Clinical Trials: Page 16


  • Group of colleagues sitting around a conference table.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    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
  • A person with obesity prepares a drug for injection.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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
  • Trendline

    Neuroscience drug development

    Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

    By BioPharma Dive staff
  • An illustration of neuron cells in abstract dark space.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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
  • A logo of Gilead Sciences
    Image attribution tooltip
    Permission granted by Gilead Sciences
    Image attribution tooltip

    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 Ned Pagliarulo • June 20, 2024
  • Image attribution tooltip
    Elizabeth Regan/BioPharma Dive
    Image attribution tooltip

    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.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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
  • An illustration of B cells producing antibodies
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    Immune reset

    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
  • abstact
    Image attribution tooltip
    Permission granted by PetersenWest/MenariniSilicon Biosystems
    Image attribution tooltip
    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
    Image attribution tooltip
    Joe Raedle/Getty Images via Getty Images
    Image attribution tooltip

    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
  • People pass an office building with signage spelling Pfizer in New York City.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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 Ned Pagliarulo , June 12, 2024
  • An Ultragenyx sign is seen on the side of an office building.
    Image attribution tooltip
    Permission granted by Ultragenyx
    Image attribution tooltip

    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.
    Image attribution tooltip
    Maddie Meyer via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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"
    Image attribution tooltip
    Alyssa Eckel-Martin/BioPharma Dive
    Image attribution tooltip
    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
  • A sign reading Food and Drug Administration is seen above a door to a government building.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns

    “I just feel very convinced that I had to vote no,” said one member of the committee, which was unconvinced by Lykos Therapeutics’ data on MDMA-assisted treatment for post-traumatic stress disorder.

    By Updated June 4, 2024
  • A micrograph showing triglyceride fat accumulated inside liver cells.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Viking says biopsy data confirm MASH drug’s benefit

    The company may look to license the experimental liver disease drug as it focuses on an obesity treatment that's shown early promise.

    By June 4, 2024
  • A micrograph of an epiphyseal growth plate, stained in color to show layers of cartilage
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    BridgeBio data show sustained benefit for achondroplasia drug

    Longer follow-up results from a mid-stage trial indicate the company’s treatment for a genetic cause of dwarfism may be competitive to an approved therapy from BioMarin Pharmaceutical.

    By Ned Pagliarulo • June 4, 2024
  • Physicians, researchers and healthcare professionals attend ASCO's annual Meeting on June 2, 2023 in Chicago.
    Image attribution tooltip

    ASCO / Nick Agro

    Image attribution tooltip

    ASCO24: Tagrisso in the spotlight, Caribou’s adjustment and Lilly’s KRAS competitor

    AstraZeneca’s therapy could see wider use after ASCO data. Elsewhere, Caribou sought to explain an alternative cell therapy strategy that will delay its study plans.

    By BioPharma Dive staff • June 3, 2024
  • Image attribution tooltip
    Spencer Platt via Getty Images
    Image attribution tooltip

    Structure pill leads to competitive weight loss in obesity study

    Shares in the company soared by more than 50% as study data showed the pill led to similar levels of weight loss as a rival drug being developed by Eli Lilly.

    By June 3, 2024
  • 3D Art
    Image attribution tooltip

    Menarini Silicon Biosystems

    Image attribution tooltip
    Sponsored by Menarini Silicon Biosystems

    A true liquid biopsy hub – Menarini Silicon Biosystem

    Liquid biopsy has emerged as a revolutionary tool for clinical trials, offering cellular and cell-free methods that provide valuable insights into disease progression and treatment response.

    June 3, 2024
  • Physicians, researchers and healthcare professionals attend ASCO's annual Meeting on June 2, 2023 in Chicago.
    Image attribution tooltip

    ASCO / Nick Agro

    Image attribution tooltip

    GSK builds case for return of multiple myeloma drug Blenrep

    Study results showed the antibody-drug conjugate helped stave off disease progression better than a standard treatment. But eye-related side effects remained common.

    By June 2, 2024
  • Enhertu
    Image attribution tooltip
    Permission granted by Daiichi Sankyo
    Image attribution tooltip

    With new Enhertu data, an ADC could overtake chemo in breast cancer

    The results are a step forward for antibody-drug conjugates, which Enhertu makers AstraZeneca and Daiichi Sankyo see replacing chemo in many tumors.

    By June 2, 2024
  • A person speaks at a podium next to four people seated at a lower table.
    Image attribution tooltip
    Jonathan Gardner/BioPharma Dive
    Image attribution tooltip

    AstraZeneca immunotherapy extends survival by two years in rarer type of lung cancer

    The findings, from a trial testing Imfinzi in limited-stage small cell lung cancer, could help AstraZeneca expand the drug's use.

    By Updated June 2, 2024
  • Image attribution tooltip
    Justin Sullivan via Getty Images
    Image attribution tooltip

    Gilead’s Trodelvy misses goal in bladder cancer study

    Treatment didn’t significantly improve overall survival in the trial, a finding that one analyst described as a “meaningful setback” to Gilead’s oncology pipeline.

    By Ned Pagliarulo • May 31, 2024
  • A microscopic image of chronic myeloid leukemia cells, magnified 1000 times.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Novartis study points to larger role for targeted leukemia drug

    Results from a trial called ASC4FIRST show Scemblix outperformed Gleevec and other drugs in treating newly diagnosed chronic myeloid leukemia.

    By Ned Pagliarulo • Updated June 3, 2024