Clinical Trials
-
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 -
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 -
Explore the Trendline➔
Douglas Cliff via Getty Images
TrendlineThe obesity drug revolution
GLP-1 agonists like Ozempic and Wegovy can drive significant weight loss and, at least in Wegovy’s case, protect the heart. Their adoption is changing how doctors treat obesity.
By BioPharma Dive staff -
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 -
SDI Productions via Getty Images
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 -
Douglas Cliff via Getty Images
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 -
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 -
Michael M. Santiago via Getty Images
Obesity drugsViking 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 -
Elizabeth Regan / Industry Dive
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 -
Stock via Getty Images
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 -
FDA rejects Regeneron lymphoma drug, setting back company’s oncology push
The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers.
By Jonathan Gardner • March 25, 2024 -
AdobeStock/ Eakkachai
Sponsored by TriNetXImproving clinical trial design with real-world data
Leveraging real-world data (RWD) transforms global clinical trials, enhancing patient engagement and improving regulatory decision-making.
March 25, 2024 -
Courtesy of Roche
Roche autoimmune disease drug disappoints in closely watched trial
Though the medicine hit its goal in a Phase 3 study in myasthenia gravis, the results fell short of expectations in a boost to rival drug developers like Argenx and AstraZeneca.
By Jonathan Gardner • March 21, 2024 -
MadamLead via Getty Images
Acelyrin eye drug heads to late-stage testing after trial win
The biotech, which raised $540 million in an initial public offering last year, is pitching the medicine as a potential challenger to Amgen’s blockbuster eye drug Tepezza.
By Jacob Bell • March 20, 2024 -
Sean Gallup via Getty Images
With new data, Bayer readies rival to Astellas menopause drug
Following a third successful Phase 3 trial, the company is planning approval filings for the medicine, which it acquired in a $425 million deal four years ago.
By Delilah Alvarado • March 19, 2024
