Clinical Trials


  • 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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    Meletios Verras via Getty Images
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    Trendline

    Oncology's research boom

    More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

    By BioPharma Dive staff
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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 12, 2024
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    Sarah Silbiger via Getty Images
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    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
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    Jose Luis Calvo Martin, Jose Enrique Garcia-Maurino Muzquiz via Getty Images
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    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 June 4, 2024
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    Dr_Microbe via Getty Images
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    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
  • Physicians, researchers and healthcare professionals attend ASCO's annual Meeting on June 2, 2023 in Chicago.
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    ASCO / Nick Agro

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    ASCO24

    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
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    Spencer Platt via Getty Images
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    Obesity drugs

    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
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    Menarini Silicon Biosystems

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    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
  • Enhertu
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    Permission granted by Daiichi Sankyo
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    ASCO24

    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
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    Jonathan Gardner/BioPharma Dive
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    ASCO24

    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
  • Physicians, researchers and healthcare professionals attend ASCO's annual Meeting on June 2, 2023 in Chicago.
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    ASCO / Nick Agro

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    ASCO24

    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
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    Justin Sullivan via Getty Images
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    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 May 31, 2024
  • A microscopic image of chronic myeloid leukemia cells, magnified 1000 times.
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    jarun011 via Getty Images
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    ASCO24

    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 Updated June 3, 2024
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    Mario Tama via Getty Images
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    J&J antidepressant eases symptoms, improves sleep in key trial

    The company has put high expectations on the drug, an orexin-2 antagonist called seltorexant, as a cornerstone of its neuropsychiatry pipeline.

    By May 29, 2024
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    Elizabeth Regan / Industry Dive
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    Insmed shares double as lung drug data convince Wall Street

    After reporting positive clinical trial results for its drug brensocatib, Insmed plans to later this year file for U.S. approval in bronchiectasis that’s not associated with cystic fibrosis.

    By May 28, 2024
  • Physicians, researchers and healthcare professionals attend ASCO's annual Meeting on June 2, 2023 in Chicago.
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    ASCO / Nick Agro

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    ASCO24

    Certain menopausal hormone therapy could raise ovarian cancer risk, study finds

    The findings, from two trials involving thousands of women, could influence guidelines around use of hormonal treatment for menopause symptoms.

    By May 23, 2024
  • Physicians, researchers and healthcare professionals attend ASCO's annual Meeting on June 2, 2023 in Chicago.
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    ASCO / Nick Agro

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    News roundup

    ASCO24: An early look at cancer drug study results

    Clinical trial abstracts posted Thursday ahead of this year’s ASCO meeting give a peek at anticipated datasets from Immunocore, Merus, J&J and Merck & Co.

    By BioPharma Dive staff • Updated May 24, 2024
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    Elizabeth Regan / Industry Dive
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    Dyne shares jump on trial data for muscle disease drugs

    Updated study results for the biotech’s medicines for myotonic dystrophy Type 1 and Duchenne muscular dystrophy appeared to impress analysts and investors on Wall Street.

    By May 20, 2024
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    iStock / Worawut Prasuwan

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    Sponsored by Panalgo

    The ABCs of SDOH: Meaningful strategies to improve patient outcomes

    As biopharmaceutical and medical device companies increasingly recognize the impact of SDOH, a question emerges: how can these sponsors effectively integrate SDOH data into clinical trial recruitment and real-world evidence strategies?

    By Meg Richards, PhD, MPH, Executive Director, Scientific Strategy at Panalgo, with Andrew Goldstein, VP of Client Partnerships at Panalgo • May 20, 2024
  • 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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    Detailed trial data show Bayer drug alleviates menopause symptoms

    Full study results disclosed ahead of a medical meeting showed elinzanetant consistently reduced the frequency and severity of hot flashes.

    By May 16, 2024
  • A white sign with the word Lilly written in red stands outside of an office.
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    Scott Olson via Getty Images
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    Lilly’s once-weekly insulin matches daily shots in late-stage tests

    The results, which showed Lilly’s drug was as effective at controlling blood sugar as standard injections, come as Novo Nordisk seeks approval for a competing once-weekly insulin.

    By May 16, 2024