Clinical Trials
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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 -
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 -
Trendline
COVID-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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 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 -
Deep Dive
New 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 -
RSV vaccines
Pfizer, 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 -
Obesity drugs
Trial 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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
Obesity drugs
Viking stays in obesity drug race with early data for weight loss pill
The results are from a small Phase 1 study, but suggest Viking’s oral GLP-1 drug may not come with high rates of gastrointestinal side effects.
By Jonathan Gardner • March 26, 2024 -
Stoke shares surge on updated results for Dravet drug
The biotech is trying to develop a Spinraza-like drug for the condition, a form of genetic epilepsy. Fresh data appear supportive of a high dose’s effectiveness.
By Ned Pagliarulo • March 26, 2024 -
Axsome drug succeeds in narcolepsy symptoms trial
Despite the late-stage victory, shares of the New York-based biotech dipped more than 3%. One analyst argued that Axsome’s drug has “largely been falling under investor radars.”
By Jacob Bell • March 25, 2024