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In the once-daily group the endpoint occurred in 25 percent of the 25-mg group, 24 percent of the 50-mg group and 7 percent of the 200-mg group. Read More
When the FDA gets tough on clinical trial transparency, the industry listens. The problem is the FDA doesn’t get tough with enough regularity. Read More
Outside of oncology, said Friends of Cancer Research in the report, most drugs are evaluated in randomized dose-ranging trials that support a broader understanding of the impact of different doses on efficacy and toxicity. Read More
The group previously established a collaborative research initiative to harmonize the use of ctDNA to monitor treatment response to determine if changes in ctDNA levels accurately reflect the therapeutic effect of immunotherapies in advanced lung cancer. Read More
Sponsors seeking accelerated approval from the FDA should know that a required postapproval confirmatory trial takes about seven months longer than the typical phase 3 trial, leading some researchers to suggest that accelerated approval doesn’t give a drugmaker as much advantage as it appears. Read More
Using outmoded dosing structures, oncologists may be giving patients unnecessarily high doses of cancer meds, which provides no added benefit to the patient and, in fact, causes unnecessary side effects. The answer? More trials in oncology. Read More
Lecanemab, the antiamyloid antibody being jointly developed by Eisai and Biogen, grabbed the clinical trial world with a fresh look at extension data and news of its inclusion in an important treatment trial for genetically driven Alzheimer’s disease. Read More
Valneva reported positive phase 3 results last month, claiming that VLA2001 induced higher levels of neutralizing antibodies in adults 30 years and older than AstraZeneca’s shot. Read More
The biomarker known as circulating tumor DNA (ctDNA) is well-suited to become an early endpoint in oncology, as it has the potential to improve confidence in the efficacy of novel therapies, thus bringing better treatments to patients faster. Read More
A new national registry, sponsored by the Alzheimer’s Association, will track real-world outcomes data for Alzheimer’s patients receiving FDA-approved treatments for the disease, including the antiamyloid antibody Aduhelm. Read More