Biotech


  • A Merck & Co. sign sits in front of a Georgia facility July 9, 2002 in Duluth, Georgia.
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    Erik S. Lesser via Getty Images
    Emerging biotech

    Merck pays startup Orna $150M as ‘circular RNA’ attracts industry interest

    The pharmaceutical company has formed an alliance with Orna and invested $100 million in its Series B round, hoping the young biotech’s approach could lead to multiple new vaccines and drugs. 

    By Aug. 16, 2022
  • 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

    Amid market turbulence, a Flagship startup pushes off an IPO with a new fundraise

    Senda Biosciences decided to raise a $123 million Series C round rather than test public markets with an initial offering, its top executive said.

    By Aug. 16, 2022
  • Colorized scanning electron micrograph of a natural killer cell from a human donor. Explore the Trendline
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    National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
    Trendline

    Cell therapy

    Six CAR-T cell therapies are now approved in the U.S., and their continued emergence has helped fueled further research into next-generation approaches.

    By BioPharma Dive staff
  • 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.
    Emerging biotech

    ‘Treg’ cell therapy: bringing CAR-T to autoimmune disease

    At least seven companies, including five richly funded startups, are developing cell-based treatments for inflammatory conditions, making it one of biotech’s most competitive fields. 

    By Aug. 16, 2022
  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Jacob Bell / BioPharma Dive

    Despite failed trial, Brainstorm asks FDA to approve ALS drug

    The move comes less than a month after the agency agreed to review Biogen’s tofersen — another ALS drug with a questionable record in clinical testing.

    By Aug. 15, 2022
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    Gabriel Kuchta via Getty Images

    UK approves Moderna’s two-pronged COVID-19 booster

    Britain’s drug regulator is the first public health authority to clear a vaccine designed to fight omicron as well as the original strain of the virus. 

    By Aug. 15, 2022
  • A photo of a Seattle Genetics laboratory
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    Permission granted by Seagen

    Seagen loses arbitration case to Daiichi Sankyo over cancer drug technology

    An arbitrator ruled against Seagen in a dispute over technology used in Enhertu and other Daiichi Sankyo drugs, stopping an attempt by Seagen to collect lucrative royalties.

    By Aug. 12, 2022
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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.

    By Aug. 11, 2022
  • A photograph of Upstream Bio CEO Samantha Truex
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    Permission granted by Upstream Bio
    Q&A

    Samantha Truex on biotech hiring, competing for funding and Upstream’s next steps

    The CEO recently led Upstream through a $200 million financing that will support development of an inflammatory disease drug. “We have what investors probably want at this time,” she told BioPharma Dive.

    By Aug. 9, 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.”

    By Aug. 8, 2022
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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.

    By Aug. 5, 2022
  • 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.

    By Aug. 4, 2022
  • 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.

    By Aug. 3, 2022
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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.

    By Aug. 3, 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.

    By Aug. 2, 2022
  • 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.

    By Aug. 2, 2022
  • 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.

    By Updated Aug. 2, 2022
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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.

    By Aug. 1, 2022
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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.

    By Aug. 1, 2022
  • 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.

    By July 29, 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.

    By July 28, 2022
  • 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.

    By July 28, 2022
  • 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. 

    By July 27, 2022
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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.

    By July 26, 2022
  • 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.

    By July 26, 2022
  • 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.

    By July 26, 2022