Clinical Trials: Page 14
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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 -
Explore the Trendline➔
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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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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 -
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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 -
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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 -
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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 -
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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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Wave sees RNA editing validation in early trial results
The data provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.
By Ben Fidler , Ned Pagliarulo • Oct. 16, 2024 -
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FDA puts Novavax flu vaccine trials on hold
The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza.
By Delilah Alvarado • Oct. 16, 2024 -
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GSK says antibody drug succeeds in testing for chronic nasal condition
The company has set high expectations for depemokimab, which it is also advancing in three other inflammatory diseases, including asthma.
By Delilah Alvarado • Oct. 14, 2024 -
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Sponsored by Thermo Fisher ScientificFrom maximizing recruitment to promoting diversity: How to deploy NGS technologies to achieve clinical trial success
Learn how the right NGS technology can enhance clinical research while supporting downstream efforts toward global commercialization.
Oct. 14, 2024 -
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Sponsored by PearsonSuccessful COA selection paves the path to drug development
Choosing the right clinical outcome assessments (COAs) is an important part of successfully advancing drug development and securing regulatory approval.
Oct. 14, 2024
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