EU Ruling On Market Exclusivity Period Turns Days Into EURmillions For Drug Companies
This article was originally published in SRA
Executive Summary
Just a few days could make a big difference for your company, perhaps millions of Euros. Thanks to a ruling from the Court of Justice of the European Union, some innovative products could have their market exclusivity period extended in some EU markets by a number of days or maybe weeks.
You may also be interested in...
Germany Confirms No Reimbursement Status For ‘Lifestyle’ Drug Wegovy
In Germany Novo Nordisk’s obesity drug Wegovy will remain excluded from reimbursement for obesity, unlike Rhythm’s Imcivree.
New HTA Evidence Guidelines In EU Could Spell Trouble For Advanced Therapy Companies
New guidelines that cast doubt over use of single-arm and non-randomized studies are “discouraging” for rare disease patients and the advanced therapy sector, says ARM, the Alliance for Regenerative Medicines.
Germany Courts Clinical Trials With Regulator Reshuffle & New Federal Ethics Committee
Plans to rejig two regulators’ roles and streamline the ethics committee system have drawn some criticism.