Navigation Links
ViroPharma Incorporated Reports Second Quarter 2009 Financial Results
Date:7/29/2009

n statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of future events. Forward looking statements in this press release include our financial guidance for 2009, and statements regarding our clinical development programs, the effectiveness of our Vancocin and Cinryze sales efforts, our estimates of future tax rates, or our ability to execute a successful launch of Cinryze, our ability to conduct future studies with maribavir, and the timing and potential outcomes of the review of our regulatory submission related to an acute treatment indication for Cinryze.

We plan to remain vigorous in our opposition to any bioequivalence approach considered for use in approving generic formulations of Vancocin that does not require rigorous scientific methods to demonstrate safety and efficacy consistent with good medicine and science. The FDA will convene a meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to discuss bioequivalence recommendations for oral vancomycin hydrochloride capsule drug products. The meeting is scheduled for August 4, 2009. We have submitted briefing materials to the Advisory Committee for its consideration on the issues presented by OGD's bioequivalence recommendation, and we expect to present these issues at the meeting. There can be no assurance that the FDA will agree with the positions stated in our Vancocin related submissions or that our efforts to oppose the FDA's December 2008 bioequivalence guidance for Vancocin will be successful. We cannot predict the timeframe in which the FDA will make a decision regarding either our citizen petition for Vancocin or the approval of generic versions of Vancocin. If we are unable to change the recommendation set forth by the FDA in December 2008, the threat of generic competition will be high. The entry of competing
'/>"/>

SOURCE ViroPharma Incorporated
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Related medicine news :

1. ViroPharma to Release 2009 Second Quarter Financial Results on July 29, 2009
2. ViroPharma Announces Appointment of Frank Baldino, Jr., Ph.D. to Board of Directors
3. ViroPharma Announces Meeting of FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology on Bioequivalence Recommendations for Oral Vancomycin Hydrochloride Products
4. ViroPharma to Present at Two May Healthcare Conferences
5. ViroPharma to Present at the Cowen & Company 29th Annual Healthcare Conference
6. ViroPharma to Host Investor Teach-In Educational Symposium on Hereditary Angioedema
7. ViroPharma to Release 2008 Fourth Quarter and Full Year Financial Results on February 24, 2009
8. ViroPharma Reports Results of Phase 3 Clinical Trial for Maribavir in Bone Marrow Transplant Patients
9. ViroPharma to Present at the 27th Annual J.P. Morgan Healthcare Conference
10. ViroPharma Provides Update on Vancocin(R)
11. ViroPharma Submits Supplemental Biologics License Application for Cinryze(TM) to Treat Acute Attacks of Hereditary Angioedema
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... (PRWEB) July 11, 2014 Utilizing the ... own, Dr. William Koenig, has topped a record number ... he has performed over 400 successful procedures without the ... Koenig is well known across the country for his ... safety record has long been the foundation for numerous ...
(Date:7/11/2014)... CA (PRWEB) July 11, 2014 Ticket Down ... at the Concord Pavilion . When it comes to the ... Luke Bryan. The 37-year-old Georgia native is one of the biggest ... the entertainment business. Bryan is currently out on his “That’s My ... the many stops the tour will be making through the rest ...
(Date:7/11/2014)... 2014 Biostimulants are widely applied in ... and ornamentals. These also help turf and ornamentals in ... roots. Turf, ornamentals, and flowers appear healthy and strong ... has increased from the last few years. The most ... is Europe, with around 40% share in 2013, and ...
(Date:7/11/2014)... PULLMAN, Wash.The largest study of its kind has ... suite of advantages over their conventional counterparts, including ... , The study looked at an unprecedented 343 ... of organic and conventional plant-based foods, including fruits, ... meta-analysis techniques to quantify differences between organic and ...
(Date:7/11/2014)... Down is a reliable source for cheap Luke Bryan tickets ... years Luke Bryan has been honored by almost every major association ... award shows, but each summer, he hits the road on what ... and this summer is more of the same. When it comes ... success that is currently entitled to Luke Bryan. The native of ...
Breaking Medicine News(10 mins):Health News:Rochester Surgeon Hits Milestone with Keller Funnel 2Health News:Luke Bryan Ticket Prices Slashed at Concord Pavilion 2Health News:Luke Bryan Ticket Prices Slashed at Concord Pavilion 3Health News:Biostimulants Market in Turf and Ornamentals is Expected to Reach $ 3.8 Billion by 2018 - New Report by MicroMarket Monitor 2Health News:Biostimulants Market in Turf and Ornamentals is Expected to Reach $ 3.8 Billion by 2018 - New Report by MicroMarket Monitor 3Health News:Major study documents nutritional and food safety benefits of organic farming 2Health News:Major study documents nutritional and food safety benefits of organic farming 3Health News:Luke Bryan Tickets Shoreline Amphitheatre in Mountain View, CA: Ticket Down Slashes Ticket Prices for Luke Bryan in Mountain View at the Shoreline Amphitheatre 2Health News:Luke Bryan Tickets Shoreline Amphitheatre in Mountain View, CA: Ticket Down Slashes Ticket Prices for Luke Bryan in Mountain View at the Shoreline Amphitheatre 3
... Eastern Mediterranean Meeting (EMM), which was held in Antalya (TR) ... be organised on 23 and 24 January 2009 in the ... eastern Mediterranean area are expected to participate. , Professor ... I have learnt from the previous EMM meeting is that ...
... WASHINGTON, Jan. 5 Leventhal Consulting, www.leventhalconsulting.net ... lawyers to lose weight, opened today in Washington, ... approach, and works with clients over the phone, ... office.The approach of Leventhal Consulting consists of four ...
... efforts to,educate, inform, and empower the people of Chicago, ... its 25-minute live call-in,show, "Community Health," on Chicago ... PM on Channel 21. , ... Arthur Dorf,Eye Physician and Surgeon on how to choose ...
... Inc., a leader in health care,quality management solutions ... new contract with Summa Health Network (SHN), the,physician-hospital ... largest,organized delivery healthcare systems in Ohio. SHN is ... insurers and one regional insurer,all of which have ...
... 5 Horizon Gynecology & Obstetric,Associates -- a ... & Obstetrics and Gynecology & Obstetrics of,DeKalb -- ... and Sage,Intergy EHR electronic health records system to ... and streamline workflow. , ...
... Mass. and SOUTH SAN FRANCISCO, Calif., Jan. 5 ... venture capital firm, announced today the hiring of Edward ... M.D., Ph.D., as a Principal in the Firm,s Cambridge, ... rooted in their deep understanding of science and technology," ...
Cached Medicine News:Health News:EAU 2nd Eastern Mediterranean Meeting expected to highlight cystectomy 2Health News:Leventhal Consulting Opens for Business 2Health News:For Your Eyes Only - How to Choose and Use Your Eye Doctor 2Health News:Summa Health Network Announces Contract with MDdatacor to Support Multi-Insurer Health Care Quality Initiative; Initiative to Use Clinical Data to Supplement Claims Data and Enhance Outcomes 2Health News:Summa Health Network Announces Contract with MDdatacor to Support Multi-Insurer Health Care Quality Initiative; Initiative to Use Clinical Data to Supplement Claims Data and Enhance Outcomes 3Health News:Horizon Gynecology & Obstetric Associates Chooses Sage Intergy EHR 2Health News:Horizon Gynecology & Obstetric Associates Chooses Sage Intergy EHR 3Health News:Clarus Ventures Hires Former Merck President Ed Scolnick and Broad Institute Scientist Finny Kuruvilla 2Health News:Clarus Ventures Hires Former Merck President Ed Scolnick and Broad Institute Scientist Finny Kuruvilla 3
(Date:1/15/2014)... Corporation (the "Company") (NASDAQ: CLSN ) today ... to purchase an aggregate of approximately $15 million of ... offering, led by a dedicated health care fund. ... these investors pursuant to which the Company agreed to ...
(Date:1/15/2014)... 2014 Shire plc (LSE: SHP, NASDAQ: ... Trading (OFT) approval condition to the announced tender offer for all ... As a result of the waiver, the transaction is no ... tender offer on January 24, 2014 following the currently scheduled expiration ...
(Date:1/15/2014)... BreedIT Corp (OTC: BRDT), through its Israeli ... sophisticated agro-breeding solutions for plant breeders and researchers, today ... of directors appointed chemistry and pharmaceutical industry expert Dr. ... the board. From 1975 to 2012, Dr. ...
Breaking Medicine Technology:Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 2Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 3Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 3BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 2BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 3
This is the modular VICTOR2 multilabel counter with the TR-fluorometry, stacker and robot loading options.The addition of a xenon flash lamp brings the time-resolved fluorescence counting mode to th...
Flexible and sensitive fluorescence/luminescence microplate reader for endpoint and kinetic...
The DELFIA Platewash is a general purpose microtitration plate and strip washer especially standardized for use with DELFIA diagnostic kits....
... with a 25-microplate capacity ... and aspiration and dispense ... On-board software for user ... programs. External vacuum pump ...
Medicine Products: