Clinical Trials


  • A general view of the Pfizer Headquarters sign on November 10, 2020 in Tadworth, England.
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    Dan Kitwood via Getty Images
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    Pfizer says antibiotic is effective against tough-to-treat infections

    A drug the company acquired from AstraZeneca and developed for gram-negative infections — a growing public health threat — could be headed for a regulatory review later this year.

    By June 2, 2023
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    Stock via Getty Images
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    Novartis drug helps stop breast cancer’s return in large study

    Treatment with Kisqali reduced the risk of disease recurrence when used after surgery, potentially positioning Novartis to win a similar adjuvant approval as Lilly’s rival therapy Verzenio.

    By Updated 9 hours ago
  • Colorized scanning electron micrograph of a natural killer cell from a human donor. Explore the Trendline
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    National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
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    Trendline

    Cell therapy

    Six CAR-T cell therapies are now approved in the U.S., and their continued emergence has helped fueled further research into next-generation approaches.

    By BioPharma Dive staff
  • Corporate logos are seen outside  on May 15, 2006, in Macclesfield, England.
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    Christopher Furlong via Getty Images
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    AstraZeneca abandons experimental bowel disease drug

    The drugmaker cited testing delays and an evolving “competitive landscape” in its decision to discontinue development of its IL-23 inhibitor brazikumab.

    By June 1, 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
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    FDA pauses PepGen’s plans to test muscle disease drug

    The company’s oligonucleotide-based treatment is the latest neuromuscular disease therapy to face a regulatory roadblock prior to human testing.

    By May 31, 2023
  • A photo of Sanofi headquarters in Paris, France.
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    Courtesy of Sanofi
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    Sanofi drug, acquired from a startup, shows early potential in MS

    The medicine, licensed from biotech ImmuNext in 2017, is one of two later-stage MS drug prospects in the French drugmaker’s portfolio.

    By May 31, 2023
  • A computer screen shows the Pfizer logo and stock price at the New York Stock Exchange
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    Michael M. Santiago via Getty Images
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    Pfizer says hemophilia drug succeeded in Phase 3 study

    The drug, called marstacimab, could potentially become another option for hemophilia patients just as new gene therapies arrive on the market in the U.S.

    By May 30, 2023
  • A micrograph of a myeloma neoplasm in a bone marrow biopsy.
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    OGphoto via Getty Images
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    J&J antibody drug combination shows promise in multiple myeloma

    Bispecific antibodies, like the two J&J is testing together in multiple myeloma, could compete with CAR-T cell therapies in certain treatment lines.

    By May 25, 2023
  • A micrograph showing a bone marrow biopsy
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    rightdx via Getty Images
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    Bristol Myers data make case for earlier use of bone marrow disease drug

    Data released ahead of next month’s ASCO meeting detail how well Bristol Myers’ Reblozyl outperformed the decades-old standard Epogen in treating anemia from myelodysplastic syndromes.

    By May 25, 2023
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    ASCO / Scott Morgan
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    ASCO puts spotlight on advancing antibody-drug conjugate pipeline

    Study abstracts released Thursday give investors and analysts a better look at cancer treatments recently licensed by Merck and BioNTech as well as fresh details on other closely watched ADC candidates.

    By May 25, 2023
  • A photo of a sign inside an Apellis Pharmaceuticals building
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    Courtesy of Apellis Pharmaceuticals
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    Apellis abandons ALS drug after study miss

    The trial failure is the second for an ALS medicine this week, adding to a lengthy list of study setbacks that have thinned the pipeline of experimental medicines for the disease in recent years.

    By Kristin Jensen • May 25, 2023
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    gchutka via Getty Images
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    Annexon claims a silver lining in failed eye drug study

    The company’s geographic atrophy drug didn’t slow the growth of eye lesions, as similar medicines have in clinical testing. But executives said it may have helped preserve some patients’ vision.

    By May 25, 2023
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    Novo Nordisk
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    Obesity drugs

    Novo says oral version of obesity drug succeeds in large study

    The company plans to seek approvals of the drug, a more convenient form of the popular injectable medicine Wegovy, later this year.

    By May 23, 2023
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    Getty Images
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    ALS drug development

    Wave shelves ALS drug following trial setback

    A small study found patients on the experimental therapy fared no better than those receiving a placebo, dealing yet another blow to Wave’s research efforts.

    By May 23, 2023
  • 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 reports ‘encouraging’ early data for one of its rare disease medicines

    Now known for its vaccine research, the biotech said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.

    By May 19, 2023
  • A building showing a logo of Teva Pharmaceutical
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    Courtesy of Teva Pharmaceutical
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    Teva puts rival to Prometheus, Pfizer drugs at center of turnaround plans

    At an investor day, executives highlighted an experimental inflammatory disease drug targeting the protein TL1A as important to their long-term growth.

    By Updated May 19, 2023
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    Elizabeth Regan / Industry Dive
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    PTC’s drug for PKU succeeds in late-stage clinical trial

    The biotech plans to discuss the study results with regulators to determine next steps toward an approval application for the rare disease treatment.

    By May 17, 2023
  • A photo of a nerve cell attacked by antibodies
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    peterschreiber.media via Getty Images
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    Roche pushes forward with MS drug amid rivals’ setbacks

    The company said its “reversible” BTK inhibitor, which trails competitors from Sanofi and Merck KGaA, succeeded in Phase 2 testing without raising new safety concerns.

    By May 17, 2023
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    Lydia Polimeni, National Institutes of Health
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    Gene therapy consortium targets eight rare diseases for clinical trials

    Backed by nearly $100 million, the public-private consortium aims to create a standard development roadmap for gene therapies using AAV viral vectors.

    By Updated May 16, 2023
  • A photo of Sanofi headquarters in Paris, France.
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    Courtesy of Sanofi
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    Sanofi, AstraZeneca study results add support for their RSV drug in infants

    The antibody reduced RSV infections requiring hospitalization by 83% in a large study, bolstering evidence for the drug ahead of a U.S. approval decision later this year.

    By May 12, 2023
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    Getty
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    New Alzheimer's drugs

    Alzheimer’s doctors see promise, limits in Lilly’s latest drug data

    While some see the new donanemab results as adding to a “watershed moment” in Alzheimer’s research, others say they reinforce the limitations of so-called anti-amyloid therapies.

    By May 10, 2023
  • Roche Pharmaceutical Group's office building in Shanghai, China
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    iStock via Getty Images
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    Roche pays China-based biotech $70M for a new HER2 drug

    The drug, currently in Phase 1, is an oral medicine designed to cross the blood-brain barrier and better treat HER2 tumors that have spread to the brain.

    By May 9, 2023
  • An illustration of different blood cells types
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    Grigorii Yalukov via Getty Images
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    FibroGen’s anemia pill falls short in blood cancer study

    The medicine, available in Europe but rejected two years ago by U.S. regulators, didn’t eliminate the need for blood transfusions among patients with myelodysplastic syndrome.

    By May 5, 2023
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    Erik Karits via Getty Images
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    Valneva, Pfizer push back timeline for Lyme disease vaccine

    After issues with a contract research group, the partners now expect to file an approval application for their shot in 2026, one year later than initially anticipated.

    By May 4, 2023
  • A photo of a Biogen sign
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    Permission granted by Biogen
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    Lilly’s new Alzheimer’s data may both help and hinder rival Biogen

    The success of Lilly’s donanemab in slowing Alzheimer’s progression should reinforce the potential of Leqembi — a similar, recently approved medicine from Eisai and Biogen — but may also make for stiff competition.

    By May 3, 2023
  • A 3D illustration showing amyloid plaques in brain tissue
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    Dr_Microbe via Getty Images
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    New Alzheimer's drugs

    Lilly drug slows Alzheimer’s decline in large study

    The company plans to quickly submit an application for U.S. approval based on the trial results, which showed a consistent benefit to treatment with the drug, called donanemab.

    By , Updated May 3, 2023