Phase III
At the virtual Congress of the ECTRIMS meeting this week, multiple companies present data for ongoing studies of therapies for multiple sclerosis. BioSpace takes a look at some of the data.
Less private investment and innovation in the development of new antibiotics are impeding efforts to combat drug-resistant infections.
The drug is limited to patients who test at least 20% for a Ki-67 score on an FDA-approved test.
Its Phase III MODIFY study had hoped to find a positive effect of its oral substrate reduction therapy lucerastat on adult patients who have been diagnosed with Fabry disease.
Roche’s candidate drug for Alzheimer’s treatment received breakthrough therapy designation which has increased its chance of getting full FDA approval.
According to Fauci, kids can safely go trick-or-treating outdoors this Halloween. He did add that children who are eligible for COVID-19 vaccinations should do so for an “extra degree of protection.”
If authorized, it could be available in the U.S. before the end of the year. It is also working to submit applications to other regulators worldwide.
This year – 2021 – will be a transformational year, Rosen predicted, citing three important milestones.
Based on results from the Phase II and Phase III TAK-620-303 (SOLSTICE) trials, members of the AMDAC unanimously voted in favor of using maribavir.
PRESS RELEASES