Navigation Links
European Medicines Agency's Committee For Medicinal Products For Human Use Issues Positive Opinion For Conditional Approval On Marketing Authorization Application For Pixuvri™
Date:2/17/2012

Coiffier, M.D., Ph.D., Professor of Hematology at the Department of Hematology, Hospices Civils de Lyon and the University Lyon 1 in Lyon, France.  

Similar to accelerated approval regulations in the United States, conditional marketing authorizations are granted to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

The CHMP has accepted PIX306, CTI's ongoing randomized controlled phase 3 clinical trial, which compares Pixuvri-rituximab to gemcitabine-rituximab in 2nd line patients with aggressive B‑cell NHL who failed front-line CHOP-R and who are not eligible for autologous stem cell transplant ("ASCT") or as 3rd or 4th line therapy in aggressive B-cell NHL. As a condition of approval, CTI has agreed to have available the PIX306 clinical trial results by June 2015.

For more information visit the EMA website at http://www.ema.europa.eu.

About Non-Hodgkin Lymphoma

NHL is caused by the abnormal proliferation of lymphocytes, cells key to the functioning of the immune system. It usually originates in lymph nodes and spreads through the lymphatic system. NHL can be broadly classified into two main forms—aggressive NHL is a rapidly growing form of the disease that moves into advanced stages much faster than indolent NHL, which progresses more slowly. The World Health Organization's International Agency for Research on Cancer's 2008 GLOBOCAN database most recent estimates state that in European Union approximately 74,162 people will be diagnosed with NHL and 31,371 are estimated to die from NHL e
'/>"/>

SOURCE Cell Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Delcath CHEMOSAT Presented as Innovative Treatment for Liver Metastases by European Institute of Oncology
2. Intellect Neurosciences Submits Statement Setting Grounds for Appeal in European Patent Proceedings
3. European Pharmaceutical and Biotech Contract Manufacturing Markets
4. Amsterdam Molecular Therapeutics Announces European Commission Delays Decision on Glybera® Marketing Authorisation and Requests Further Information From the CHMP
5. ULURU Inc. Extends the European Altrazeal® License to Include the Middle East and Africa
6. Kinex Pharmaceuticals Acquires Rights for Technology and Products from Hanmi Pharmaceuticals, in United States and European Union Territories
7. BioMarin Receives Positive Opinion from European Regulatory Authorities for Expanded Biologics Manufacturing Facility
8. Dehaier Medical Enters European Homecare Medical Product Market
9. Successful ILM-Blue Patent Opposition Proceedings Before the European Patent Office; Patent Validity Confirmed
10. No European Scientists Left by 2020?
11. US and European Bariatric (Obesity) Surgical Devices Industry
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/31/2015)... -- Ariana Smith, a 17-year-old Taylor teen, became the first patient ... a part of the Detroit Medical Center (DMC), and the ... a revolutionary 3D printed heart model to aid heart specialists ... In November, 2014, Ariana,s mom Jacqueline Foster ... a test that checks for problems with the electrical activity ...
(Date:3/31/2015)... ALPHARETTA, Ga. , March 31, 2015   ... Health Care, today announced it was awarded a new ... line of face masks. Effective March 1, 2015, Halyard,s ... masks with SO SOFT* lining, will be available to ... as well as 15,000 ambulatory surgery centers, physician practices ...
(Date:3/31/2015)... VICTORIA, BC , March 31, 2015 /CNW/ - T-Bird ... company focused on developing premium quality medical marijuana products ... the Marihuana for Medical Purposes Regulations ( Canada ... has received notice from The Corporation of the District ... rezoning approval of the Company,s premises which now allows ...
Breaking Medicine Technology:Taylor Teen Becomes First Patient in Michigan to Benefit From 3D Printed Heart Model to Treat Life-Threatening Aneurysm 2Taylor Teen Becomes First Patient in Michigan to Benefit From 3D Printed Heart Model to Treat Life-Threatening Aneurysm 3Taylor Teen Becomes First Patient in Michigan to Benefit From 3D Printed Heart Model to Treat Life-Threatening Aneurysm 4Taylor Teen Becomes First Patient in Michigan to Benefit From 3D Printed Heart Model to Treat Life-Threatening Aneurysm 5Halyard Health Signs First GPO Contracts As Independent Company 2Halyard Health Signs First GPO Contracts As Independent Company 3T-Bird Pharma Inc. Announces Final Municipal Rezoning Approval 2T-Bird Pharma Inc. Announces Final Municipal Rezoning Approval 3
... 29, 2011 Professional and Trade Relations groups play ... to professional, payer and patient groups. However, today,s restrictive ... PTR activities - thus creating pressure on PTR groups ... optimize their impact.   Recognizing changing needs ...
... Centocor Ortho Biotech Products, L.P., today announced that ... for trabectedin for the treatment of women with recurrent ... U.S. Food and Drug Administration,s (FDA) recommendation that an ... The NDA was submitted to the FDA ...
Cached Medicine Technology:Professional Relations Excellence Outlined in New Best Practices, LLC Report 2Centocor Ortho Biotech Products, L.P. Voluntarily Withdraws NDA for Trabectedin 2
(Date:3/31/2015)... Dr. Parsa Mohebi, founder of Parsa Mohebi Hair Restoration ... forefront of using beard hair to fill in balding ... novelty has now become an absolute option for giving patients the ... do believe that beard to scalp hair transplant can be a ... isn’t as dense as we would like it,” says Dr. Parsa ...
(Date:3/31/2015)... Calling all runners, walkers and everyone who wants to join ... annual “Lyme Walk & Run” will be held Sunday, April ... hosted by Lyme Research Alliance (LRA) & Tick-Borne ... and education about Lyme and other tick-borne diseases. , ... feature 5K and 10K runs and one-mile and three-mile Walks ...
(Date:3/31/2015)... OnChip Devices , a world leader in Integrated ... chip targeted towards low voltage LED applications. Adding to its ... for protecting circuits by suppressing voltage higher than 3.0 Volts. ... up to 350W and 20A, providing protection of 8kV when ... These diodes do not exhibit any device degradation when compared ...
(Date:3/31/2015)... March 31, 2015 Dr. ... by the American Board of Dermatology and fellowship ... research training at the National Cancer Institute of ... his internship in internal medicine at the Emory ... Pennsylvania in Philadelphia. Dr. Li pursued further training ...
(Date:3/31/2015)... Dr. Uzma Parvez is having a busy start ... Grand Grounds Presentations at St. Michael’s Medical Center for attending ... The event was attended by a large gathering of ... feedback from the Grand Rounds. It was said that ... a while. , Ahead, Dr. Parvez has been invited ...
Breaking Medicine News(10 mins):Health News:Is Beard to Scalp Hair Transplant the Future? 2Health News:Lyme Research Alliance & Tick-Borne Disease Alliance to Kick-Off 1st “Lyme Walk & Run” Event, April 26 2Health News:OnChip Introduces Low Voltage Diodes for High-Brightness LED Protection 2Health News:Dr. Andrew Li of Warren Skin Care Center Is Celebrating 3 Years Recognized as an "NJ Top Doc" 2Health News:NJ Top Docs Presents, Dr. Uzma Parvez of Total Pain Care 2
... AEGON N.V.,and the international humanitarian organization Right ... the organization,s mission to help,children in deprived areas ... donated EUR 1 million as part of a ... Winter Olympic games in Vancouver, Canada., (Photo: ...
... benefit from further study of vitespen, researchers say , , ... vitespen didn,t increase recurrence-free survival among kidney cancer patients ... standard treatment for kidney cancer, but many patients are ... effective adjuvant treatment, according to background information in the ...
... at work, one expert says , , THURSDAY, July 3 (HealthDay ... man,s chances of developing erectile dysfunction, Finnish researchers report. , ... body. It,s what we in vascular surgery refer to as ... Sadeghi-Nejad, an associate professor of urology at UMDNJ New Jersey ...
... director of the National Alliance on Mental Illness ... the lives,of individuals and families affected by mental ... monitor the callous treatment and tragic death of,Ms. ... the psychiatric,ward at Kings County Hospital in Brooklyn, ...
... Renowned stroke researcher Dr. Vladimir Hachinski has been named ... for his lifetime contributions in the field of neurology. ... University of Western Ontario in the Department of Clinical ... Dentistry. He is the founding and current chairman ...
... is a condition that unexpectedly and unexplainably takes the lives ... year. Now researchers of the European Molecular Biology Laboratory in ... crib or cot death, which remains the leading cause of ... The model, published in this week,s issue of Science ...
Cached Medicine News:Health News:AEGON and Right To Play Announce Global Partnership 2Health News:AEGON and Right To Play Announce Global Partnership 3Health News:Kidney Cancer Vaccine Shows No Boost in Survival 2Health News:Lots of Sex May Prevent Erectile Dysfunction 2Health News:Kings County Death: NAMI Calls for Criminal Probe; Survey Shows Psychiatric Emergency Room Delays Are National Problem 2Health News:Pioneering stroke researcher awarded Canada's highest honor 2Health News:New research sheds light on the molecular basis of crib death 2
Ishihara test chart book for color blindness. 14 plate. A simple accurate method for discovering congenital color blindness....
10 plate suitable for children and the illiterate....
Accepted by leading authorities as a simple and accurate method for discovering congenital color blindness of two type total color blindness and red/green blindness. This book is used for children an...
Stainless steel disposable retinal MVR blade, 10 pcs / box....
Medicine Products: