Clinical Trials


  • A person sits in an office chair next to a sign reading Cerevel.
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    Permission granted by Cerevel Therapeutics
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    Cerevel, in ‘major surprise,’ finds success in late-stage Parkinson’s study

    Analysts had low expectations for Cerevel’s drug tavapadon, which was something of an afterthought in AbbVie’s proposed buyout of the biotech.

    By April 18, 2024
  • A white sign with the word Lilly written in red stands outside of an office.
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    Scott Olson via Getty Images
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    Obesity drugs

    Lilly obesity drug shows benefit in sleep disorder study, pointing to new use

    Positive data for Lilly’s medicine tirzepatide in sleep apnea are the latest signal the benefits of GLP-1 agonists could extend beyond diabetes and weight loss.

    By April 17, 2024
  • An injection pen containing the drug semaglutide lies on a white plate. Explore the Trendline
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    Douglas Cliff via Getty Images
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    Trendline

    The obesity drug revolution

    GLP-1 agonists like Ozempic and Wegovy can drive significant weight loss and, at least in Wegovy’s case, protect the heart. Their adoption is changing how doctors treat obesity.

    By BioPharma Blog staff
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    noparrit via Getty Images
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    Sage’s cognition drug fails in Parkinson’s study

    Following negative results, the company doesn’t plan to further test SAGE-718 in Parkinson’s. Other studies in Huntington’s and Alzheimer’s remain ongoing.

    By April 17, 2024
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    Eoneren via Getty Images
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    Intra-Cellular builds case for depression drug with late-stage trial win

    Shares of the biotech rose 25% after a large trial found adding its drug Caplyta onto antidepressant therapy significantly helped people with major depression.

    By April 16, 2024
  • Roche Pharmaceutical Group's office building in Shanghai, China
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    iStock via Getty Images
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    Roche reports survival data for new dual-acting lymphoma drug

    The results could give Roche’s Columvi an edge over a rival medicine from AbbVie and Genmab, while Regeneron awaits an approval of its own therapy.

    By April 15, 2024
  • 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
  • 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
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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
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    Seth Babin/BioPharma Blog
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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 / Biopharma Blog
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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