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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
The problems inherent in studying antibiotic-resistant bacteria could be better solved with a widespread automated system that pulls real-world data from electronic health records (EHR). Read More
Study investigator Nicolas Girard, head of the Thorax Institute Curie Montsouris in Paris, called the results of the Checkmate-816 trial “groundbreaking.” Read More