Government
BIO’s Jim Greenwood hailed the executive order as an important decision to foster biology-driven solutions to nutrition and improving crop yield.
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.
Government agencies in the United States and U.K. are scrutinizing Roche’s planned acquisition of the gene therapy company.
The guidance tends to focus on getting sponsor companies to include more historically underserved populations in clinical trials, including women, the elderly and minorities.
While the NIH research has been impacted, HHS said no research conducted outside of the NIH, which includes universities conducting research under NIH grants, will be affected at this time.
The approval marks Emgality as the first calcitonin gene-related peptide (CGRP) antibody to be approved for two distinct headache disorders.
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2019. We want to know your if you have ‘work-life balance’ with your job.
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.
Nivolumab plus ipilimumab meet primary endpoint of MD Anderson NEOSTAR Phase II trial
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