Clinical Trials: Page
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Roche, following setbacks, turns to its next Alzheimer’s drug
Roche said its experimental Alzheimer’s disease drug trontinemab showed it might be able to clear brain plaques faster than other medicines.
By Jonathan Gardner • March 11, 2024 -
Permission granted by Amylyx Pharmaceuticals
Q&AAmylyx CEOs look for a path forward following major setback
Justin Klee and Joshua Cohen spoke to BioPharma Dive about the next steps for their company, which is considering pulling its only product from market after the drug failed a confirmatory study in ALS.
By Jacob Bell • March 11, 2024 -
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TrendlineRadiopharmaceuticals
A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.
By BioPharma Dive staff -
Permission granted by Amylyx Pharmaceuticals
Amylyx ALS drug fails crucial study, putting company’s future in doubt
The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.
By Jacob Bell • Updated March 8, 2024 -
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NodThera says inflammation drug has positive effect in Parkinson’s
The results from the privately held biotech add to early evidence supporting the potential of an increasingly popular drug target known as NLRP3 inflammasomes.
By Jacob Bell • March 7, 2024 -
Courtesy of Novo Nordisk
Novo’s latest obesity pill spurs major weight loss in small trial
Early results from a Phase 1 study suggest the drug, amycretin, could be as potent as injectable medicines already sold by Novo and rival Eli Lilly.
By Jonathan Gardner • March 7, 2024 -
Alnylam, Roche blood pressure drug scores in second mid-stage trial
The study results further validate Roche’s recent decision to acquire rights to the drug, which is being developed for people with a stubborn form of hypertension.
By Jonathan Gardner • March 5, 2024 -
Courtesy of Apogee Therapeutics
Apogee data hint at potential for long-lasting eczema drug
The biotech, which raised $300 million in an IPO last year, disclosed early results suggesting its therapy could be dosed less frequently than medicines from Eli Lilly and Regeneron.
By Kristin Jensen • March 5, 2024 -
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Akero strengthens MASH drug’s case with new study data
The updated results show that responses to the drug, which is currently in late-stage testing, deepened with time, helping the company rebound from an earlier setback.
By Ben Fidler • March 4, 2024 -
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Sponsored by QIAGENUsing knowledge graphs to drive drug discovery
How are knowledge graphs changing the path of drug discovery?
March 4, 2024 -
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Incannex says psilocybin therapy lowered anxiety in small study
Shares of the Australian biotech rocketed up about 55% after the company announced results from a mid-stage study in generalized anxiety disorder.
By Jacob Bell • Feb. 28, 2024 -
Elizabeth Regan/BioPharma Dive
Viking data suggest obesity drug could rival Zepbound, Wegovy
The biotech’s drug led to significant weight loss in a Phase 2 trial, causing shares to double as analysts compared results to the marks set by drugs from Eli Lilly and Novo Nordisk.
By Jonathan Gardner • Feb. 27, 2024 -
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Janux shares triple on early cancer immunotherapy data
Analysts viewed results for one of Janux’s drug, a T cell engager aimed at metastatic prostate cancer, as potentially best-in-class in a field that’s crowded with competitors.
By Ned Pagliarulo • Feb. 27, 2024 -
Courtesy of U.S. Food and Drug Administration
Minerva schizophrenia drug rejected by FDA
The agency’s complete response letter knocks back Minerva’s attempt to secure approval of the drug over agency reviewers’ objections.
By Ned Pagliarulo • Feb. 27, 2024 -
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GSK drug meets goal in late-stage gonorrhea study
The drug, one of several GSK is developing for drug-resistant bacteria, has now succeeded in testing against two different infections.
By Delilah Alvarado • Feb. 26, 2024 -
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Obesity drug from Boehringer, Zealand succeeds in MASH trial
Zealand shares rose by more than one-third on the data, which provide further evidence so-called incretin drugs could help treat people with the liver disease.
By Ben Fidler • Feb. 26, 2024 -
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NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease
The full results spotlight cell therapy’s potential to treat lupus and other inflammatory conditions, but also the problems drugmakers must still solve.
By Ben Fidler • Feb. 21, 2024 -
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Bavarian Nordic terminates cancer vaccine work
The Danish company scrapped a vaccine in Phase 1 testing and will exit oncology altogether, focusing instead on infectious disease research.
By Jonathan Gardner • Feb. 21, 2024 -
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AstraZeneca gets new Tagrisso OK as drug succeeds in another trial
The FDA approved the targeted therapy together with chemo for first-line metastatic lung cancer, while fresh trial results supported earlier use.
By Ned Pagliarulo • Feb. 20, 2024 -
iStock / metamorworks
Sponsored by AllucentTranslating complex data into actionable insights, to create big value for smaller biotech companies
Why clinical pharmacology is critical to accelerating drug development, and how it can help drive value in a complex and rapidly evolving landscape.
Feb. 20, 2024 -
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ALS drug developmentALS drug from Denali, Sanofi falls short in mid-stage study
The disclosure the experimental therapy missed its trial goal comes after Sanofi had earmarked the drug for advancement into Phase 3.
By Delilah Alvarado • Feb. 16, 2024 -
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Alnylam changes to heart drug trial spark doubts, sinking shares
Analysts pressed Alnylam executives on the reasons for changes to HELIOS-B, a Phase 3 study in ATTR amyloidosis with cardiomyopathy that is important to the company’s future.
By Ben Fidler • Feb. 15, 2024 -
Elizabeth Regan/BioPharma Dive
Kalvista pill succeeds in late-stage study for rare swelling disorder
The biotech's drug quickly alleviated symptoms of the swelling attacks associated with hereditary angioedema, supporting the idea it could be an oral alternative to existing medicines.
By Ben Fidler • Updated Feb. 13, 2024 -
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CSL heart drug misses goal in large study
The failure of CSL’s plasma-derived infusion, which contains a protein in “good” cholesterol, follows a similar path as pills from Lilly, Merck, Pfizer and Roche.
By Jonathan Gardner • Feb. 12, 2024 -
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Takeda speeds narcolepsy drug to late-stage testing
New results have convinced Takeda to “rapidly” pursue a late-stage program for its drug TAK-861 in one type of narcolepsy, while in another the company opted not to continue.
By Jacob Bell • Feb. 9, 2024 -
Courtesy of Johnson & Johnson
J&J says top drug prospect works across autoimmune disorders
The pharma disclosed positive results from two studies testing its antibody drug nipocalimab in generalized myasthenia gravis or Sjögren's disease.
By Jacob Bell • Feb. 5, 2024
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