Clinical Trials

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    FDA, aiming to lower drug costs, moves to speed approval of biosimilars

    The agency will no longer require studies comparing copycat biologics to their branded counterparts, which could help developers bring them to market more quickly and cheaply. 

    By • Oct. 29, 2025
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    BridgeBio chalks up another win for its rare disease research

    The company reported its second late-stage study success, this time with a drug that could become a new treatment standard for an uncommon endocrine disease.

    By • Oct. 29, 2025
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    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
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    Merck kidney cancer drug succeeds in two large trials

    The results could help expand use of Welireg, one of the medicines Merck is counting on to drive revenue growth when its top-selling immunotherapy Keytruda loses patent protection. 

    By • Oct. 28, 2025
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    Courtesy of Intellia Therapeutics
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    Gene editing

    Intellia pauses two CRISPR drug studies after safety scare

    A study volunteer receiving Intellia’s transthyretin amyloidosis treatment was hospitalized due to severe signs of liver stress, prompting the company to pause enrollment and dosing while evaluating a new safety protocol. 

    By • Oct. 27, 2025
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    Permission granted by BridgeBio Pharma
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    BridgeBio to seek approval of limb-girdle drug following new study data

    The company intends to meet with the FDA to discuss results that showed a level of improvement on a marker of muscle stability that one executive described as a “home run.”

    By • Oct. 27, 2025
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    News roundup

    Chugai buys a kidney biotech; ICER targets rising launch prices

    Chugai is acquiring partial rights to a marketed IgA nephropathy drug. Elsewhere, ICER claimed Americans are often “overpaying” for medicines and Summit raised $500 million.

    By BioPharma Dive staff • Oct. 24, 2025
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    Ventyx shares soar after study suggests cardiovascular benefits for experimental drug

    The drug’s effects on cardiovascular and inflammation markers outshined its failure to spur weight loss, analysts wrote.

    By Kristin Jensen • Oct. 23, 2025
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    Maddie Meyer via Getty Images
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    Vaccines

    Moderna says CMV vaccine once seen as future blockbuster fails key study

    A shot analysts projected as a multibillion-dollar seller produced results “well below” the company’s expectations, heightening pressure on Moderna’s flagging respiratory vaccine business.

    By • Oct. 22, 2025
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    Courtesy of Sanofi
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    Sanofi drug acquired in buyout succeeds in rare disease trial

    The drug’s success in a Phase 2 study in alpha-1 antitrypsin deficiency “validates” Sanofi’s 2024 acquisition of Inhibrx, according to one analyst.

    By • Oct. 22, 2025
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    Alector dementia drug, partnered with GSK, fails in key study

    The negative readout led to a collapse in share price for Alector, which now plans to cut almost half of its workforce while refocusing and finding a new R&D leader.

    By Kristin Jensen • Oct. 22, 2025
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    Alamy
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    AstraZeneca, Daiichi’s Datroway excels in hard-to-treat breast cancer

    Presented at the European Society for Medical Oncology, study results showed Datroway extended survival in breast cancer patients for whom immunotherapy is not an option.

    By • Oct. 20, 2025
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    Summit’s dual-acting drug scores lung cancer win

    A closely watched trial in Chinese patients is raising hope that ivonescimab will outperform Keytruda in a large global study that could reshape first-line treatment regimens.

    By • Oct. 20, 2025
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    Exelixis shares dip on colorectal cancer data

    Some on Wall Street weren’t too impressed with results from a pivotal trial that tested an Exelixis drug, zanzalintinib, in combination with Tecentriq.

    By • Oct. 20, 2025
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    Roche pill delays tumor progression in closely watched breast cancer study

    Results presented at the European Society for Medical Oncology meeting could help separate Roche’s medicine from similar hormone-degrading drugs for breast tumors.

    By • Oct. 18, 2025
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    J&J claims success in study testing earlier Tecvayli use in multiple myeloma

    The result marks a potential advance for dual-targeting antibody drugs like Tecvayli, which are currently relegated to later-line settings for the persistent blood cancer.

    By • Oct. 16, 2025
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    Scott Olson via Getty Images
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    Obesity drugs

    Lilly, battling skepticism, reinforces GLP-1 pill’s case with new study data

    Some Wall Street analysts have questioned orforglipron’s sales outlook in obesity, but see great potential in diabetes, where on Wednesday it succeeded in two more late-stage trials. 

    By Kristin Jensen • Oct. 15, 2025
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    William Walker/BioPharma Dive
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    Sponsored by Pearson

    [Podcast] The Progress Profile: Alzheimer’s Research in Focus

    Discover the latest breakthroughs in Alzheimer's research, diagnosis, and prevention in this expert-led podcast series.

    By BioPharma Dive's studioID • Oct. 15, 2025
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    Obesity drugs

    Kailera nets $600M more to advance Zepbound-like obesity drug

    Among the largest private biotech funding rounds this year, the financing will support global trials of an obesity shot that just succeeded in late-stage testing in China.

    By • Oct. 14, 2025
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    iStock Image/cofotoisme

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    Sponsored by Norstella

    Pharma’s real-world data dilemma: Strategic asset or wasted resource?

    To maximize RWD’s potential, pharma companies should begin with their business or clinical goals.

    By Ilan Behm, VP, Real-World Data Engagement, Norstella and Ted Search, General Manager, Real-World Data, Norstella • Oct. 13, 2025
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    DMP via Getty Images
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    Sponsored by Labcorp

    Maximizing biomarker insights from minimal samples

    Unlock value with optimized workflows and scalable technologies.

    Oct. 13, 2025
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    Regeneron, with ‘game-changing’ new data, to seek approval of hearing loss gene therapy

    Study results published in The New England Journal of Medicine show the therapy significantly improved hearing in nearly a dozen children with a rare, genetic form of deafness.

    By • Oct. 12, 2025
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    Alamy
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    AstraZeneca, Daiichi drug extends survival in hard-to-treat breast cancer

    The results could pave the way for Datroway to supplant chemotherapy in certain triple-negative tumors, adding to existing clearances in other breast and lung malignancies.

    By • Oct. 6, 2025
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    Obesity drugs

    Skye shares crash as obesity drug falls short in key study

    The findings are the latest setback for weight loss medicines that target a specific cannabinoid receptor and are meant to boost the effects of incretin therapies like Wegovy.

    By • Oct. 6, 2025
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    shutterstock.com/fizkes

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    Sponsored by 1nHealth

    The advantage of engaging patient recruitment partners as strategic allies, not emergency backups

    The secret to on-time trials? Engaging recruitment partners early.

    By Ryan Day and Steve Wimmer • Oct. 6, 2025
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    Alamy
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    Amgen claims ‘landmark’ study result that could widen heart drug’s use

    In a first-of-its-kind finding, Amgen’s PCSK9 drug protected heart health when tested as a “primary prevention” therapy, which could pave the way for access to a much broader population. 

    By • Oct. 2, 2025