Epix Medical
This article was originally published in The Gray Sheet
Executive Summary
Phase III clinical trials for the AngioMARK (MS-325) injectable MRI contrast imaging agent for peripheral vascular indications are slated to begin in early 1999, Epix President and CEO Mike Webb reports Nov. 30 at the BancBoston Robertson Stephens conference in New York City. Data from Phase II clinicals were presented the same week at the Radiological Society of North America meeting in Chicago. The company expects to file a new drug application with FDA in the first half of 2000, Webb says
You may also be interested in...
Investors Go Beserk For Viking, Putting It Top Of Q1 Winners
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.