Clinical Trials

  • A 3D illustration of the hepatitis B virus.
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    iStock via Getty Images

    GSK moves hepatitis B drug into late-stage testing

    The British drugmaker sees potential for the medicine to be a functional cure for chronic infections, and is beginning two Phase 3 trials to test its promise. 

    By Kristin Jensen • Feb. 2, 2023
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    Novartis confirms it has stopped development of experimental Huntington’s drug

    Termination of the branaplam program, according to Novartis, was due to an “overall assessment of the risk-benefit profile” observed in a mid-stage clinical trial that raised safety concerns last year.

    By Feb. 1, 2023
  • 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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    Sponsored by Koneksa Health

    How are digital biomarkers reshaping Parkinson’s disease research?

    Your Parkinson’s disease trials need better data. Hear how digital biomarkers change the game.

    Jan. 30, 2023
  • A micrograph of a myeloma neoplasm in a bone marrow biopsy.
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    OGphoto via Getty Images

    J&J, Legend’s cancer cell therapy has early success in key clinical trial

    The trial is an important test of Carvykti’s potential for earlier use in multiple myeloma and found treatment helped extend progression-free survival over standard regimens.

    By Jan. 27, 2023
  • An illustration of red blood cells
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    ismagilov via Getty Images

    Magenta halts study of targeted conditioning drug after participant’s death

    The biotech said one patient died after receiving an experimental antibody drug designed to deplete certain blood and bone marrow cells before a transplant.

    By Updated Jan. 26, 2023
  • Exterior sign of Bristol-Myers Squibb
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    Permission granted by Bristol-Myers Squibb

    Bristol Myers says CAR-T therapy curbed leukemia in long-running study

    The company’s drug Breyanzi led to remission in adults with chronic lymphocytic leukemia, a blood cancer for which CAR-T therapies aren’t yet approved to treat.

    By Jan. 26, 2023
  • Merck sign
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    Marko Georgiev / Stringer via Getty Images

    Merck reports one success, one setback from late-stage Keytruda trials

    The top-selling immunotherapy bested chemo in treating bile duct cancer, but fell short in a study testing it with other drugs for metastatic prostate tumors.

    By Jan. 25, 2023
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    yodiyim via Getty Images

    Pliant shares jump on new data for lung disease drug

    A high dose of the company’s experimental medicine appeared potent in patients with idiopathic pulmonary fibrosis, an elusive target for drugmakers. The results are from a small and short clinical trial, however.

    By Jan. 23, 2023
  • Roche Pharmaceutical Group's office building in Shanghai, China
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    iStock via Getty Images

    Roche says Tecentriq immunotherapy reduces risk of liver cancer recurrence

    While the company did not reveal specific study data, the results could help Tecentriq become the first drug approved for adjuvant liver cancer treatment.

    By Jan. 19, 2023
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    Maddie Meyer via Getty Images

    Moderna reports positive RSV vaccine results, pressuring Pfizer, GSK

    The biotech’s results appear competitive to past data for RSV shots being developed by GSK and Pfizer. Moderna plans to follow those companies in asking for FDA approval.

    By Jan. 18, 2023
  • Transmission electron micrograph of HIV-1 virus particles budding and replicating from a segment of a chronically infected H9 cell.
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    National Institute of Allergy and Infectious Diseases. (2022). "HIV Virus" [Micrograph]. Retrieved from Flickr.

    Large study of J&J’s HIV vaccine stopped after shot found ineffective

    The result from the nearly 4,000-person trial is the latest setback in a long-running effort to develop a safe and effective shot for HIV infections.

    By Jan. 18, 2023
  • A sign for the Food and Drug Administration is seen on July 20, 2020 in Maryland.
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    Sarah Silbiger via Getty Images

    FDA approves Alzheimer’s drug from Eisai, Biogen in closely watched decision

    The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.

    By Updated Jan. 6, 2023
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    SciePro via Getty Images

    Novocure shares soar on positive lung cancer data

    A regimen involving the Swiss biotech’s electrical field-based treatment extended lives in a late-stage trial. But data comparing the medical device to standard chemotherapy is less persuasive.

    By Jan. 5, 2023
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    Elizabeth Regan / Industry Dive

    Roivant reveals positive data for IBD drug, intensifying rivalry with Prometheus

    The results left Wall Street analysts torn about which company holds the advantage as both race to get a new type of therapy to market.

    By Jan. 4, 2023
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    Kendall Davis/BioPharma Dive
    Deep Dive

    10 clinical trials to watch in the first half of 2023

    Highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s, while a pair of high-priced acquisitions could be put to the test.

    By BioPharma Dive staff • Jan. 3, 2023
  • A view of Pfizer's steel logo from below.
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    Spencer Platt / Staff via Getty Images

    Pfizer advances diabetes, obesity drug hopeful into mid-stage testing

    The pharma dosed the first patient in a Phase 2 study testing a treatment it hopes could compete with closely-watched weight-loss drugs from Lilly, Novo Nordisk and Amgen.

    By Kristin Jensen • Dec. 21, 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

    FDA halts planned trial of Entrada Duchenne drug

    Shares in the Boston-based biotech fell on the news, which comes shortly after a deal with Vertex around another type of muscular dystrophy.

    By Dec. 20, 2022
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    Permission granted by Gilead Sciences

    Doubts around cancer drug target persist after Gilead, Arcus study results offer ‘mixed picture’

    While long anticipated trial data were technically positive, analysts questioned whether drugs aimed at ‘TIGIT’ will prove a meaningful treatment addition.

    By Dec. 20, 2022
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    Megan Quinn/BioPharma Dive

    Government spending bill would tighten FDA oversight of accelerated drug approvals

    The proposed bill would strengthen rules around confirmatory testing, help speed product withdrawals and set up a panel of agency officials to better coordinate policy.

    By Dec. 20, 2022
  • A micrograph showing triglyceride fat accumulated inside liver cells.
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    Dr_Microbe via Getty Images

    Madrigal shares triple on positive NASH study results

    The company said its experimental drug helped patients with the fatty liver disease while also improving fibrosis. One analyst called the readout a “major win” for Madrigal and the NASH field.

    By Dec. 19, 2022
  • Third Harmonic CEO Natalie Holles
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    Permission granted by Third Harmonic

    Third Harmonic halts study of lead drug over safety risk

    The biotech, previously a success story this year, will end development of its chronic hives treatment and search for alternative drug candidates. 

    By Dec. 15, 2022
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    Courtesy of Sanofi

    Kymera shares jump on Sanofi’s decision to advance protein-degrading drug

    Early data from a small, Phase 1 study exceeded Kymera’s expectations and, the biotech’s CEO claimed, offer “clinical validation” for its scientific approach. 

    By Dec. 14, 2022
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    Moderna vaccine succeeds in early-stage skin cancer study with Merck’s Keytruda

    The positive data are the most significant findings for the mRNA developer’s pipeline of experimental treatments outside of infectious diseases, where it has reaped billions from COVID-19 vaccine sales. 

    By Dec. 13, 2022
  • Attendees of the American Society of Hematology's annual meeting walk through a conference hall in New Orleans in December 2022.
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    Courtesy of Rodney White / American Society of Hematology

    At ASH, Regeneron plays catch-up with its next cancer drugs

    Two bispecific antibodies are “foundational” to the company’s plan to build an oncology business, according to a top executive. But Regeneron will have to surpass a crowd of competitors. 

    By Dec. 12, 2022
  • Attendees of the American Society of Hematology's annual meeting walk across a conference hall in December 2022.
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    Courtesy of Matt Herp / American Society of Hematology

    J&J’s next myeloma drug, Argenx’s second act and a new question for Bluebird: 3 ASH takeaways

    The year’s biggest meeting on blood diseases kicked off this past weekend. Here are three of the most important storylines to emerge from the past few days of presentations.

    By , Updated Dec. 12, 2022