Navigation Links
ADVENTRX Receives Refuse to File Letter from FDA on ANX-530 New Drug Application
Date:3/1/2010

and uncertainties include, but are not limited to: FDA's requirements for the ANX-530 NDA to be accepted for review do not justify continued development of ANX-530; ADVENTRX's dependence on the success of ANX-530, and increased uncertainty as to whether ANX-530 will receive regulatory approval or be commercialized successfully; the potential that FDA may not accept a resubmitted ANX-530 NDA for review, or that the bioequivalence data and other information included in the ANX-530 NDA may not adequately support bioequivalence with Navelbine, including as a result of performing pharmacokinetic equivalence analyses based on a patient population other than the population on which ADVENTRX based its analysis; the potential that changes made in transferring the manufacturing process for ANX-530 may result in a lack of comparability between the commercial product and the material used in clinical trials, and that FDA may require ADVENTRX to perform additional non-clinical or clinical studies; the potential for FDA to impose other requirements to be completed before or after approval of the ANX-530 NDA; ADVENTRX's reliance on third parties to assist with its bioequivalence trials, regulatory submissions, manufacturing and other important aspects of the ANX-530 development program, and the risk that FDA approval may be delayed if their performance is found to have been substandard; the possibility that patent claims covering ANX-530 will not issue or, if they do, that such claims, which likely will be limited to a specific intravenous emulsion formulation of vinorelbine, will not be sufficient to preclude development of other formulations of vinorelbine by competitors; the risk of investigator bias in reporting adverse events as a result of the open-label nature of the ANX-530 bioequivalence study, including bias that increased the reporting of adverse events associated with Navelbine and/or that decreased the reporting of adverse events associated with ANX-530; the risk that
'/>"/>
SOURCE ADVENTRX Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. ADVENTRX Announces Management Promotions
2. ADVENTRX Appoints Icahn Representative to Board of Directors
3. ADVENTRX Pharmaceuticals to Present at the 12th Annual BIO CEO & Investor Conference on February 9
4. ADVENTRX Pharmaceuticals to Present at the Lippert/Heilshorn Life Sciences Virtual Conference
5. ADVENTRX Pharmaceuticals Reports Additional Pre-Clinical Data for ANX-514
6. ADVENTRX Pharmaceuticals to Present at the BIOCOM Investor Conference on October 26
7. ADVENTRX Pharmaceuticals Announces Closing of Financing
8. ADVENTRX Announces Results From ANX-514 Bioequivalence Study
9. ADVENTRX Completes Patient Enrollment in ANX-514 Bioequivalence Study
10. ADVENTRX Announces Preliminary Response Rate Data From Discontinued Phase 3 Trial of CoFactor(R)
11. ADVENTRX Announces CoFactor(R) Phase 2b Clinical Trial Overall Survival Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2015)... , July 30, 2015  Today we bring you a special edition of ... to remind you about some of our Medicare resources and continue highlighting the success ... Check out our latest infographics and videos here: ... ... ...
(Date:7/30/2015)... OAKS, Calif. , July 30, 2015  Amgen (NASDAQ: ... Hassan , partner and managing director of Warburg Pincus LLC, ... are pleased to welcome Fred Hassan and the ... the Amgen Board," said Robert A. Bradway , chairman ... and commitment to innovation will serve Amgen well." ...
(Date:7/30/2015)... July 30, 2015 Future Market ... titled, "Continuous Glucose Monitoring Systems Market: Global Industry Analysis ... report, the global continuous glucose monitoring systems market was ... expected to reach US$ 788.4 Mn by 2020, registering ... to 2020. Global continuous glucose monitoring systems ...
Breaking Medicine Technology:Happy 50th Anniversary Medicare! 2Happy 50th Anniversary Medicare! 3Amgen Announces Appointment Of Fred Hassan To Board Of Directors 2Amgen Announces Appointment Of Fred Hassan To Board Of Directors 3Global Continuous Glucose Monitoring (CGM) Systems Market: Transmitters and Monitors Most Dominant Segment, Says Future Market Insights 2Global Continuous Glucose Monitoring (CGM) Systems Market: Transmitters and Monitors Most Dominant Segment, Says Future Market Insights 3Global Continuous Glucose Monitoring (CGM) Systems Market: Transmitters and Monitors Most Dominant Segment, Says Future Market Insights 4
... 18, 2011 The U.S. Food and Drug Administration ... treatment of head lice infestation in patients ages 4 ... ) Head lice are parasitic insects found ... human blood several times a day but are not ...
... 2011 Norgenix Pharmaceuticals, LLC ( www.norgenixpharma.com ), ... Smith Corporation, and Fertility Focus Limited ( www.fertility-focus.com ... of the Fertiloscope ™ , a CE marked ... diagnosis and immediate corrective surgery of physical causes ...
Cached Medicine Technology:FDA Approves Head Lice Treatment for Children and Adults 2Co-Promotion of a New Medical Device for Female Infertility Announced 2
(Date:7/31/2015)... ... July 31, 2015 , ... Well-known for its unique pastries ... wedding cakes with custom designs, making life just a little bit sweeter for ... cakes for each customer who orders one. , The bakery provides a full line ...
(Date:7/31/2015)... ... 31, 2015 , ... Cosmetic Town has proven itself as ... plastic surgery procedures including, but not limited to, abdominoplasty, blepharoplasty, rhinoplasty and septoplasty. ... and fillers. , Staying up to date with the latest cosmetic trends ...
(Date:7/31/2015)... ... July 31, 2015 , ... The 2015 New ... and family members, medical professionals, and researchers, covering a variety of topics related ... a collaborative effort between the Mesothelioma Applied Research Foundation and Memorial Sloan Kettering ...
(Date:7/31/2015)... ... 2015 , ... Creating one of the most modern fertility centers in the ... that goes beyond the boundaries of fertility medicine. , As the leading gynecology ... dependable patient support, affordable treatments, unending hope, and high fertility success rates — all ...
(Date:7/31/2015)... ... ... Girl Scouts of Historic Georgia and Peach State Health Plan are teaming up ... First" program. Representatives from Peach State Health Plan presented a $10,000 check for the ... parent company, Centene Corporation, are dedicated to raising anti-bullying awareness. We are very proud ...
Breaking Medicine News(10 mins):Health News:Pastry Palace of Las Vegas Announces It Is Now Offering Custom Wedding Cakes in Las Vegas 2Health News:Cosmetic Town: Now Providing Interactive And Vital Medical Knowledge 2Health News:New York Area Mesothelioma Specialists to Present at Conference 2Health News:New York Area Mesothelioma Specialists to Present at Conference 3Health News:New Hope IVF Now Offers Most Affordable Assisted Reproductive Treatment in the UAE 2Health News:New Hope IVF Now Offers Most Affordable Assisted Reproductive Treatment in the UAE 3Health News:Peach State Health Plan Presents $10,000 Check for “Be a Friend First” Anti-Bullying Program to Local Girl Scouts 2
... , , , , ... ABT ) today announced financial results for the second quarter ended June ... Diluted earnings per share, excluding specified items, were $0.89, at the high end of ... Accepted Accounting Principles (GAAP) were $0.83. , Worldwide operational ...
... , , LOS ANGELES, July 15 ... get the best possible results with Face Lift Dentistry, a breakthrough ... health and optimal appearance of the mouth and face. , ... DDS, MAGD, long renowned for his high tech cosmetic and bite ...
... ... , ... July 15, 2009 -- HCC Medical Insurance Services is pleased to announce that ... as HCC Medical Insurance Services (HCCMIS), bringing increased financial security to the Company,s portfolio ...
... , LONDON, July 15 realbuzz.com is ... live a healthy, active life and,we,ve been looking at the most ... shorts and head off for your annual summer,holiday, take a peek ... work, and which ones are a total waste of your holiday-prepping,time! ...
... ... featured expert on searchjointpain.com, a new informational Web site devoted to all aspects of ... ... Sinatra , a board-certified cardiologist, nutritionist, and anti-aging specialist, is now a featured expert ...
... , , , SAN ... from the planned spinoff of Cardinal Health,s clinical and medical products businesses, ... principal amount of senior unsecured notes. The notes consist of the ... $250 million aggregate principal amount of 4.125% senior notes due ...
Cached Medicine News:Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 2Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 3Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 4Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 5Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 6Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 7Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 8Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 9Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 10Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 11Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 12Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 13Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 14Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 15Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 16Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 17Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 18Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 19Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 20Health News:Abbott Reports Strong Second Quarter Results; Confirms Double-Digit Earnings Growth Outlook for 2009 21Health News:Los Angeles Cosmetic Dentist Sam Muslin's Breakthrough Procedure: Face Lift Dentistry 2Health News:Los Angeles Cosmetic Dentist Sam Muslin's Breakthrough Procedure: Face Lift Dentistry 3Health News:Los Angeles Cosmetic Dentist Sam Muslin's Breakthrough Procedure: Face Lift Dentistry 4Health News:MultiNational Underwriters Is Now HCC Medical Insurance Services 2Health News:realbuzz.com Top 10 Diets 2Health News:realbuzz.com Top 10 Diets 3Health News:realbuzz.com Top 10 Diets 4Health News:Board-Certified Cardiologist Dr. Stephen Sinatra Featured on Searchjointpain.com 2Health News:CareFusion Prices $1.4 Billion of Senior Notes 2
... whole blood hematology control manufactured specifically for ... and the Coulter AcT5diff instruments. The composition ... cell differential, positioning the populations within the ... The product offers 105-day closed-vial stability and ...
... blood control for evaluating the accuracy and ... blood cell counts in patient body fluid ... WBC values for the Abbott CELL-DYN 3200, ... (levels 2 and 3 only) and Sysmex ...
... is a gene expression ... the risk of metastasis ... It is based on ... the Netherlands Cancer Institute ...
... The Pilot® thoracolumbar pedicle ... to deliver implants safely and ... instrumenting through an open procedure ... the unique screw insertion instrumentation ...
Medicine Products: