• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Gamida Cell wins additional EMA orphan drug designation for NiCord

March 23, 2017 By Sarah Faulkner

Gamida Cell wins additional EMA orphan drug designation for NiCordGamida Cell said today that the European Medicines Agency granted its NiCord cell graft an additional orphan drug designation as a treatment for hematopoietic stem cell transplantation, or bone marrow transplantation.

The treatment is a graft derived from umbilical cord blood which has been expanded and enriched with stem and progenitor cells, according to the company. The EMA previously granted orphan drug designation to NiCord for acute myeloid leukemia.

The Jerusalem-based company’s cell graft was designed as an alternative to bone marrow transplantation for patients with blood cancer who do not have a fully matched donor.

“We are very encouraged that the EMA has widened NiCord’s orphan drug designation to include BMT, and believe it is an important recognition of the unmet needs in these indications,” president & CEO Yael Margolin said in prepared remarks. “This broadened regulatory designation adds a key layer of market exclusivity for NiCord as we move forward with our Phase III study and prepare for commercialization.”

The FDA granted NiCord orphan drug designation for the treatment of AML, acute lymphoblastic leukemia, Hodgkin’s lymphoma, myelodysplastic syndromes and chronic myelogenous leukemia. The U.S. watchdog also awarded Gamida Cell with the breakthrough therapy designation for NiCord in blood cancers.

In February, the company said that the 1st patient has been treated in the Phase III registration trial of its NiCord cell graft for patients with blood cancer.

The trial, which is slated to enroll 120 patients, will evaluate the safety and efficacy of NiCord compared to un-manipulated cord blood in patients with hematological malignancies, Gamida Cell reported. The study’s primary endpoint is the time to neutrophil engraftment.

Filed Under: Featured, Oncology, Regulatory/Compliance, Stem Cells, Wall Street Beat Tagged With: Gamida Cell

IN CASE YOU MISSED IT

  • Insulet hires new chief HR officer from J&J
  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes
  • Medtronic Diabetes names CFO with consumer experience ahead of separation
  • Diabeloop launches insulin delivery algorithm in Germany
  • GlucoModicum has positive data for needle-free CGM

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS