Navigation Links
FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)
Date:2/3/2009

ward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide the Company's current expectations or forecasts of future events. Forward-looking statements in this press release include statements regarding ViroPharma's clinical development programs. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. The development and commercialization of pharmaceutical products is subject to risks and uncertainties. The data that were submitted to the U.S. Food and Drug Administration includes data from two separate studies including the pivotal Phase 3 study of Cinryze in acute HAE attacks and the ongoing open-label study of Cinryze for acute treatment of HAE, which includes partial data from an ongoing open label study. There can be no assurance that the complete data from the open label study will demonstrate that Cinryze successfully treats all types of acute hereditary angioedema (HAE) attacks and may not be predictive of the results of any future testing. The FDA may view the data regarding the use of Cinryze for acute treatment of HAE we have submitted as a supplemental BLA as insufficient or inconclusive, not accept our submission, request additional data, require additional clinical studies, delay any decision past the time frames anticipated by us, limit any approved indications, deny the approval of Cinryze for acute treatment of HAE or approve a competing product which has been granted orphan drug designation thereby preventing Cinryze from reaching the market for acute treatment of HAE. These factors, and other factors, including, but not limited to those described in ViroPharma's annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission during 2008, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in t
'/>"/>
SOURCE ViroPharma Incorporated
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. US FDA Grants Orphan Drug Status to Immtechs Pafuramidine for Treatment of African Sleeping Sickness
2. Chinese SFDA Grants Immtech Fast Track Status
3. Ethics Group Asks USAID Inspector General to Investigate Legality of Grants to Soros Groups
4. NTMir Announces Research Grants for Epidemiology and Household Water as Source of Infection
5. FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial
6. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
7. FDA Grants Priority Review for ACIPHEX(R) (rabeprazole sodium) sNDA for Short-Term Treatment of GERD in Adolescents
8. FDA Grants Priority Review for PROMACTA(R) (eltrombopag)
9. FDA Grants NeoVistas Request to Expand CABERNET Trial to 30 Sites in the U.S.
10. FDA Grants Market Clearance for the LipiScan(TM) Coronary Imaging System Developed by InfraReDx, Inc. - A Novel Spectroscopy System for the Identification of Lipid Core Containing Plaques of Interest in the Coronary Arteries
11. FDA Grants Pediatric Exclusivity for TOPAMAX(R), Extending the Marketing Exclusivity by Six Months
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... - Bedrocan Cannabis Corp., previously Bedrocan Canada Inc. ("Bedrocan") ... of Directors, enhancing executive oversight and strengthening the ... licensed producer of medicinal cannabis in ... experience in producing and supplying government-regulated pharmaceutical-grade cannabis ... As previously announced in a press ...
(Date:8/21/2014)... CYBX ) today announced results for the quarter ended ... Operating results for the first quarter of fiscal ... other achievements, include: , Worldwide net product sales of ... net sales of $13.2 million, an increase of 14.5% on ... reached a new high of $58.8 million, an increase of ...
(Date:8/21/2014)... Calif. , Aug. 21, 2014 Asterias ... the emerging field of regenerative medicine, announced today the ... to the Company,s newly expanded Board of Directors. With ... eight directors, three of whom are independent. ... experience working with emerging growth companies. He is currently ...
Breaking Medicine Technology:Senior Life Sciences Executives Join Bedrocan as Independent Directors 2Senior Life Sciences Executives Join Bedrocan as Independent Directors 3Cyberonics Reports Fiscal 2015 First Quarter Results 2Cyberonics Reports Fiscal 2015 First Quarter Results 3Cyberonics Reports Fiscal 2015 First Quarter Results 4Cyberonics Reports Fiscal 2015 First Quarter Results 5Cyberonics Reports Fiscal 2015 First Quarter Results 6Cyberonics Reports Fiscal 2015 First Quarter Results 7Cyberonics Reports Fiscal 2015 First Quarter Results 8Cyberonics Reports Fiscal 2015 First Quarter Results 9Cyberonics Reports Fiscal 2015 First Quarter Results 10Cyberonics Reports Fiscal 2015 First Quarter Results 11Cyberonics Reports Fiscal 2015 First Quarter Results 12Cyberonics Reports Fiscal 2015 First Quarter Results 13Cyberonics Reports Fiscal 2015 First Quarter Results 14Cyberonics Reports Fiscal 2015 First Quarter Results 15Cyberonics Reports Fiscal 2015 First Quarter Results 16Asterias Biotherapeutics Appoints Two Independent Directors and Announces Completion of Series A Common Stock Distribution 2Asterias Biotherapeutics Appoints Two Independent Directors and Announces Completion of Series A Common Stock Distribution 3Asterias Biotherapeutics Appoints Two Independent Directors and Announces Completion of Series A Common Stock Distribution 4
... today,announced that its WaveReady 3000 series has ... compatible with Brocade-based Storage Area,Network (SAN) infrastructures ... Data Center Ready Program. The program is ... Brocade-based data center,environments., "We are pleased ...
... Covers Compositions and Methods, ROCKVILLE, Md., June ... clinical-stage pharmaceutical company developing,therapeutics for the treatment of ... U.S. Patent No. 7,371,741 covering analogs of 2-,methoxyestradiol ... use intellectual property protection through 2025 for analogs,of ...
Cached Medicine Technology:JDSU WaveReady Receives Brocade Data Center Ready Status for Brocade-Based Storage Area Network (SAN) Infrastructures 2JDSU WaveReady Receives Brocade Data Center Ready Status for Brocade-Based Storage Area Network (SAN) Infrastructures 3EntreMed Receives New Patent for 2-Methoxyestradiol Analogs 2EntreMed Receives New Patent for 2-Methoxyestradiol Analogs 3
(Date:8/21/2014)... According to a new market research report "Near ... and Auxiliary), Application (Payment, Transportation, Booking, Data Sharing, Service, ... Geography - Global Forecasts to 2022", published by MarketsandMarkets, ... Billion by 2022 at an estimated CAGR of 8.83% ... Tables and 105 Figures spread through 298 Pages and ...
(Date:8/21/2014)... 21, 2014 It's a terrible thing when ... to a serious substance abuse issue. When that happens to ... action is getting reliable help from the qualified substance abuse ... facility isn’t always easy for those young adults living in ... significant addiction issue. , Thankfully there is a new ...
(Date:8/21/2014)... Rockville, Maryland (PRWEB) August 21, 2014 ... developed with guidance from Lockton Companies and builds ... the industry’s only cellular glucometer, combined with Accountable ... and robust data analytic capabilities and adds a ... provider care, including eye exams, provider visits, HbA1c ...
(Date:8/21/2014)... (PRWEB) August 21, 2014 Sleep Apnea Doctors ... the U.S. This provides doctors with a convenient way to ... a doctor are that much closer to finding remedies ... no idea they are experiencing this sleep disorder , ... treatment at all. , Thanks to Sleep Apnea Doctors U.S., ...
(Date:8/21/2014)... (PRWEB) August 21, 2014 Relias Learning, ... the health and human services markets, announced the latest ... capabilities incorporating the Tin Can API. , “Supporting ... employees have the most advanced mobile learning capabilities and ... adult learning tools and techniques,” says Jim Triandiflou, CEO ...
Breaking Medicine News(10 mins):Health News:Near Field Communication Market by Product (IC/Chips, Tags, Readers, and Auxiliary) Worth $16.25 Billion by 2022 – New Report by MarketsandMarkets 2Health News:Near Field Communication Market by Product (IC/Chips, Tags, Readers, and Auxiliary) Worth $16.25 Billion by 2022 – New Report by MarketsandMarkets 3Health News:Near Field Communication Market by Product (IC/Chips, Tags, Readers, and Auxiliary) Worth $16.25 Billion by 2022 – New Report by MarketsandMarkets 4Health News:Young Adults in Pompano Beach, FL Are Finding Success With Innovative New Helpline 2Health News:Accountable Health Expands Diabetes Management Solutions to Address Gaps in Provider Care 2Health News:Accountable Health Expands Diabetes Management Solutions to Address Gaps in Provider Care 3Health News:Sleep Apnea Doctors US is Now Offering Complimentary Listings to Sleep Apnea Doctors Across the United States 2Health News:Relias Learning Announces Support for Tin Can API 2
... (HealthDay News) -- Infants with Down syndrome who weigh less than ... lung disorders that increase their chances of dying, a new study ... than 50,000 very low birth weight (VLBW) infants who weighed between ... this group of babies, those born with Down syndrome were about ...
... that control the age of sexual maturation in women. ... weight regulation or biological pathways related to fat metabolism. ... was a collaborative effort by the international ReproGen consortium, ... Boston University School of Medicine (BUSM) and Boston University ...
... 1. Low Income Individuals Are Donating Fewer Kidneys ,Kidney ... Research shows that people with low incomes are ... receive a living donor kidney transplant than people of other ... kidneys, Jagbir Gill, MD (St. Paul,s Hospital, University of British ...
... HealthDay Reporter , FRIDAY, Nov. 19 (HealthDay News) -- ... from the U.S. market because they,ve been linked to ... Friday. The U.S. Food and Drug Administration said ... is voluntarily taking the drugs off the market. The ...
... , FRIDAY, Nov. 19 (HealthDay News) -- A new, small ... doctors determine the best dose of tamoxifen, a drug commonly used ... that the body absorbs cough medicine at about the same rate ... respond to the breast-cancer drug. "This study is starting ...
... 16, 2010) A clinical trial that aims to speed ... of breast cancer now has a designated study site ... University of Colorado Hospital. This study, called I-SPY ... Response with Imaging and Molecular Analysis 2) will evaluate ...
Cached Medicine News:Health News:Tiniest Newborns With Down Syndrome Face Other Health Risks 2Health News:Genes link puberty timing and body fat in women 2Health News:Efforts needed to address disparities in kidney transplantation 2Health News:Efforts needed to address disparities in kidney transplantation 3Health News:Efforts needed to address disparities in kidney transplantation 4Health News:FDA Pulls Darvon and Companion Drug Due to Heart Risks 2Health News:FDA Pulls Darvon and Companion Drug Due to Heart Risks 3Health News:Cough Syrup Might Help With Dosing of Breast Cancer Drug 2Health News:I-SPY 2 study speeds up treatment for breast cancer 2Health News:I-SPY 2 study speeds up treatment for breast cancer 3
Desmarres Retractor Size 4...
Desmarres Lid Retractor thin solid blades. Size 2....
... system introduces a new level ... microsurgical instrumentation. It has an ... with advanced microcomputer control of ... operate with a full range ...
Multiple Modulation Phaco (MMP) programmability with eight surgeon settings for maximum versatility. The combination of the peristaltic power balanced pump and the piezoelectric handpiece results in ...
Medicine Products: