The meeting focused on the phase I clinical trial, the ongoing phase II clinical trial, and next actions to be taken
Based on the successful FDA Open Seminar conference series, we’ll host a 2 hour crash course webinar. You will hear about the latest US drug regulation news and will obtain a solid introduction into FDA Regulatory Affairs.
Last week, Remco Munnik, Asphalion´s Regulatory Information Director, attended the meeting at EMA for S&P subgroup and the Regulatory Optimization Group (ROG)
During the two day meeting, the partners presented and discussed vividly the work and progress within the work packages, laying a thorough basis for the second year of the project.
Igenomix receives EMA Orphan Drug Designation for its product indicated for Asherman’s Syndrome with Asphalion support
Igenomix, a company leader in reproductive genetics and experts in infertility problems announced that its product autologous adult bone marrow-derived non-expanded CD133+ haematopoietic stem cells (IGX1) was granted the Orphan Drug Designation (ODD) on March 15th 2017 by the European Medicines Agency (EMA). The product is aimed at the treatment of patients with the Asherman’s syndrome (AS), a rare disease defined by the presence of intrauterine adhesions.