Clinical Trials: Page 9


  • An image of the lab inside Recursion Pharmaceuticals.
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    Permission granted by Recursion Pharmaceuticals
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    AI specialist Recursion says lead drug is safe, but efficacy less clear

    The Phase 2 results for Recursion’s treatment are the first in a series of important trial readouts for the high-profile “techbio” company.

    By Sept. 3, 2024
  • A photo of a nerve cell attacked by antibodies
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    peterschreiber.media via Getty Images
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    Sanofi finds a silver lining in mixed MS drug results

    Tolebrutinib, which Sanofi acquired in a $3.7 billion deal, failed two studies in people with relapsing disease, but succeeded in a type of multiple sclerosis that has no approved therapies.

    By Sept. 3, 2024
  • 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

    The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

    By BioPharma Dive staff
  • Red human heart drawing on blue background
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    Jolygon via Getty Images
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    Full study data back Alnylam heart drug’s benefit, but leave doctors with tough choices

    Shares of Alnylam fell as much as 9% amid skepticism vutrisiran hasn’t clearly shown it’s superior to other medicines for ATTR cardiomyopathy.

    By Aug. 30, 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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    Keytruda fails lung and skin cancer trials, limiting further expansion

    The trial setbacks for Merck’s best-selling drug, which faces patent expiration in 2028, are a blow to the company’s plans for further indication expansion.

    By Aug. 29, 2024
  • An illustration of a brain disintegrating
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    Eoneren via Getty Images
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    Neurocrine’s mixed schizophrenia data disappoint Wall Street

    Despite “positive” results, shares of the biotech slid by 20%. Analysts cautioned that Neurocrine shouldn’t get “the benefit of the doubt” with its data.

    By Aug. 28, 2024
  • gloved hands cutting psilocybin mushrooms growing in a container
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    Stock via Getty Images
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    After an FDA rejection, here’s what’s next in the psychedelics pipeline

    By rejecting the first MDMA therapy this month, the FDA signaled to the psychedelic drug field that the road to approval isn’t easy.

    By Amy Baxter • Aug. 28, 2024
  • Multiracial group of scientists working at the laboratory researching
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    andresr via Getty Images
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    Sponsored by Worldwide Clinical Trials

    Radiopharmaceutical trials: The critical role of site selection and support

    Through effective collaboration, partnerships can accelerate the development of lifesaving therapies and improve patient outcomes.

    Aug. 26, 2024
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    Daniel Tadevosyan via Getty Images
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    Avidity, Kymera raise fresh funds; Walgreens partners with BARDA

    Avidity raised $345 million to advance development of RNA medicines designed to combine the advantages of oligonucleotides and antibodies.

    By BioPharma Dive staff • Aug. 20, 2024
  • A sign shows the logo of Eli Lilly's Research Laboratories
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    jetcityimage via Getty Images
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    Lilly’s tirzepatide cuts diabetes risk, study data show

    Treatment with the GLP-1 drug, which Lilly sells as Mounjaro and Zepbound, lowered the risk of Type 2 diabetes progression by 94% versus placebo.

    By Aug. 20, 2024
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    Thomas Lohnes via Getty Images
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    FDA lifts partial hold on study of BioNTech-partnered ADC

    Partner MediLink Therapeutics is limiting the drug’s dosing after reports of lowered white blood cell counts and inflammation of the digestive tract.

    By Updated Aug. 19, 2024
  • Pfizer's logo cast in metal.
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    Jeenah Moon via Getty Images
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    Pfizer, BioNTech stumble in effort to develop combination flu, COVID shot

    The vaccine didn’t spur a strong enough immune response against a particular flu strain in a Phase 3 trial, leading the companies to ponder adjustments. 

    By Aug. 16, 2024
  • Following FDA rejection, a journal retracts papers on MDMA-assisted therapy

    Editors at Psychopharmacology cited "unethical conduct" that the study authors didn't disclose when submitting the papers. Lykos Therapeutics says it filed a complaint with a third party to review the way the journal came to its decision.

    By Aug. 12, 2024
  • Pfizer's logo cast in metal.
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    Jeenah Moon via Getty Images
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    Pfizer builds case for RSV shot with data from immunocompromised adults

    Results from a Phase 3 study could help Pfizer broaden use of its vaccine Abrysvo to younger adults whose medical history puts them at higher risk.

    By Aug. 12, 2024
  • A photo of a sign inside an Apellis Pharmaceuticals building
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    Courtesy of Apellis Pharmaceuticals
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    Apellis plans FDA filing after drug success in kidney trial

    Analysts at Evercore ISI called pegcetacoplan’s data in two kidney conditions a “left-field hit” that compare favorably to results for a Novartis treatment.

    By Aug. 8, 2024
  • A person in a white sweater holds a drug injection pen.
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    CR via Getty Images
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    Obesity drugs

    Lilly obesity drug shows heart benefit in late-stage trial

    The drug led to a 38% reduction in the risk of death or complications from a type of heart failure, a finding that compared favorably to available treatments.

    By Aug. 1, 2024
  • Pfizer CEO Albert Bourla
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    Drew Angerer via Getty Images
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    Pfizer’s Bourla confident in company’s obesity drug position, despite delays

    The CEO noted how Pfizer's danuglipron could still be the second oral GLP-1 treatment to enter registrational tests after Lilly's orforglipron.

    By July 30, 2024
  • A woman's hands over her abdomen.
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    Doucefleur via Getty Images
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    Ventyx’s TYK2 drug suffers second setback

    The company claimed “higher than anticipated” scores from trial volunteers on placebo led to the disappointing data, prompting it to halt internal trials.

    By July 29, 2024
  • A stethoscope rests on top of an EKG printout. A cool blue cast dominates the scene.
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    DNY59 via Getty Images
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    NewAmsterdam heart drug hits trial goal, but data appear to disappoint investors

    The study is the latest test of a class of cholesterol medicines known as CETP inhibitors, which were abandoned by several large drugmakers last decade.

    By July 29, 2024
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    Elizabeth Regan/BioPharma Dive
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    Viking shares jump on plans to speed obesity drug into late-stage testing

    The drug’s advancement continued what one analyst described as a “torrid” pace for Viking’s closely watched medicine, which started human testing in 2022 and could reach a Phase 3 trial next year.  

    By Kristin Jensen • July 25, 2024
  • A photo of a Biogen building
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    Permission granted by Biogen
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    Biogen, Sage tremor drug fails key trial

    Known as SAGE-324, the drug was one of the key assets Biogen gained rights to through a billion-dollar research deal inked back in 2020.

    By July 24, 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 claims late-stage study success for RSV antibody

    The drug, a rival to Sanofi and AstraZeneca’s fast-selling Beyfortus, met its main goals in a Phase 3 trial. But undisclosed study results leave its full potential unclear.

    By Updated July 23, 2024
  • A conceptual illustration of neural activity in a brain.
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    nopparit via Getty Images
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    Ionis plots next steps for Angelman drug Biogen passed on

    The company plans to start a late-stage study next year, after a smaller trial found its drug offered “robust and consistent” benefits on communication, cognition and motor function.

    By July 22, 2024
  • A Roche logo is seen on the side of a building.
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    Courtesy of Roche
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    Obesity pill from Roche shows promising weight loss in small study

    Treatment led to "clinically meaningful" weight loss over four weeks, but longer studies will be needed to compare it to Wegovy and Zepbound.

    By July 17, 2024
  • Colorful DNA double helix.
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    iStock via Getty Images
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    Lexeo gene therapy shows signs of heart benefit in small study

    The biotech, which went public late last year, argued the results justify exploring an accelerated approval. But shares fell by double digits amid investor skepticism.

    By July 15, 2024
  • A human brain is imaged with a MRI scan.
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    Popartic via Getty Images
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    UniQure stock surges on data for Huntington’s gene therapy

    The biotech’s stock rose more than 60% as fresh data appeared to alleviate some investor concerns about the therapy’s effectiveness and reliability.

    By July 9, 2024