Navigation Links
ViroPharma Receives Complete Response Letter for Cinryze™ (C1 Esterase Inhibitor [Human]) Industrial Scale Supplement
Date:10/22/2010

EXTON, Pa., Oct. 22 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding Cinryze™ (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities. The FDA has requested additional information related to observations from the pre-approval inspection and review of the technical processes.  

"We and our partner Sanquin will begin working immediately to respond to the FDA as expeditiously as possible," said Vincent Milano, ViroPharma's president and chief executive officer.  "And, we plan to commence manufacturing industrial scale lots at risk in the first quarter of 2011."  

Continued Milano, "We remain committed to provide patients with an uninterrupted supply of Cinryze.  In addition to our efforts around our industrial scale, we expect our currently approved manufacturing process alone will yield up to 60,000 doses annually."

Conference Call and Webcast

ViroPharma is hosting a brief live teleconference and webcast with senior management on October 22, 2010 at 11:00 a.m. Eastern. To participate in the conference call, please dial (888) 299-4099 (domestic) and (302) 709-8337 (international).  After placing the call, please tell the operator you wish to join the ViroPharma investor conference call.  

Alternatively, the live webcast of the conference call can be accessed via ViroPharma's website at http://www.viropharma.com.  Windows Media or Real Player will be needed to access the webcast.  An audio archive will be available at the same address until November 5, 2010.

About Cinryze™ (C1 esterase inhibitor [human])

Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1
'/>"/>

SOURCE ViroPharma Incorporated
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. ViroPharma to Present at Three Upcoming Healthcare Conferences
2. ViroPharma to Present at the Natixis Bleichroeder Conference
3. ViroPharma To Present at the Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
4. ViroPharma to Release 2008 First Quarter Financial Results on April 30, 2008
5. ViroPharma Announces Discontinuation of HCV-796 Development
6. ViroPharma Announces Completion of Enrollment in Phase 3 Study of Maribavir in Stem Cell Transplant Patients
7. ViroPharma Incorporated Completes Acquisition of Lev Pharmaceuticals
8. ViroPharma Announces Presentation of Cinryze(TM) Data in Acute Treatment of Hereditary Angioedema
9. ViroPharma Announces Discontinuation of Maribavir Phase 3 Study in Liver Transplant Patients
10. ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
11. ViroPharma Incorporated Reports Third Quarter 2009 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/19/2014)... , Deutschland, October 19, 2014 ... gefragt. Das Problem dabei ist, dass ... mit der Kompetenz zu teilen. Es ... deshalb freuen wir uns umso mehr, dass es ... ihre Gepflogenheiten bei Kühlketten aufzuschreiben - mit einem ...
(Date:10/17/2014)... , Oct. 17, 2014 With ... Medical Affairs function has come across several challenges ... efficiently and managing globalization.  The ... LLC is dedicated to providing benchmarking and best ... Affairs Consortium is a service composed of three ...
(Date:10/17/2014)... -- Hanger, Inc. (NYSE: HGR ) announced today ... for the quarter ended September 30, 2014, on Thursday, ... call to discuss these results is scheduled to begin ... Those wishing to participate should call 1-877-662-6095. A replay ... dialing 1-855-859-2056 and referencing Conference ID # 91880739. ...
Breaking Medicine Technology:Vergleichsbericht zu Pharma-Kühlketten und CRT 2Early Key Findings from the Medical Affairs Consortium Research 2
... 27 Due to rising patient responsibility for ... state laws requiring disclosure of information on hospital charges, ... estimates for healthcare services. Competitive hospitals also realize they ... accountability to key stakeholders, protect against compliance risks, focus ...
... , , ... 280,000 external defibrillators used worldwide in health care facilities, public places, or in the home ... Drug Administration warned today. , , , ... , , , ...
Cached Medicine Technology:Craneware Shares Patient Estimation Revenue Integrity Insights 2Craneware Shares Patient Estimation Revenue Integrity Insights 3Craneware Shares Patient Estimation Revenue Integrity Insights 4FDA Warns Users About Faulty Components in 14 External Defibrillator Models 2FDA Warns Users About Faulty Components in 14 External Defibrillator Models 3
(Date:10/20/2014)... NY (PRWEB) October 20, 2014 ... non-profit organization that helps New Yorkers living with ... changes toward health, housing, recovery and self-sufficiency. Each ... transformed the local community through their tireless efforts. ... Marc Shapses , has been selected as ...
(Date:10/20/2014)... CA (PRWEB) October 20, 2014 JZ ... expertise, nutritional coaching, corporate wellness programming, authorship, international lecturing ... is excited to announce the release of the JZ ... After many years of coaching thousands of individuals on ... tracking app that does not require calorie counting or ...
(Date:10/20/2014)... 20, 2014 Rockynol Retirement Community ... on Oct. 14. The $11 million project will include ... a cooked-to-order kitchen with full-service restaurant style dining. , ... for first class Assisted Living apartments,” said Kara Hanzie, ... the highest quality of care and this investment is ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 Unveiled at the ... Strategic Direction Scorecard conservatively estimates member hospital ROI on membership ... on dues, The Center provides $12.50 in value to member ... (Member Value – Member Dues)/Member Dues. , “This is ... this number and we think the methodology is really sound,” ...
(Date:10/19/2014)... (PRWEB) October 20, 2014 Hastings and ... 30 years of service throughout the greater Phoenix area ... legal representation with regard to catastrophic automobile accidents. Statistics ... the country and throughout Arizona. As such, Hastings and ... for legal representation for those who have been injured ...
Breaking Medicine News(10 mins):Health News:Savills Studley's Marc Shapses To Be Honored as 2014 "Positive Changemaker" by ASCNYC 2Health News:Savills Studley's Marc Shapses To Be Honored as 2014 "Positive Changemaker" by ASCNYC 3Health News:JZ Fitness Nutrition App Launches on iTunes 2Health News:JZ Fitness Nutrition App Launches on iTunes 3Health News:Rockynol Retirement Community Expands Assisted Living Center 2Health News:Scorecard Estimates Hospital ROI at $12.50 for every $1 Spent on Dues 2Health News:Scorecard Estimates Hospital ROI at $12.50 for every $1 Spent on Dues 3Health News:Scorecard Estimates Hospital ROI at $12.50 for every $1 Spent on Dues 4Health News:Hastings And Hastings Reports Record Demand In 2014 For Legal Representation With Regard To Catastrophic Automobile Accidents 2Health News:Hastings And Hastings Reports Record Demand In 2014 For Legal Representation With Regard To Catastrophic Automobile Accidents 3
... suffering from posttraumatic stress disorder (PTSD) are as likely ... disease risk factors such as an elevated white blood ... healthcare providers screen for PTSD in the same way ... , Exposure to trauma has not only psychological effects, ...
... Name ... Same Commitment to ... the Health of all Babies, CINCINNATI, Feb. ... that 4-year-old Bradley,Coffey of Kennedy Heights and his family will serve as ... WalkAmerica,March for Babies is the March of Dimes premier fundraising event that,benefits ...
... /PRNewswire-FirstCall/ - LMS Medical Systems (TSX:,LMZ, AMEX: LMZ), ... information system and risk management software tools for,obstetrics, ... third,quarter ended December 31, 2007. All amounts are ... new installations and growing recurring maintenance,and technical service ...
... Briefing on Feb. 12, WASHINGTON, Feb. ... a significant role in preparing federal legislation,received ... groups. The American Society of Transplantation (AST), ... Organ Sharing (UNOS),and Association of Organ Procurement ...
... (Nasdaq: DYNT ) will release financial results ... February 14, 2008., Dynatronics has scheduled a ... p.m. ET to discuss its results for the ... should call 800-839-9416 and use,passcode: 1383812., Dynatronics ...
... Gen-Probe Incorporated,(Nasdaq: GPRO ) announced today that ... Mid-Cap Growth Conference on Friday, February 15,2008 at approximately ... is scheduled to be webcast live and may be ... . The webcast will,be available for 30 days following ...
Cached Medicine News:Health News:Geisinger study: PTSD a medical warning sign for long-term health problems 2Health News:Local Families Chosen for Ambassador Role for 2008 March for Babies 2Health News:Local Families Chosen for Ambassador Role for 2008 March for Babies 3Health News:LMS Third Quarter 2008 Financial Results - Q3 Revenue Increases 88% to $1.0 Million - YTD Revenue Increases 87% to $2.6 Million 2Health News:LMS Third Quarter 2008 Financial Results - Q3 Revenue Increases 88% to $1.0 Million - YTD Revenue Increases 87% to $2.6 Million 3Health News:LMS Third Quarter 2008 Financial Results - Q3 Revenue Increases 88% to $1.0 Million - YTD Revenue Increases 87% to $2.6 Million 4Health News:Transplant Community Unites to Educate Capitol Hill Staffers About the 'Gift of Life' 2Health News:Gen-Probe to Webcast Presentation at Deutsche Bank Small- and Mid-Cap Growth Conference 2
Hatsis tying forceps, titanium, long thin tying platforms....
Gills Colibri forceps, very fine pointed tips....
Fine tying forceps, curved tips, wide handle....
Castroviejo tying forceps, tying platforms, straight, 0.3 mm teeth....
Medicine Products: