Navigation Links
Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
Date:8/19/2007

l in the U.S., all patients are eligible to enter a separate open-label extension study in which they will receive XIAFLEX if they were initially given placebo or have other affected joints that need treatment. All patients in these studies will be monitored for a minimum of 12 months following initial dosing for efficacy and safety parameters.

The Australian study is a double-blind, randomized, placebo-controlled study with an open-label extension that will enroll 60 patients. The design of this study is similar to that of the U.S. pivotal phase III trial and its open-label extension.

In addition to the double-blind studies and their open-label extensions, the Company plans to concurrently conduct two phase III open-label studies in approximately 440 patients. These studies will provide additional safety and efficacy data and will contribute to the safety database that is required for the BLA.

"As XIAFLEX is ultimately targeted for worldwide markets, we believe that it is very important to perform well-controlled clinical trials at sites inside and outside of the U.S.," said Dr. Jyrki Mattila M.D., Ph.D., Executive Vice President of R&D, Business Development and Technical Operations. "The Company is eager to raise global physician and patient understanding of the potential benefits of XIAFLEX."

With respect to the clinical program for XIAFLEX for the treatment of Dupuytren's contracture, Auxilium expects to:

- complete enrollment in the pivotal U.S. trial and the Australian trial

by the end of 2007;

- release top-line results from the double-blind phase III clinical trials

in the second quarter of 2008; and

- file the BLA for approval of XIAFLEX by FDA in early 2009.

Conference Call

Auxilium will hold a conference call today, Thursday, August 16, 2007 at 10:00 a.m. Eastern Time. The conference call will be simultaneously web cast on Auxilium's web site and archived for future review until August
'/>"/>

SOURCE Auxilium Pharmaceuticals, Inc.

Copyright©2007 PR Newswire.

Page: 1 2 3 4 5 6

Related medicine technology :

1. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
2. Auxilium Announces New Data That Show Total Testosterone Blood Levels Increase Significantly Following Switch from AndroGel(R) to Testim(R)
3. Keryx Biopharmaceuticals, Inc. Announces Positive Phase I and Phase II Data on KRX-0401 in Patients with Relapsed/Refractory Multiple Myeloma and Waldenstroms Macroglobulinemia
4. Keryx Biopharmaceuticals, Inc. Announces Poster Presentations Highlighting Mechanism of Action and Clinical Activity of Sulonex(TM) (sulodexide oral gelcap) at the Upcoming American Diabetes Association 67th Scientific Sessions in Chicago, Illinois
5. Molecular Insight Pharmaceuticals, Inc. Presents Preclinical Data on Molecular Imaging Pharmaceutical for Prostate Cancer
6. Molecular Insight Pharmaceuticals, Inc. Presents Preclinical Data at Society Of Nuclear Medicine 2007 Annual Meeting
7. CytRx Announces RNAi Delivery Nanoparticle Technology Exclusively Licensed to Subsidiary, RXi Pharmaceuticals, Described in Peer-Reviewed Journal
8. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
9. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
10. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
11. Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/1/2014)... 2014 Research and Markets ... Medical Biosensors Market 2014-2018" report to their ... Medical biosensors are used to analyze ... These biosensors monitor health status, disease betterment, and ... They are cost-effective and user-friendly devices. Also, they ...
(Date:8/1/2014)... , Aug. 1, 2014 MGC Diagnostics ... company, announced today that it has completed its ... of cardiorespiratory diagnostic products based in Sorinnes, ... served the European cardiorespiratory diagnostics market since 1977. ... of approximately €4.7 million ($6.3 million) and incurred ...
(Date:8/1/2014)... 1, 2014  Neuland Laboratories Ltd., (NSE:NEULANDLAB; BSE-Scrip ... ingredients (APIs), complex intermediates and custom ... countries, today announced financial results for the first ... 30, 2014. "Neuland,s results in the ... to accommodate certain customer needs, and we do ...
Breaking Medicine Technology:Global Medical Biosensors Market 2014-2018: Key Vendors are Abbott, Bayer, LifeScan and F. Hoffmann-La Roche 2MGC Diagnostics Corporation Completes Acquisition of MediSoft SA 2MGC Diagnostics Corporation Completes Acquisition of MediSoft SA 3MGC Diagnostics Corporation Completes Acquisition of MediSoft SA 4Neuland Labs Reports First Quarter Fiscal Year 2015 Financial Results 2Neuland Labs Reports First Quarter Fiscal Year 2015 Financial Results 3
... presented at Israel Society of Nephrology Conference ... months from single treatment - Data continue to ... expensive injections MISGAV, Israel and LONDON, March 27 ... latest, encouraging results of the Company,s ongoing EPODURE Biopump ...
... of Clinical Lipidology publishes largest study comparing cancer ... using FDA database -BOSTON, March 25 A ... ezetimibe mono and ezetimibe/simvastatin combination treatments, compared to ... The study, conducted by Tufts Medical Center ...
Cached Medicine Technology:Medgenics' Phase I/II Clinical Trial Now Shows EPODURE Continuous Anemia Treatment Lasting 5 Months in Kidney Disease Patients 2Medgenics' Phase I/II Clinical Trial Now Shows EPODURE Continuous Anemia Treatment Lasting 5 Months in Kidney Disease Patients 3Medgenics' Phase I/II Clinical Trial Now Shows EPODURE Continuous Anemia Treatment Lasting 5 Months in Kidney Disease Patients 4Ezetimibe and Ezetimibe/Simvastatin Combo Pose No Increased Cancer Risk, Study Shows 2
(Date:8/1/2014)... research at Washington University School of Medicine in St. ... in males and frequently are more harmful than similar ... malignant brain tumors, are diagnosed twice as often in ... do not survive as long. , The researchers found ... cancer risk, is significantly less active in male brain ...
(Date:8/1/2014)... -- The U.S. Food and Drug Administration announced on ... help fight type 2 diabetes. Jardiance (empagliflozin) ... regimens to control blood sugar levels in the overall ... Office of Drug Evaluation II in the FDA,s Center ... statement. The FDA also recommended that Jardiance be ...
(Date:8/1/2014)... 2014 The evolving healthcare landscape ... pharmacies. At ThoughtSpot 2014, AmerisourceBergen and Good Neighbor ... and resources to enhance patient care and profitability. ... critical issues to give independent pharmacists the tools ... , ThoughtSpot show attendance experienced a nearly 70% ...
(Date:8/1/2014)... Growing prevalence of chronic ailments, ... are boosting healthcare market growth, although a reduction ... increasing generic consumption is a major challenge. , ... 2013, having grown at a Compound Annual Growth ... of the Health Transformation Program (Saglikta Donus, um ...
(Date:8/1/2014)... FRIDAY, Aug. 1, 2014 (HealthDay News) -- Patients with ... pulmonary disease (COPD) have a new weapon to battle ... Thursday. The agency approved a new treatment, ... the third leading killer of Americans. COPD, which is ... as chronic bronchitis and emphysema. Patients with ...
Breaking Medicine News(10 mins):Health News:Study reveals one reason brain tumors are more common in men 2Health News:FDA Approves New Type 2 Diabetes Drug 2Health News:ThoughtSpot 2014 Inspires as General Session Concludes 2Health News:ThoughtSpot 2014 Inspires as General Session Concludes 3Health News:ThoughtSpot 2014 Inspires as General Session Concludes 4Health News:ThoughtSpot 2014 Inspires as General Session Concludes 5Health News:Turkey Pharmaceutical and Medical Device Market Worth $21.5B & $3.3B by 2020 Respectively, Says a Report Available at MarketOptimizer.org 2Health News:Turkey Pharmaceutical and Medical Device Market Worth $21.5B & $3.3B by 2020 Respectively, Says a Report Available at MarketOptimizer.org 3Health News:Turkey Pharmaceutical and Medical Device Market Worth $21.5B & $3.3B by 2020 Respectively, Says a Report Available at MarketOptimizer.org 4Health News:FDA Approves New Treatment for People With COPD 2
... Urges Senate to Quickly Pass this Important Lifesaving ... Connor, American Lung Association President and CEO:Today in ... in favor with a strong bipartisan majority for ... the Family Smoking Prevention and Tobacco Control Act ...
... Finding could steer caregivers away from situations that would add ... levels of a stress hormone may be responsible for the ... children with a certain type of autism. , ... not experience the normal twofold increase of cortisol upon waking ...
... CITY, Mo., April 2 Argus Health Systems, Inc., ... received an award from the Flaspohler Research Group as ... of Interest" in the 2008 PBM Survey of ... ranked by survey participants based on specific attributes, including ...
... know where and when patients and staff interact, giving ... influenza transmission patternsATLANTA, April 2 Radianse, Inc. today ... University Hospital Midtown, Atlanta, is using the Radianse ... know early and reliably where, when and with whom ...
... 2009 Can we always see what is in front of ... and Cognitive Neuroscience at The City College of New York (CCNY), ... Journal of Neuroscience " by Professor Ro and colleagues from the ... brainwave activity is in a trough. , "We may have our ...
... (omega-3s), namely EPA and DHA found in seafood and ... benefits, but evidence of other benefits continues to stack ... menopausal women and healthier weight loss in obese dieters ... these topics are summarized in the March 2009 ...
Cached Medicine News:Health News:U.S. House of Representatives Again Votes with a Strong Bipartisan Majority in Favor of Granting the U.S. FDA Regulatory Control Over Tobacco Products 2Health News:Asperger Syndrome Tied to Low Cortisol Levels 2Health News:Argus Honored by Flaspohler Research Group as Highest-Rated PBM for 'No Conflicts of Interest' 2Health News:Radianse Announces Real-Time Tracking of Emory ED Staff and Patients to Trace and Contain Infectious Disease Spread 2Health News:Neuroscientists demonstrate link between brainwave acticity and visual perception 2Health News:Omega-3s May Benefit Newborns, Menopausal Women and Obese Individuals 2
Headquartered in Burlington, North Carolina, LabCorp has more than 23,500 employees and offers more than 4,400 clinical tests ranging from routine blood analyses to the most sophisticated molecular d...
... Clinical Reference Laboratories at National Jewish ... general and specialized testing for clients ... diagnostic reference laboratories, they provide comprehensive, ... areas of immunology and flow cytometry, ...
Disposable Microscissors: Horizontal Curved Microscissors...
Sharp tipped illuminated scissors with a curvature of 12 mm to follow the contour of the retina. For cutting in the plane parallel to the retina, cutting membranes adherent to the retinal surface and...
Medicine Products: