Navigation Links
ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study
Date:11/16/2007

U.S. Food, Drug & Cosmetic Act (FDCA) allows the Food and Drug Administration (FDA) to approve a follow-on drug on the basis of data in the scientific literature or conclusions regarding safety or effectiveness made by the FDA in the approval of other drugs. This regulatory pathway potentially makes it easier for drug manufacturers to obtain rapid approval of new forms of drugs based on the FDA's approval of the original drug. Some examples of products that may be allowed to follow a 505(b)(2) path to approval are drugs that have a new dosage form, strength, route of administration, formulation or indication. Upon approval, a drug may be marketed only for the FDA-approved indications in the approved dosage forms. Further clinical trials are necessary to gain approval for the use of the product for any additional indications or dosage forms. To the extent a Section 505(b)(2) applicant is relying on the FDA's findings for an already-approved drug, the applicant is required to certify to the FDA concerning any patents listed for the approved drug in the FDA's Orange Book publication, which may include a certification that listed patents are invalid or will not be infringed by the manufacture, use or sale of the new drug.

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases. The Company seeks to improve the performance and safety of existing treatments by addressing significant problems such as drug metabolism, bioavailability, excessive toxicity and treatment resistance. More information can be found on the Company's web site at http://www.adventrx.com.

Forward Looking Statement

ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that
'/>"/>

SOURCE ADVENTRX Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
2. ADVENTRX Announces Completion of Patient Enrollment in ANX-530 Marketing-Enabling Clinical Study
3. Genzyme Announces Second Pivotal Mozobil Trial Meets Primary Endpoint
4. ERBITUX(R) Meets Primary Endpoint of Increasing Survival in Phase III Lung Cancer Study
5. Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults
6. Tezampanel Meets Primary Endpoint in Phase IIb Clinical Trial in Acute Migraine Headache
7. A Phase II, Randomized, Double Blind, Placebo-Controlled Dose-Escalating Study, Meets the Clinical Endpoints of MTR106 Tablets During the Treatment of Acute Migraine Attacks Without Aura in Females
8. New Research May Lead to Earlier Diagnosis and Treatment of Primary Biliary Cirrhosis in Families
9. Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of VELCADE(R) (Bortezomib) for Injection Based Therapy Across All Endpoints
10. Cethromycin Achieves All Endpoints in Second Pivotal Phase III Trial for Treatment of Pneumonia
11. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... , Dec. 24, 2014  Novastem, a ... its first patient in its study for ischemic ... American Stroke Association, ischemic strokes account for 87 ... enroll qualified patients in the study, entitled "Internal ... of Allogeneic Mesenchymal Stem Cells and Intrathecal Administration ...
(Date:12/24/2014)... HARRISBURG, Pa. , Dec. 24, 2014  Commonwealth Cornerstone ... New Markets Tax Credits transaction on Tuesday to help fund ... Health Network (PHN) in Sharon . ... operating in Pennsylvania . It is the ... district, with more than 150 people on staff. ...
(Date:12/24/2014)... 2014 Kinex Pharmaceuticals announced today that the ... Park Cancer Institute. KX2-361 (KX02), a dual ... shown potent inhibitory activity against a broad panel of ... to Temozolomide (T98G), the most widely used chemotherapy for ... tumor mouse model, KX2-361 consistently clears brain tumors after ...
Breaking Medicine Technology:Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 2Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 3Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 4Commonwealth Cornerstone Group Announces $8 Million in Tax Credits to Expand and Consolidate Healthcare Services in Sharon 2Commonwealth Cornerstone Group Announces $8 Million in Tax Credits to Expand and Consolidate Healthcare Services in Sharon 3Kinex Pharmaceuticals Announces First Patient Dosed with KX2-361 in a Phase 1 Clinical Study 2Kinex Pharmaceuticals Announces First Patient Dosed with KX2-361 in a Phase 1 Clinical Study 3
... 2011 For the second year in a row Royce ... Associates, received a supplier recognition from Carestream Health, the world,s ... Carestream Health, which supplies a complete line of Medical and ... Royce their 2010 Supplier of the Year , Carestream,s ...
... 2011 Transgenomic, Inc. (OTC/BB: TBIO) today reported financial results for ... update. First Quarter Financial Results ... $7.5 million, an increase of 37 percent compared with $5.4 million ... or 56 percent of net sales, compared with gross profit of ...
Cached Medicine Technology:Royce Receives Coveted Medical Products Award 2Transgenomic Reports First Quarter Financial Results 2Transgenomic Reports First Quarter Financial Results 3Transgenomic Reports First Quarter Financial Results 4Transgenomic Reports First Quarter Financial Results 5Transgenomic Reports First Quarter Financial Results 6Transgenomic Reports First Quarter Financial Results 7Transgenomic Reports First Quarter Financial Results 8Transgenomic Reports First Quarter Financial Results 9
(Date:12/26/2014)... California (PRWEB) December 26, 2014 Plugin and ... the TransPack Volume 5 Plugin for Final Cut Pro X. ... a hard light tool to pull off an industry professional ... users get their hands on TransPack Volume 5, a new ... 5 is a set of over 50 Final Cut Pro ...
(Date:12/26/2014)... DW-InductionHeating.com (DaWei Induction Heating Co.) is a ... producing and marketing of a series of induction heating ... new series of induction brazing equipments . , ... induction brazing refers to the joining of two ... heat. The manager says that there are fundamental differences ...
(Date:12/25/2014)... The click strand woven bamboo ... durability. Today, the business announces a click strand ... Jan. 30, 2015. , Click strand woven bamboo ... is a well-known brand in the bamboo industry. ... a reliable bamboo flooring supplier. , “We are ...
(Date:12/25/2014)... (PRWEB) December 26, 2014 “Every three months ... market changes. A-line sweetheart evening dress will be one of ... sales manager of Yunx.co.uk says. Today, the company releases 26 ... discounts, up to 80% off. , “We are trying ... unique style with our latest designs. Along with affordable prices, ...
(Date:12/25/2014)... Recently, BellasDress has launched its Christmas ... BellasDress has chosen their best-selling lace wedding dresses, vintage ... holiday season. , Now, BellasDress.com features popular women’s ... at discount prices. The business hopes everyone can have ... , “All our elegant products are made with ...
Breaking Medicine News(10 mins):Health News:Today a new plugin was announced from Pixel Film Studios, TransPack Volume 5 for Final Cut Pro X 2Health News:Induction Brazing Equipment Series From DaWei Induction Heating Co., A Reliable Supplier Of Induction Heating Equipment 2Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health News:BellasDress.com’s Christmas Sale: Trendy Wedding Dresses With Big Discounts 2
... recent increase in the number of men who are going under ... of men undergoing nip and tuck surgery has rocketed by 140 ... ,The phenomenon has been dubbed the 'menopaunch' as men fork ... to be facing pressures as women to look good thus they ...
... and body, a rare medical anomaly. And doctors say that laser ... ,Prithviraj Patil, son of a well-to-do farmer in Sangalwadi near ... like any normal child. ,,Prithiviraj has no problem with his ... awful - there is no itch or rash on the skin ...
... A type of skin cancer that was rare three decades ... the Journal of the American Medical Association (JAMA) found . ... increasingly more common in the United States in the decades ... July issue of Archives of Dermatology, which is part of ...
... on a teenager from wearing a so-called "purity ring" at school ... ,Lydia Playfoot, 16, said she was "disappointed" by the ruling in ... West Sussex, denies infringing her human rights, saying that the ring ... its uniform policy. ,"As a Christian I do not ...
... could dramatically lower the rapidly rising costs of several ... specialists suggest in a commentary in the Journal ... Mark Ratain, MD, and Ezra Cohen, MD, call attention ... certain foods can alter absorption or delay breakdown of ...
... is a universal problem that doctors need to ... Wake Forest University School of Medicine in ... Archives of Dermatology. ,He said non-compliance ... to treatment. ,Physicians must develop practical ...
Cached Medicine News:Health News:Men Under Knife to Reduce Bulging Waistline in Britian 2Health News:Hairy Boy Bets on Laser Treatment for Cure 2Health News:Value Meal Would Lower Drug Costs 2Health News:Value Meal Would Lower Drug Costs 3Health News:Patients Not Complying With Their Dermatologic Problem 2Health News:Patients Not Complying With Their Dermatologic Problem 3
... Blot is an FDA approved confirmatory test ... fluid sample. Repeatedly reactive results of initial ... HIV-1 Microelisa System can be confirmed with ... the same OraSure sample. The OraSure HIV-1 ...
Prognosis / Patient Management. HIV-1 Viral Load Assay. NucliSens HIV-1 QT covers the entire dynamic range of viral load testing from a single patient sample, without reflex testing or thermalcycli...
... genome of the Human Immunodeficiency Virus (HIV-1) ... in response to anti-viral drug treatment. Some ... render the virus resistant to the action ... the treatment.,The detection of mutations in HIV-1 ...
EIA for Donor Screening. Synthetic peptide Enzyme Immunoassay (EIA) for the detection of antibodies to Human Immunodeficiency Virus Types 1 and/or 2,(HIV-1 and HIV-2) in human serum, plasma or ca...
Medicine Products: