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  • Futuristic 3D cubes showing DNA base pairs and a double helix.
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    JuSun via Getty Images
    CRISPR gene editing

    FDA halts testing of Beam’s base editing cancer therapy

    The regulator has put on hold human testing of a blood cancer treatment called BEAM-201, one of two the biotech aims to bring into clinical trials this year.

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    Getty Images

    Nuvation to cut workforce by 35% as it scraps lead drug program

    The company, which is led by former Medivation executives and focuses on cancer research, said the shake-up is in response to an “internal risk-benefit analysis” that raised doubts about its most advanced program.

  • An illustration of T cells attacking cancer cells
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    Meletios Verras via Getty Images

    Ipsen, continuing oncology push, pays a startup $45M for two cancer drugs

    The French company will work with Marengo Therapeutics in an alliance that could be worth as much as $1.6 billion.

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    Sarah Silbiger via Getty Images

    Concert to seek approval for hair loss drug after second study success

    The biotech plans to file an application with the FDA in the first half of next year for clearance in alopecia areata, potentially positioning it to compete with Eli Lilly and Pfizer for market share.

  • 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

    AbbVie cancer drug sales fall as AstraZeneca competitor gains ground

    Imbruvica, long one of AbbVie’s top-selling medicines, has ceded market share in treating chronic lymphocytic leukemia to AstraZeneca’s Calquence.

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    Photo illustration by Maura Sadovi/BioPharma Dive; photograph by Carl Court via Getty Images

    US secures updated COVID boosters in $1.7B deal with Moderna

    Health officials are gearing up for a fall vaccination campaign and aim to deploy shots modified to better match circulating omicron subvariants.

  • A photograph of a Sarepta building in Boston, MA
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    Courtesy of Sarepta

    Sarepta to ask FDA for accelerated approval of Duchenne gene therapy

    After discussions with the FDA, the biotech aims to submit an application this fall — sooner than expected and ahead of a Phase 3 study that’s now ongoing.

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    Dan Kitwood via Getty Images

    Pfizer sales of COVID-19 vaccine, pill beat forecasts as company prepares for future waves

    The company plans to ready a booster shot by the fall that targets the BA.4 and BA.5 strains that are currently most prevalent in the U.S. and other countries.

    Updated July 28, 2022
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    Alnylam Pharmaceuticals

    Alnylam reveals longer wait for anticipated drug trial results

    Important data from the APOLLO study of the biotech's drug Onpattro are due before the end of August, Alnylam said Thursday.

  • Vicinitas Therapeutics founder Daniel Nomura
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    Courtesy of Vicinitas Therapeutics
    Emerging biotech

    Novartis-linked startup launches with technology designed to remove ‘destroy’ tags on helpful proteins

    Vicinitas and its protein-stabilizing research have attracted $65 million from a group of investors that includes a16z, Deerfield and GV.

  • 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

    FDA signs off on Bavarian Nordic plant, allowing distribution of monkeypox vaccine doses

    The agency’s decision means hundreds of thousands of additional doses can be made available in the U.S., which now accounts for the most cases globally.

    FDA
  • A photo of an Editas Medicine scientist in the lab.
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    Permission granted by Editas Medicine

    Editas treats first patient in sickle cell trial as FDA lifts partial hold

    The sickle cell therapy being studied is the second CRISPR-based medicine that Editas has advanced into clinical testing. Initial trial results could come as soon as the end of this year. 

  • An AbCellera scientist preparing reagents for a molecular biology assay
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    Courtesy of AbCellera
    Emerging biotech

    Versant partners with AbCellera to arm startups with better antibodies

    The companies pitch their collaboration as a way to give young drugmakers backed by Versant a head start. “Our business is advanced by great ideas coming into the funnel,” said AbCellera’s CEO. 

  • A photograph of an infusion bag of Abecma, a CAR-T therapy from Bristol Myers Squibb and Bluebird bio
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    Courtesy of Bristol Myers Squibb and Bluebird bio

    Bristol Myers CAR-T sales rise despite production problems

    Demand has increased faster than Bristol Myers can make Abecma, although the company said supply is improving. A manufacturing issue for Breyanzi, meanwhile, impacted sales. 

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    Jens Schlueter via Getty Images

    Pfizer, BioNTech to study 'bivalent' booster as FDA weighs approach

    The small-scale study is part of the companies’ efforts to update their vaccine in time for a potential fall vaccination campaign to help boost waning immunity.

  • A building showing a logo of Teva Pharmaceutical
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    Courtesy of Teva Pharmaceutical

    Teva reaches deal in principle to settle opioid lawsuits for over $4B

    The generics maker joins other pharmaceutical companies attempting to resolve litigation over their alleged contributions to the opioid epidemic.

  • A double exposure image of a glass flask in a laboratory with stock market information in the background.
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    MadamLead via Getty Images
    Deep Dive // Emerging biotech

    'Flat is the new up': After biotech correction, venture investors turn to safer bets

    New companies are being built more carefully and platform technologies are less in vouge as the downturn's effects ripple through the private sector.

  • A photo of a Biogen building
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    Permission granted by Biogen
    ALS drug development

    FDA, in another test of its flexibility, agrees to review Biogen's closely watched ALS drug

    Known as tofersen, the drug failed in the main study being used to support its approval. But an apparent effect on a protein of interest in ALS research has Biogen convinced the treatment will pass muster with regulators.

  • A 3D illustration of a DNA double helix
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    libre de droit via Getty Images
    Emerging biotech

    Epigenetic editing: a tunable CRISPR alternative

    Three startups have recently emerged with plans to edit the epigenome rather than DNA directly. Here’s why that matters and what they aim to do. 

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    Elizabeth Regan / Industry Dive

    BridgeBio advances drug for dwarfism after study data

    The highest tested dose of BridgeBio’s drug helped the bones of children with achondroplasia grow faster, leading the company to expand study enrollment.

  • A photo of a Seattle Genetics laboratory
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    Permission granted by Seagen

    Seagen, Astellas claim positive results in study key to cancer drug's success

    The mid-stage trial tested the companies’ drug Padcev with Merck’s Keytruda in first-line bladder cancer. The data are reportedly a factor in Merck’s talks with Seagen over a potential buyout.

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    Sarah Silbiger via Getty Images

    AstraZeneca, Daiichi breast cancer drug set for speedy FDA review

    The agency agreed to quickly assess the companies’ drug Enhertu for “HER2 low” metastatic breast cancer, an indication for which it could become the first targeted treatment option.

    FDA
  • The World Health Organization emblem of a snake symbol for medicine coiling around UN symbol.
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    Sean Gallup via Getty Images

    EU speeds approval of monkeypox vaccine as WHO declares public health emergency

    Vaccine maker Bavarian Nordic said it is meeting demand for its shot with production capacity of 30 million doses a year.

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    Novartis

    Novartis asks FDA to approve biosimilar for Biogen’s top-selling MS drug

    Biogen will try to enforce patents protecting Tysabri, but an executive last week acknowledged that copycat drugs could launch when approved in the U.S.

  • Single strand ribonucleic acid, RNA research
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    luismmolina via Getty Images

    China-based biotech licenses Sanofi's RNA drug technology

    The Lilly-backed Rona Therapeutics gains rights to a platform for small interfering RNA, along with a slate of preclinical candidates aimed at targets in the liver and other tissues.

    Updated July 25, 2022