Clinical Trials: Page 14
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Novartis study points to larger role for targeted leukemia drug
Results from a trial called ASC4FIRST show Scemblix outperformed Gleevec and other drugs in treating newly diagnosed chronic myeloid leukemia.
By Ned Pagliarulo • Updated June 3, 2024 -
Mario Tama via Getty Images
J&J antidepressant eases symptoms, improves sleep in key trial
The company has put high expectations on the drug, an orexin-2 antagonist called seltorexant, as a cornerstone of its neuropsychiatry pipeline.
By Ned Pagliarulo • May 29, 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 -
Elizabeth Regan/BioPharma Dive
Insmed shares double as lung drug data convince Wall Street
After reporting positive clinical trial results for its drug brensocatib, Insmed plans to later this year file for U.S. approval in bronchiectasis that’s not associated with cystic fibrosis.
By Ned Pagliarulo • May 28, 2024 -
ASCO / Nick Agro
Certain menopausal hormone therapy could raise ovarian cancer risk, study finds
The findings, from two trials involving thousands of women, could influence guidelines around use of hormonal treatment for menopause symptoms.
By Delilah Alvarado • May 23, 2024 -
ASCO / Nick Agro
ASCO24: An early look at cancer drug study results
Clinical trial abstracts posted Thursday ahead of this year’s ASCO meeting give a peek at anticipated datasets from Immunocore, Merus, J&J and Merck & Co.
By BioPharma Dive staff • Updated May 24, 2024 -
Elizabeth Regan/BioPharma Dive
Dyne shares jump on trial data for muscle disease drugs
Updated study results for the biotech’s medicines for myotonic dystrophy Type 1 and Duchenne muscular dystrophy appeared to impress analysts and investors on Wall Street.
By Ned Pagliarulo • May 20, 2024 -
iStock / Worawut Prasuwan
Sponsored by PanalgoThe ABCs of SDOH: Meaningful strategies to improve patient outcomes
As biopharmaceutical and medical device companies increasingly recognize the impact of SDOH, a question emerges: how can these sponsors effectively integrate SDOH data into clinical trial recruitment and real-world evidence strategies?
By Meg Richards, PhD, MPH, Executive Director, Scientific Strategy at Panalgo, with Andrew Goldstein, VP of Client Partnerships at Panalgo • May 20, 2024 -
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Detailed trial data show Bayer drug alleviates menopause symptoms
Full study results disclosed ahead of a medical meeting showed elinzanetant consistently reduced the frequency and severity of hot flashes.
By Delilah Alvarado • May 16, 2024 -
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Lilly’s once-weekly insulin matches daily shots in late-stage tests
The results, which showed Lilly’s drug was as effective at controlling blood sugar as standard injections, come as Novo Nordisk seeks approval for a competing once-weekly insulin.
By Ned Pagliarulo • May 16, 2024 -
Courtesy of Roche
Roche keeps pace in obesity drug field with early study data
A drug Roche acquired in a buyout of Carmot Therapeutics and that works similarly to Zepbound helped people lose nearly 19% of their body weight in a Phase 1 trial.
By Jonathan Gardner • May 16, 2024 -
Permission granted by Biogen
ALS drug developmentBiogen, Ionis shelve ALS drug following study failure
While results indicated the drug works as intended, it didn’t have enough of an effect on a protein that’s become integral to many ALS research programs.
By Jacob Bell • May 16, 2024 -
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Novo Holdings buys stake in life sciences tools company; BioMarin lays off 170
The parent of Novo Nordisk is acquiring 60% ownership of Single Use Support, which specializes in handling of advanced therapies. Elsewhere, BioMarin and gene therapy developer Tenaya are cutting jobs.
By Ned Pagliarulo • May 15, 2024 -
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Sponsored by PearsonAcknowledging comorbidities in trial design is essential for successful outcomes
Examine why adaptive trials that consider comorbidities are critical for a successful trial outcome.
May 13, 2024 -
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Patient dies in Pfizer study of Duchenne gene therapy
Pfizer said the patient, a young boy who was treated earlier last year, died suddenly from cardiac arrest. The company is working with trial researchers to investigate further.
By Ben Fidler • Updated May 8, 2024 -
Seth Babin/BioPharma Dive
Verve moves forward with backup base editing therapy
Weeks after a safety setback derailed its lead candidate, the company has treated the first participant in a trial of its heart disease treatment Verve-102.
By Ned Pagliarulo • May 7, 2024 -
Shutterstock / Rocketclips, Inc.
Sponsored by Elligo Health ResearchOptimized trials are the easiest way to meet the FDA’s latest diversity requirements
Optimized clinical trials will help sponsors align with new FDORA diversity requirements.
May 6, 2024 -
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Amgen shares soar as executives outline obesity drug push
The company said data for its Wegovy competitor was promising enough to move the drug into late-stage testing, triggering a stock jump that added billions to Amgen’s market value.
By Jonathan Gardner • May 3, 2024 -
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Deep Dive // State of PlayChasing Novo and Lilly: The obesity drugs that could challenge Wegovy and Zepbound
Large and small drugmakers are vying for a piece of what analysts view as one of the biggest market opportunities in the pharma industry's history. Here’s what’s coming next.
By Jonathan Gardner • April 30, 2024 -
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Prime gets FDA green light to begin first trial test of ‘prime editing’
The company will soon start a Phase 1/2 study of its treatment for chronic granulomatous disease, a milestone for the search-and-replace gene editing technology.
By Ned Pagliarulo • April 29, 2024 -
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AstraZeneca, Daiichi look to broaden Enhertu use again with new study data
The drug benefited people whose tumors have “ultralow” levels of HER2 protein, a result that could extend its reach in HER2-positive breast cancer.
By Ben Fidler • April 29, 2024 -
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Sponsored by FortreaSystems thinking: A new paradigm for clinical trial design and operations
Applying a systems thinking framework to clinical trial design prompts purposeful and productive collaboration among stakeholders.
By John Doyle, Dr.P.H., President of Consulting at Fortrea • April 29, 2024 -
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Neurocrine scores surprise win with depression drug
Shares of the biotech rose about 5% after a medicine licensed from Takeda hit the main and key secondary goals of a mid-stage study focused on major depressive disorder.
By Jacob Bell • April 23, 2024 -
Permission granted by Cerevel Therapeutics
Cerevel, in ‘major surprise,’ finds success in late-stage Parkinson’s study
Analysts had low expectations for Cerevel’s drug tavapadon, which was something of an afterthought in AbbVie’s proposed buyout of the biotech.
By Ned Pagliarulo • April 18, 2024 -
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Lilly obesity drug shows benefit in sleep disorder study, pointing to new use
Positive data for Lilly’s medicine tirzepatide in sleep apnea are the latest signal the benefits of GLP-1 agonists could extend beyond diabetes and weight loss.
By Jonathan Gardner • April 17, 2024 -
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Sage’s cognition drug fails in Parkinson’s study
Following negative results, the company doesn’t plan to further test SAGE-718 in Parkinson’s. Other studies in Huntington’s and Alzheimer’s remain ongoing.
By Jacob Bell • April 17, 2024
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