Clinical Trials
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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 -
Stock via Getty Images
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 -
Explore the Trendline➔
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
TrendlineCOVID-19 vaccines
The urgency of the pandemic’s first two years is giving way to questions of how to sustain public health responses and prepare for what could come next. In the U.S., health officials are urging booster shots and preparing for private sector distribution of vaccines.
By BioPharma Dive staff -
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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 -
koto_feja via Getty Images
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 -
Scott Olson via Getty Images
Obesity drugsLilly 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 -
Eoneren via Getty Images
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 -
Chris McGrath via Getty Images
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 -
iStock via Getty Images
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 -
Mario Tama via Getty Images
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 -
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Deep DiveNew postpartum depression drugs are here. Diagnosis, treatment hurdles still stand in the way.
The first medicine approved for PPD, Sage’s Zulresso, never gained traction. The company is in the midst of launching its second, but long-standing challenges could slow uptake.
By Delilah Alvarado • April 10, 2024 -
Jeenah Moon via Getty Images
RSV vaccinesPfizer, with new study results, seeks to bring RSV shot to adults aged 18-59
The company plans to submit the trial data to regulators in a bid to win approval of its vaccine Abrysvo in adults as young as 18 years old.
By Delilah Alvarado • April 9, 2024 -
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Obesity drugsTrial shows Wegovy can ease heart failure symptoms
The results were the second time Novo has shown its weight loss treatment can help with the condition, and may help it secure broader use of the drug.
By Jonathan Gardner • April 8, 2024 -
Stock via Getty Images
Women want to participate in clinical trials. Lack of flexibility is still a problem.
Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.
By Kelly Bilodeau • April 8, 2024 -
Kena Betancur via Getty Images
Merck puts KRAS cancer drug competitor to the test
A Phase 3 study will compare Merck’s experimental KRAS inhibitor together with its immunotherapy Keytruda against Keytruda alone in lung cancer.
By Ned Pagliarulo • April 4, 2024 -
Maximusnd via Getty Images
Roivant reveals positive immune drug data, share buyback plans
A Pfizer drug licensed to a Roivant subsidiary surpassed expectations in a type of uveitis, while a stock purchase plan will see Roivant buy out shares owned by Sumitomo Pharma.
By Delilah Alvarado • April 2, 2024 -
Meletios Verras via Getty Images
Gritstone shares fall on shaky study results for colorectal cancer vaccine
While the company claimed its shot showed signs of working in a Phase 2 trial, the data weren’t strong enough to prove a treatment benefit.
By Ben Fidler • April 2, 2024 -
Seth Babin/BioPharma Dive
Verve pauses base editing trial, shifts strategy after treatment side effect
Lab abnormalities in one study participant led the company to halt enrollment and prioritize a different version of its genetic medicine for heart disease.
By Ned Pagliarulo • April 2, 2024 -
Courtesy of Vertex Pharmaceuticals
Vertex moves kidney disease drug into late-stage testing
The drug, inaxaplin, is an important pipeline prospect for Vertex, which is working to expand beyond the cystic fibrosis medicines that made its name.
By Delilah Alvarado • April 1, 2024 -
National Cancer Institute, NIH
Bristol Myers says KRAS drug succeeds in key trial
Confirmatory results for Krazati, which Bristol Myers acquired via its buyout of Mirati, could help the drug win full approval while Amgen has been set back.
By Jonathan Gardner • March 29, 2024 -
koto_feja via Getty Images
European study finds popular ALS drug ineffective
The failure of a medicine known as TUDCA is yet another disappointment for ALS patients, as it comes just after Amylyx’s therapy Relyvrio proved unsuccessful in confirmatory testing.
By Jacob Bell • March 27, 2024
