Phase III
The U.S. Food and Drug Administration announced they are investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib).
The same advantage against HIV-1 possessed by a person with the inactive CCR5 variant potentially doubles as resistance to any virus that capitalizes on or manipulates that receptor.
COVID-19 is a respiratory illness and presents many other symptoms, including blood clots. For more details and other COVID-19 news, continue reading.
The FDA’s decision is based on favorable results from Sanofi’s Phase III CARDINAL trial, a 26-week open label, single arm study on 24 CAD patients.
FDA Action Alert for February 7
It was a relatively quiet week for clinical trial announcements. Here’s a look.
UCB hit the mark in its Phase III clinical trial assessing zilucoplan, while Vanda failed its late-stage study of tradipitant.
Data from Phase III ECHELON-1 clinical study conducted with either stage III or stage IV cHL showed consistent improvement in OS across each of the six 28-day cycles completed.
The company indicated that its timeline for an accelerated approval request for its own Alzheimer’s drug, donanemab, was no longer on schedule for the first quarter after the CMS draft guidance.
Humira will begin to lose exclusivity in 2023, and numerous biosimilar competitors are waiting to break in on the drug’s lucrative market.
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