The proposed joint clinical assessment methodology would have rejected nearly 90% of the ATMPs currently authorised in the EU, claims the Alliance for Regenerative Medicine (ARM). According to ARM, all seven gene therapies for rare genetic diseases would have been rejected under the baseline methodologies proposed… Read More
DDW’s Diana Spencer explores the European Commission’s proposed changes to EU pharmaceutical legislation, the reaction from industry and possible impact on smaller companies. The European Commission (EC) has proposed the largest reform to the EU’s pharmaceutical legislation in over 20 years. The EC says the revisions will make the… Read More
With European life sciences R&D investment at a 20-year low, biopharmaceutical associations and MEPs are calling on the EU to modernise its policies. DDW’s Diana Spencer asks what will be needed for Europe to compete in the growing global market for advanced therapies. … Read More
