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:9/30/2014)...  According to their CEO, Rob Bohacs ... is going through a complete transformation with highly ... the current clinical trial management process isn,t configured ... trials, which will ultimately drive the prescription cancer ... has been recognized by the National Cancer Institute as ...
(Date:9/30/2014)... -- Alimera Sciences, Inc. (NASDAQ: ALIM ) (Alimera), ... and commercialization of prescription ophthalmic pharmaceuticals, announced today that ... Technology Growth Capital, Inc. (NYSE: HTGC ) ... under the Loan and Security Agreement that Alimera,s subsidiary ... Sciences Limited, entered into with Hercules in April of ...
(Date:9/30/2014)... , Sept. 30, 2014 A study ... (OCT), offered a new look at the composition of ... how physicians understand and treat the disease, a leading ... at Baptist Health Lexington between September 2010 and May ... the Journal of the American College of Cardiology ...
Breaking Medicine Technology:Small Denver Company Pharmatech driving a large revolution in how cancer clinical trials are managed 2Alimera Sciences Receives $25 Million Advance from Hercules Technology Growth Capital 2New Imaging Tool May Allow Tailoring of Stroke Prevention to Each Patient 2
... 15, 2011 ULURU Inc. (NYSE AMEX: ... on the development of a portfolio of wound management ... into agreements for investment commitments with Ironridge Global BioPharma ... in two transactions, subject to certain conditions, to purchase ...
... 15, 2011 VIVUS, Inc. (NASDAQ: VVUS ) ... agreement with officials of the Endocrine and Metabolic Division of ... for an early resubmission of the QNEXA New Drug Application ... to seek approval for an initial indication that includes obese ...
Cached Medicine Technology:ULURU Inc. Enters Into Strategic Financings of Up to $1.6 Million at a Premium to Current Share Price 2ULURU Inc. Enters Into Strategic Financings of Up to $1.6 Million at a Premium to Current Share Price 3VIVUS Provides Regulatory Update on QNEXA 2VIVUS Provides Regulatory Update on QNEXA 3VIVUS Provides Regulatory Update on QNEXA 4
(Date:10/1/2014)... MI (PRWEB) October 01, 2014 To help ... wellness center , Cutler Integrative Medicine, is detailing several tips ... , According to Dr. Cutler, women should start ... quality time for yourself that will help ‘center’ yourself for ... of stress,” he says. , Other health and fitness ...
(Date:9/30/2014)... needs to be proactive about potential disease outbreaks like ... , In an Editorial in the October issue of ... , Allen Cheng from Monash University and Heath Kelly ... public health crises. , "Australia would do well to ... proactive in co-ordinating a consistent and outward looking response," ...
(Date:9/30/2014)... (HealthDay News) -- Children conceived either less than one year ... sibling could be at increased risk for autism, a new ... an outside expert agree that the research can,t prove that ... importantly, it is important that parents understand that the odds ... close together or far apart," said outside expert Dr. Andrew ...
(Date:9/30/2014)... Alan Mozes Health Day ... -- Colon cancer patients who are overweight or obese ... for developing a second weight-related cancer, new research suggests. ... of colon cancer recurrence, only the potential for developing ... that colorectal cancer survivors who reported being overweight or ...
(Date:9/30/2014)... Keystone Symposia will convene the first conference of its ... Health Series on "The Modes of Action of ... following the conclusion of the Grand Challenges Meeting for ... the Keystone Symposia Global Health Series, supported by the ... travel awards for 36 investigators from developing countries to ...
Breaking Medicine News(10 mins):Health News:In Recognition of National Women’s Health and Fitness Day, Cutler Integrative Medicine Details Tips for Living a Healthier and Happier Life 2Health News:Spacing Between Sibling Births Tied to Autism Risk in Study 2Health News:Obesity Tied to Higher Cancer Risk for Colon Cancer Survivors 2Health News:Obesity Tied to Higher Cancer Risk for Colon Cancer Survivors 3Health News:Keystone Symposia launches 2014-2015 meeting series with Global Health Vaccines Conference 2
... M&A activity in the,life sciences and healthcare sector is ... in 2008. CEOs, CFO,s and other business executives from,pharmaceutical, ... by some of the most sophisticated investors in the ... April 30-May 1, 2008,in Chicago., Deal volume in ...
... Simplifies Enrollment Process, SAN JOSE, Calif., Jan. ... the 47 million uninsured in America are,eligible for ... for Health Coverage Education (FHCE) has captured, on ... to,help people in need of health coverage., ...
... To Consumers Key Factor In Voter Opposition Compared To,Other ... than one,in five California voters (16%) support legislation, backed ... requires,proof of private health insurance when they are told ... according to a new poll., Overall, nearly two-thirds ...
... with popularity of hormone therapy, study finds , , WEDNESDAY, ... replacement therapy raise the risk of breast cancer in ... specific type of malignancy: lobular breast cancer. , The ... the January issue of Cancer Epidemiology, Biomarkers & ...
... that throughout this release there are hypnotic suggestions about why you ... you be able to pick out the suggestions? Or would they ... going on in the news, you came to the realization that ... to know unless you read on , In his fifth and ...
... with a Turn-Key Solution for Health Portal ... ... 16 HealthCare.com,( http://www.healthcare.com ), the leading healthcare provider directory and,online ... ( http://www.mediresource.com ), a leading creator and,syndicator of interactive health content ...
Cached Medicine News:Health News:Healthcare M&A Activity on the Rise 2Health News:Internet Comes to Rescue of 14 Million Uninsured in U.S.; Providing Access to Gov. Health Programs They're Not Aware of 2Health News:Internet Comes to Rescue of 14 Million Uninsured in U.S.; Providing Access to Gov. Health Programs They're Not Aware of 3Health News:New Poll: Only 16% of Californians Support Mandatory Purchase of Private Health Insurance; 71% Behind Regulation of Premium Increases 2Health News:HRT Raises Risk of Lobular Breast Cancer 2Health News:HRT Raises Risk of Lobular Breast Cancer 3Health News:Hypnotist ready to kick cigarette butt 2Health News:HealthCare.com & MediResource Partner to Distribute and License Health Content, Directory and Tools 2Health News:HealthCare.com & MediResource Partner to Distribute and License Health Content, Directory and Tools 3
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: