Clinical Trials
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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 -
Explore the Trendline➔
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TrendlineImmunology
Promising new mechanisms of action are driving significant pharmaceutical company investment into drugs for immune diseases like psoriasis and Crohn’s.
By BioPharma Dive staff -
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
Biogen, 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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News roundupNovo 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
Gene editingVerve 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 -
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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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Obesity drugsAmgen 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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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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Obesity drugs
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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Intra-Cellular builds case for depression drug with late-stage trial win
Shares of the biotech rose 25% after a large trial found adding its drug Caplyta onto antidepressant therapy significantly helped people with major depression.
By Jacob Bell • April 16, 2024 -
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Ukraine was pharma’s clinical trial ‘darling.’ As war drags on, will the industry return?
While some new drug studies are getting underway, activity is still far below bustling pre-war levels.
By Meagan Parrish • April 16, 2024 -
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Roche reports survival data for new dual-acting lymphoma drug
The results could give Roche’s Columvi an edge over a rival medicine from AbbVie and Genmab, while Regeneron awaits an approval of its own therapy.
By Jonathan Gardner • April 15, 2024 -
Permission granted by Neumora Therapeutics
Neumora’s schizophrenia drug hit with clinical hold
Shares of the biotech dipped by double digits following disclosure the FDA had paused an early-stage study of Neumora’s muscarinic-targeting drug.
By Jacob Bell • April 15, 2024 -
Image courtesy of Ultragenyx.
Ultragenyx says Angelman therapy is working, but safety questions remain
Treatment appeared to result in functional and cognitive gains in people with the neurological disorder. Three participants experienced lower extremity weakness, however.
By Ned Pagliarulo • April 15, 2024 -
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European regulator concludes no suicide link to obesity drugs
The decision clears a concern hanging over GLP-1 medicines like Ozempic since reports of suicidal ideation and self-harm among people taking the drugs surfaced in July.
By Jonathan Gardner • April 12, 2024 -
Novartis
Novartis pauses enrollment in some Kisqali trials to fix manufacturing
The company said the pause is necessary to meet regulatory limits on nitrosamine, but added it will not affect commercial supply nor regulatory review of the drug in early breast cancer.
By Jonathan Gardner • April 10, 2024
