Clinical Trials: Page 2


  • Neumora CEO Henry Gosebruch stands for a photo against a blurred office background
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    Permission granted by Neumora Therapeutics
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    Neumora’s schizophrenia drug hit with clinical hold

    Shares of the biotech dipped by double digits following disclosure the FDA had paused an early-stage study of Neumora’s muscarinic-targeting drug.

    By April 15, 2024
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    Image courtesy of Ultragenyx.

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    Ultragenyx says Angelman therapy is working, but safety questions remain

    Treatment appeared to result in functional and cognitive gains in people with the neurological disorder. Three participants experienced lower extremity weakness, however.

    By April 15, 2024
  • An illustration of B cells producing antibodies Explore the Trendline
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    Love Employee via Getty Images
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    Trendline

    Immunology

    Promising new mechanisms of action are driving significant pharmaceutical company investment into drugs for immune diseases like psoriasis and Crohn’s.

    By BioPharma Dive staff
  • Boxes of the diabetes drug Ozempic rest on a pharmacy counter.
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    Mario Tama via Getty Images
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    European regulator concludes no suicide link to obesity drugs

    The decision clears a concern hanging over GLP-1 medicines like Ozempic since reports of suicidal ideation and self-harm among people taking the drugs surfaced in July.

    By April 12, 2024
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    Novartis
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    Novartis pauses enrollment in some Kisqali trials to fix manufacturing

    The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.

    By April 10, 2024
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    SDI Productions via Getty Images
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    Deep Dive

    New postpartum depression drugs are here. Diagnosis, treatment hurdles still stand in the way.

    The first medicine approved for PPD, Sage’s Zulresso, never gained traction. The company is in the midst of launching its second, but long-standing challenges could slow uptake.

    By April 10, 2024
  • Pfizer's logo cast in metal.
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    Jeenah Moon via Getty Images
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    RSV vaccines

    Pfizer, with new study results, seeks to bring RSV shot to adults aged 18-59

    The company plans to submit the trial data to regulators in a bid to win approval of its vaccine Abrysvo in adults as young as 18 years old.

    By April 9, 2024
  • An injection pen containing the drug semaglutide lies on a white plate.
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    Douglas Cliff via Getty Images
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    Obesity drugs

    Trial shows Wegovy can ease heart failure symptoms

    The results were the second time Novo has shown its weight loss treatment can help with the condition, and may help it secure broader use of the drug.

    By April 8, 2024
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    Stock via Getty Images
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    Women want to participate in clinical trials. Lack of flexibility is still a problem.

    Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.

    By Kelly Bilodeau • April 8, 2024
  • 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 puts KRAS cancer drug competitor to the test

    A Phase 3 study will compare Merck’s experimental KRAS inhibitor together with its immunotherapy Keytruda against Keytruda alone in lung cancer.

    By April 4, 2024
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    Maximusnd via Getty Images
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    Roivant reveals positive immune drug data, share buyback plans

    A Pfizer drug licensed to a Roivant subsidiary surpassed expectations in a type of uveitis, while a stock purchase plan will see Roivant buy out shares owned by Sumitomo Pharma.

    By April 2, 2024
  • An illustration of immune cells attacking a tumor.
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    Meletios Verras via Getty Images
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    Gritstone shares fall on shaky study results for colorectal cancer vaccine

    While the company claimed its shot showed signs of working in a Phase 2 trial, the data weren’t strong enough to prove a treatment benefit.

    By April 2, 2024
  • A photo of Sekar Kathiresan, CEO of Verve Therapeutics
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    Seth Babin/BioPharma Dive
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    Verve pauses base editing trial, shifts strategy after treatment side effect

    Lab abnormalities in one study participant led the company to halt enrollment and prioritize a different version of its genetic medicine for heart disease.

    By April 2, 2024
  • A photo of Vertex Pharmaceuticals' Boston headquarters.
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    Courtesy of Vertex Pharmaceuticals
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    Vertex moves kidney disease drug into late-stage testing

    The drug, inaxaplin, is an important pipeline prospect for Vertex, which is working to expand beyond the cystic fibrosis medicines that made its name. 

    By April 1, 2024
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    National Cancer Institute, NIH
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    Bristol Myers says KRAS drug succeeds in key trial

    Confirmatory results for Krazati, which Bristol Myers acquired via its buyout of Mirati, could help the drug win full approval while Amgen has been set back.

    By March 29, 2024
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    koto_feja via Getty Images
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    European study finds popular ALS drug ineffective

    The failure of a medicine known as TUDCA is yet another disappointment for ALS patients, as it comes just after Amylyx’s therapy Relyvrio proved unsuccessful in confirmatory testing.

    By March 27, 2024
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    Michael M. Santiago via Getty Images
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    Obesity drugs

    Viking stays in obesity drug race with early data for weight loss pill

    The results are from a small Phase 1 study, but suggest Viking’s oral GLP-1 drug may not come with high rates of gastrointestinal side effects. 

    By March 26, 2024
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    Elizabeth Regan / Industry Dive
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    Stoke shares surge on updated results for Dravet drug

    The biotech is trying to develop a Spinraza-like drug for the condition, a form of genetic epilepsy. Fresh data appear supportive of a high dose’s effectiveness. 

    By March 26, 2024
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    Stock via Getty Images
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    Axsome drug succeeds in narcolepsy symptoms trial

    Despite the late-stage victory, shares of the New York-based biotech dipped more than 3%. One analyst argued that Axsome’s drug has “largely been falling under investor radars.”

    By March 25, 2024
  • FDA rejects Regeneron lymphoma drug, setting back company’s oncology push

    The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers. 

    By March 25, 2024
  • Data
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    AdobeStock/ Eakkachai

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    Sponsored by TriNetX

    Improving clinical trial design with real-world data

    Leveraging real-world data (RWD) transforms global clinical trials, enhancing patient engagement and improving regulatory decision-making.

    March 25, 2024
  • A Roche logo is seen on the side of a building.
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    Courtesy of Roche
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    Roche autoimmune disease drug disappoints in closely watched trial

    Though the medicine hit its goal in a Phase 3 study in myasthenia gravis, the results fell short of expectations in a boost to rival drug developers like Argenx and AstraZeneca.

    By March 21, 2024
  • A double exposure photo illustration of a glass flask and a scientist holding a tube in a laboratory, with stock market information in the background.
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    MadamLead via Getty Images
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    Acelyrin eye drug heads to late-stage testing after trial win

    The biotech, which raised $540 million in an initial public offering last year, is pitching the medicine as a potential challenger to Amgen’s blockbuster eye drug Tepezza.

    By March 20, 2024
  • The logo of German pharmaceuticals and chemicals giant Bayer stands over Bayer corporate offices on September 14, 2016 in Berlin, Germany.
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    Sean Gallup via Getty Images
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    With new data, Bayer readies rival to Astellas menopause drug

    Following a third successful Phase 3 trial, the company is planning approval filings for the medicine, which it acquired in a $425 million deal four years ago.

    By March 19, 2024
  • Merck sign
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    Marko Georgiev / Stringer via Getty Images
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    Merck reveals plans to develop newer HPV shots

    The pharma intends to test a single-dose regimen as well as a shot that may provide broader protection than the current versions of Gardasil that regularly generate billions in annual sales.

    By March 13, 2024
  • An illustration of neuron cells in abstract dark space.
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    whitehoune via Getty Images
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    Acadia drug fails schizophrenia trial, setting back company’s expansion plans

    The setback shuts out Acadia’s top medicine from a large sales opportunity and heightens the biotech’s dependence on a pipeline filled with risky drug prospects. 

    By Kristin Jensen • March 12, 2024