Clinical Trials

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    Arcus cancels work on Gilead-partnered cancer combo after trial setback

    A study using TIGIT and PD-1 drugs for gastrointestinal disease was canceled for “futility” at an early checkpoint, another blow to research on a once-promising target.

    By • Dec. 12, 2025
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    Brain drug revival

    AC Immune posts positive data for Parkinson’s immunotherapy

    Shares of AC Immune rose by double-digits on news that the company, encouraged by new data, now intends to ask drug regulators for feedback to “potentially accelerate” the time to an approval filing. 

    By • Dec. 11, 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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    Obesity drugs

    Lilly’s three-pronged drug puts obesity field ‘on notice’

    Lilly’s closely watched retatrutide spurred as much as 29% weight loss in a Phase 3 study, a finding that is “raising the bar” for future obesity drug competitors, one analyst wrote.

    By Kristin Jensen • Dec. 11, 2025
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    Novartis notches another win for drug acquired in MorphoSys deal

    Ianalumab, which has already succeeded in testing against Sjogren’s syndrome, proved impactful in a condition that causes low platelet counts.

    By • Dec. 9, 2025
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    News roundup

    FDA raises CAR-T approval standards; Novartis bets on an AI startup

    CAR-T cancer therapies now need to succeed in randomized, controlled trials to earn approvals. Elsewhere, a drug from Bristol Myers Squibb and BioNTech proved effective in breast cancer patients.

    By BioPharma Dive staff • Dec. 9, 2025
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    J&J’s ‘remarkable’ Tecvayli data support earlier use in multiple myeloma

    In a step forward for bispecific antibodies, study results presented at ASH suggest a Tecvayli-based combination could have curative potential early in a patient’s disease course.

    By • Dec. 9, 2025
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    Terns drug shows potential to challenge Novartis’ blockbuster leukemia treatment

    While early, study results presented at ASH show Tern’s drug could surpass Novartis’ Scemblix and “raise the bar in efficacy” for chronic myeloid leukemia medicines, the company’s CEO said.

    By • Dec. 8, 2025
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    At ASH, Lilly makes case to widen Jaypirca use in leukemia, lymphoma

    In a head-to-head trial, Lilly’s drug was as effective as Imbruvica at inducing responses and displayed certain safety advantages that could make it a preferred treatment in early lines of care. 

    By • Dec. 7, 2025
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    Courtesy of Vertex Pharmaceuticals
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    Vertex CRISPR therapy hits early goal in children with blood disorders

    Casgevy, now a "national priority" drug, helped kids with sickle cell and beta thalassemia, results which may help toward a label expansion and stronger commercial uptake.

    By • Dec. 6, 2025
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    Vaccines

    12 former FDA chiefs blast Prasad’s move to toughen vaccine standards

    In an article published in NEJM, nearly all living ex-FDA commissioners lambasted the CBER head’s plans to use a probe into COVID vaccine safety to upend longstanding regulatory protocols.

    By • Dec. 4, 2025
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    After finding ‘irregularities,’ Bristol Myers to extend key trial of Cobenfy in Alzheimer’s psychosis

    Data from the "ADEPT-2" study, which analysts had hoped would arrive before year's end, are now expected sometime in 2026.

    By • Dec. 3, 2025
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    Capricor soars on positive results for Duchenne cell therapy

    Shares quadrupled now that the company appears on track to reverse an earlier FDA rejection of what could be the first treatment for heart-related complications of Duchenne.

    By Kristin Jensen • Dec. 3, 2025
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    Pharvaris’ pill succeeds in late-stage trial for rare swelling disorder

    Phase 3 data could make the Dutch biotech's drug competitive in the increasingly crowded market of hereditary angioedema treatments.

    By • Dec. 3, 2025
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    FDA details plan to scale back animal tests for some antibody drugs

    The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.

    By • Dec. 2, 2025
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    Belite continues ascent as Stargardt drug hits mark in late-stage trial

    The results position Belite, one of the sector’s top-performing companies since 2022, to seek approval of what could be the first marketed medicine for the rare eye condition.

    By • Dec. 1, 2025
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    iStock/SDI Productions

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    Sponsored by Labcorp

    Expanding access in oncology trials: The case for a paired tissue-plasma approach

    Paired tissue-liquid biopsy: A smarter path to faster enrollment and better trial outcomes. 

    Dec. 1, 2025
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    Novartis cuts hundreds of jobs; Novo’s dual-acting diabetes drug heading to Phase 3

    The layoffs affect Swiss manufacturing facilities. Elsewhere, the FDA pushed back an approval deadline and a mid-stage study showed Novo’s amycretin helps regulate blood sugar.

    By BioPharma Dive staff • Nov. 26, 2025
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    Kelun, Merck tout ADC as potential first-line treatment in lung cancer

    The partners said a TROP2-targeting antibody drug conjugate succeeded in a late-stage trial, paving the way for potential approval in the first-line setting.

    By • Nov. 25, 2025
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    Bayer’s experimental blood-thinner notches trial win in stroke prevention

    Asundexian's Phase 3 study results raise hopes for a new class of cardiovascular drugs that has seen clinical setbacks.

    By • Nov. 24, 2025
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    Novo Nordisk’s GLP-1 misses goal in closely watched Alzheimer’s studies

    The studies offer perhaps the most concrete rebuttal yet to an idea that GLP-1 drugs, which have profound benefits on weight loss and heart health, might also help combat neurodegeneration.

    By • Nov. 24, 2025
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    A brain biotech’s top drug fails against MS

    Shares of Contineum Therapeutics dipped by the double-digits late Thursday after investors learned of a clinical setback for a drug that’s also piqued Johnson & Johnson’s interest.

    By • Nov. 21, 2025
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    Agios shares fall on mixed sickle cell results for blood disease drug

    Pyrukynd, which Agios sells for a rare type of anemia, missed one of its main objectives in a study seen as crucial for its commercial outlook and the company’s reinvention as a rare disease specialist.

    By • Nov. 19, 2025
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    Roche pill notches win in early breast cancer

    Roche claimed the results make its drug giredestrant the first of its kind, a so-called oral SERD, to show a benefit in the “adjuvant” setting after surgery. 

    By • Nov. 18, 2025
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    Adobe Stock/Corona Borealis

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    Sponsored by IQVIA Technologies

    The inspection-ready operating model for clinical trials

    Turn readiness into routine with roles, controls and audit trails across systems.

    By IQVIA Technologies • Nov. 17, 2025
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    Bristol Myers, J&J’s new blood thinner fails first big test

    Milvexian’s failure in acute coronary syndrome dampens the outlook for other anticoagulants like it and is the latest in a series of clinical setbacks this year for Bristol Myers.

    By • Nov. 14, 2025