Aplidin (plitidepsin) to be re-evaluated by the EMA for Multiple Myeloma
- The European Commission (EC) has acknowledged that an expert from the Scientific Advisory Group, who was developing a rival product was allowed to participate in the Marketing Authorization procedure for Aplidin (plitidepsin).
- The EC requests the European Medicines Agency, EMA, to re-evaluate the application for Aplidin in Multiple Myeloma.
- This exceptional decision supports what PharmaMar has always maintained, namely that there was a conflict of interest among the EMA experts who evaluated the therapy.
- The Company will demand the reassessment process to be conducted with absolute impartiality, equality and transparency by the EMA.
Share:
More News
“Initiation of the TEADCO Phase 1b/2 basket trial is another important milestone for the ODM-212 clinical development program and reflects our commitment to patients with difficult-to-treat cancers,” said Professor Outi Vaarala, Executive Vice President, Research & Development at Orion. “Together with the ongoing TEADES study, TEADCO highlights the versatility of
“In this study, tovecimig showed an impressive overall response rate which translated into a clinically meaningful and highly statistically significant improvement in PFS for patients with previously treated BTC. The remarkable 56% reduction in the risk of disease progression is unprecedented in this patient population without an actionable mutation in
“We are encouraged to see taletrectinib (IBTROZI) added to the NCCN Guidelines® for CNS Cancers given its demonstrated high rates of intracranial response that are durable in ROS1+ NSCLC patients with brain metastases,” said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. “Given the prevalence of
Daniel Getts, Ph.D., CEO of CREATE, added “MT-304 is proof of what our platform can do, and what our team can execute. Our mRNA-LNP leadership enables us to move from concept to clinic with remarkable speed. Just last weekend at AACR, we presented compelling preclinical data across our in vivo