Clinical Trials

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    Courtesy of Roche

    Roche study failure gives Alzheimer’s researchers new clues in drug quest

    Detailed clinical trial data for Roche's gantenerumab showed treatment cleared far less toxic protein from patients' brains than expected, potentially explaining its divergent result from Eisai’s lecanemab.

    By , • Dec. 1, 2022
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    Lilly’s Alzheimer’s drug bests Aduhelm in plaque clearance study

    The company's experimental treatment donanemab reduced amyloid levels in the brain by more than Biogen's approved medicine, but the data’s significance is unclear until Lilly reveals results from a larger study next year. 

    By • Dec. 1, 2022
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    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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    Dr_Microbe via Getty Images

    What to make of Eisai and Biogen’s latest Alzheimer’s drug data

    At a medical conference, the companies detailed clinical trial results that could help support approval of their drug, lecanemab. Still, some doctors aren’t yet convinced the medicine’s risks are worth its potential benefits.

    By , • Nov. 29, 2022
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    nortonrsx via Getty Images

    CinCor shares dive after blood pressure drug fails key trial

    The company, one of several testing a drug for resistant hypertension, had previously pulled off one of the top performing biotech IPOs this year.

    By • Nov. 28, 2022
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    Stock via Getty Images

    Axsome says drug eased Alzheimer’s symptom in positive study

    Shares of the New York-based biotech rose by a third Monday morning, as fresh clinical trial results showed its drug AXS-05 both delayed and prevented the recurrence of Alzheimer’s agitation.

    By • Nov. 28, 2022
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    Courtesy of Sarepta

    FDA grants speedy review to Sarepta’s Duchenne gene therapy

    The agency will decide on an accelerated approval of Sarepta’s treatment by May 29, months before results are expected from a potentially confirmatory Phase 3 trial.

    By • Nov. 28, 2022
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    Permission granted by ICON
    Sponsored by ICON

    Mainstreaming cell and gene therapy – Realizing its potential

    The challenges biopharma companies face in running clinical trials and tips on how to surmount those obstacles.

    Nov. 28, 2022
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    Sponsored by Veeva Systems

    A unified, connected foundation is transforming the future of digital trials

    A holistic approach allows stakeholders to adapt to the ever-increasing number of clinical trials and data points.

    By Jodi Helmer • Nov. 21, 2022
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    Gene editing

    Editas to seek partner for CRISPR medicine after lackluster study results

    While the biotech will not develop the gene editing therapy further on its own, CEO Gilmore O’Neill claimed the data are still a meaningful demonstration of what CRISPR can accomplish. 

    By • Nov. 17, 2022
  • Colorized scanning electron micrograph of a VERO E6 cell heavily infected with SARS-COV-2 virus particles, isolated from a patient sample.
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.

    Moderna data supports use of omicron booster over original vaccine

    New results show the two-pronged booster the FDA cleared in August sparks a stronger immune response against omicron and its subvariants than Moderna’s original shot.

    By • Nov. 14, 2022
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    National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.

    Trial failures end latest hope for Roche’s Alzheimer’s drug

    Eight years after gantenerumab failed a Phase 3 study, the drug came up short in late-stage testing again, proving unable to meaningfully slow cognitive decline in two closely watched trials. 

    By , • Nov. 14, 2022
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    Amgen Inc.

    Early data hint at benefit for Amgen’s obesity drug

    Newly released study results suggest treatment could lead to quicker weight loss, on less frequent dosing, than therapies from Eli Lilly and Novo Nordisk.

    By • Nov. 8, 2022
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    Courtesy of GSK

    GSK myeloma drug comes up short in confirmatory test

    The drug, Blenrep, did not outperform a standard treatment in relapsed or refractory multiple myeloma, setting back GSK's plans to confirm the conditional approval it received in 2020.  

    By • Nov. 7, 2022
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    Amgen Inc.

    Amgen to test new way to lower heart risk with large drug trial

    Buoyed by strong mid-stage study results, the biotech will soon start a cardiovascular outcomes trial of a drug designed to target a genetic risk factor called lipoprotein(a).

    By • Nov. 7, 2022
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    Jonathan Gardner / BioPharma Dive

    Bispecific cancer drugs and gene therapy advances: What to watch at next month’s ASH meeting

    Competition is increasing behind newly approved drugs from Roche and J&J, while the long-term benefit of gene therapies for chronic blood disorders is being put to the test.

    By , • Nov. 4, 2022
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    Getty / Edited by BioPharma Dive

    Abeona to submit cell therapy for approval after positive results for skin disorder treatment

    The company said its therapy, which could become the first drug for a type of epidermolysis bullosa, helped heal wounds and reduce pain in a clinical trial.

    By • Nov. 3, 2022
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    David Dee Delgado via Getty Images

    Pfizer gets first positive result for an RSV vaccine in pregnant women

    The shot kept newborns from getting severe respiratory infections in a Phase 3 trial, paving the way for the drugmaker to seek approval before its top rivals.

    By • Nov. 1, 2022
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    Permission granted by Bristol-Myers Squibb

    With positive trial results, Bristol Myers looks to widen use of blood disease drug

    Reblozyl, one of the drugmaker’s key assets, outperformed an older anemia drug in early-stage myelodysplastic syndrome, which could double the number of potentially eligible patients. 

    By • Oct. 31, 2022
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    RoosterHD via Getty Images
    Sponsored by Worldwide Clinical Trials

    What the FDA’s guidance on diversity means for rare disease sponsors

    Bringing more diversity to clinical trials is a slow process and it takes time to get right. Learn how Worldwide Clinical Trials can diversify the reach of your orphan drug trial.

    Oct. 31, 2022
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    Warren Little via Getty Images

    GSK shelves filing plans for arthritis drug after trial results

    GSK said the drug, formerly a top prospect licensed from German biotech Morphosys, showed “limited efficacy” in a Phase 3 study of patients with rheumatoid arthritis.

    By • Oct. 27, 2022
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    Stock via Getty Images

    AstraZeneca extends run of trial successes with breast cancer drug results

    On the heels of a major approval for Enhertu, the pharma reported positive results for two experimental drugs in settings where rival medicines from Roche and Sanofi recently failed.

    By • Oct. 26, 2022
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    magicmine, iStock / Getty Images Plus via Getty Images

    Vaxcyte rides investor enthusiasm for early pneumococcal vaccine data

    Encouraging study results for a vaccine with broader coverage than Pfizer’s Prevnar 20 sent Vaxcyte’s valuation soaring and could make the company a potential takeover target.

    By • Oct. 24, 2022
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    Novartis

    Novartis rival to AstraZeneca rare disease drugs succeeds in study

    The pharma said iptacopan, one of its top pipeline prospects, outperformed Alexion’s Soliris and Ultomiris in certain patients with a disease called PNH.

    By • Oct. 24, 2022
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    Sarah Silbiger via Getty Images

    FDA advisers back withdrawal of controversial drug for preterm birth

    A committee of independent experts voted 14-1 that the agency shouldn’t allow the treatment from Covis Pharma to remain on the market while further testing is conducted.

    By • Updated Oct. 19, 2022
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    Porpeller via Getty Images

    NGM shares plunge as Merck-partnered eye drug fails Phase 2 test

    Executives said the biotech could search for a new partner for the geographic atrophy drug if Merck decides not to license it under an existing deal.

    By • Oct. 17, 2022