Navigation Links
Allos Therapeutics' PDX Granted Orphan Medicinal Product,Designation by the European Commission

WESTMINSTER, Colo., April 19, 2007 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. today announced that the Commission of the European Communities, with a favorable opinion of the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA), has granted orphan drug designation to the Company's novel antifolate PDX (pralatrexate) for the treatment of patients with peripheral T-cell lymphoma (PTCL). In July 2006, the U.S. Food and Drug Administration (FDA) awarded orphan drug designation to PDX for the treatment of patients with T-cell lymphoma. In October 2006, the FDA granted fast track designation to PDX for the treatment of patients with T-cell lymphoma.

"This designation underscores the critical need for new therapies to treat peripheral T-cell lymphoma and reinforces our belief that PDX has the potential to become an important therapeutic option for patients with this devastating disease," said Paul L. Berns, President and Chief Executive Officer.

The EMEA Orphan Medicinal Product Designation is intended to promote the development of drugs that may provide significant benefit to patients suffering from rare diseases identified as life-threatening or very serious. Under EMEA guidelines, Orphan Medicinal Product Designation provides ten years of potential market exclusivity once the product candidate is approved for marketing for the designated indication in the European Union. Orphan Medicinal Product Designation also provides potential protocol assistance, advice on the conduct of clinical trials, a reduced Marketing Authorization Application (MAA) filing fee for the drug's sponsor and the potential for grant funding.

PDX is currently the subject of PROPEL, a pivotal Phase 2, international, multi-center, open-label, single-arm study that will seek to enroll 100 evaluable patients with relapsed or refractory PTCL who have progressed after at least one prior treatmen
'"/>




Page: 1 2 3 4

Related medicine technology :

1. Allos Therapeutics Reports Results for Phase 3 Enrich Study of Efaproxyn in Women With Brain Metastases Originating From Breast Cancer
2. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
3. A 4-Week Therapy with Transition Therapeutics E1-I.N.T. Leads to Sustained Reductions in Blood Glucose Levels for 6 Months Post-treatment in Type 2 Diabetes Patients
4. Pixantrone Granted Fast Track Designation by FDA for Relapsed Indolent NHL Patients
5. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
6. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
7. AOP Orphan Pharmaceuticals and Lantibio Announce Positive Phase II Study with Novel Cystic Fibrosis Therapy
8. Generex Biotechnology to Make Presentations At 46th Annual Meeting of the European Society of Pediatric Endocrinology
9. Positive ZIO-201 Interim Phase II Sarcoma Data Presented at European Society for Medical Oncology
10. DOR BioPharma Announces Issuance of European Patent for Its Oral Multivalent Botulinum Toxin Vaccine BT-VACC
11. European Society for Medical Oncology (ESMO) Presents Data from the Clinical Trial of MediGenes Cancer-Killing Virus in Press Conference
Post Your Comments:
(Date:3/30/2015)... 2015 Research and Markets ... of the "Urological Catheters - Global ... offering. This report analyzes the ... Units and US$ Thousands by the following ... Peritoneal Catheters), and Urinary Catheters (Foley Catheters, ...
(Date:3/30/2015)... 2015  Caris Life Sciences® today announced the presentation ... may have potentially significant benefit in a select subset ... highlighted today in an oral presentation in a Plenary ... Annual Meeting on Women,s Cancer in Chicago, ... of four presented at the annual meeting that utilizes ...
(Date:3/30/2015)... VALENCIA, Calif. , March 30, 2015 /PRNewswire/ ... Schloffman has decided to leave Cochlear to join ... mentor and friend, Jeff Greiner , who ... the Chief of Market Development and will be ... use of Valencia,s coin-sized ...
Breaking Medicine Technology:Urological Catheters - Global Strategic Business Report 2015-2020: Burgeoning Ageing Populace to Propel Catheter Usage 2Urological Catheters - Global Strategic Business Report 2015-2020: Burgeoning Ageing Populace to Propel Catheter Usage 3Urological Catheters - Global Strategic Business Report 2015-2020: Burgeoning Ageing Populace to Propel Catheter Usage 4Urological Catheters - Global Strategic Business Report 2015-2020: Burgeoning Ageing Populace to Propel Catheter Usage 5Urological Catheters - Global Strategic Business Report 2015-2020: Burgeoning Ageing Populace to Propel Catheter Usage 6Urological Catheters - Global Strategic Business Report 2015-2020: Burgeoning Ageing Populace to Propel Catheter Usage 7Caris Life Sciences' Multiplatform Tumor Profiling Enhances Understanding of Molecular Drivers and Treatment Selection in Uterine Carcinomas 2Caris Life Sciences' Multiplatform Tumor Profiling Enhances Understanding of Molecular Drivers and Treatment Selection in Uterine Carcinomas 3Caris Life Sciences' Multiplatform Tumor Profiling Enhances Understanding of Molecular Drivers and Treatment Selection in Uterine Carcinomas 4Cochlear VP of U.S. Sales Jerry Schloffman Accepts Chief of Market Development Position at Valencia Technologies 2
... Dec. 6 Researchers today report that after ... agents (ESAs), a significantly greater proportion of anemic ... received ESAs needed blood transfusions and utilized more ... who received ESAs prior to implementation of coverage ...
... Opioid Use, and Reduces Opioid Related Adverse Events ... , PARSIPPANY, N.J., ... study of a single intraoperative administration of EXPAREL(TM) ... or TKA, showed that the novel, sustained-release analgesic ...
Cached Medicine Technology:Observational Study Finds Changes in Medicare Reimbursement for Erythropoiesis-Stimulating Agents Associated With Increased Need for Blood Transfusion 2Observational Study Finds Changes in Medicare Reimbursement for Erythropoiesis-Stimulating Agents Associated With Increased Need for Blood Transfusion 3Observational Study Finds Changes in Medicare Reimbursement for Erythropoiesis-Stimulating Agents Associated With Increased Need for Blood Transfusion 4Observational Study Finds Changes in Medicare Reimbursement for Erythropoiesis-Stimulating Agents Associated With Increased Need for Blood Transfusion 5Observational Study Finds Changes in Medicare Reimbursement for Erythropoiesis-Stimulating Agents Associated With Increased Need for Blood Transfusion 6Positive Phase II Study of Pacira's EXPAREL(TM) (DepoBupivacaine) in Total Knee Arthroplasty Presented at International College of Surgeons World Congress 2Positive Phase II Study of Pacira's EXPAREL(TM) (DepoBupivacaine) in Total Knee Arthroplasty Presented at International College of Surgeons World Congress 3Positive Phase II Study of Pacira's EXPAREL(TM) (DepoBupivacaine) in Total Knee Arthroplasty Presented at International College of Surgeons World Congress 4
(Date:3/30/2015)... New York, NY (PRWEB) March 30, 2015 ... packaging that includes a convenient flute for opening/closing and for ... pour wine on the go. Health-conscious New Yorkers, professionals, and ... that is sophisticated yet delicious to kick back socially or ... should arise. , “ V/NO is dealcoholized wine and ...
(Date:3/30/2015)... The “Orthopedic Software Market [By Product ... Applications (Orthopedic Surgery, Joint Replacement, Fracture Management, ... Global Forecast to 2020” analyzes and studies ... North America, Europe, Asia-Pacific and the Rest ... Buying: http://www.marketsandmarkets.com/Enquiry_Before_Buying.asp?id=94720371 , This report ...
(Date:3/30/2015)... (PRWEB) March 30, 2015 Software ... Drummond Certified™ in the second AS4 test and ... the trusted leader in interoperability software testing. New ... and Software AG participated in this vendor-neutral test ... the first AS4 interoperability certifications for IBM, Oracle ...
(Date:3/30/2015)... People from all walks of life who are interested ... want a refreshingly simple and easy way forward -- can ... MindBody Sessions. The app can be accessed via computer or ... can be downloaded for mobile devices from the App ... by MindBody Sessions LLC, the app features hundreds of guided ...
(Date:3/30/2015)... March 30, 2015 Corra Group is continuing ... the needs of every industry that requires this form of ... mandates or seek new ways to increase productivity and cut ... panels that will help detect substance abuse with a wide ... drug tests,” said Corra Group Co-Founder, Gordon Basichis. ...
Breaking Medicine News(10 mins):Health News:Napa Valley Alcohol-Removed Red, White & Rosé Wines Have Launched. 2Health News:The Global Orthopedic Software Market is Expected to Reach $308.5 Million by 2020 – Report Published by MarketsandMarkets 2Health News:The Global Orthopedic Software Market is Expected to Reach $308.5 Million by 2020 – Report Published by MarketsandMarkets 3Health News:The Global Orthopedic Software Market is Expected to Reach $308.5 Million by 2020 – Report Published by MarketsandMarkets 4Health News:Latest AS4 Standard-Based Products Drummond Certified™ 2Health News:Latest AS4 Standard-Based Products Drummond Certified™ 3Health News:New Web, iOS and Android App “MindBody Sessions” Makes Mindfulness and Meditation Easy 2Health News:New Web, iOS and Android App “MindBody Sessions” Makes Mindfulness and Meditation Easy 3Health News:Corra Group Adds New Employment Screening Drug Test Solutions for Clients in Every Industry 2Health News:Corra Group Adds New Employment Screening Drug Test Solutions for Clients in Every Industry 3
... in the June issue of the Journal of ... the university recruitment strategy and process could raise the ... suggests that specific procedural steps could assist in identifying ... surgery departments. , Despite equaling or exceeding ...
... 2008) The American College of Emergency Physicians (ACEP) ... of Emergency Medicine," an honor the organization bestows upon ... medicine, their communities and their patients. , Dr. ... at Harbor-UCLA Medical Center (LA BioMed) researcher to be ...
... 80 years have passed since the German scientist Hans ... for the field of embryonic development. After dividing a ... specifically, the half that gives rise to the ... other ,back, (dorsal) half that develops into its head, ...
... still to really pan out, expert warns , , THURSDAY, June ... developed an immune response to an investigational vaccine lived twice ... new research shows. , "If you were an immune responder, ... author Dr. Susan Domchek, an associate professor of medicine at ...
... Superior Efficacy to Avastin at Improving Visual Acuity When, ... Percent Patient Share, ... from Decision Resources, WALTHAM, Mass., June 26 ... firms focusing on pharmaceutical and,healthcare issues, finds that Genentech/Novartis,s ...
... June 26 ACM today announced the ... as the company,s new,Executive Vice President of ... operations, and client service management, Ms.,Bryngelson will ... of,ACM,s infrastructure -- including technology, call center ...
Cached Medicine News:Health News:Improving university recruitment process may increase female surgical faculty, study finds 2Health News:LA BioMed researcher named 'Hero of Emergency Medicine' 2Health News:Weizmann Institute scientists discover how an injured embryo can regenerate itself 2Health News:Breast Cancer Vaccines Look Promising 2Health News:Breast Cancer Vaccines Look Promising 3Health News:Because of Its Ability to Generate Higher Total Sales in the United States and Europe, Lucentis Will Earn Clinical Gold Standard Status by 2011 for the Treatment of Diabetic Retinopathy 2Health News:ACM Adds Top Industry Executive to Its Leadership Team 2
... Low Binding 20l Barrier Tips. Low binding technology ... proteins bound to the tip. Most other filter ... the focus is on liquid not adhering to ... low binding which reduces the binding of valuable ...
... false signals and contamination caused by ... Barrier Tips offer performance and economy ... (PCR(a)), radioactive isotopes, tissue culture fluids, ... , ,Promega Barrier Tips are made ...
... Aerosol Resistant Tips offer a safe alternative ... are designed for applications such as PCR(a), ... addition, ART Tips are excellent for tissue ... studies. ART Tips prevent aerosol contaminants and ...
Diamond Filter Tips play a critical role in preventing aerosol-borne contamination. Also available sterilized (no need to autoclave) and certified free of detectable RNase, DNase, DNA, RNA, and prote...
Medicine Products: