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Data from the clinical study showed that 40% of people treated with the Polivy regimen achieved a complete response.
The approval was built on data from the Phase III KEYNOTE-048 clinical trial.
The guidance tends to focus on getting sponsor companies to include more historically underserved populations in clinical trials, including women, the elderly and minorities.
With more than 16,000 attendees from 67 countries and hundreds, even thousands of presentations, it can be difficult to get a real grip on everything that went on at the 2019 BIO International Convention held in Philadelphia. Here’s a look at just a few of the highlights.
The researchers, in analyzing more than 400,000 genomes and associated health records, found that individuals with two mutated copies of the CCR5 gene, the one He Jiankui modified, had a significantly higher death rate between the ages 41 and 78 than people with one or no copies.
The approval marks Emgality as the first calcitonin gene-related peptide (CGRP) antibody to be approved for two distinct headache disorders.
Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia are life-threatening hospital-related pulmonary infections that can particularly impact patients who are already dealing with severe underlying medical conditions.
Accsense Monitoring System Automates Data Archive and Alarming
Here’s a look at what’s on the U.S. Food and Drug Administration’s calendar for the next two weeks.
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