Navigation Links
Pharmasset Voluntarily Halts Clinical Studies with Clevudine in Hepatitis B Infected Patients
Date:4/20/2009

- Company will increase focus on HCV pipeline

- Conference call at 8:00 AM ET today

PRINCETON, N.J., April 20 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that after a discussion with its independent Data Safety Monitoring Board (DSMB) and the FDA, the company has decided to voluntarily terminate its Phase III QUASH studies of clevudine for the treatment of chronic hepatitis B (HBV) infection.

Pharmasset recently became aware of a number of spontaneous Serious Adverse Event reports and Events of Special Interest in patients receiving clevudine as prescribed therapy for hepatitis B in South Korea. Though only a small number of cases of mild to moderate myopathy, or muscle weakness associated with creatine kinase elevations, were reported in the QUASH studies, many of the patients in South Korea have had longer exposures to clevudine than patients in the QUASH studies and have reported more serious myopathy than have patients in the Pharmasset clinical trials. Given the number and severity of cases observed in South Korea, Pharmasset concluded it was in the best interest of patients to terminate the studies at this time.

"The safety of patients in the QUASH studies is our top priority and, therefore, we have decided to stop treatment with clevudine," stated Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "Although the number of cases of myopathy in the QUASH trials was low and the severity was mild, more severe reports from other trials and post marketing surveillance led us to believe the risk benefit ratio for clevudine was insufficient to continue development. We would like to take this opportunity to thank patients and our investigators for their participation in the QUASH studies."

As part of the study shut down, Pharmasset plans
'/>"/>

SOURCE Pharmasset, Inc.
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related medicine technology :

1. Pharmasset Initiates First Time in Human Study of PSI-7851 for the Treatment of Hepatitis C (HCV)
2. Pharmasset Reports Fiscal Year End 2008 Financial Results
3. Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C
4. Richard E.T. Smith, Ph.D. Joins Pharmasset as Vice President of Investor Relations and Corporate Communications
5. Pharmasset to Present at the UBS Global Life Sciences Conference on Wednesday, September 24th
6. Pharmasset Reports Financial Results for Quarter Ended June 30, 2008
7. Pharmasset Reports Preliminary Results of a 4-week Combination Study of R7128 for the Treatment of Chronic Hepatitis C
8. Pharmasset Announces Initiation of Combination Study of Clevudine and Viread(R) for HBV by French National Agency for Research on AIDS and Viral Hepatitis (ANRS)
9. Pharmasset Receives Notice of Allowance
10. Pharmasset Nominates PSI-7851 as a Lead Development Candidate for the Treatment of Chronic Hepatitis C
11. Pharmasset Commences Dosing R7128 Cohorts 3 and 4 for the Treatment of Chronic Hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2013)... PHILADELPHIA , May 21, 2013 ... image and impressive new product developments at the Special Libraries ... ten years of unerring focus on product literature databases and ... to mark the occasion," said founding director Nigel ... interesting developments of benefit to our clients and what better ...
(Date:5/21/2013)... May 21, 2013  Zacks.com announces the list of ... Zacks Equity Research analysts discuss the latest news and ... featured in the blog include Actavis, Inc.,s (NYSE: ... SA (NYSE: TOT ), Petrobras (NYSE: PBR ... (Logo: http://photos.prnewswire.com/prnh/20101027/ZIRLOGO ) ...
(Date:5/21/2013)... -- IsoRay, Inc. (AMEX: ISR ), ( http://www.isoray.com/ ... exclusive international distribution agreement with IASIS Medical for the ... Greece . IsoRay is a medical technology company ... for brain cancer, lung cancer, head and neck cancer, ... IASIS Medical is ideally suited to support IsoRay,s products, ...
Breaking Medicine Technology:Pi2 Solutions' 10th Anniversary Heralds New Corporate Image as Platinum Sponsor of SLA PHT Meeting in Philadelphia 2Pi2 Solutions' 10th Anniversary Heralds New Corporate Image as Platinum Sponsor of SLA PHT Meeting in Philadelphia 3The Zacks Analyst Blog Highlights: Actavis, BP, Total, Petrobras and Devon Energy 2The Zacks Analyst Blog Highlights: Actavis, BP, Total, Petrobras and Devon Energy 3The Zacks Analyst Blog Highlights: Actavis, BP, Total, Petrobras and Devon Energy 4The Zacks Analyst Blog Highlights: Actavis, BP, Total, Petrobras and Devon Energy 5IsoRay Announces A New International Distributor For Greece 2IsoRay Announces A New International Distributor For Greece 3
(Date:5/21/2013)... CA (PRWEB) May 21, 2013 According to ... to Rethink the Use of Botox,” Botox injections ... since their approval in 2002 (Go to goo.gl/8iYbD). Although it ... quite popular with men. The injection makes facial wrinkles less ... Botox injection last for about three months. This means that ...
(Date:5/21/2013)... May 21, 2013 Global Proving Ground ... Bodybuilding.com, the largest online retailer of health and fitness ... reality-based sports show, Warrior Island. “We cast the ... Facebook & Twitter, with our unique social networking platform,” ... these elite fighters on an island in the Pacific ...
(Date:5/21/2013)... into genetic features of pulmonary fibrosis by physicians and ... may lead to improved treatment of this deadly lung ... JAMA . , The study found that a particular ... pulmonary fibrosis, a chronic progressive disease with a median ... study, researchers may want to consider including genetic testing ...
(Date:5/21/2013)... 21, 2013 The Las Vegas personal injury ... announce that Crawford Gates, a senior at Coronado High School, ... scholarship essay contest . As the winner of the essay ... contest started on Dec. 1, 2012 and ran through April ... submit a three-page minimum essay on “The Role of the ...
(Date:5/21/2013)... While North Carolina is synonymous with ... guides. Brunswick Plantation & Golf Resort is synonymous with ... to 27 holes of "Top10" championship golf. , ... knowing the Top 10 from an industry ... overwhelming task of selecting the course to play. Guests ...
Breaking Medicine News(10 mins):Health News:Botox – Is the World’s Most Popular Cosmetic Procedure Safe? 2Health News:Bodybuilding.com Partners with Global Proving Ground’s New Reality Show Warrior Island 2Health News:Bodybuilding.com Partners with Global Proving Ground’s New Reality Show Warrior Island 3Health News:Researchers find genetic tie to improved survival time for pulmonary fibrosis 2Health News:Benson, Bertoldo, Baker & Carter is Pleased to Announce the Winner of its First Annual College Scholarship Essay Contest 2Health News:Brunswick Plantation & Golf Resort Named in Top 10 Golf Resorts in North Carolina 2
... Oct. 17 ,PainCare Holdings, Inc. (Amex: ... providers,of pain-focused medical and surgical solutions and ... MDFI), a company specializing in,portable electronic medical ... of a partnership created to market the ...
... Help Pave the Way Toward Malaria ... Eradication U.S. Presidential Candidates Urged to Sustain and Expand ... Malaria Initiative, ... audacious goal - to reach a,day when no human being has malaria, and no mosquito ...
... Well Life Center in Mesa,Arizona, a leader in adult ... its "10 Healing Secrets to Health,& Longevity Workshop" on ... This session will teach you principals to achieve longevity ... tips on how to set,health goals that are inline ...
... Oct. 17 In its Statement on Risk ... Oncologists (SGO) provides concise guidelines, usable in a,primary ... women with a personal,or family history of breast, ... risk assessment. SGO,s Statement on Risk Assessment ...
... 17 Laser Energetics,Inc. (Pink Sheets: LNGT) announced ... BrightStar solid-state Alexandrite lasers, for a non-lethal laser,defense ... The BrightStar(TM) laser is part of the Company,s ... BrightStar(TM) laser was purchased,for experiments that are classified, ...
... be published in the October edition of Hypertension Research ... bark of the French maritime pine tree, helps individuals ... to an increase in blood flow and oxygen supply ... produced by the body, increases blood flow that serves ...
Cached Medicine News:Health News:PainCare Holdings and MedeFile International Form Partnership to Market Personal Electronic Medical Records Direct to Consumers 2Health News:PainCare Holdings and MedeFile International Form Partnership to Market Personal Electronic Medical Records Direct to Consumers 3Health News:PainCare Holdings and MedeFile International Form Partnership to Market Personal Electronic Medical Records Direct to Consumers 4Health News:PainCare Holdings and MedeFile International Form Partnership to Market Personal Electronic Medical Records Direct to Consumers 5Health News:PainCare Holdings and MedeFile International Form Partnership to Market Personal Electronic Medical Records Direct to Consumers 6Health News:Bill and Melinda Gates Call for New Global Commitment to Chart a Course for Malaria Eradication 2Health News:Bill and Melinda Gates Call for New Global Commitment to Chart a Course for Malaria Eradication 3Health News:Society of Gynecologic Oncologists Provides Guidelines for Offering Genetic Risk Assessment to Women With a Personal or Family History of Breast, Ovarian, Uterine or Colorectal Cancer 2Health News:Society of Gynecologic Oncologists Provides Guidelines for Offering Genetic Risk Assessment to Women With a Personal or Family History of Breast, Ovarian, Uterine or Colorectal Cancer 3Health News:Laser Energetics Delivers BrightStar(TM) Alexandrite Laser to Fortune 50 Defense Company 2Health News:New study: pine bark extract boosts nitric oxide production 2Health News:New study: pine bark extract boosts nitric oxide production 3
Features soft, low friction sheath that extends beyond the tip....
Designed to retain the desired curve during oral intubation....
Stylet tube, endotracheal, sterile, stainless steel, malleable, one size, overall length 13"(33cm)....
SunGlide™ Stylette - Blue Neonatal. Use in 2.0 to 3.5mm tubes. 25/box....
Medicine Products: