Clinical Trials
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Elizabeth Regan / Industry Dive
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 -
Permission granted by Biogen
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 Jacob Bell • July 24, 2024 -
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TrendlineOncology'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 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 Ben Fidler • Updated July 23, 2024 -
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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 Jacob Bell • July 22, 2024 -
Courtesy of Roche
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 Jonathan Gardner • July 17, 2024 -
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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 Ben Fidler • July 15, 2024 -
Popartic via Getty Images
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 Jacob Bell • July 9, 2024 -
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HilleVax’s norovirus vaccine ineffective in large trial of infants
Shares in HilleVax plummeted after the company reported its experimental shot failed to meet the primary and secondary goals of the Phase 2b study.
By Delilah Alvarado • July 8, 2024 -
Kendall Davis/BioPharma Dive
Deep Dive10 clinical trials to watch in the second half of 2024
Study results are expected for two closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.
By BioPharma Dive staff • July 1, 2024 -
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Novo nixes trial of blood pressure drug it bought in $1.3B deal
The failure of a Phase 3 study led the Wegovy maker to take an accounting charge that will hit its operating profit growth this year.
By Jonathan Gardner • June 26, 2024 -
Scott Olson via Getty Images
Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?
Obesity drugs like Wegovy are proving useful in many diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.
By Delilah Alvarado • June 26, 2024 -
del Aguila III, Ernesto. (2018). "CRISPR Cas9" [Illustration]. Retrieved from Flickr.
First-of-its-kind Intellia data suggest CRISPR drug could be given more than once
The findings provide early proof that multiple doses of a gene editing medicine can be safely administered with additive effects, overcoming a key constraint of the complex therapies.
By Ben Fidler • June 26, 2024 -
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Wave, with new data, plots path forward for Huntington’s drug
The company plans to make a case to regulators for a new accelerated approval pathway. But investors didn't seem as hopeful, sending shares down by double digits.
By Ned Pagliarulo • June 25, 2024 -
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Novo fills in positive picture for preventive hemophilia drug
Phase 3 trial results should support an approval application for the drug, which analysts view as a competitor to Roche’s blockbuster medicine Hemlibra.
By Ned Pagliarulo • June 24, 2024 -
Ivan-Balvan via Getty Images
Alnylam says heart drug succeeds in closely watched study
Positive results from a Phase 3 trial of vutrisiran in transthyretin amyloidosis cardiomyopathy come eight months after the FDA rejected another medicine Alnylam developed for the condition.
By Ben Fidler • Updated June 24, 2024 -
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Sponsored by FortreaBridging science and humanity: Systems thinking in clinical trial design
Benefits of adopting the systems thinking approach in clinical trial design.
By Clare Campbell-Cooper, Global Head of Digital Health and Innovation at FORTREA • June 24, 2024 -
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Obesity drugsObesity drug from Zealand shows potential in early trial
Interim study data suggest the Danish drugmaker can remain in the race to develop new kinds of weight loss drugs as doctors seek alternatives to the now dominant GLP-1s.
By Jonathan Gardner • June 20, 2024 -
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FDA lifts hold on PTC Huntington’s disease trial
The agency has lifted a partial trial suspension based on one-year data showing PTC’s pill suppressed a key protein associated with the disorder.
By Jonathan Gardner • June 20, 2024 -
Permission granted by Gilead Sciences
Twice-yearly shots of Gilead HIV drug effective in large prevention study
Researchers recommended Gilead end testing early as lenacapavir proved 100% effective in protecting cisgender women in the Phase 3 trial.
By Ned Pagliarulo • June 20, 2024 -
Elizabeth Regan / Industry Dive
Intra-Cellular depression drug succeeds in second late-stage study
The results position the company to unlock what’s believed to be a multibillion-dollar sales opportunity for Caplyta, which is already used to treat schizophrenia and bipolar disorder.
By Kristin Jensen • June 18, 2024 -
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Takeda drug for rare types of epilepsy misses goal in late-stage trial
Called soticlestat, the drug had seemed promising in earlier studies for people with Dravet and Lennox-Gastaut syndrome, enough to persuade Takeda to take on full rights to the drug.
By Jonathan Gardner • June 17, 2024 -
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New data showcase promise, growing pains of CAR-T in autoimmune disease
One expert described trial results presented at EULAR in June as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.
By Ben Fidler • June 17, 2024 -
Permission granted by PetersenWest/MenariniSilicon Biosystems
Sponsored by Menarini Silicon BiosystemsThe critical role of comprehensive RNA sequencing in liquid biopsy for biomarker discovery and clinical trials
Elevate precision medicine: dose optimization and immune monitoring through advanced liquid biopsies.
By Harshil Patel, MBA, CGMBS, ASCP - Sr. Marketing Manager • June 17, 2024 -
Joe Raedle/Getty Images via Getty Images
Moderna says next-gen COVID shot effective in study
Trial data suggest the shot — an important component of an upcoming combination inoculation — has proven at least as effective, and in some cases superior, to the company’s initial COVID vaccine.
By Kristin Jensen • June 13, 2024 -
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Pfizer gene therapy for Duchenne fails to meet goals of key trial
The negative results from the Phase 3 study, called Ciffreo, come a little more than a month after Pfizer said a patient died in another trial of the gene therapy.
By Ned Pagliarulo , Ben Fidler • June 12, 2024
