Clinical Trials: Page 15
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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 Jonathan Gardner • Updated Aug. 19, 2024 -
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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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Pfizer, BioNTech stumble in effort to develop combination flu, COVID shot
The vaccine didn’t spur a strong enough immune response against a particular flu strain in a Phase 3 trial, leading the companies to ponder adjustments.
By Delilah Alvarado • Aug. 16, 2024 -
Retrieved from Drug Enforcement Administration.
Following FDA rejection, a journal retracts papers on MDMA-assisted therapy
Editors at Psychopharmacology cited "unethical conduct" that the study authors didn't disclose when submitting the papers. Lykos Therapeutics says it filed a complaint with a third party to review the way the journal came to its decision.
By Jacob Bell • Aug. 12, 2024 -
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Pfizer builds case for RSV shot with data from immunocompromised adults
Results from a Phase 3 study could help Pfizer broaden use of its vaccine Abrysvo to younger adults whose medical history puts them at higher risk.
By Delilah Alvarado • Aug. 12, 2024 -
Courtesy of Apellis Pharmaceuticals
Apellis plans FDA filing after drug success in kidney trial
Analysts at Evercore ISI called pegcetacoplan’s data in two kidney conditions a “left-field hit” that compare favorably to results for a Novartis treatment.
By Ned Pagliarulo • Aug. 8, 2024 -
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Obesity drugsLilly obesity drug shows heart benefit in late-stage trial
The drug led to a 38% reduction in the risk of death or complications from a type of heart failure, a finding that compared favorably to available treatments.
By Ben Fidler • Aug. 1, 2024 -
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Pfizer’s Bourla confident in company’s obesity drug position, despite delays
The CEO noted how Pfizer's danuglipron could still be the second oral GLP-1 treatment to enter registrational tests after Lilly's orforglipron.
By Jonathan Gardner • July 30, 2024 -
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Ventyx’s TYK2 drug suffers second setback
The company claimed “higher than anticipated” scores from trial volunteers on placebo led to the disappointing data, prompting it to halt internal trials.
By Jonathan Gardner • July 29, 2024 -
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NewAmsterdam heart drug hits trial goal, but data appear to disappoint investors
The study is the latest test of a class of cholesterol medicines known as CETP inhibitors, which were abandoned by several large drugmakers last decade.
By Ben Fidler • July 29, 2024 -
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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 -
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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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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 -
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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 -
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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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