Clinical Trials: Page

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    Sponsored by Fortrea

    Bridging science and humanity: How systems thinking should shape clinical trial execution

    Applying a systems thinking approach can create improvements in scientific integrity, operational feasibility and scalability.

    By Tetyana Korchak, MD - Global Lead & Executive Director, Strategic Delivery & Growth, at Fortrea • Sept. 16, 2024
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    Sponsored by Worldwide Clinical Trials

    Accelerating the new wave of CAR T therapy trials

    Applying CAR T-cell therapy in new clinical settings presents unique challenges. Worldwide Clinical Trials is at the forefront, partnering with drug development teams to map this new path forward.

    Sept. 16, 2024
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    Trendline

    Radiopharmaceuticals

    A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.   

    By BioPharma Dive staff
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    Ten-year survival data show long-term benefit of immunotherapy in melanoma

    “It’s a real opportunity to reinforce hope and to start getting comfortable with the word ‘cure,” said a leader of the study, which tested Opdivo and Yervoy.

    By • Sept. 15, 2024
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    TIGIT drug from iTeos shrinks lung tumors in trial

    Results presented at ESMO showed tumor response rates that matched the bar set by analysts for success. But they may not yet be enough to dispel doubts around TIGIT as a target.

    By Ned Pagliarulo • Sept. 14, 2024
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    Fulcrum shares collapse as Sanofi-partnered muscular dystrophy drug fails key test

    The biotech will now suspend development of a drug prospect that Sanofi acquired partial rights to just four months ago. 

    By • Sept. 12, 2024
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    Dupixent succeeds in chronic hives study, giving Sanofi, Regeneron a chance to rebound

    Following an FDA rejection last year, the partners plan to resubmit their application for approval of Dupixent in chronic spontaneous urticaria.

    By Kristin Jensen • Sept. 11, 2024
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    Permission granted by Centessa Pharmaceuticals
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    Investors are waking up to Centessa’s sleepiness drug

    A small, early study produced what one analyst called “highly compelling” results that lifted the company’s shares by as much as 15% Tuesday.

    By • Sept. 10, 2024
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    New data add to doubts about AstraZeneca, Daiichi’s Enhertu successor

    The partners’ ADC didn’t significantly extend survival in lung cancer patients who were expected to benefit the most from treatment in a Phase 3 trial.

    By • Sept. 10, 2024
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    Relay breast cancer drug shows potential in early trial

    Results from a small study suggest Relay's drug could avoid some of the toxicity associated with existing PI3Ka inhibitors like Novartis' Piqray.

    By Ned Pagliarulo • Sept. 9, 2024
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    shutterstock.com/Juan Gaertner

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    Early study data puts Terns among obesity drug contenders

    A once-daily pill the biotech is developing helped some people with obesity lose more than 5% of their weight in a month, spurring a stock bump and plans to bring the drug into further testing. 

    By • Sept. 9, 2024
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    Summit lung cancer drug shows ‘striking’ benefit over Keytruda

    Detailed study results backed up Summit's claim that its drug "decisively beat" Merck's dominant immunotherapy in a first-of-its-kind finding.

    By • Updated Sept. 8, 2024
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    GSK antibody drug reduces COPD attacks in trial

    New trial results could offer support for an expansion of Nucala’s label after U.S. regulators rejected GSK’s submission in 2018.

    By Kristin Jensen • Sept. 6, 2024
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    Lilly builds case for weekly insulin shot

    New data show Lilly’s longer-lasting insulin matched daily shots in controlling blood sugar, adding to positive findings the company disclosed in May.

    By • Sept. 5, 2024
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    George Frey/Reuters

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    Deep Dive

    A decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology

    Over the past 10 years, PD1-blocking medicines have transformed cancer care. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.

    By • Sept. 4, 2024
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    Vaxcyte’s “best-case” data for pneumococcal vaccine boost shares

    The company's value jumped by several billion dollars as trial results showed its experimental shot could match and, in some cases, even outperform Pfizer's market-leading Prevnar 20.

    By • Sept. 3, 2024
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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 Ned Pagliarulo • Sept. 3, 2024
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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
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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
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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
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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
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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
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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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    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
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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 Ned Pagliarulo • Aug. 20, 2024
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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