The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
Actelion Settles REMS Dispute with Generic Drug Manufacturers
This settlement follows an October 2013 decision in the case by U.S. District Judge Noel Hillman denying Actelion’s motion for judgment on the pleadings and allowing the case to proceed to discovery. However that ruling did not address the merits of the issues at the core of the lawsuit, and with this settlement it appears that these questions will remain unresolved for now.
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017
On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders...03 January 2017