Clinical Trials: Page 8
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Roche’s TIGIT-targeting drug for cancer fails its biggest test
Long-awaited results released Tuesday showed adding tiragolumab to Roche's immunotherapy Tecentriq did not extend survival in a closely followed Phase 3 study called SKYSCRAPER-01.
By Ned Pagliarulo • Nov. 26, 2024 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
Alector turns to layoffs as Alzheimer’s drug fails
The brain drug developer is letting go of around 41 of its 238 employees, in a move the company says will help “align resources” with its strategic priorities.
By Jacob Bell • Nov. 26, 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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New data could help Merck expand use of cardiovascular drug
Positive study results for Winrevair could help the drugmaker achieve sales growth past top-seller Keytruda’s upcoming patent expirations this decade.
By Jonathan Gardner • Nov. 25, 2024 -
Courtesy of Biohaven Ltd.
Biohaven muscle drug misses goal of SMA study, but advances in obesity
The setback likely removes one competitor to an emerging spinal muscular atrophy medicine from Scholar Rock, but sets the stage for a pair of readouts with implications for weight loss research.
By Ben Fidler • Nov. 25, 2024 -
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Sage’s string of research failures continues
Negative results from a Huntington’s trial add to a calamitous year for Sage, which last month decided to overhaul its research, reconfigure its executive team and lay off a third of its staff.
By Jacob Bell • Nov. 20, 2024 -
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J&J pill clears skin in two late-stage psoriasis studies
The drug, called icotrokinra and developed together with Protagonist Therapeutics, is an oral peptide designed to tamp down the inflammation involved in psoriasis and other immune diseases.
By Ned Pagliarulo • Nov. 19, 2024 -
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FDA endorses speedy approval path for Regenxbio Duchenne gene therapy
The agency's openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.
By Ben Fidler • Nov. 18, 2024 -
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Sponsored by Thermo Fisher ScientificLeveraging NGS to move precision oncology forward, from CDx to commercialization
Learn how the optimal NGS solution can help you hit your milestones during clinical trials, throughout CDx development and into global commercialization.
Nov. 18, 2024 -
Courtesy of AbbVie
Brain drug revivalOn Wall Street, ‘flat out’ failure of AbbVie schizophrenia drug leaves analysts stunned
Negative data cost AbbVie billions of dollars in market value and convinced analysts Bristol Myers had placed a better bet in buying Karuna Therapeutics.
By Jacob Bell • Nov. 11, 2024 -
Sarah Silbiger via Getty Images
FDA lifts pause on Novavax flu vaccine trials
After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.
By Delilah Alvarado • Nov. 11, 2024 -
Courtesy of AbbVie
AbbVie’s $9B bet collapses as closely watched schizophrenia drug fails studies
Shares in AbbVie slumped Monday after the company disclosed its psychiatric medicine emraclidine didn’t best placebo in two Phase 2 trials.
By Jacob Bell • Nov. 11, 2024 -
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Sponsored by LabConnect7 steps to selecting the right global central lab
Unlock global clinical trial success with seamless sample logistics and standardized testing.
Nov. 11, 2024 -
Peddalanka Ramesh Babu via Getty Images
Cancer cell therapy from Arcellx, Gilead shows promise in early data
The companies’ CAR-T seemed to cause fewer movement disorders in a multiple myeloma trial than J&J's Carvykti has in other tests, although Wall Street analysts were divided on how the two drugs compare.
By Jonathan Gardner • Nov. 5, 2024 -
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Viking data provide latest test of oral obesity drug potential
Wall Street analysts were impressed by data showing competitive rates of weight loss for Viking’s therapy, but shares in the company still slipped.
By Ned Pagliarulo • Nov. 4, 2024 -
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Sponsored by CognizantCenters of excellence or product-centric BizDevOps managed services?
As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinical development platforms to streamline operations.
Nov. 4, 2024 -
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Novo, with new results, to seek approval for obesity drug in MASH
The Phase 3 findings position semaglutide to become the first drug of its kind for the liver disease. But they also confirm GLP-1s aren't a "silver bullet" for MASH, one analyst argued.
By Ben Fidler • Nov. 1, 2024 -
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New Alzheimer's drugsRoche weighs whether speedy approval path is open for latest Alzheimer’s drug
In an investor presentation, executives hinted at the possibility of seeking an accelerated approval of trontinemab if it can significantly lower levels of amyloid in a Phase 3 trial.
By Jonathan Gardner • Oct. 31, 2024 -
Teemu Tretjakov/Adobe Stock and Edited by: TriNetX
Sponsored by TriNetXWith new diversity guidance, EHR data plus AI will be critical
With the new clinical trial diversity guidelines, the combination of EHR data and AI will be essential.
Oct. 28, 2024 -
Adobe Stock/# 501471652, by Puwasit Inyavileart
Sponsored by LabConnectDon’t let your samples slip: Why every clinical trial needs biospecimen management
Assure the integrity and efficiency of your clinical trials with support from a Biospecimen Manager.
Oct. 28, 2024 -
del Aguila III, Ernesto. (2018). "CRISPR Cas9" [Illustration]. Retrieved from Flickr.
Intellia data spark debate about CRISPR drug’s potential
Newly published data show the therapy reduced the rate of swelling attacks in people with hereditary angioedema, but didn't silence questions about its commercial outlook.
By Kristin Jensen • Oct. 24, 2024 -
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Alto hits new low as depression drug flunks key test
While analysts still see value in Alto’s approach to brain drugmaking, investors may have lost some faith, as the biotech’s shares were down by two-thirds Wednesday morning.
By Jacob Bell • Oct. 23, 2024 -
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Otsuka’s startup bet pays off with kidney disease drug results
A medicine the pharma acquired in a 2018 buyout of Visterra succeeded in a Phase 3 trial in IgA nephropathy, a crowded corner of drug research.
By Ben Fidler • Oct. 22, 2024 -
Courtesy of Novo Nordisk
Oral version of Novo diabetes drug protects heart health in large study
The medicine, which Novo sells as Rybelsus, cut the risk of cardiovascular complications by 14% when added to standard therapies in people with diabetes and heart disease.
By Jonathan Gardner • Oct. 21, 2024 -
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Sponsored by AltasciencesPharmaceutical research on mRNA and CAR T-cell therapy in cancer: Pioneering the future of oncology
Immunotherapy and precision medicine show promise in better fighting cancer. What else does the research tell us?
Oct. 21, 2024 -
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Merck antibody reduces RSV-related disease, hospitalizations in trial
Detailed data from a Phase 2b/3 study of Merck’s treatment clesrovimab should support the company’s efforts to win approval by the 2025-2026 season.
By Delilah Alvarado • Oct. 18, 2024
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