Biotech: Page 11


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    Otsuka tops Vera with kidney drug data; Regenxbio sinks on Duchenne update

    Late-stage results Otsuka presented in IgA nephropathy triggered a sell-off in Vera shares. Elsewhere, investors scrutinized Regenxbio’s Duchenne data and a brain drug study failed.

    By BioPharma Dive staff • June 6, 2025
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    Immune reset

    Cullinan doubles down on bispecifics for autoimmune disease with Genrix deal

    The deal gives Cullinan T cell engagers aimed at BCMA and CD19, which drugmakers are exploring as possible targets for antibody- and cell-based drugs for inflammatory conditions.

    By Kristin Jensen • June 5, 2025
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    Spencer Platt via Getty Images
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    Trendline

    Emerging biotech

    New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

    By BioPharma Dive staff
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    Biotech funding plummets as Trump policies unnerve investors: Jefferies

    The investment bank says funding was down 57% last month, to $2.7 billion, and argues the new administration’s FDA restructuring, NIH cuts and drug pricing rules are “exacerbating” the decline.

    By June 4, 2025
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    Regeneron makes obesity push; Atai, Alto ink brain drug deals

    Regeneron licensed a weight loss drug and revealed study data for a pair of muscle-preserving medicines. Elsewhere, two neuroscience biotechs cut deals and Bluebird officially went private.

    By BioPharma Dive staff • June 4, 2025
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    Kymera, with new data, takes early step toward a Dupixent-like pill

    Phase 1 results disclosed Monday indicate the company’s protein-degrading drug can affect a tough-to-reach target called STAT6 that’s implicated in many autoimmune conditions.  

    By June 2, 2025
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    Vera drug scores in closely watched study in rare kidney disease

    Phase 3 results revealed Monday led shares to surge and should yield an approval application in IgA nephropathy, a competitive corner of drug research, later this year. 

    By June 2, 2025
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    Bristol Myers allies with BioNTech on bispecific cancer drug

    The oncology giant will pay $1.5 billion to co-develop a BioNTech drug that targets the proteins PD-L1 and VEGF, following Merck and Pfizer into what’s become a competitive development race. 

    By Ned Pagliarulo • June 2, 2025
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    Sponsored by Natera

    Genetics is a missing link in kidney disease drug development

    Genetic research is driving progress in kidney disease drug discovery.

    June 2, 2025
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    New Summit data could slow US approval plans for PD-1/VEGF drug

    Ivonescimab helped cut the risk of lung tumor progression in half in a multi-country Phase 3 trial. But it hasn’t yet clearly extended survival, which will be necessary to support an FDA submission.

    By May 30, 2025
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    Keros lays off nearly half its staff; Astellas buys into a China biotech’s ADC

    Keros will also stop work on a cardiovascular disease drug. Elsewhere, Stealth Biotherapeutics and Taysha Gene Therapies each think they've found a path to FDA approval.

    By BioPharma Dive staff • May 30, 2025
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    Vaccines

    HHS terminates Moderna contract to develop bird flu vaccine

    The funding was meant to help the U.S. prepare for pandemics triggered by avian flu strains, but now leaves the future of Moderna’s program uncertain. 

    By May 29, 2025
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    Gene editing

    Intellia filing spurs safety concerns over CRISPR drug

    Shares lost a quarter of their value after the company disclosed, in a regulatory filing, signs of liver stress in a study participant given one of its gene editing treatments. 

    By Kristin Jensen • May 29, 2025
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    The medtech IPO window is finally open. Or is it?

    After a three-year drought, the industry is questioning whether the window for medtech public offerings is open following a small burst of activity.

    By Ricky Zipp • May 29, 2025
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    Biotech zombies

    Cancer drugmaker iTeos to shut down

    Weeks after shelving a TIGIT drug prospect, the biotech is seeking to sell off its assets and intellectual property in a bid to "maximize" shareholder value.

    By May 28, 2025
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    Obesity drugs

    Muscle-sparing obesity drug safe for Phase 3 trial, Veru says

    The company is preparing a Phase 3 trial of enobosarm with a novel formulation that could extend its patent life.

    By May 28, 2025
  • Behind the Breakthroughs: How Almac Powers Clinical Trial Success With Care – A partnership with BioPharma Dive, highlighting Almac’s commitment to patient-centric clinical trial support.
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    Sponsored by Almac Clinical Services

    [Podcast] Behind the Breakthroughs: How Almac Powers Clinical Trial Success with Care

    Agile biopharma firms are driving breakthroughs. Learn how they ensure clinical trial success in this podcast.

    By BioPharma Dive's studioID • May 28, 2025
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    Biogen strikes RNAi deal with City; Aurion withdraws IPO

    City will receive $46 million from Biogen under the alliance. Elsewhere, Angelini Pharma licensed a rare disease therapy and the FDA refused to review a Savara lung drug.

    By BioPharma Dive staff • May 27, 2025
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    Patient dies in trial of Rocket gene therapy for heart condition

    The FDA has placed a clinical hold on the study while Rocket works with trial monitors and experts to investigate the cause of the patient’s death.

    By Ned Pagliarulo • May 27, 2025
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    GlycoEra raises $130M, riding interest in protein degraders

    The startup is the latest beneficiary of investors’ appetite for protein-degrading technology, which offers a way to reach drug targets other technologies can’t.

    By May 27, 2025
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    iStockPhoto / Jacob Wackerhausen

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    Sponsored by Sapio Sciences

    The transformative impact of integrated informatics platforms on biopharma R&D

    Integrated informatics platforms boost R&D speed, data quality and ROI across BioPharma

    By Nicola Brookman-Amissah, PhD • May 27, 2025
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    Obesity drugs

    Novo pressures GLP-1 compounders as FDA ban takes hold

    The Danish drugmaker unveiled a series of initiatives to increase access to Wegovy and clamp down on use of the knock-off versions that have dented its sales forecasts.

    By Kristin Jensen • May 22, 2025
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    FDA advisers pan Pfizer’s PARP drug; Sarepta to resume Duchenne study

    An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K. regulators cleared Sarepta to restart an Elevidys study and Altos Labs bought a startup.

    By BioPharma Dive staff • May 22, 2025
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    Reproductive health startup raises $65M for infertility drugs

    Founded in 2021, ReproNovo has licensed rights to two drugs from Mereo BioPharma and ObsEva that it thinks could address fertility issues in men and women.

    By May 21, 2025
  • The Moderna headquarters is seen on November 30, 2020 in Cambridge, Massachusetts.
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    Vaccines

    Moderna pulls application for combo COVID, flu shot

    The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from yesterday.

    By May 21, 2025
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    Roche strikes second Orionis deal to develop ‘molecular glues’ for cancer

    The Swiss pharma has inked several collaborations in this field, suggesting it sees the approach as promising to rid the body of destructive proteins that are hard to target by other means.

    By Kristin Jensen • May 21, 2025