Notice of the withdrawal of pan-EU marketing authorizations applications by Kiadis Pharma and Aradigm are noted in the agenda of the latest meeting of the European Medicines Agency's key scientific committee, the CHMP.
Two companies – Kiadis Pharma and Aradigm – have formally withdrawn pan-EU marketing authorization applications (MAAs) after they were told these were likely to be rejected. A third company, Actelion, has withdrawn an application to extend an indication of an already marketed product.
The MAAs relate to Kiadis Pharma’s lead product and stem cell transplant adjunct, ATIR101, and Aradigm’s inhaled antibiotic,...
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.
US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
