Navigation Links
FDA Advisory Committee Unanimously Recommends Approval of XIAFLEX(TM) for Treatment of Dupuytren's Disease
Date:9/21/2009

LYNBROOK, N.Y., Sept. 16 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first-in-class collagenase-based products, today announced that the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration's (FDA) unanimously recommended by a vote of 12 to 0 that XIAFLEX(TM) (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, be granted marketing approval by the FDA for the treatment of Dupuytren's disease, a debilitating disorder resulting from excessive collagen deposition that causes contractures of the fingers.

"We believe that the Advisory Committee's very supportive vote today for XIAFLEX represents a major advance for both the patients suffering from Dupuytren's disease, as well as for BioSpecifics and its shareholders," stated Thomas L. Wegman, President of BioSpecifics. "We congratulate our partner Auxilium on its thorough and thoughtful presentation today and look forward to the FDA's decision regarding the approval of XIAFLEX."

The Advisory Committee's recommendations are not binding, but will be considered by the FDA in its review of the XIAFLEX BLA. Auxilium Pharmaceuticals, Inc. has licensed the rights to XIAFLEX from BioSpecifics for three clinical indications: Dupuytren's disease; Peyronie's disease; and frozen shoulder (adhesive capsulitis). Auxilium filed its BLA for XIAFLEX for the treatment of Dupuytren's disease on February 27, 2009 and received a target date under the Prescription Drug User Fee Act (PDUFA) date of August 28, 2009, which has not been updated.

About BioSpecifics Technologies Corp.

BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collag
'/>"/>

SOURCE BioSpecifics Technologies Corp.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Robert Fanning Named to PerfectServe Advisory Board
2. Dr. Stuart Baker Named to PerfectServe Advisory Board
3. William Dwyer Named to PerfectServe Advisory Board
4. Dr. Michael Guthrie Named to PerfectServe Advisory Board
5. Alan Weinstein Named Chairman of PerfectServe Advisory Board
6. Pennsylvania Patient Safety Authority Releases September Advisory
7. Judy Benjamin Named to PerfectServe Advisory Board
8. GENova appoints Dr. Wang Chong to Scientific Advisory Board
9. GENova appoints Dr. Philip Gould to Scientific Advisory Board
10. Dey Issues Advisory
11. Social Security Advisory Board Warns of Consequences of Unsustainable Growth in The Cost of Health Care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/23/2014)... 23, 2014 The American Telemedicine ... ATA’s twentieth annual meeting and tradeshow focused exclusively ... to attract over 5,000 attendees and more than ... May 3-5, 2015, in Los Angeles. , ATA’s ... technology professionals from researchers, clinicians, hospital and university ...
(Date:7/23/2014)... the secrets to better treating the pernicious disorders of ... a paper from American University,s Center for Behavioral Neuroscience. ... obesity with therapies aimed at areas of the brain ... on the hippocampus could play a role in reducing ... therapies and preventive measures often fall short. This is ...
(Date:7/23/2014)... not be the sole domain of humans, with new ... comes to the love of their master. When ... stuffed dog, the real puppies in the study responded ... researchers from the University of California, San Diego (UCSD). ... attending to the stuffed dog and not when they ...
(Date:7/23/2014)... research on human cancer genes have been focused on ... to be translated in the form of amino acids ... a regulatory region or activator which controls the expression ... little was known of the role exerted such DNA ... today in Nature in collaboration with the ...
(Date:7/23/2014)... (PRWEB) July 23, 2014 CarePoint Health ... first hospital in New Jersey to receive the da ... robotics platform in the da Vinci series. This 4th ... profound step forward in innovation. The intuitive da Vinci ... a wide spectrum of minimally invasive and complex surgical ...
Breaking Medicine News(10 mins):Health News:ATA Seeks Speakers to Present at the World’s Largest Telemedicine, mHealth and Telehealth Conference 2Health News:Targeting the brain to treat obesity 2Health News:Targeting the brain to treat obesity 3Health News:Dogs Can Get Jealous, Too 2Health News:CarePoint Health is First in New Jersey to Receive Newest Surgical Robot Platform 2Health News:CarePoint Health is First in New Jersey to Receive Newest Surgical Robot Platform 3Health News:CarePoint Health is First in New Jersey to Receive Newest Surgical Robot Platform 4
... to provide guidance for global market development.SUNNYVALE, Calif. ... Systems, Inc., a technology leader in developing novel ... of Hironori Yamamoto, MD, PhD, of Jichi Medical ... privileged that Dr. Yamamoto has elected to join ...
... Other Health Insurers Are Illegally Denying Treatment to Autistic ... being released by Consumer Watchdog: Who: Guillermo Arce , ... father of Frank Nagle , Harvey Rosenfield ... insurance reform initiative, Proposition 103 , Scott Glovsky ...
... how autoimmune diseases are triggered , , TUESDAY, Feb. ... by exposure to pig brains might help researchers learn ... More than a year ago, workers at pork processing ... and tingling in their arms and legs. Their common ...
... MDVN ) today announced that it will ... on Wednesday, February 25, at 4:30 p.m. Eastern Time ... ongoing Phase 1-2 clinical trial of the Company,s novel ... Scher, M.D., principal investigator of the trial and chief ...
... TrinityCare Senior Living, Inc. (formerly OTCBB: JKAN) (the ... facilities, today announced that its Board of Directors has ... the public entity from July 31st to December 31st. ... and re-incorporation was completed and approved on February 16, ...
... HARRISBURG, Pa., Feb. 24 Swiss Villa Dairy Farm ... monocytogenes contamination and resumed sales of raw milk on ... milk is milk that has not been pasteurized. ... have samples of their milk laboratory tested due to ...
Cached Medicine News:Health News:Avantis Medical Systems Announces Key Addition to Scientific Advisory Board 2Health News:Avantis Medical Systems Announces Key Addition to Scientific Advisory Board 3Health News:Avantis Medical Systems Announces Key Addition to Scientific Advisory Board 4Health News:Parents of Autistic Children Fight Back - Warn HMO Regulator Against Changing Rules to Favor Insurers That Deny Access to Medical Treatment 2Health News:Medivation to Host Conference Call and Slide Presentation at 4:30 p.m. EST Wednesday, February 25, to Discuss New MDV3100 Efficacy and Safety Data From Trial in Castration-Resistant Prostate Cancer Patients 2Health News:TrinityCare Senior Living, Inc. Changes Fiscal Year End to December 31st 2
(Date:7/23/2014)... Research and Markets  has announced the ... Product, End-user & by Lead Type - Global Forecast ... http://photos.prnewswire.com/prnh/20130307/600769 The global ... segments, namely, holter monitor, resting, and stress type diagnostic ... million in 2013 and is poised to grow at ...
(Date:7/23/2014)... -- RT Oncology Services Corporation today announced that Craig ... directors. Mr. Mundie is currently senior advisor to the ... projects within the company and on technology strategy and ... officer. Mike Martin , president ... a visionary technology executive. His appointment is part of ...
(Date:7/23/2014)... July 23, 2014  Nonin Medical, Inc., the inventor ... medical monitoring, announced today that Mark VanderWerf , ... elected Chairman of the American Telemedicine Association,s (ATA) Industry ... The ATA is the leading international resource ... technologies. The ATA and its diverse membership work to ...
Breaking Medicine Technology:Global Diagnostic Electrocardiograph (Resting, Stress, Holter Monitor) (ECG) Market - Forecast to 2020 2Global Diagnostic Electrocardiograph (Resting, Stress, Holter Monitor) (ECG) Market - Forecast to 2020 3Craig Mundie Joins RainTree Oncology Board of Directors 2Craig Mundie Joins RainTree Oncology Board of Directors 3Nonin Medical Announces that Mark VanderWerf has been Elected Chairman of the American Telemedicine Association's Industry Council 2
... Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: ... on developing topically administered products using its proprietary transdermal ... exploring strategic alternatives aimed at enhancing shareholder value with ... Advisors, a division of KEMA Partners.  The goal ...
... 31, 2011 Nephros, Inc. (OTC Bulletin Board: ... marketing filtration products for therapeutic applications, infection control, and ... Form S-1 for its previously announced rights offering to ... 2011 by the Securities and Exchange Commission. ...
Cached Medicine Technology:Transdel Pharmaceuticals Announces Exploration of Strategic Alternatives 2Transdel Pharmaceuticals Announces Exploration of Strategic Alternatives 3Nephros Rights Offering Registration Statement Declared Effective 2Nephros Rights Offering Registration Statement Declared Effective 3Nephros Rights Offering Registration Statement Declared Effective 4
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... 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: