Clinical Trials

  • A castor bean tick on a leaf
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    Erik Karits via Getty Images

    Pfizer, Valneva take next step with Lyme disease shot, starting large trial

    The experimental vaccine is the most advanced candidate for the tick-borne disease and, if successful, would be the first to reach the market since withdrawal of GSK’s Lymerix.

    By Aug. 9, 2022
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    SciePro via Getty Images

    Fresh off Enhertu success, AstraZeneca and Daiichi claim progress for next cancer drug

    A treatment that AstraZeneca acquired for up to $6 billion in 2020 is showing early promise as a combination agent in lung cancer, where it’s being tested alongside Merck & Co.’s Keytruda.

    By Aug. 9, 2022
  • 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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    National Cancer Institute, NIH

    Amgen data on KRAS cancer drug disappoints, opening door for rival Mirati

    Highly anticipated trial results for Lumakras combinations with immunotherapy fell short of expectations, showing significant liver toxicity that limited dosing.

    By Aug. 8, 2022
  • Lilly takes long view on Alzheimer’s drug as FDA starts expedited review

    The pharma said Thursday the FDA had accepted its application for donanemab, starting a six month evaluation for potential accelerated approval.

    By Aug. 5, 2022
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    Jolygon via Getty Images

    Alnylam drug succeeds in key heart disease study, boosting company

    The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on a planned approval application.

    By Aug. 3, 2022
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    Hero Images via Getty Images
    Sponsored by Janssen Pharmaceuticals

    The promise of oral therapies for cytokine inhibition

    The science behind new oral therapies for cytokine inhibition and why they could be transformational for patients.

    By David Lee, Global Therapeutic Area Head, Immunology • Aug. 1, 2022
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    Alnylam Pharmaceuticals

    Alnylam reveals longer wait for anticipated drug trial results

    Important data from the APOLLO study of the biotech's drug Onpattro are due before the end of August, Alnylam said Thursday.

    By July 28, 2022
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    Jens Schlueter via Getty Images

    Pfizer, BioNTech to study 'bivalent' booster as FDA weighs approach

    The small-scale study is part of the companies’ efforts to update their vaccine in time for a potential fall vaccination campaign to help boost waning immunity.

    By July 27, 2022
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    Elizabeth Regan / Industry Dive

    BridgeBio advances drug for dwarfism after study data

    The highest tested dose of BridgeBio’s drug helped the bones of children with achondroplasia grow faster, leading the company to expand study enrollment.

    By July 26, 2022
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    Permission granted by Seagen

    Seagen, Astellas claim positive results in study key to cancer drug's success

    The mid-stage trial tested the companies’ drug Padcev with Merck’s Keytruda in first-line bladder cancer. The data are reportedly a factor in Merck’s talks with Seagen over a potential buyout.

    By July 26, 2022
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    Ryan McKnight, Vertex Pharmaceuticals Inc.

    Vertex to move non-opioid painkiller into late-stage tests after FDA agreement

    Trial results released earlier this year showed potential for the drug, which has become one of Vertex’s top pipeline prospects.

    By July 22, 2022
  • A 3D rendered image of a neuron cell network on black background.
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    koto_feja via Getty Images

    Atara shares sink after update on multiple sclerosis trial

    Much-anticipated interim results from Atara’s Phase 2 study revealed little about the likelihood of the trial’s success, spurring a market sell-off.

    By July 13, 2022
  • 3D Illustration Concept of Human Respiratory System Lungs Anatomy
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    magicmine, iStock / Getty Images Plus via Getty Images

    With new data, Pliant drug shows promise in tough-to-treat lung disease

    The drug’s potential impact on the lung health of idiopathic pulmonary fibrosis patients, many of whom take medicines from Roche and Boehringer Ingelheim, came as a “surprise” given the study’s small size, according to one analyst.

    By July 11, 2022
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    Sarah Silbiger via Getty Images

    New analysis encourages Intercept to refile NASH drug for approval

    The company said the new examination is more “in line” with FDA guidance and still found that its drug, known as OCA, helped reduce liver scarring.

    By July 7, 2022
  • Beta-Amyloid Plaques and Tau in the Brain
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    National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.

    FDA, under fire for Aduhelm approval, starts review of another Alzheimer's drug

    The regulator could clear Biogen and Eisai’s lecanemab by early January. A decision before Phase 3 results could amplify the criticism the agency already faces, however.

    By July 6, 2022
  • An illustrated image of clinical development for a BioPharma Dive 2021 outlook story
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    Kendall Davis/BioPharma Dive
    Deep Dive

    10 clinical trials to watch in the second half of 2022

    The biotech industry's downturn accelerated in the first half of the year. Important study readouts for Eisai, Gilead, Merck and Seagen, among others, could determine whether the slump endures.

    By , , July 5, 2022
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    Jose Luis Calvo Martin & Jose Enrique Garcia-Maurino Muzquiz via Getty Images

    Celldex, continuing comeback, adds to early promise for skin disease drug

    New study results show the medicine appears as effective, or stronger, than standard care for chronic urticarias, a common condition that drugs from Regeneron and Novartis have struggled to treat.  

    By July 1, 2022
  • A photo of Sanofi headquarters in Paris, France.
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    Courtesy of Sanofi

    FDA halts tests of Sanofi drug, acquired in $3.7B buyout, due to side effects

    Liver problems in trial volunteers led the agency to curtail studies of the drug, marking the second major setback related to Sanofi’s acquisition of Principia Biopharma.

    By June 30, 2022
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    Jacob Bell

    Jazz drug fails in late-stage study for multiple sclerosis

    The drug, part of Jazz’s $7 billion acquisition of GW Pharmaceuticals, didn’t perform significantly better than placebo in treating the muscle spasticity that’s tied to the disease.

    By Updated June 29, 2022
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    Sanofi Pasteur

    Sanofi, GSK say dual-acting vaccine prevents COVID-19 from omicron in large trial

    A shot the partners have been developing reduced symptomatic infections associated with the variant by 72% compared to a placebo, positioning it as a potential option, if approved, to combat omicron.  

    By June 24, 2022
  • A photograph of a Sarepta building in Boston, MA
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    Courtesy of Sarepta

    FDA suspends US testing of Sarepta Duchenne drug over safety concerns

    The regulator stopped dosing in the U.S. for a drug that’s meant to be a more potent version of Sarepta's marketed medicine Exondys 51, after a patient experienced dangerously low magnesium levels.

    By June 23, 2022
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    libre de droit via Getty Images

    UniQure buoyed by early data for Huntington's gene therapy

    After one year, researchers detected important protein changes in patients who received a low dose of the experimental treatment. Further testing and functional data are needed to assess its potential, however.

    By June 23, 2022
  • Ajay Purohit, a Biogen employee, points to brain scans of people with Alzheimer's
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    Permission granted by Biogen

    Biogen, citing insurance challenges, shutters one of its Aduhelm studies

    The company says a recent coverage decision by Medicare has forced it to end an observational trial of the Alzheimer's drug after enrolling just 29 participants.

    By June 22, 2022
  • An illustration of necrotic muscle fiber in Duchenne muscular dystrophy.
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    Jose Luis Calvo Martin, Jose Enrique Garcia-Maurino Muzquiz via Getty Images

    Mixed results for PTC Duchenne drug put spotlight on EU approval

    A confirmatory study of PTC Therapeutics’ muscular dystrophy treatment Translarna missed its main goal, although the company highlighted the trial’s overall positive results. 

    By June 21, 2022
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    Christopher Furlong via Getty Images

    Ionis, AstraZeneca claim success for competitor to Alnylam rare disease drug

    A medicine at the center of a multibillion-dollar alliance between the two companies passed a major test in transthyretin amyloidosis. Full study details were not disclosed, however. 

    By June 21, 2022