Australia Insists Orphan Designations Will Last Only Six Months, Overrides Industry Objections
Executive Summary
Sponsors making drugs for rare diseases in Australia who fail to file for approval within six months of being granted orphan designation will see their designation disappear, the Therapeutic Goods Administration has decided. The new procedure will be problematic for orphan drug sponsors and might even make it more difficult for them to use the new expedited pathways the agency is planning to introduce for innovative drugs.
You may also be interested in...
India Pushing Ahead With Rare Disease Policy Plan
India appears to be on course to developing a national rare disease policy, with the adoption of a specific definition for rare diseases and the initiation of a rare disease registry in the country.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Moment Of Truth For Seven EU Filings; Cytokinetics To Make Its Case For Heart Failure Drug
The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.