccine is the most advanced candidate for the tick-borne disease and, if successful, would be the first to reach the market since withdrawal of GSK’s Lymerix.

  • senator Chuck Schumer pauses under an arch in the United States Senate. Both of his hands are raised and giving a 'thumbs up'
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    Drew Angerer/Getty Images via Getty Images

    Senate passage of drug pricing bill brings major defeat closer for pharma industry

    The legislation, which would allow Medicare to negotiate prices on up to 60 drugs by 2029, passed on a party-line vote and now goes to the House, where it is expected to pass.

  • A sign for Pfizer is seen outside the Pfizer headquarters on November 9, 2020 in New York City.
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    David Dee Delgado via Getty Images

    Pfizer buys sickle cell drugmaker Global Blood for $5.4B

    The acquisition gives Pfizer access to Oxbryta, an approved drug for the blood condition, as well as two experimental medicines.

    Updated Aug. 8, 2022
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    Elizabeth Regan / Industry Dive

    Karuna shares soar on schizophrenia drug results

    The company plans to ask regulators to approve its KarXT therapy based on the results, which one analyst called “as good as one could hope for.”

  • 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.

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    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.

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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 accelerated approval.

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    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 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.