Navigation Links
VIVUS to Present at the Deutsche Bank BioFEST Conference
Date:12/1/2011

s. These factors include, but are not limited to, the timing and substance of our response to the FDA's requests from the End of Review meeting; our response to, and continued dialogue with, the FDA relating to matters raised in the FDA's 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 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 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 concerns, that the FDA will not require us to conduct any additional  p
'/>"/>
SOURCE VIVUS, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. VIVUS Reports Third Quarter and First Nine Months 2011 Financial Results
2. VIVUS to Present at the BioCentury NewsMakers Conference
3. VIVUS to Participate in Three Investor Conferences in September
4. VIVUS Announces Positive Phase 3 Results of Avanafil in Radical Prostatectomy Patients
5. VIVUS Reports First Quarter 2011 Financial Results
6. VIVUS to Present at Four Upcoming Investor Conferences in May
7. VIVUS to Present at the 10th Annual Needham Healthcare Conference
8. Data on VIVUS QNEXA to be Presented in Six Posters at The Obesity Societys Annual Meeting
9. VIVUS to Present at Four Upcoming Investor Conferences
10. VIVUS to Present at Two Upcoming Investor Conferences
11. VIVUS Reports Third Quarter 2009 Highlights and Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... 17, 2014 This report is ... Tubing industry. For an overview analysis, the report ... industry chain structure, industry overview, policy analysis, and ... industry has witnessed rapid development with key ... acquisitions. This report mentions quartz tubing upstream raw ...
(Date:12/17/2014)... (PRWEB) December 17, 2014 Gene ... that it has entered into a technology access ... (ADM) to apply DNA2.0’s proprietary protein engineering technology, ... process. , “We are extremely excited that the ... platform. This proprietary bioengineering technology has now ...
(Date:12/17/2014)...  Vermillion, Inc. (NASDAQ: VRML ), a ... the next step in its expanded strategy to rebuild ... the naming of current Chief Operating Officer, Valerie ... current Chairman of the Board and CEO James ... changes are effective January 1, 2015. "Jim ...
(Date:12/17/2014)... Dec. 17, 2014 CASI Pharmaceuticals, Inc. (Nasdaq: ... the acquisition, development and commercialization of innovative therapeutics addressing ... market with a primary commercial focus on ... granted a Type C meeting with the U.S. Food ... be held in February 2015.  During this meeting the ...
Breaking Biology Technology:2020 Quartz Tubing Market: Global Development & Forecasts Analysis Now at DeepResearchReports.com 2ADM and DNA2.0 Enter Into Protein Engineering Technology Access and Service Agreement 2Vermillion Names Valerie Palmieri CEO; James LaFrance to continue as Chairman of Board 2Vermillion Names Valerie Palmieri CEO; James LaFrance to continue as Chairman of Board 3Vermillion Names Valerie Palmieri CEO; James LaFrance to continue as Chairman of Board 4CASI Pharmaceuticals Granted Type C Meeting With U.S. FDA For ENMD-2076 In Fibrolamellar Carcinoma 2CASI Pharmaceuticals Granted Type C Meeting With U.S. FDA For ENMD-2076 In Fibrolamellar Carcinoma 3CASI Pharmaceuticals Granted Type C Meeting With U.S. FDA For ENMD-2076 In Fibrolamellar Carcinoma 4CASI Pharmaceuticals Granted Type C Meeting With U.S. FDA For ENMD-2076 In Fibrolamellar Carcinoma 5
... Inc. (OTC Bulletin Board: LIXT) today announced the,trading of ... Symbol LIXT. Commenting on this important milestone, President ... being a publicly traded company will,enable us to pursue ... private company. Having access to the capital markets is ...
... of HPV Viral Load a Possible Indicator of Cervical ... ... 24 Cepheid (Nasdaq:,CPHD) today announced that it has entered into ... by Quantovir,AB of Sweden for the quantitative measurement of high-risk HPV ...
... - Follows the Companies, Previous Announcement of MGCD0103,s ... Lymphoma in the United States -, BOULDER, ... PHRM ) and MethylGene, Inc. (TSX: MYG) ... the European,Commission (EC) designated MGCD0103, a histone deacetylase ...
Cached Biology Technology:Lixte Biotechnology Holdings, Inc. Announces the Initial Trading of Its Common Stock Under the Symbol: LIXT 2Lixte Biotechnology Holdings, Inc. Announces the Initial Trading of Its Common Stock Under the Symbol: LIXT 3Lixte Biotechnology Holdings, Inc. Announces the Initial Trading of Its Common Stock Under the Symbol: LIXT 4Cepheid Enters Agreement To Exclusively License HPV Portfolio Developed by Quantovir AB 2Cepheid Enters Agreement To Exclusively License HPV Portfolio Developed by Quantovir AB 3Cepheid Enters Agreement To Exclusively License HPV Portfolio Developed by Quantovir AB 4Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Hodgkin's Lymphoma 2Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Hodgkin's Lymphoma 3Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Hodgkin's Lymphoma 4
(Date:12/17/2014)... DUBLIN , Dec. 15, 2014 Research ... announced the addition of the "Samsung Galaxy ... Analysis" report to their offering. ... on a totally different sensing technology than the ... a fingerprint sensor in its product. ...
(Date:12/17/2014)... -- Valencell, a leader in performance biometric data sensor ... leaders such as Intel, Jabra, Atlas, and Scosche to ... These products will be showcased at CES 2015, taking ... . "Our partners choose PerformTek biometrics, ... with the clinical data to back it up," said ...
(Date:12/15/2014)... 2014 Research and Markets ( ... "Global Facial Recognition Market 2015-2019" report ... http://photos.prnewswire.com/prnh/20130307/600769 Facial recognition is a ... recognition system measures the overall facial feature of ... and the distance between eyes. Facial recognition is ...
Breaking Biology News(10 mins):Samsung Galaxy S5 - Home Button Synaptics Fingerprint Sensor Technology Analysis 2Valencell PerformTek Biometrics Power the Most Accurate Wearables at CES 2015 2Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 2Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 3
... Escherichia coli, one of the best-studied single-celled organisms ... be thought of as a factory with just one product: ... business plan is to make them at the lowest possible ... case of a bacterium, can be defined by the energy ...
... ancient relative of modern humans may have evolved to ... as part of a survival strategy, according to a ... includes Florida State University,s Dennis E. Slice. The ... National Academy of Science, challenge a long-standing hypothesis ...
... to return to Russia to oversee preparations for the launch ... 16 March 2009. This follows implementation of the corrective measures ... launch of GOCE by Eurockot Launch Services last October. ... Plesetsk Cosmodrome in northern Russia to arrange logistical matters while ...
Cached Biology News:Bacteria are models of efficiency 2March launch planned for ESA's gravity mission 2
... Biotech presents PsiPort Mass Directed Auto ... and data acquisition system designed for ... the life science and pharmaceutical discovery ... specifically to simplify high throughput mass ...
... Anti-M13 Anti-M13 polyclonal antibody was ... M13 bacterial phage particles.Recombinant protein domains such ... M13 coat protein pIII and displayed on ... the phage-based system utilized in the Ph.D. ...
... Ligation Kit enables ligation of ... in just 5 min at ... the DNA concentration, either circular ... (high DNA concentration) ligation products ...
... Kinase catalyzes the transfer of ... the 5-terminus of polynucleotides or ... group. The enzyme, purified from ... used to phosphorylate RNA, DNA ...
Biology Products: