New orphan maintenance assessment reports are expected to increase transparency around the European Medicines Agency's decision-making process on whether an orphan-designated drug continues to qualify as an orphan once it gets on to the market.
The European Medicines Agency has started publishing its reasons for why drugs that were designated as orphan medicines during their development do or do not continue to fulfil the necessary criteria to be designated as orphans after they are recommended for approval by the agency.
The agency is publishing these decisions in the form of an orphan maintenance assessment report, the first of which was...
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
The Council of the EU’s vision for the pharma reform package includes a stronger role for member states regarding the supply of medicines and the prevention of indication-stacking for orphan drugs.
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.
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
