Clinical Trials: Page 2
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Courtesy of Matt Herp / American Society of Hematology
ASH24: Darzalex in smoldering myeloma, Merck’s ADC data and Novo’s sickle cell drug
J&J aims to expand Darzalex's use even further in the blood cancer, while Merck & Co. and Novo Nordisk presented at ASH mid-stage findings for important new medicines.
By Ned Pagliarulo , Jonathan Gardner , Ben Fidler • Dec. 9, 2024 -
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Deep DiveEndometriosis drug research, long underfunded, confronts familiar problems in women’s health
Despite the disease’s prevalence, endometriosis remains misunderstood, and research into drugs that might treat it draws scant funding — problems that have deep roots.
By Delilah Alvarado • Dec. 9, 2024 -
Explore the Trendline➔
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TrendlineVaccine development
Vaccine developers are turning from COVID-19 to invest more heavily in shots for RSV, influenza and pneumococcal disease.
By BioPharma Dive staff -
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Obesity drugsLilly’s Zepbound beats Novo’s Wegovy in high-stakes obesity drug trial
Results from the head-to-head study showed treatment with Zepbound resulted in 47% greater relative weight loss than Wegovy, a finding that could advantage Lilly in the companies’ market competition.
By Jonathan Gardner • Updated Dec. 4, 2024 -
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Obesity drugsAmgen obesity drug cuts weight in study, but results miss Wall Street’s high mark
Shares in Amgen fell by double digits Tuesday on results for the company’s MariTide shot, which is viewed as a potential rival to Wegovy and Zepbound.
By Jonathan Gardner • Nov. 26, 2024 -
Courtesy of Roche
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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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
On 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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Obesity drugsNovo, 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 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 -
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 -
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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