Clinical Trials


  • A Roche logo is seen on the side of a building.
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    Courtesy of Roche
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    Obesity pill from Roche shows promising weight loss in small study

    Treatment led to "clinically meaningful" weight loss over four weeks, but longer studies will be needed to compare it to Wegovy and Zepbound.

    By July 17, 2024
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    iStock via Getty Images
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    Lexeo gene therapy shows signs of heart benefit in small study

    The biotech, which went public late last year, argued the results justify exploring an accelerated approval. But shares fell by double digits amid investor skepticism.

    By July 15, 2024
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    Douglas Cliff via Getty Images
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    Trendline

    The obesity drug revolution

    GLP-1 agonists like Ozempic and Wegovy can drive significant weight loss and, at least in Wegovy’s case, protect the heart. Their adoption is changing how doctors treat obesity. 

    By BioPharma Dive staff
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    Popartic via Getty Images
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    UniQure stock surges on data for Huntington’s gene therapy

    The biotech’s stock rose more than 60% as fresh data appeared to alleviate some investor concerns about the therapy’s effectiveness and reliability.

    By July 9, 2024
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    Joe Raedle via Getty Images
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    HilleVax’s norovirus vaccine ineffective in large trial of infants

    Shares in HilleVax plummeted after the company reported its experimental shot failed to meet the primary and secondary goals of the Phase 2b study.

    By July 8, 2024
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    Kendall Davis/BioPharma Dive
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    Deep Dive

    10 clinical trials to watch in the second half of 2024

    Study results are expected for two closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.

    By BioPharma Dive staff • July 1, 2024
  • A sign reading Novo Nordisk is seen on the side of a building.
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    Victor Golmer via Getty Images
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    Novo nixes trial of blood pressure drug it bought in $1.3B deal

    The failure of a Phase 3 study led the Wegovy maker to take an accounting charge that will hit its operating profit growth this year.

    By June 26, 2024
  • Two prescription drug cartons are seen standing vertically on end, bearing the word Wegovy.
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    Scott Olson via Getty Images
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    Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?

    Obesity drugs like Wegovy are proving useful in many diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.

    By June 26, 2024
  • An illustration of CRISPR-cas9 gene editing
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    del Aguila III, Ernesto. (2018). "CRISPR Cas9" [Illustration]. Retrieved from Flickr.
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    First-of-its-kind Intellia data suggest CRISPR drug could be given more than once

    The findings provide early proof that multiple doses of a gene editing medicine can be safely administered with additive effects, overcoming a key constraint of the complex therapies.  

    By June 26, 2024
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    koto_feja via Getty Images
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    Wave, with new data, plots path forward for Huntington’s drug

    The company plans to make a case to regulators for a new accelerated approval pathway. But investors didn't seem as hopeful, sending shares down by double digits.

    By June 25, 2024
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    hapabapa via Getty Images
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    Novo fills in positive picture for preventive hemophilia drug

    Phase 3 trial results should support an approval application for the drug, which analysts view as a competitor to Roche’s blockbuster medicine Hemlibra.

    By June 24, 2024
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    Ivan-Balvan via Getty Images
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    Alnylam says heart drug succeeds in closely watched study

    Positive results from a Phase 3 trial of vutrisiran in transthyretin amyloidosis cardiomyopathy come eight months after the FDA rejected another medicine Alnylam developed for the condition.

    By Updated June 24, 2024
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    David Oxberry via Getty Images
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    Sponsored by Fortrea

    Bridging science and humanity: Systems thinking in clinical trial design

    Benefits of adopting the systems thinking approach in clinical trial design.

    By Clare Campbell-Cooper, Global Head of Digital Health and Innovation at FORTREA • June 24, 2024
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    iStock / Getty Images Plus via Getty Images
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    Obesity drugs

    Obesity drug from Zealand shows potential in early trial

    Interim study data suggest the Danish drugmaker can remain in the race to develop new kinds of weight loss drugs as doctors seek alternatives to the now dominant GLP-1s.

    By June 20, 2024
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    whitehoune via Getty Images
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    FDA lifts hold on PTC Huntington’s disease trial

    The agency has lifted a partial trial suspension based on one-year data showing PTC’s pill suppressed a key protein associated with the disorder.

    By June 20, 2024
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    Permission granted by Gilead Sciences
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    Twice-yearly shots of Gilead HIV drug effective in large prevention study

    Researchers recommended Gilead end testing early as lenacapavir proved 100% effective in protecting cisgender women in the Phase 3 trial.

    By June 20, 2024
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    Elizabeth Regan / Industry Dive
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    Intra-Cellular depression drug succeeds in second late-stage study

    The results position the company to unlock what’s believed to be a multibillion-dollar sales opportunity for Caplyta, which is already used to treat schizophrenia and bipolar disorder. 

    By Kristin Jensen • June 18, 2024
  • A sign with the logo for the Takeda pharmaceutical company.
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    Stock via Getty Images
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    Takeda drug for rare types of epilepsy misses goal in late-stage trial

    Called soticlestat, the drug had seemed promising in earlier studies for people with Dravet and Lennox-Gastaut syndrome, enough to persuade Takeda to take on full rights to the drug.

    By June 17, 2024
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    Love Employee via Getty Images
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    New data showcase promise, growing pains of CAR-T in autoimmune disease

    One expert described trial results presented at EULAR in June as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.

    By June 17, 2024
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    Permission granted by PetersenWest/MenariniSilicon Biosystems
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    Sponsored by Menarini Silicon Biosystems

    The critical role of comprehensive RNA sequencing in liquid biopsy for biomarker discovery and clinical trials

    Elevate precision medicine: dose optimization and immune monitoring through advanced liquid biopsies.

    By Harshil Patel, MBA, CGMBS, ASCP - Sr. Marketing Manager • June 17, 2024
  • a nurse gives a vaccination to a woman sitting in a chair
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    Joe Raedle/Getty Images via Getty Images
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    Moderna says next-gen COVID shot effective in study

    Trial data suggest the shot — an important component of an upcoming combination inoculation — has proven at least as effective, and in some cases superior, to the company’s initial COVID vaccine.

    By Kristin Jensen • June 13, 2024
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    George Clerk via Getty Images
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    Pfizer gene therapy for Duchenne fails to meet goals of key trial

    The negative results from the Phase 3 study, called Ciffreo, come a little more than a month after Pfizer said a patient died in another trial of the gene therapy.

    By , June 12, 2024
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    Image courtesy of Ultragenyx.

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    Ultragenyx, Mereo drug reduces fractures in bone disorder study

    New data show the treatment’s effect on fractures and bone density held up over time, boosting the drug’s prospects ahead of a Phase 3 readout.

    By Kristin Jensen • June 12, 2024
  • The Moderna headquarters is seen on November 30, 2020 in Cambridge, Massachusetts.
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    Maddie Meyer via Getty Images
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    Moderna says combination flu, COVID shot succeeds in study

    Positive results from the trial could position Moderna to bring the two-in-one vaccine to market in 2025.

    By June 10, 2024
  • Multicolored MDMA pills are seen on a white fabric background in this photo illustration.
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    Makhbubakhon Ismatova via Getty Images
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    After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next

    A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.

    By June 7, 2024
  • This image depicts the podcast series image for BioLine's BioPharma Dive series, "The Power of Persistence: From Biotech Incubator to First Product Launch"
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    Alyssa Eckel-Martin/BioPharma Dive
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    Sponsored by BioLineRx

    [Podcast] The Power of Persistence: From Biotech Incubator to Product Launch

    How can small and mid-sized biotech companies better manage pharmacovigilance during clinical trials? Listen to the podcast to learn how strategic alliances are helping.

    By BioPharma Dive's studioID • Updated June 18, 2024