ATMP Withdrawals Are Keeping EU Regulators Awake At Night
Executive Summary
Europe is becoming less competitive in the advanced therapy space, something that is reflected in the number of EU ATMP marketing authorization withdrawals, speakers said at an event organized by the Alliance for Regenerative Medicine.
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.