Clinical Trials


  • 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
  • An illustration of B cells producing antibodies Explore the Trendline
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    Love Employee via Getty Images
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    Trendline

    Immunology

    Promising new mechanisms of action are driving significant pharmaceutical company investment into drugs for immune diseases like psoriasis and Crohn’s.

    By BioPharma Dive staff
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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
  • A Roche logo is seen on the side of a building.
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    Courtesy of Roche
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    Obesity drugs

    Roche keeps pace in obesity drug field with early study data

    A drug Roche acquired in a buyout of Carmot Therapeutics and that works similarly to Zepbound helped people lose nearly 19% of their body weight in a Phase 1 trial.

    By May 16, 2024
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    Permission granted by Biogen
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    ALS drug development

    Biogen, Ionis shelve ALS drug following study failure

    While results indicated the drug works as intended, it didn’t have enough of an effect on a protein that’s become integral to many ALS research programs.

    By May 16, 2024
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    Daniel Tadevosyan via Getty Images
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    News roundup

    Novo Holdings buys stake in life sciences tools company; BioMarin lays off 170

    The parent of Novo Nordisk is acquiring 60% ownership of Single Use Support, which specializes in handling of advanced therapies. Elsewhere, BioMarin and gene therapy developer Tenaya are cutting jobs.

    By May 15, 2024
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    Phynart Studio via Getty Images
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    Sponsored by Pearson

    Acknowledging comorbidities in trial design is essential for successful outcomes

    Examine why adaptive trials that consider comorbidities are critical for a successful trial outcome.

    May 13, 2024
  • A sign for Pfizer is seen outside the Pfizer headquarters on November 9, 2020 in New York City.
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    David Dee Delgado via Getty Images
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    Patient dies in Pfizer study of Duchenne gene therapy

    Pfizer said the patient, a young boy who was treated earlier last year, died suddenly from cardiac arrest. The company is working with trial researchers to investigate further.

    By Updated May 8, 2024
  • A photo of Sekar Kathiresan, CEO of Verve Therapeutics
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    Seth Babin/BioPharma Dive
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    Gene editing

    Verve moves forward with backup base editing therapy

    Weeks after a safety setback derailed its lead candidate, the company has treated the first participant in a trial of its heart disease treatment Verve-102.

    By May 7, 2024
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    Shutterstock / Rocketclips, Inc.

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    Sponsored by Elligo Health Research

    Optimized trials are the easiest way to meet the FDA’s latest diversity requirements

    Optimized clinical trials will help sponsors align with new FDORA diversity requirements.

    May 6, 2024
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    Mario Tama via Getty Images
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    Obesity drugs

    Amgen shares soar as executives outline obesity drug push

    The company said data for its Wegovy competitor was promising enough to move the drug into late-stage testing, triggering a stock jump that added billions to Amgen’s market value.

    By May 3, 2024
  • A large group of dosing pens for subcutaneous injection of anti-obesity medication piled in a heap.
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    aprott via Getty Images
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    State of Play

    Chasing Novo and Lilly: The obesity drugs that could challenge Wegovy and Zepbound

    Large and small drugmakers are vying for a piece of what analysts view as one of the biggest market opportunities in the pharma industry's history. Here’s what’s coming next.

    By April 30, 2024
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    JuSun via Getty Images
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    Prime gets FDA green light to begin first trial test of ‘prime editing’

    The company will soon start a Phase 1/2 study of its treatment for chronic granulomatous disease, a milestone for the search-and-replace gene editing technology.

    By April 29, 2024
  • Scientific illustration of a migrating breast cancer cell
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    Stock via Getty Images
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    AstraZeneca, Daiichi look to broaden Enhertu use again with new study data

    The drug benefited people whose tumors have “ultralow” levels of HER2 protein, a result that could extend its reach in HER2-positive breast cancer.

    By April 29, 2024
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    FatCamera via Getty Images
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    Sponsored by Fortrea

    Systems thinking: A new paradigm for clinical trial design and operations

    Applying a systems thinking framework to clinical trial design prompts purposeful and productive collaboration among stakeholders.

    By John Doyle, Dr.P.H., President of Consulting at Fortrea • April 29, 2024
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    koto_feja via Getty Images
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    Neurocrine scores surprise win with depression drug

    Shares of the biotech rose about 5% after a medicine licensed from Takeda hit the main and key secondary goals of a mid-stage study focused on major depressive disorder.

    By April 23, 2024
  • A person sits in an office chair next to a sign reading Cerevel.
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    Permission granted by Cerevel Therapeutics
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    Cerevel, in ‘major surprise,’ finds success in late-stage Parkinson’s study

    Analysts had low expectations for Cerevel’s drug tavapadon, which was something of an afterthought in AbbVie’s proposed buyout of the biotech.

    By April 18, 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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    Obesity drugs

    Lilly obesity drug shows benefit in sleep disorder study, pointing to new use

    Positive data for Lilly’s medicine tirzepatide in sleep apnea are the latest signal the benefits of GLP-1 agonists could extend beyond diabetes and weight loss.

    By April 17, 2024
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    noparrit via Getty Images
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    Sage’s cognition drug fails in Parkinson’s study

    Following negative results, the company doesn’t plan to further test SAGE-718 in Parkinson’s. Other studies in Huntington’s and Alzheimer’s remain ongoing.

    By April 17, 2024
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    Eoneren via Getty Images
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    Intra-Cellular builds case for depression drug with late-stage trial win

    Shares of the biotech rose 25% after a large trial found adding its drug Caplyta onto antidepressant therapy significantly helped people with major depression.

    By April 16, 2024
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    Chris McGrath via Getty Images
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    Ukraine was pharma’s clinical trial ‘darling.’ As war drags on, will the industry return?

    While some new drug studies are getting underway, activity is still far below bustling pre-war levels.

    By Meagan Parrish • April 16, 2024
  • Roche Pharmaceutical Group's office building in Shanghai, China
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    iStock via Getty Images
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    Roche reports survival data for new dual-acting lymphoma drug

    The results could give Roche’s Columvi an edge over a rival medicine from AbbVie and Genmab, while Regeneron awaits an approval of its own therapy.

    By April 15, 2024