Navigation Links
ADVENTRX Announces ANX-514 Clinical Development Plan Affirmed by the FDA
Date:9/10/2007

netics between ANX-514 (docetaxel emulsion) and the FDA-approved version of docetaxel, marketed under the brand name Taxotere. ANX-514 administered intravenously did not cause hypersensitivity reactions, as opposed to acute hypersensitivity reactions that were observed following intravenous treatment with Taxotere. Antitumor activity of the two products in animal models was similar.

About ANX-514 (docetaxel emulsion)

ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug docetaxel, which is marketed under the brand name Taxotere. ANX-514 is formulated without polysorbate 80 or other detergents and is intended to reduce the severity and/or incidence of hypersensitivity reactions. Docetaxel is an anti-cancer agent that acts by disrupting the cellular microtubular network that is essential for cell division. Immunosuppressant premedication is recommended for docetaxel therapy to reduce the incidence and severity of hypersensitivity reactions. Docetaxel is approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers.

About Section 505(b)(2)

Section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act (FDCA) allows the 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. In connection with a Section 50
'/>"/>

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

0

GOOD

Page: 1 2 3 4

Related biology technology :

1. Speaker announces business members of IT Task Force
2. Doyle announces technology tax credits for Berbee
3. Doyle announces new energy, global warming policies
4. Doyle announces $80M renewable energy strategy
5. GE announces first installation of Discovery VCT
6. UWM announces winners of RGI awards
7. Third Wave announces two senior management appointments
8. Mirus announces new method for making antibodies
9. Merge announces sofware updates, upcoming acquisition
10. Small Tree announces ethernet solution for Apple Xserv G5
11. TEKLYNX International announces new RFID software
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/18/2013)... 2013 In support of Swiss contributions ... General of Switzerland in New York is pleased to ... Tûranor PlanetSolar , to Manhattan. PlanetSolar is in ... 2013 tour with scientists on board from the University ... runs exclusively on energy from the sun and eliminates ...
(Date:6/18/2013)... DuPont welcomes 48 of the nation’s finest ... AgriScience Teachers Ambassador Academy this week (NATAA) at the ... , The NATAA “Ag Academy” is a professional ... project of the National FFA Foundation and ... The highly recommended agriscience teachers, who are participating ...
(Date:6/18/2013)... 2013 Edison Investment ... announces the initiation of full coverage of ... developing and marketing products for orphan oncology ...      (Logo: http://photos.prnewswire.com/prnh/20130417/608168) Edison has ... investment merits of BioAlliance Pharma, focusing in ...
(Date:6/18/2013)... June 18, 2013 This webinar ... pharmaceutical advertising and promotion, and review the basic ... learn how to apply these principles through real ... ,     The fundamentals on FDA regulations and ... labeling ,     Assessing traditional and newer forms ...
Breaking Biology Technology:Switzerland’s MS Tûranor PlanetSolar, the World’s Largest Solar Boat, Arrives in New York City 2Switzerland’s MS Tûranor PlanetSolar, the World’s Largest Solar Boat, Arrives in New York City 3Switzerland’s MS Tûranor PlanetSolar, the World’s Largest Solar Boat, Arrives in New York City 4DuPont Sponsors National AgriScience Ambassador Academy 2DuPont Sponsors National AgriScience Ambassador Academy 3Edison Expands French Healthcare Sector Coverage With Initiation of Coverage on BioAlliance Pharma 2Edison Expands French Healthcare Sector Coverage With Initiation of Coverage on BioAlliance Pharma 3Drug Advertising and Promotion Labeling: FDA Regulations, New Webinar Hosted by Xtalks 2
... United Nations World Diabetes Day, Experts Publish, Practical ... Diabetes, NEW YORK, Nov. 14 The Global ... in the world,s attitude,and approach toward diabetes treatment and ... recognised by the first United,Nations (UN) World Diabetes Day. ...
... and TORONTO, Nov. 13 /PRNewswire/ - BioRelix, ... based therapeutic agents and,Dalton Medicinal Chemistry, have ... therapeutics. Dalton Medicinal Chemistry will utilize ... novel classes of compounds against selected,RiboSwitch targets. ...
... EAST WALPOLE, Mass., Nov. 13 Hollingsworth ... of nonwovens and technical papers,today introduced its ... enhance the development and commercialization of,breakthrough products. ... enhanced R&D process focused on,creating a new ...
Cached Biology Technology:International Diabetes Experts Call for Stepped-Up Action and Shared Responsibility to Curb Rising Global Diabetes Epidemic and Impact 2International Diabetes Experts Call for Stepped-Up Action and Shared Responsibility to Curb Rising Global Diabetes Epidemic and Impact 3International Diabetes Experts Call for Stepped-Up Action and Shared Responsibility to Curb Rising Global Diabetes Epidemic and Impact 4BioRelix and Dalton Medicinal Chemistry Sign Research Agreement to Capitalize on RiboSwitch Technology 2H&V Introduces HVision Technology Platform to Accelerate Development of Breakthrough Products 2
(Date:6/17/2013)... Biochemical and Biophysical Research Communications , Saint Louis University ... unknown viruses. The technique offers the potential to screen ... a particular virus as the likely source of an ... use blood serum as a biological source to categorize ... deciphering of the human genome, SLU researchers used a ...
(Date:6/17/2013)... MANHATTAN, KAN. -- A Kansas State University research associate ... on mosquitoes and ways to prevent the spread of ... received the National Institutes of Health,s National Research Service ... years. He is the seventh Kansas State University researcher ... on campus to currently hold such an award. , ...
(Date:6/17/2013)... news release is available in French . ... memory pathology in older mice with Alzheimer,s disease can be ... Neurological Institute and Hospital - The Neuro, at McGill University ... of a specific receptor in the brain of mice with ... results, published in the Journal of Neuroinflammation in ...
Breaking Biology News(10 mins):Saint Louis University researchers discover a way to detect new viruses 2Saint Louis University researchers discover a way to detect new viruses 3NIH fellowship helps researcher fight malaria, understand mosquito immunity 2Blocking overactive receptor in Alzheimer's recovers memory loss and more 2
... / - PlatformQ , a digital media company ... energy markets, and LabRoots , a free social ... the initial slate of speakers and sponsors for ... its kind online-only conference for the life science and ...
... Calif. Turfgrass plays an important role in the ... California,s economy. Aesthetically pleasing and present in everyday ... and recreational activities and is known to increase home ... California and water conservation efforts in the state become ...
... novel approach to the treatment of a devastating lung disease, ... Houston report they are the first to link the osteopontin ... online and will be in the January 2010 print issue ... Federation of American Societies for Experimental Biology. More than ...
Cached Biology News:BioConference Live Attracts Major Life Science Sponsors 2BioConference Live Attracts Major Life Science Sponsors 3UCR Turfgrass Field Day to focus on water conservation, disease management, & natural turf 2UT scientists discover link between protein and lung disease 2
... corresponding to the third cytoplasmic loop of ... to KLH. The immunizing peptide has 79% ... Physical form: Solution in phosphate buffered ... Titertest method: IHC (p). Titertest ...
Canine Chondrocytes (CnC) (500,000 cells)...
... 6-Fam, Hex, Tet Cy3, Cy5, Texas ... Black Hole Quenchers Molecular Beacons* ... Joe 3 Dabcyl Dabcyl*Licensed from ... Double labelled probes are purified either by ...
... high performance spectral scanning multimode reader ... the advanced SkanIt Software it offers ... discovery assay development. Varioskan provides unlimited ... fluorescence and photometric assays and a ...
Biology Products: