Navigation Links
VIVUS Announces Positive Phase 3 Results of Avanafil in Radical Prostatectomy Patients
Date:5/25/2011

e indicated by such forward-looking statements. These factors include, but are not limited to, the timing and substance of our response to the FDA's requests from the QNEXA End-of-Review meeting; our response to, and continued dialogue with, the FDA relating to matters raised in the FDA's QNEXA CRL; the timing and results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy; the FDA's interpretation of and agreement with the information VIVUS submitted and may submit relating to teratogenicity and cardiovascular safety; the FDA's interpretation of the data from our SEQUEL study, or OB-305; the FDA's requests, if any, to conduct additional prospective studies or retrospective observational studies or to provide further analysis of clinical trial data; the review and questions from the EMA and CHMP on the QNEXA MAA; substantial competition; the impact on future sales based on specific indication and contraindications contained in the label and the extent of the Risk Evaluation and Mitigation Strategies program; uncertainties of litigation and intellectual property and patent protection; reliance on sole-source suppliers; limited sales and marketing resources and dependence upon third parties; risks related to the development of innovative products; risks related to the failure to obtain FDA or foreign authority clearances or approval; noncompliance with FDA or foreign regulations; and our dependence on the performance of our collaborative partners. As with any pharmaceutical in development, there are significant risks in the development, the regulatory approval, and commercialization of new products. There are no guarantees that our response to the FDA's CRL on QNEXA or the results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy and subsequent meetings and communications will be sufficient to satisfy the FDA's safety conc
'/>"/>
SOURCE VIVUS, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. VIVUS Reports First Quarter 2009 Financial Results and Highlights
2. Data on VIVUS Qnexa To Be Presented During Two Podium Presentations at ADA Annual Meeting
3. VIVUS to Present at the Needham and Company Life Sciences Conference
4. VIVUS to Present at the Canaccord Adams 29th Annual Global Growth Conference
5. VIVUS to Present at Four Upcoming Healthcare Conferences
6. VIVUS Announces Positive Results From Two Phase 3 Studies; Obese Patients on Qnexa Achieve Average Weight Loss up to 14.7% and Significant Improvements in Co-Morbidities
7. VIVUS Reports Third Quarter 2009 Highlights and Financial Results
8. VIVUS to Present at Two Upcoming Investor Conferences
9. VIVUS to Present at Four Upcoming Investor Conferences
10. Data on VIVUS QNEXA to be Presented in Six Posters at The Obesity Societys Annual Meeting
11. VIVUS to Present at the 10th Annual Needham Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... , Aug. 21, 2014  Decision Resources ... Brazil and Mexico ... uptake of several newly approved agents, the anticipated ... indication and the launch of emerging biologics will ... In particular, the emerging IL-5 inhibitors will introduce ...
(Date:8/21/2014)... Cord Blood Corporation (NYSE: CO ) (the ... for the first quarter of fiscal year 2015 on ... US.  The Company will host a ... 29, 2014 to discuss its financial performance and give ... by a question and answer session.  Interested parties may ...
(Date:8/21/2014)... 21, 2014 Ontotext S4 , ... Ontotext . Now the same enterprise hardened ... structured and unstructured data is available to start-ups and ... enterprise technology. Organizations that do not have resources to ... can use S4 since there is no need for ...
(Date:8/21/2014)... August 21, 2014 On Wednesday of last ... to use Redox Signaling molecules, became available for purchase in ... , "The way that RENU 28 works is, if you ... down of the rate of cellular renewal within your body. ... increasing of that rate of cellular renewal. What RENU 28 ...
Breaking Biology Technology:Asthma Agents Currently Face a Suboptimal Coverage Environment in Brazil and Mexico, and as the Treatment Armamentarium Expands, Competitiveness Will Further Intensify 2Asthma Agents Currently Face a Suboptimal Coverage Environment in Brazil and Mexico, and as the Treatment Armamentarium Expands, Competitiveness Will Further Intensify 3China Cord Blood Corporation to Report First Quarter of Fiscal 2015 Financial Results 2Ontotext Releases Text Mining & Semantic Technology Running in the Cloud – Welcome to “S4? 2Ontotext Releases Text Mining & Semantic Technology Running in the Cloud – Welcome to “S4? 3Ontotext Releases Text Mining & Semantic Technology Running in the Cloud – Welcome to “S4? 4RENU 28 Skin Care Now Available in Australia and New Zealand 2
... 16, 2011 Genesis Biopharma, Inc. (OTC ... developing targeted cancer therapies, today announced it is expanding ... various cancers.  The Company will focus on establishing a ... new strategy will be discussed during a presentation today ...
... SAN DIEGO, March 15, 2011 PR Newswire, ... solutions, today announced the extension of their exclusive ... be the preferred provider of content distribution services ... science association. (Logo: http://photos.prnewswire.com/prnh/20000306/PRNLOGO) ...
... Biotechnology company ImmusanT, Inc. today announced it ... is advancing its strategy to develop an immunotherapeutic ... disease. The company completed the acquisition of a ... Ltd., based in Melbourne, Australia, and secured seed ...
Cached Biology Technology:Genesis Biopharma Announces Plans to Develop Active Immunotherapy Platform 2PR Newswire and BIOCOM Purchasing Group Announce Renewal of Exclusive Partnership 2PR Newswire and BIOCOM Purchasing Group Announce Renewal of Exclusive Partnership 3Start-Up ImmusanT Seeks to Restore Tolerance to Gluten in Celiac Disease with Immunotherapy 2Start-Up ImmusanT Seeks to Restore Tolerance to Gluten in Celiac Disease with Immunotherapy 3Start-Up ImmusanT Seeks to Restore Tolerance to Gluten in Celiac Disease with Immunotherapy 4
(Date:8/22/2014)... the 29th Annual International Papillomavirus Conference shows that ... combats three types of human papillomavirus, including the ... cancer. , When tested in several cultured human ... HPV-18 and HPV-11 cells, according to Louise T. ... the findings at the Seattle conference. The National ...
(Date:8/22/2014)... can probably remember the after-effects, including pain, swelling or ... back against the injury. When tissue in the body ... tissue regeneration. An inflammatory response acts as a protective ... to heal after injuries such as wounds and burns. ... situations in which foreign material is introduced, for example ...
(Date:8/22/2014)... tea polyphenols are strong antioxidants and can ... spinal cord neurons against oxidative stress? Jianbo ... Hospital of Liaoning Medical University, China discovered ... stress and inhibit neuronal apoptosis, indicating green ... spinal cord neurons under oxidative stress. The ...
Breaking Biology News(10 mins):Tissue regeneration using anti-inflammatory nanomolecules 2
... have won national awards for their research on the ... northern spotted owl. Martin Raphael and Eric Forsman, research ... Station, were named recipients of the Wings Across the ... the station,s Olympia, Wash., lab and Forsman at the ...
... barrier (BBB) remains a major obstacle to the successful ... disorders, reports Genetic Engineering and Biotechnology News ... approaches to preserve the ability of the BBB to ... and to permit the passage of effective medicines for ...
... plant pollen grains, sperm cells, which carry the genetic ... within larger "companion" cells that are called pollen vegetative ... nourishment, and push them towards their targets during fertilization. ... Spring Harbor Laboratory (CSHL) led by Professor Robert Martienssen, ...
Cached Biology News:Federal scientists recognized for contributions to knowledge of bird ecology and habitat 2GEN reports on strategies to overcome blood-brain barrier 2CSHL scientists discover how 'companion' cells to sperm protect them from genetic damage 2CSHL scientists discover how 'companion' cells to sperm protect them from genetic damage 3
... The kit measures mitochondria intactness ... mitochondrial membrane potential. Features and Benefits: ... method for staining isolated mitochondria and ... Contains all the reagents required for ...
... dispensers save space and organize ... and other garb. They are ... for small parts used in ... acrylic. Many other sizes and ...
... These handy dispensers save space and ... and other garb. They are the ... parts used in labs, processing and ... charges and the particles they attract. ...
... Microarrays designed for genome-wide microRNA ... flexible and powerful Paraflo microfluidic on-chip ... as part of our comprehensive microRNA ... Content The Mammals microRNA Microarray ...
Biology Products: