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The companies plan to submit a supplemental Biologics License Application to the FDA to expand the vaccine’s approval to include children aged 12 years and older. Read More
More than 40 percent of patients in pivotal phase 3 trials of Aduhelm (aducanumab), Biogen’s FDA-approved Alzheimer’s treatment, experienced either brain swelling or microhemorrhages associated with the now-approved 10 mg/kg dose. Read More
Public Citizen has called on the FDA to take strong action against two Minneapolis, Minn., investigators and the institutional review board (IRB) at Hennepin County Medical Center (HCMC) over investigational new drug (IND) and informed consent issues on some of their trials. Read More
The two-dose Pfizer-BioNTech COVID-19 vaccine regimen was 100 percent effective in preventing disease in children aged 12-15 years, the companies reported. Read More
Citing declining lymphocyte and T-cell counts in some patients, Merck has stopped its phase 2 trial of a dual-agent HIV antiretroviral regimen and is probing similar studies for this concerning safety signal. Read More
AstraZeneca’s one-time dual-antibody injection cut the risk of symptomatic COVID-19 by up to 83 percent and the risk of severe disease by 88 percent in two studies of high-risk patients. Read More
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
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