Navigation Links
ADVENTRX Announces Positive Data From Preclinical Pharmacokinetic,Testing of ANX-514 (Docetaxel Emulsion)

tere induced an anaphylactoid type reaction consistent with hypersensitivity reactions, including acute increases in blood histamine levels and decreased blood pressure. In contrast, no hypersensitivity reactions, including no elevations in histamine levels and no changes in blood pressure were observed following dosing with ANX-514.

ADVENTRX is continuing to conduct additional preclinical pharmacokinetic testing of ANX-514 to compare this product candidate with the approved version of the product, marketed under the brand name Taxotere. The Company currently plans to seek guidance from the FDA with respect to the appropriateness of a Section 505(b)(2) NDA regulatory path for ANX-514, and pending agreement on clinical protocol design with the FDA, initiate a marketing-enabling clinical trial of ANX-514 in 2007.

About ANX-514 (docetaxel emulsion)

ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug docetaxel, a product marketed under the brand name Taxotere. ANX-514 is designed to eliminate the need for multi-day immunosuppressant premedication. 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 allergic reactions. Docetaxel is approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers. In connection with a Section 505(b)(2) NDA covering ANX-514, ADVENTRX must certify that all applicable Taxotere patents have expired prior to the manufacture, use or sale of ANX-514.

About Section 505(b)(2)

Section 505(b)(2) of the 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
'"/>




Page: 1 2 3 4 5

Related medicine technology :

1. ADVENTRX to Present CoFactor Multiagent Therapy Data at AACR Annual Meeting
2. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
3. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
5. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
6. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
7. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
8. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
9. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
10. Protox Announces Positive Clinical Data from Prostate Cancer Study
11. Inspire Announces Webcast of Presentation at C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
Post Your Comments:
(Date:7/10/2014)... , July 10, 2014 Integrated Silicon Solution, ... advanced memory and analog IC solutions, today announced that ... July 24, 2014, at 7:00 a.m. Pacific Time (10:00 ... for the fiscal 2014 third quarter ended June 30, ... telephone, dial 1-888-556-4997 before 6:50 a.m. Pacific time on ...
(Date:7/10/2014)... JORDAN, Utah , July 10, 2014  BC ... solutions, and MiE America , Inc., a leading ... have entered into a long-term agreement naming BC Technical ... the US. MiE and BC Technical ... strategic agreement to establish BC Technical as the service ...
(Date:7/10/2014)... BURLINGTON, Mass. , July 10, 2014 /PRNewswire/ ... three-quarters of surveyed infectious disease (ID) specialists are ... Medicines Company,s Orbactiv (oritavancin) for use as OPAT, ... to prescribe these agents to their hospital inpatients. ... percent) of OPAT patients are initiated on OPAT ...
Breaking Medicine Technology:BC Technical Partners With MiE America To Be Authorized Provider Of Systems & Service 2Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 2Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 3
... ST. LOUIS , Feb. 1 Stereotaxis (Nasdaq: ... featured Dr. Mauricio Arruda , a leading electro-physiologist ... in Cleveland, Ohio , performing a live cardiac ablation ... The patient was a 69 year old woman who suffered ...
... BRISBANE, Calif. , Feb. 1 InterMune, ... Food and Drug Administration,s (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) ... for pirfenidone on March 9, 2010 .  Pirfenidone is ... idiopathic pulmonary fibrosis (IPF).   , "There is an urgent ...
Cached Medicine Technology:Stereotaxis System Procedure Featured on NBC's The TODAY Show 2InterMune to Participate in Pulmonary-Allergy Drugs Advisory Committee Meeting on March 9, 2010 2InterMune to Participate in Pulmonary-Allergy Drugs Advisory Committee Meeting on March 9, 2010 3InterMune to Participate in Pulmonary-Allergy Drugs Advisory Committee Meeting on March 9, 2010 4InterMune to Participate in Pulmonary-Allergy Drugs Advisory Committee Meeting on March 9, 2010 5
(Date:7/10/2014)... New York, US (PRWEB) July 10, 2014 ... . , Merrill DataSite recently streamed the live webinar ... featuring a discussion from a group of several M&A ... are seeing in the broader energy transaction marketplace. These ... hot and how the deal market in this sector ...
(Date:7/10/2014)... 2014 CBPartners, a global leader in ... a new website. The redesigned site boasts improved ... to the firm’s thought pieces, blog posts, and conference ... to showcase our insights, capabilities, and to provide timely ... Executive Officer, Cyrus Chowdhury. “An enhanced online presence ...
(Date:7/10/2014)... Best Drug Rehabilitation , which ... close by during a stay in rehab can ... the process is successful, has launched an inspiring ... http://www.bestdrugrehabilitation.com/success-stories/ . , The new Success Stories section ... Best Drug Rehabilitation graduates who wanted to help ...
(Date:7/10/2014)... York (PRWEB) July 10, 2014 ... to protecting the rights of victims injured by ... brought a lawsuit over allegations that the woman’s ... by a power morcellator used during a routine ... filed against Richard Wolf Medical Instruments Corporation over ...
(Date:7/10/2014)... new study from Colorado School of Public Health shows ... a major problem in the Navajo Nation and among ... Americans is abysmal with more than three times the ... Batliner, DDS, MBA, associate director of the Center for ... Health. "The number one problem is access to care." ...
Breaking Medicine News(10 mins):Health News:Register to Download Merrill DataSite's Report: Capitalizing on the Shifting Sands of the Energy Market 2Health News:CBPartners Announces New Website 2Health News:Best Drug Rehabilitation Launches New Success Stories Section of Website 2Health News:Couple Sues Over Alleged Cancer Risk Associated with use of a Power Morcellator During the Woman's Laparoscopic Fibroid Removal Procedure, Parker Waichman Comments 2Health News:Couple Sues Over Alleged Cancer Risk Associated with use of a Power Morcellator During the Woman's Laparoscopic Fibroid Removal Procedure, Parker Waichman Comments 3Health News:Couple Sues Over Alleged Cancer Risk Associated with use of a Power Morcellator During the Woman's Laparoscopic Fibroid Removal Procedure, Parker Waichman Comments 4Health News:Couple Sues Over Alleged Cancer Risk Associated with use of a Power Morcellator During the Woman's Laparoscopic Fibroid Removal Procedure, Parker Waichman Comments 5Health News:Study finds widespread oral health problems among Navajo 2
... ,Hidden Health Tax, is the Undisclosed Premium Surcharge that Pays ... People Join the Ranks of the Uninsured, the ,Hidden Health ... Higher in 2009WASHINGTON, May 28 The so-called ... $1,017 in 2008 according to a report released today by ...
... Elsevier, would like to announce the publication of ... Treatment by Peter Miller, PhD. , The ... the field of addictions treatment is leading to ... based solely on clinical intuition rather than hard ...
... 2009) Kevin Bruhn, PhD, is the winner of the ... at nurturing excellence and providing support for a young scientist ... to LA BioMed in 2005 after receiving his PhD in ... Los Angeles in 2004 and completing a postdoctoral fellowship in ...
... BIRMNGHAM, Ala. An experimental drug derived from cottonseed ... widely considered the most lethal brain cancer, said researchers ... The new results are from a Phase II clinical ... compound in cottonseed that overcomes the abnormal growth patterns ...
... fractional laser was featured today on NBC,s Today ... for scars. During the broadcast, triplets who were severely ... story and discussed recent treatments with the Lumenis UltraPulse ... and DeepFX technologies, the triplets Jordan, Trae and Chandra ...
... Deliciously Cool, Smooth Drink While It,s HotBATTLE CREEK, Mich., May 28 ... season doesn,t feature the bells and whistles of most sought-after new ... to get their hands on it just the same. ... (R) brand is introducing the brand,s first ...
Cached Medicine News:Health News:'Hidden Health Tax' for Family Health Care Coverage Climbed to $1,017 in 2008 2Health News:'Hidden Health Tax' for Family Health Care Coverage Climbed to $1,017 in 2008 3Health News:Exciting Innovation in Burn Scar Treatment Using Lumenis(R) UltraPulse(R) Laser Treatments Revealed on the Today Show 2Health News:Exciting Innovation in Burn Scar Treatment Using Lumenis(R) UltraPulse(R) Laser Treatments Revealed on the Today Show 3Health News:Exciting Innovation in Burn Scar Treatment Using Lumenis(R) UltraPulse(R) Laser Treatments Revealed on the Today Show 4Health News:Special K(R) Brand Shakes Things Up with New Weight-Management Protein Shake 2Health News:Special K(R) Brand Shakes Things Up with New Weight-Management Protein Shake 3Health News:Special K(R) Brand Shakes Things Up with New Weight-Management Protein Shake 4
... endoscope is the first Video ... instrument incorporates a 2.0mm instrument ... insertion tube. The slim size ... easy introduction even through areas ...
... Used for temporary internal drainage from ... Supplied sterile in peel-open packages. Intended ... is advised; C-Flex® and Sof-Flex® stents ... six (6) months; silicone stents must ...
... internal drainage from the ureteropelvic junction to ... for ease of placement and patient compliance. ... for repositioning and ease of removal. AQ® ... that when activated, attracts and holds water ...
... Double Pigtail Ureteral Stents have an ... maximizes migration. They also feature unique ... cost savings. Each Classic Double PigTail ... Double PigTail Ureteral Stent with attached ...
Medicine Products: