Clinical Trials: Page 2

  • This is the cover image for the podcast series Thinking Big for Small and Mid-Sized Biotechs.
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    Adeline Kon/BioPharma Dive
    Sponsored by Allucent

    [Podcast] Thinking Big for Small and Mid-Sized Biotechs

    This podcast series explores how to help small and mid-sized companies get innovative treatments to the people who need help small and mid-sized companies get innovative treatments to the people who need them.

    By BioPharma Dive's studioID • Updated Dec. 15, 2022
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    Spencer Platt via Getty Images

    Pharvaris, pushing through trial pause, sees shares surge with new study results

    Though the FDA halted testing of the biotech’s pill for hereditary angioedema in August, enough patients were already enrolled to accrue results that sent shares soaring. 

    By Dec. 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
  • Novartis gets second trial win for blockbuster hopeful

    The company plans to seek broad approval of the oral medication, iptacopan, next year after it met its primary endpoint in a new pool of patients with the rare blood disease PNH.

    By Kristin Jensen • Dec. 8, 2022
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    Prapat Aowsakorn via Getty Images

    Relmada sinks further as depression drug fails second large trial

    The company claimed an “unplausible” placebo response caused both studies to fail and is making substantive changes to its other remaining late-stage trial as a result. 

    By Dec. 8, 2022
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    Elizabeth Regan / Industry Dive

    Prometheus shares soar on new data for inflammation drug

    Having scored positive results in two key studies for ulcerative colitis and Crohn’s disease, Prometheus now intends to advance the drug, called PRA023, into pivotal testing.

    By Dec. 7, 2022
  • An anatomical model of the heart sits on a desk in a doctor's office
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    Ivan-Balvan via Getty Images

    Esperion, without data, says cholesterol pill lowered heart risk in study

    The large cardiovascular outcomes trial is a major test for Esperion, which has struggled to sell its drug Nexletol since winning U.S. approval in 2020.

    By Dec. 7, 2022
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    Sarah Silbiger via Getty Images

    MEI, Kyowa stop lymphoma drug trials after FDA meeting

    The decision not to run a Phase 3 trial is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs called PI3 kinase inhibitors. 

    By Dec. 6, 2022
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    Novartis prostate cancer drug succeeds in study key to company’s sales hopes

    The positive results could help Novartis secure approval for earlier use of the radiopharmaceutical drug Pluvicto, potentially broadening the number of eligible patients by several times the current market.

    By Dec. 5, 2022
  • NK Cell (Natural Killer Cell) Attacking a Cancer Cell
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    luismmolina via Getty Images

    With new data, Nkarta builds case for ‘natural killer’ cell therapy

    The updated study results add to evidence that such therapies may help treat B-cell lymphomas. But it’s still unclear how long their effects could last. 

    By Dec. 5, 2022
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    Yuri Arcurs/Alamy Stock Photo

    Sponsored by Allucent

    When it comes to small populations, biotechs need to think big

    Maria-Cruz Morillo, global therapeutic operations lead for rare diseases at Allucent, discusses the unique challenges of rare disease drug development and how the right expertise can help.

    Dec. 5, 2022
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    Permission granted by Syneos Health
    Sponsored by Syneos Health

    We must improve diversity in clinical trials. These 5 steps will help.

    The pandemic shined a light on the importance of diversity in clinical trials. Syneos Health can help your team devise a diversity strategy.

    Dec. 5, 2022
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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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    Dr_Microbe via Getty Images

    What to make of Eisai and Biogen’s Alzheimer’s drug results

    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
  • A photograph of a Sarepta building in Boston, MA
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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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    Permission granted by Veeva Systems
    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
  • A photo of an Editas Medicine scientist in the lab.
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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
  • 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.

    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