Clinical Trials: Page 6
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Roche sticks with Parkinson’s drug despite second study failure
Even with another mid-stage setback, Roche believes there were enough positive signs to “merit further exploration” of the drug, which it’s been developing with Prothena for more than a decade.
By Jacob Bell • Dec. 19, 2024 -
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Regeneron says study data support big bet on new blood thinners
The company is planning a “broad Phase 3 program” for two anticoagulants after they outperformed marketed medicines in a pair of mid-stage trials.
By Jonathan Gardner • Dec. 19, 2024 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
TrendlineCell therapy
The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.
By BioPharma Dive staff -
Courtesy of Vertex Pharmaceuticals
Vertex ‘ends the year in pain’ as latest non-opioid drug data disappoint
Mixed results from a study focused on lower back pain left analysts wanting as well as confused about Vertex's plans to forge ahead in the indication.
By Jacob Bell • Dec. 19, 2024 -
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Sanofi, Teva say study results show gut disease drug could be ‘best in class’
Phase 2 results in inflammatory bowel disease hinted the therapy could be more potent than similar medicines from Merck and Roche, each of which were acquired in multibillion-dollar deals.
By Ben Fidler • Dec. 17, 2024 -
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Maternal mortality trends are dire — and reversing them remain an uphill battle
Rising maternal mortality, particularly among vulnerable groups, has roots in insufficient research involving pregnant women.
By Michael Gibney • Dec. 17, 2024 -
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Edgewise weighs fast approval path for muscular dystrophy drug
The biotech company will meet with regulators to discuss Phase 2 biomarker data that sent its shares climbing by more than 20% Monday.
By Ned Pagliarulo • Dec. 16, 2024 -
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Merck calls quits on two immunotherapies for cancer
The company is scrapping two drugs aimed at targets called TIGIT and LAG-3, both of which were in the middle of Phase 3 testing.
By Jonathan Gardner • Dec. 16, 2024 -
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Keros shares collapse on ‘unanticipated’ setback for lung disease drug
Safety concerns Keros observed in a Phase 2 trial triggered a stock selloff for what had been one of the sector’s most successful initial public offerings of the last four years, according to BioPharma Dive data.
By Kristin Jensen • Dec. 12, 2024 -
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With new data, Lilly sets pace for next wave of breast cancer drugs
While other big pharmas have faltered, Lilly made headway in a Phase 3 trial that could provide a treatment option to replace fulvestrant.
By Jonathan Gardner • Updated Dec. 11, 2024 -
ASH/Todd Buchanan
ASH24: Leukemia drug sequencing, sickle cell questions and a new kind of CAR-T
Data from Eli Lilly and AstraZeneca could help doctors decide treatment order in chronic lymphocytic leukemia. Elsewhere, answers remained elusive on Pfizer's abrupt withdrawal of Oxbryta.
By Ned Pagliarulo • Dec. 10, 2024 -
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NewAmsterdam drug shows ‘unexpected’ signs of protecting the heart in latest study
The findings add to evidence that the company’s drug, obicetrapib, could change the narrative surrounding a once-abandoned class of heart medicines called CETP inhibitors.
By Ben Fidler • Dec. 10, 2024 -
Courtesy of Matt Herp / American Society of Hematology
ASH24: Darzalex in smoldering myeloma, Merck’s ADC data and Novo’s sickle cell drug
J&J aims to expand Darzalex's use even further in the blood cancer, while Merck & Co. and Novo Nordisk presented at ASH mid-stage findings for important new medicines.
By Ned Pagliarulo , Jonathan Gardner , Ben Fidler • Dec. 9, 2024 -
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Deep DiveEndometriosis drug research, long underfunded, confronts familiar problems in women’s health
Despite the disease’s prevalence, endometriosis remains misunderstood, and research into drugs that might treat it draws scant funding — problems that have deep roots.
By Delilah Alvarado • Dec. 9, 2024 -
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Obesity drugsLilly’s Zepbound beats Novo’s Wegovy in high-stakes obesity drug trial
Results from the head-to-head study showed treatment with Zepbound resulted in 47% greater relative weight loss than Wegovy, a finding that could advantage Lilly in the companies’ market competition.
By Jonathan Gardner • Updated Dec. 4, 2024 -
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Obesity drugsAmgen obesity drug cuts weight in study, but results miss Wall Street’s high mark
Shares in Amgen fell by double digits Tuesday on results for the company’s MariTide shot, which is viewed as a potential rival to Wegovy and Zepbound.
By Jonathan Gardner • Nov. 26, 2024 -
Roche’s TIGIT-targeting drug for cancer fails its biggest test
Long-awaited results released Tuesday showed adding tiragolumab to Roche's immunotherapy Tecentriq did not extend survival in a closely followed Phase 3 study called SKYSCRAPER-01.
By Ned Pagliarulo • Nov. 26, 2024 -
National Institute on Aging. (2017). "Beta-Amyloid Plaques and Tau in the Brain" [Image]. Retrieved from Flickr.
Alector turns to layoffs as Alzheimer’s drug fails
The brain drug developer is letting go of around 41 of its 238 employees, in a move the company says will help “align resources” with its strategic priorities.
By Jacob Bell • Nov. 26, 2024 -
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New data could help Merck expand use of cardiovascular drug
Positive study results for Winrevair could help the drugmaker achieve sales growth past top-seller Keytruda’s upcoming patent expirations this decade.
By Jonathan Gardner • Nov. 25, 2024 -
Courtesy of Biohaven Ltd.
Biohaven muscle drug misses goal of SMA study, but advances in obesity
The setback likely removes one competitor to an emerging spinal muscular atrophy medicine from Scholar Rock, but sets the stage for a pair of readouts with implications for weight loss research.
By Ben Fidler • Nov. 25, 2024 -
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Sage’s string of research failures continues
Negative results from a Huntington’s trial add to a calamitous year for Sage, which last month decided to overhaul its research, reconfigure its executive team and lay off a third of its staff.
By Jacob Bell • Nov. 20, 2024 -
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J&J pill clears skin in two late-stage psoriasis studies
The drug, called icotrokinra and developed together with Protagonist Therapeutics, is an oral peptide designed to tamp down the inflammation involved in psoriasis and other immune diseases.
By Ned Pagliarulo • Nov. 19, 2024 -
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FDA endorses speedy approval path for Regenxbio Duchenne gene therapy
The agency's openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.
By Ben Fidler • Nov. 18, 2024 -
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Sponsored by Thermo Fisher ScientificLeveraging NGS to move precision oncology forward, from CDx to commercialization
Learn how the optimal NGS solution can help you hit your milestones during clinical trials, throughout CDx development and into global commercialization.
Nov. 18, 2024 -
Courtesy of AbbVie
Brain drug revivalOn Wall Street, ‘flat out’ failure of AbbVie schizophrenia drug leaves analysts stunned
Negative data cost AbbVie billions of dollars in market value and convinced analysts Bristol Myers had placed a better bet in buying Karuna Therapeutics.
By Jacob Bell • Nov. 11, 2024 -
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FDA lifts pause on Novavax flu vaccine trials
After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.
By Delilah Alvarado • Nov. 11, 2024
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