Clinical Trials: Page 14
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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 -
Explore the Trendline➔
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TrendlineNeuroscience drug development
Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.
By BioPharma Dive staff -
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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 -
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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 -
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Alnylam says heart drug succeeds in closely watched study
Positive results from a Phase 3 trial of vutrisiran in transthyretin amyloidosis cardiomyopathy set up a market competition with Pfizer and BridgeBio.
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 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/BioPharma 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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Immune resetNew 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 -
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Ultragenyx, Mereo drug reduces fractures in bone disorder study
New data show the treatment’s effect on fractures and bone density held up over time, boosting the drug’s prospects ahead of a Phase 3 readout.
By Kristin Jensen • June 12, 2024 -
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Moderna says combination flu, COVID shot succeeds in study
Positive results from the trial could position Moderna to bring the two-in-one vaccine to market in 2025.
By Delilah Alvarado • June 10, 2024 -
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After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next
A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.
By Jacob Bell • June 7, 2024 -
Alyssa Eckel-Martin/BioPharma Dive
Sponsored by BioLineRx[Podcast] The Power of Persistence: From Biotech Incubator to Product Launch
How can small and mid-sized biotech companies better manage pharmacovigilance during clinical trials? Listen to the podcast to learn how strategic alliances are helping.
By BioPharma Dive's studioID • Updated June 18, 2024 -
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FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns
“I just feel very convinced that I had to vote no,” said one member of the committee, which was unconvinced by Lykos Therapeutics’ data on MDMA-assisted treatment for post-traumatic stress disorder.
By Jacob Bell • Updated June 4, 2024 -
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BridgeBio data show sustained benefit for achondroplasia drug
Longer follow-up results from a mid-stage trial indicate the company’s treatment for a genetic cause of dwarfism may be competitive to an approved therapy from BioMarin Pharmaceutical.
By Ned Pagliarulo • June 4, 2024 -
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Viking says biopsy data confirm MASH drug’s benefit
The company may look to license the experimental liver disease drug as it focuses on an obesity treatment that's shown early promise.
By Jonathan Gardner • June 4, 2024
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