Clinical Trials: Page 2


  • Boxes of the diabetes drug Ozempic rest on a pharmacy counter on April 17, 2023 in Los Angeles, California.
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    Mario Tama / Getty via Getty Images
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    Novo Nordisk’s Ozempic shows kidney benefit in large study

    The finding from the study of its diabetes drug, which Novo didn’t detail, could help the company in its competition with rival drugmaker Eli Lilly.

    By Oct. 11, 2023
  • Pembrolizumab Keytruda molecular model
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    Dr_Microbe via Getty Images
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    Merck data show survival benefit to early Keytruda treatment

    In the perioperative setting, Merck says its immunotherapy helps patients live longer. An approval decision is expected later this month.

    By Oct. 10, 2023
  • 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
  • A micrograph showing triglyceride fat accumulated inside liver cells.
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    Dr_Microbe via Getty Images
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    Akero drug for NASH misses goal in mid-stage study

    The biotech claimed the results still showed promise for its experimental fatty liver disease treatment, but shares sank sharply on the news.

    By Oct. 10, 2023
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    Lydia Polimeni, National Institutes of Health
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    NIH funds research for three experimental ALS drugs

    The funding, which is part of ACT for ALS, will support expanded access studies of drugs developed by Prilenia Therapeutics, Clene Nanomedicine and Rapa Therapeutics.

    By Oct. 6, 2023
  • The headquarters of the Food and Drug Administration
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    Sarah Silbiger via Getty Images
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    FDA panel finds KRAS drug data unreliable, in blow to Amgen

    The negative panel vote likely means Amgen will need more data to support a full approval for its conditionally cleared lung cancer drug Lumakras.

    By Updated Oct. 6, 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 claims positive results in early study for combo COVID, flu shot

    The company is planning to start a Phase 3 trial of the vaccine this year, and is targeting a regulatory approval in 2025.

    By Oct. 4, 2023
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    Novartis
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    Novartis’ closely watched rare disease drug scores in kidney disorder

    Called iptacopan, the experimental medicine has now scored positive results in three late-stage clinical trials, the latest in an uncommon kidney disorder known as IgA nephropathy.

    By Oct. 2, 2023
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    Maximusnd via Getty Images
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    Obesity drugs

    Structure boosted by early data for experimental obesity drug

    Shares in the biotech surged on Phase 1 trial results for an oral GLP-1 drug, reflecting investor enthusiasm for the weight loss medicines. 

    By Sept. 29, 2023
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    Mario Tama via Getty Images
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    J&J cancer drug combo beats Tagrisso in closely watched trial

    Interim results from a study called “Mariposa” found that a regimen of two J&J medicines improved progression-free survival versus AstraZeneca’s widely used therapy.

    By Sept. 28, 2023
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    ALS drug development

    BrainStorm’s ALS therapy not effective, FDA panel finds

    Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment to be effective for treating ALS. 

    By Updated Sept. 28, 2023
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    Elizabeth Regan / Industry Dive
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    Immunovant data show potential for autoimmune disease drug

    Much anticipated clinical trial data for Immunovant’s experimental FcRn inhibitor could catalyze business development decisions for its parent, Roivant Sciences.

    By Sept. 26, 2023
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    Novartis
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    Novartis radiopharmaceutical drug succeeds in first-line gut cancer study

    Novartis has made a large investment in targeted radiotherapies, sparking competition from fellow pharma companies and young biotechs.

    By Sept. 25, 2023
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    Jacob Bell / BioPharma Dive
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    AstraZeneca and Daiichi’s next cancer medicine scores in breast tumors

    Results show that the medicine helped patients who progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, according to a Friday announcement.

    By Sept. 22, 2023
  • A photo of a Seattle Genetics laboratory
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    Permission granted by Seagen
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    Seagen’s cancer drug succeeds in ‘must-win’ trial

    Compared to chemotherapy, a combination of Seagen’s Padcev and Merck’s Keytruda was significantly better at keeping bladder cancer patients alive longer and their disease from progressing.

    By Sept. 22, 2023
  • Exterior sign of Bristol-Myers Squibb
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    Permission granted by Bristol-Myers Squibb
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    Latest trial win supports expanded use of Bristol Myers’ Opdivo in lung cancer

    The drug, which is already cleared as a neoadjuvant lung cancer treatment, could better compete with Merck’s Keytruda if it gains approval in the adjuvant setting for non-small cell tumors.

    By Sept. 22, 2023
  • The front entrance of the Food And Drug Administration headquarters building.
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    Sarah Silbiger via Getty Images
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    FDA panel backs Alnylam drug despite doubts over benefit

    “There is a light wind for benefit, and no wind for risk,” said one adviser who voted with eight others to recommend the biotech’s drug Onpattro for cardiomyopathy of ATTR amyloidosis.

    By Updated Sept. 14, 2023
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    Leonid Sorokin via Getty Images
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    Emerging biotech

    After IPO success, Acelyrin hits trial setback with inflammation drug

    Acelyrin’s share value collapsed Tuesday after its lead drug fell short in the company’s first big trial test since it raised $540 million in a May IPO.

    By Kristin Jensen • Sept. 12, 2023
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    Jonathan Gardner / BioPharma Dive
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    Daiichi Sankyo, with new data, to seek FDA approval of lung cancer drug

    The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

    By Sept. 11, 2023
  • Blue and red pill capsules scattered on a table
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    Stock via Getty Images
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    In advocates’ push for superbug funding, ‘$6 billion is nothing’

    The PASTEUR Act could be heading for another setback, but advocates say they see a future for funding research into antimicrobial resistance.

    By Karissa Waddick • Sept. 8, 2023
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    Alnylam Pharmaceuticals
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    Alnylam says hypertension drug succeeded in mid-stage study

    The trial found two higher doses of Alynlam’s RNAi therapy lowered blood pressure better than placebo. But analysts say results from a different study will be more important for the drug’s future.

    By Sept. 7, 2023
  • A  3D illustration of ribonucleic acid, or RNA, strands
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    Christoph Burgstedt via Getty Images
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    Wave readies clinical testing for first RNA editing therapy

    The biotech, one of several advancing RNA editing medicines, expects to obtain “proof-of-mechanism” data in patients with the inherited disorder alpha-1 antitrypsin deficiency by next year.

    By Kristin Jensen • Updated Sept. 5, 2023
  • Illustration of lung cancer
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    SciePro via Getty Images
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    Roche claims study success for targeted drug in early lung cancer

    The Swiss pharma said, without details, that it observed “unprecedented” results that could make Alecensa the first treatment specifically available after surgery for ALK-positive lung tumors.

    By Sept. 1, 2023
  • 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
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    FibroGen’s Duchenne drug fails second trial in latest study setback

    The failure marks another Phase 3 miss for the drug, pamrevlumab, and follows a restructuring and CEO switch for the struggling biotech.

    By Aug. 30, 2023
  • Bayer reports positive early data for Parkinson’s cell therapy

    The treatment, developed by a biotech Bayer acquired in 2019, appeared safe in a small trial and showed signs of an effect on disease progression. 

    By Aug. 28, 2023
  • The Merck & Co. sign at the company's building in Summit, New Jersey.
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    Kena Betancur via Getty Images
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    Merck kicks off Phase 3 tests for PCSK9 cholesterol pill

    The company plans to enroll roughly 17,000 people in three Phase 3 trials of the drug, including a large cardiovascular study set to begin later this year.

    By Aug. 25, 2023