The Latest

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

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

    Despite newly realized fears of an activist FTC, analysts expect dealmaking to continue this year with small buyouts like Ironwood’s acquisition of VectivBio as well as larger M&A.

    Updated May 22, 2023
  • A general view of the Pfizer Headquarters sign on November 10, 2020 in Tadworth, England.
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    Dan Kitwood via Getty Images
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    Pfizer says antibiotic is effective against tough-to-treat infections

    A drug the company acquired from AstraZeneca and developed for gram-negative infections — a growing public health threat — could be headed for a regulatory review later this year.

  • Corporate logos are seen outside  on May 15, 2006, in Macclesfield, England.
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    Christopher Furlong via Getty Images
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    AstraZeneca abandons experimental bowel disease drug

    The drugmaker cited testing delays and an evolving “competitive landscape” in its decision to discontinue development of its IL-23 inhibitor brazikumab.

  • The logo of German pharmaceuticals and chemicals giant Bayer stands over Bayer corporate offices on September 14, 2016 in Berlin, Germany.
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    Sean Gallup via Getty Images
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    Bayer launches precision health unit in latest digital health venture

    The pharma company said it will work with startups and other digital health companies as it builds out the consumer-focused business unit.

  • Human respiratory syncytial virus virions are shedding from the surface of human lung cells.
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    National Institute of Allergy and Infectious Diseases. (2017). "Human Respiratory Syncytial Virus" [Micrograph]. Retrieved from Flickr.
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    RSV vaccines

    Pfizer’s RSV vaccine wins FDA approval in older adults

    The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.

    FDA
  • A thumbnail illustration for BioPharma Dive's IPO tracker
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    Adeline Kon/BioPharma Dive
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    Deep Dive

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

    Though the sample size is small, the majority of biotechs that have gone public in 2023 have so far held their value, in contrast to the sliding stock prices of companies that IPO’d in previous years.

    Updated May 26, 2023
  • A photo of Biohaven CEO Vlad Coric
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    Courtesy of Biohaven Ltd.
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    Biohaven sends latest drug to FDA, despite past trial setback

    The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.

  • 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 pauses PepGen’s plans to test muscle disease drug

    The company’s oligonucleotide-based treatment is the latest neuromuscular disease therapy to face a regulatory roadblock prior to human testing.

  • A photograph of a box of Amylyx Pharmaceuticals' ALS medicine Relyvrio
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    Permission granted by Amylyx Pharmaceuticals
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    Amylyx’s ALS drug could face rejection in Europe

    The biotech said a committee advising the European Medicines Agency is “trending” toward issuing a negative opinion of its drug Relyvrio, which was approved in the U.S. last year. 

  • A computer screen shows the Pfizer logo and stock price at the New York Stock Exchange
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    Michael M. Santiago via Getty Images
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    Pfizer says hemophilia drug succeeded in Phase 3 study

    The drug, called marstacimab, could potentially become another option for hemophilia patients just as new gene therapies arrive on the market in the U.S.

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    Grigorii Yalukov via Getty Images
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    Akebia says FDA will give its once-rejected anemia pill a second chance

    The regulator denied an appeal of its decision to turn back vadadustat, but outlined a path forward for the company to resubmit an application without running another clinical trial.

    FDA
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    Spencer Platt via Getty Images
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    Rain Oncology to cut workforce by 65% after study failure

    The company, which went public in 2021 to develop a cancer drug licensed from Daiichi Sankyo, may try to acquire a different tumor-targeting medicine to grow its pipeline.

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    Maximusnd via Getty Images
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    Atea rejects takeover bid from Concentra

    The COVID-19 drug developer said the offer from the firm that recently took over Jounce Therapeutics “fundamentally undervalues the company.”

  • Tim Springer, a Harvard University professor, smiles at the camera in his lab.
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    Permission granted by Institute of Protein Innovation
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    Q&A // Emerging biotech

    Serial biotech founder Tim Springer on investing in startups and democratizing antibody research

    Springer, who became a billionaire after investing in Moderna, highlighted gene therapy and machine learning as two fields he’s optimistic will shape biotech’s future. 

  • A micrograph of a myeloma neoplasm in a bone marrow biopsy.
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    OGphoto via Getty Images
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    J&J antibody drug combination shows promise in multiple myeloma

    Bispecific antibodies, like the two J&J is testing together in multiple myeloma, could compete with CAR-T cell therapies in certain treatment lines.

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    ASCO / Scott Morgan
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    ASCO puts spotlight on advancing antibody-drug conjugate pipeline

    Study abstracts released Thursday give investors and analysts a better look at cancer treatments recently licensed by Merck and BioNTech as well as fresh details on other closely watched ADC candidates.

  • A micrograph showing a bone marrow biopsy
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    rightdx via Getty Images
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    Bristol Myers data make case for earlier use of bone marrow disease drug

    Data released ahead of next month’s ASCO meeting detail how well Bristol Myers’ Reblozyl outperformed the decades-old standard Epogen in treating anemia from myelodysplastic syndromes.

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    Leonid Sorokin via Getty Images
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    BenevolentAI CFO resigns as company lays off staff, restructures

    The biotech, one of several AI drug discovery specialists to go public in recent years, is cutting up to 180 jobs and reorganizing its pipeline to conserve cash.

  • A sign that says Illumina is on a curb in front of red brick buildings.
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    Courtesy of Illumina
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    Illumina chair loses to Icahn pick as proxy battle ends

    The decision to replace board Chair John Thompson could change the company’s course as it decides whether to divest liquid biopsy company Grail.

    Updated May 25, 2023
  • A photo of a sign inside an Apellis Pharmaceuticals building
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    Courtesy of Apellis Pharmaceuticals
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    Apellis abandons ALS drug after study miss

    The trial failure is the second for an ALS medicine this week, adding to a lengthy list of study setbacks that have thinned the pipeline of experimental medicines for the disease in recent years.

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    gchutka via Getty Images
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    Annexon claims a silver lining in failed eye drug study

    The company’s geographic atrophy drug didn’t slow the growth of eye lesions, as similar medicines have in clinical testing. But executives said it may have helped preserve some patients’ vision.

  • Rep. Comer sits in front of a poster outlining the cost differences between a drug dispensed at Cost Plus Drugs versus CVS.
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    Rebecca Pifer/BioPharma Dive
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    House lawmakers, PBM lobby spar over committee hearing

    At the latest congressional inquiry into pharmacy benefit managers, lawmakers argued the middlemen profit at the expense of patients and taxpayers.

  • A patient speaks with their doctor via his mobile phone
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    vorDa via Getty Images
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    Digital health funding holds steady in Q1 after year of decline

    The sector defied trends seen in the broader venture capital economy, where funding has tightened. But investment is still at years-low levels.

  • A photograph of a Sarepta building in Boston, MA
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    Courtesy of Sarepta
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    FDA delays decision on Duchenne gene therapy, considers narrower approval

    The agency will extend its review of Sarepta’s treatment by one month as it weighs limiting an initial OK to children with Duchenne aged 4 to 5 years old.

    Updated May 24, 2023
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    Alvarez via Getty Images
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    PTC lays off staff, fires CFO as neuromuscular drug study fails

    The biotech is giving up on early-stage gene therapy research as part of a restructuring meant to cut costs and redirect resources toward therapies most likely to succeed.