Navigation Links
R7128 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection
Date:10/24/2007

PRINCETON, N.J., Oct. 24 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) has received fast track designation from the U.S. Food and Drug Administration (FDA) for R7128 for the treatment of chronic hepatitis C virus (HCV) infection. R7128 is a prodrug of PSI-6130, an oral cytidine nucleoside analog polymerase inhibitor of HCV that is being developed through Pharmasset's collaboration with Roche. Pharmasset is currently enrolling a 28-day Phase 1 clinical trial to evaluate R7128 in combination with Pegasys(R) (pegylated interferon) plus Copegus(R) (ribavirin) in treatment-naive patients chronically infected with hepatitis C virus (HCV) genotype 1. Please see http://www.clinicaltrials.gov or e-mail clinicaltrials@pharmasset.com for more information.

Under the FDA Modernization Act of 1997, fast track designation may facilitate the development and expedite the review of a drug candidate that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition. R7128 was granted the fast track designation primarily due to the need for HCV treatments with novel mechanisms of action, oral administration, different resistance profiles and improved safety and efficacy over the existing standard of care for both treatment-naive and treatment-experienced patients.

"The FDA's fast track designation for R7128 acknowledges the urgent need for new HCV drugs," stated Dr. Michelle Berrey, Pharmasset's Vice President, Clinical Development & Chief Medical Officer. "Currently, there are no HCV polymerase inhibitors approved for the treatment of chronic HCV infection. We cont
'/>"/>

SOURCE Pharmasset, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
2. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
3. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
4. Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
5. Based on Up to 6 Years of Follow-Up, Biovest Announces Favorable Interim Blinded Data for Fast-Tracked Pivotal Phase 3 Clinical Trial of BiovaxID Anti-Cancer Vaccine for Non-Hodgkins Lymphoma
6. Accentia Biopharmaceuticals Announces Favorable Interim Blinded Data on SinuNase in Its Fast-Tracked Pivotal Phase 3 Clinical Trial for Chronic Sinusitis
7. Stanford Researchers Track Human Stem Cells Transplanted Into Rat Brain
8. Pixantrone Granted Fast Track Designation by FDA for Relapsed Indolent NHL Patients
9. Staphylococcus aureus vaccine development on track ? safe and immunogenic in Phase I clinicaltrials
10. Allos Therapeutics PDX Granted Orphan Medicinal Product Designation by the European Commission
11. Point of Care Strep Tests Speed Treatment, Lower Costs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2014)... SALT LAKE CITY and ... EastGate Acquisitions Corporation (OTCBB: ESAQ), ... innovations in the development of improved novel ... biologically active molecules announces expansion of its ... company,s new development direction includes large molecule drugs ...
(Date:7/29/2014)... 2014  Based on its recent analysis of ... & Sullivan recognizes MobileHelp with the 2014 North ... Value Leadership. MobileHelp,s leadership in flexibility across in-home ... progression in personal emergency response, and exemplifies key ... MobileHelp is at the forefront of convenience ...
(Date:7/29/2014)... TAIPEI , July 29, 2014 Apex Medical ... Therapy and Pressure Area Care sectors, announces that it is ... Munich in Germany that ... patent. Apex notes that it has initiated invalidity challenges against ... continuous efforts in counterattacking against trivial and junk patents. ...
Breaking Medicine Technology:EastGate Acquisitions Announces Expansion of its Pharmaceutical Developments Implementing its Sub-Micron Platform Technology 2EastGate Acquisitions Announces Expansion of its Pharmaceutical Developments Implementing its Sub-Micron Platform Technology 3EastGate Acquisitions Announces Expansion of its Pharmaceutical Developments Implementing its Sub-Micron Platform Technology 4Frost & Sullivan Applauds MobileHelp for its Targeted Supplies for the PERS Market 2Frost & Sullivan Applauds MobileHelp for its Targeted Supplies for the PERS Market 3Apex Continues Fighting Against Patents to Free Up Competition 2
... Va., June 28, 2011  Burlington Medical Supplies, headquartered ... into its inventory. The Single Swing-Arm Drape attaches to ... worker from any scattered beams of radiation during patient ... black vinyl drape is 39-and-a-half inches wide by 28 ...
... SPRING, Md., June 28, 2011 The Food and Drug ... of products, including: (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO ) ... risk of blood clots Avandia and other diabetes medicines ... like antibiotics a recalled blood thinner ...
Cached Medicine Technology:Burlington Medical Supplies Introduces Single Swing-Arm Drape 2
(Date:7/29/2014)... survivors of severe combat injuries threatening more than one ... good record of safety and effectiveness in avoiding amputation, ... Plastic and Reconstructive Surgery , the official ... Surgeons (ASPS). , Experience with multiple limb salvage ... good success rates, with no increase in complications compared ...
(Date:7/29/2014)... 29, 2014 (HealthDay News) -- Chlorine helps keep pool ... likely to develop eye infections, doctors say. ... well as blurry vision, said Dr. Sampson Davis, an ... New Jersey. It,s important to understand why this ... away the outer film layer of the eye that ...
(Date:7/29/2014)... (PRWEB) July 29, 2014 According to ... of Time Magazine titled “From Kim’s Butt to Angelina’s ... Kardashian’s butt is the celebrity feature most requested ... features include Beyoncé’s butt, Jennifer Lawrence’s nose, ... information is based on data collected by an online ...
(Date:7/29/2014)... County, NJ (PRWEB) July 29, 2014 ... two leading pediatricians have joined our network, CarePoint ... Politis and Dr. Sushma Kaki. Hundreds of highly ... Group, a comprehensive network of top doctors and ... of specialties. This latest acquisition represents CarePoint Health’s ...
(Date:7/29/2014)... New high priced hepatitis C drugs will ... projected $2.9 to $5.8 billion next year, according to ... today by the Pharmaceutical Care Management Association (PCMA). Milliman ... as much as 8.6 percent in 2015 as a ... Olysio. , The study finds that the majority of ...
Breaking Medicine News(10 mins):Health News:Good outcomes with multiple limb salvage after severe combat injuries, reports Plastic and Reconstructive Surgery 2Health News:Protect Your Eyes When Hitting the Pool 2Health News:Celebrity Plastic Surgery: Kim Kardashian’s Butt Tops the List of Celebrity Plastic Surgery Requests 2Health News:Dr. Politis and Dr. Kaki Join CarePoint Health Medical Group 2Health News:Dr. Politis and Dr. Kaki Join CarePoint Health Medical Group 3Health News:New Milliman Study: Hepatitis C Drugs Could Increase Medicare Part D Spending by $2.9 to $5.8 Billion in 2015 2
... , , Diverse Donors Make the Difference ... National Minority Donor Awareness Day is August 1, and New York Blood Center ... New Jersey call on the community to help us meet the great need ... Historically, National Minority Donor Awareness Day emphasized minority organ and tissue donation, ...
... , , WASHINGTON, July 23 The ... recognized strategist in public health and science policy, as its president. , ... ) , , Lappin, an attorney, ... leading a major patient advocacy organization and serving as a senior advisor ...
... study led by researchers at the Ohio State University ... late-stage, hormone-independent prostate tumors gain the ability to grow ... growth marks an advanced and currently incurable stage of ... 2009, issue of the journal Cell , focuses ...
... 23, 2009 Case Western Reserve University School of Medicine ... Institutes of Health to determine if painful bladder syndrome ... system rather than in the bladder itself. ... M.D., professor of neurology at the Case Western Reserve ...
... the rapid growth in health care costs in the ... industries that commonly provide workers with health insurance. ... from 1987 through 2005 and compared changes in employment, ... gross domestic product for industries where a large number ...
... , FORT WORTH, Texas and AUSTIN, Texas, ... to announce a partnership with seven-time Tour de France winner Lance Armstrong ... Lance Armstrong will compete for Team RadioShack as a cyclist, runner and ... , , Lance Armstrong returned to the ...
Cached Medicine News:Health News:The Gift of Life Flows Through Your Veins! 2Health News:The Gift of Life Flows Through Your Veins! 3Health News:Council for American Medical Innovation Names Debra R. Lappin President 2Health News:Council for American Medical Innovation Names Debra R. Lappin President 3Health News:Scientists discover key event in prostate cancer progression 2Health News:Case Western Reserve University receives $3.7M NIH grant to study autonomic nervous system link to painful bladder syndrome 2Health News:Study finds rapid growth in health costs hurts economic performance of US industries 2Health News:Study finds rapid growth in health costs hurts economic performance of US industries 3Health News:RadioShack Partners With Seven-Time Tour de France Winner Lance Armstrong to Form New Cycling Team in 2010 2Health News:RadioShack Partners With Seven-Time Tour de France Winner Lance Armstrong to Form New Cycling Team in 2010 3Health News:RadioShack Partners With Seven-Time Tour de France Winner Lance Armstrong to Form New Cycling Team in 2010 4
Cruchfield Skull Traction Tong, small pattern....
Crutchfield Skull Traction Tong, large pattern....
Cushing Flat Drill, only Component Parts and Accessories for HUDSON Cranial Drill. 14 mm...
Hudson brace only. Component parts and accessories for Hudson cranial drill....
Medicine Products: