Navigation Links
ATIR Classified as "Cell Based" Medicinal Product by the EMEA
Date:12/14/2007

A Classification for Innovative New Treatments

AMSTERDAM, December 14 /PRNewswire/ -- Kiadis Pharma announced today that its lead product ATIR has received approval for regulatory classification as a "cell based" medicinal product by the Innovation Task Force (ITF), a division of the European Medicines Agency (EMEA). Based upon this regulatory classification ATIR is eligible for EMEA procedures. As a next step Kiadis Pharma will file for orphan drug designation with the EMEA to obtain additional product protection upon marketing approval. In November this year ATIR has been granted orphan drug designation by the US Food and Drug Administration (FDA).

ATIR is under development to prevent acute Graft versus Host Disease (GvHD) allowing the use of a mismatched donor for bone marrow transplantations. It's a personalized cell-based treatment prepared according to a proprietary protocol using both a novel small molecule substance and a proprietary medical device. With the official classification of ATIR as a cell based medicinal product by the EMEA, it's now categorized as an Advanced Therapy and considered to be a highly innovative treatment. The benefits are a centralized marketing authorization procedure, which harmonizes and facilitates access to the European market. In addition, it provides access to an expert Committee for Advanced Therapies within the EMEA, to address scientific, legal and regulatory issues during product development.

"We are very pleased having received a cell based medicinal product classification for ATIR. The regulatory guidelines that will rule ATIR are therefore clear and we have subsequently started with the application of the orphan drug designation with the EMEA which will be filed before the end of this year", said Manja Bouman, CEO Kiadis Pharma.

About ATIR

ATIR is designed to prevent life-threatening acute GvHD by eliminating the immune cells from the donor graft that otherwise attack
'/>"/>

SOURCE Kiadis Pharma
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Non-medicinal treatment touted for pre-schoolers with ADHD
2. Nonmedicinal treatment touted for preschoolers with ADHD
3. The ScottCare Corporation Completes Acquisition of Rozinn Electronics, a Leading Manufacturer of Cardiac Diagnostic Products
4. Physician Skin Care Specialist Says Proposed New Rules for Sunscreen Products Will Better Protect the Public
5. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
6. Three Batesville Casket Company Production Facilities Honored for Manufacturing Expertise by National Organizations
7. FDA Seeks to Regulate Complementary and Alternative Medicine; Products Such as Vegetable Juice Could Be Restricted for Medical Use
8. End-to-End HR Performance Benchmarks: Metrics That Will Help Turn the HR Cost Center into a Productivity Driver
9. Boston Micromachines Multi-DM Named One of the Years Most Innovative Products
10. Drug Detection Kits Manufactured By IDenta Corp. Shown During French Television Broadcast (at TF1) - Product Aids French Police In Bust of 600 Kilograms Of Cocaine
11. Why Are Most Health & Wellness Products Doomed to Failure?
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/1/2014)... small protein beta-amyloid is strongly associated with Alzheimer,s disease; ... this peptide is the causal agent of the onset ... such confirmation is that beta-amyloid is not harmful when ... is when it self-assembles to form the so-called amyloid ... target, beta-amyloid alone, but with multiple ones because each ...
(Date:10/1/2014)... and Physical Sciences Research Council (EPSRC) will focus ... control systems which run, for example, manufacturing plants, ... network. , The research will help understand ... the systems behind our critical national infrastructure. ... Systems (RITICS), based at Imperial College London, is ...
(Date:10/1/2014)... Familylifeinsurancequotes.org has released a new blog post ... , Senior citizens can qualify for affordable term ... seniors who are over 50 years old. Some term ... medical examination. , Term life insurance with a simplified ... qualify. Having life insurance during retirement is important for ...
(Date:10/1/2014)... Lifeinsurance-policy.com has released a new ... insurance prices for smokers. , Smoking will always have ... quotes is the best method to find affordable coverage. ... who need coverage. , Whole life insurance premiums ... policy. Since the coverage is permanent, the initial ...
(Date:10/1/2014)... 2014 Farmington Company today announced ... mission and visual identity helping brokers, consultants and ... them to create greater benefit communication synergies. They ... on empowering customers to better leverage Farmington Company’s ... jewel of the rebrand is the refreshed tagline: ...
Breaking Medicine News(10 mins):Health News:Laying siege to beta-amyloid, the key protein in Alzheimer's disease 2Health News:£2.5 million to recognize and reduce cyber-attack threats to critical infrastructure 2Health News:Affordable Term Life Insurance - Senior Citizens Can Qualify for Coverage! 2Health News:Affordable Whole Life Insurance Premiums for Smokers! 2Health News:Farmington Company Launches Rebrand and New Positioning 2
... of a key protein mediator of inflammation reduced radiation ... help to patients receiving radiation therapy, according to researchers ... Reporting in Molecular Cancer Therapeutics , the researchers ... against radiation toxicity when given before exposure to treatment, ...
... Montreal, September 1, 2009 A recent study published ... reinforced the correlation between being overweight, smoking and breast ... subjects were not diagnosed for BRCA1 and BRCA2 gene ... Instead, women with such gene mutations were excluded to ...
... PORTLAND, Ore., Sept. 1 The Regence Foundation announced today ... Oregon , WithinReach , Critical Access Hospital Network ... all support nonprofit programs with innovative plans to improve quality of care ... Regence Foundation, our mission is to support health care transformation by partnering ...
... , , Springfield AARP Volunteers ... Senator, Congressmen to Tackle Issue , , ... taking a break from Washington, AARP is making sure they don,t ... care system. With a giant inflatable Rx bottle as a ...
... , , SAN FRANCISCO, Sept. 1 ... announced that it has received the Department of Health Care Services 2009 ... throughout the state of California for Medi-Cal managed care plans. , ... said Dr. Kelly Pfeifer, SFHP Medical Director. "It,s a testament to ...
... , , , , ... Center recently honored Vigilan with the Silver Award recognizing the Administrator ... The 2009 Product & Technology Awards Program is the ... products and services for older adults, their families and care providers. ...
Cached Medicine News:Health News:Inhibition of NF-kappa B, a key inflammatory protein, reduced radiation toxicity in zebrafish 2Health News:Breast cancer: Risk increases for smokers and overweight women 2Health News:Regence Foundation Awards Nearly $250,000 in Grants to Northwest Nonprofits 2Health News:Sen. Durbin, Congressmen Get Health Care Reform 'Message in a Bottle' from AARP 2Health News:San Francisco Health Plan Recognized as Top Health Plan for Quality in the California Medi-Cal Program 2Health News:San Francisco Health Plan Recognized as Top Health Plan for Quality in the California Medi-Cal Program 3Health News:Vigilan Earns Honor in the 2009 Product & Technology Awards Program by Mature Market Resource Center 2
(Date:9/30/2014)... This report analyzes the worldwide markets for Enteral ... Enteral Feeding Pumps, Nasogastric Tubes, and Others. The ... Japan , Europe , ... and Rest of World. Annual estimates and forecasts are provided ... analysis is provided for these markets. The report ...
(Date:9/30/2014)... MiMedx Group, Inc. (NASDAQ: MDXG ... tissue and patent-protected processes to develop and market advanced ... Spinal, Sports Medicine, Ophthalmic and Dental sectors of healthcare, ... Scientific Officer, will present at the Stem Cell Meeting ... October 7, 2014, at 5:00PM Pacific Daylight Time. ...
(Date:9/30/2014)... -- STUDY OBJECTIVES The objective of BCC ... overview of the current and future characteristics of ... objective is to present a comprehensive analysis and ... tool in the treatment of various diseases. ... the protein therapeutics market, which includes peptide hormones, ...
Breaking Medicine Technology:Global Enteral Feeding Devices Industry 2Global Enteral Feeding Devices Industry 3Global Enteral Feeding Devices Industry 4Global Enteral Feeding Devices Industry 5Global Enteral Feeding Devices Industry 6Global Enteral Feeding Devices Industry 7Global Enteral Feeding Devices Industry 8Global Enteral Feeding Devices Industry 9Global Enteral Feeding Devices Industry 10Global Enteral Feeding Devices Industry 11Global Enteral Feeding Devices Industry 12Global Enteral Feeding Devices Industry 13Global Enteral Feeding Devices Industry 14Global Enteral Feeding Devices Industry 15Global Enteral Feeding Devices Industry 16Global Enteral Feeding Devices Industry 17Global Enteral Feeding Devices Industry 18Global Enteral Feeding Devices Industry 19MiMedx to Present at the Stem Cell Meeting on the Mesa 2Global Markets and Manufacturing Technologies for Protein Drugs -- Focus on Cytokines and Monoclonal Antibodies 2Global Markets and Manufacturing Technologies for Protein Drugs -- Focus on Cytokines and Monoclonal Antibodies 3Global Markets and Manufacturing Technologies for Protein Drugs -- Focus on Cytokines and Monoclonal Antibodies 4
... WOONSOCKET, R.I., Jan. 6, 2011 A new CVS ... a three-year period for patients with one or more ... medications as doctors direct may save the health care ... study findings revealed robust reductions in emergency department visits ...
... DIEGO, Jan. 6, 2011 Arena Pharmaceuticals, Inc. (Nasdaq: ... is scheduled to present at the 29th Annual J.P. Morgan ... Pacific Time (7:00 p.m. Eastern Time) at the Westin St. ... and Chief Executive Officer, is scheduled to provide a corporate ...
Cached Medicine Technology:CVS Caremark Study Finds Medication Adherence Leads to Lower Health Care Costs, Even After Accounting for Increased Prescription Drug Spending 2CVS Caremark Study Finds Medication Adherence Leads to Lower Health Care Costs, Even After Accounting for Increased Prescription Drug Spending 3Arena Pharmaceuticals to Present at the 29th Annual J.P. Morgan Healthcare Conference 2Arena Pharmaceuticals to Present at the 29th Annual J.P. Morgan Healthcare Conference 3
... Made with elastic fabric, these head ... you need to begin testing. Each Electro-Cap ... to the International 10-20 System. When you ... you are using with your head cap ...
... When testing takes you into the OR, ER, ... protection of Cadwells new shielded electrodes. Keeping noise ... and paired disc electrode has a special shielded ... the damaging effects of 60-cycle interference. That means ...
... orbital implant was conceived by Arthur C. ... a comprehensive review of the literature on ... dating back to 1885 (Mules 1885). This ... the performance of contemporary implants, allowed Perry ...
... Viewing System was developed in New ... the surgical supervision of Professor Stanley Chang, ... New York Cornell Medical Center and later ... on the market and immediately revolutionized the ...
Medicine Products: