- Center on Health Equity & Access
- Clinical
- Health Care Cost
- Health Care Delivery
- Insurance
- Policy
- Technology
- Value-Based Care
EMA Grants Orphan Status to Kiadis Pharma's Immuno-oncology Molecule
The European Medicines Agency granted an orphan status to ATIR, a T-cell immunotherapy-based medicinal product being developed to treat blood cancers.
Kiadis Pharma B.V. ("Kiadis Pharma" or "the Company"), a clinical stage biopharmaceutical company developing T-cell immunotherapy treatments for blood cancers, today announces that its lead product ATIR™ has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of acute myeloid leukemia (AML). Kiadis Pharma has previously been granted an ODD for ATIR™ by both the EMA and the FDA for the prevention of acute Graft versus Host Disease (GvHD) following an allogeneic bone marrow transplantation.
The EMA's ODD is reserved for new therapies being developed to treat life-threatening or chronically debilitating diseases or conditions that are relatively rare in the European Union and for which no satisfactory therapy is available. The ODD designation provides for incentives to support development, including fee reductions and a ten-year period of market exclusivity in the European Union after product approval.
Read the complete press release: http://prn.to/1ziVPT8
Decisions and Precision in Value-Based Cancer Care
January 7th 2025An Institute for Value-Based Medicine regional event in Houston, Texas, covered inconsistencies with the integration of precision medicine in oncology practices, the evolution of treatment for multiple myeloma, and more.
Read More
Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
Listen
FDA Approves Tislelizumab-jsgr as First-Line Therapy for HER2– Gastric Cancers
January 2nd 2025Tislelizumab-jsgr (Tevimbra) was approved in combination with chemotherapy for the treatment of unresectable or metastatic HER2-negative (HER–) gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1.
Read More
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
Listen
