Dupuytren’s Contracture News and Research

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Journal of Hand Surgery publishes XIAFLEX CORD II phase III clinical trial

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that The Journal of Hand Surgery (JHS) has published in its December 2010 online edition pivotal CORD II phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class biologic, conducted by BioSpecifics' strategic partner Auxilium Pharmaceuticals Inc., for the nonsurgical treatment of adult Dupuytren's contracture patients with a palpable cord.

8 Dec 2010

BioSpecifics Technologies third quarter net loss increases to $0.5 million

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced its financial results for the third quarter ended September 30, 2010.

8 Nov 2010

BioSpecifics Technologies second-quarter total revenues decrease to $0.9 million

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced its financial results for the second quarter ended June 30, 2010. The Company's partner, Auxilium Pharmaceuticals, Inc. markets XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord.

7 Aug 2010

BioSpecifics' partner Auxilium provides update on XIAFLEX

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that its strategic partner Auxilium Pharmaceuticals, Inc. has provided an update on XIAFLEX, its injectable collagenase product currently marketed in the U.S. for the treatment of Dupuytren's contracture.

13 Jul 2010

BioSpecifics Technologies total revenues for first-quarter increase to $2.7M

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced its financial results for the first quarter ended March 31, 2010. The Company also highlighted key commercial and regulatory progress during the quarter, and provided its expected milestones for the remainder of 2010.

7 May 2010

BioSpecifics Technologies' XIAFLEX now available to Dupuytren's contracture patients in the U.S.

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that XIAFLEX™ is now available in the U.S. by prescription, for the treatment of adult Dupuytren's contracture patients with a palpable cord. Dupuytren's contracture is a debilitating disease resulting from excessive collagen deposition that causes contractures of the fingers.

8 Mar 2010

FDA approves Xiaflex drug for treatment of Dupuytren's contracture

The U.S. Food and Drug Administration (FDA) has approved Xiaflex, a new drug to treat Dupuytren's contracture (or disease) that was discovered and developed by Marie A. Badalamente, Ph.D., and Lawrence C. Hurst, M.D., in the Department of Orthopaedics at Stony Brook University Medical Center.

4 Feb 2010

BioSpecifics Technologies' XIAFLEX receives FDA approval

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that the U.S. Food and Drug Administration (FDA) has approved XIAFLEX™, a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord.

3 Feb 2010

Xiaflex receives FDA approval for treatment of Dupuytren's contracture

The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person's ability to straighten and properly use their fingers.

2 Feb 2010

Pfizer and Auxilium Pharmaceuticals announce completion of European MAA validation phase for XIAFLEX

Pfizer Inc. and Auxilium Pharmaceuticals, Inc. today announced that Pfizer received notification from the European Medicines Agency that the Marketing Authorization Application (MAA) for XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, biologic for the treatment of Dupuytren’s contracture (a condition resulting in the contracture of the fingers into the palm), has completed the validation phase successfully. As a result, the scientific/technical review procedure commenced on 21 January 2010.

21 Jan 2010

BioSpecifics Technologies revenues increases by 100% for the third quarter ended September 30, 2009

BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first-in-class collagenase-based products, today announced its financial results for the third quarter ended September 30, 2009.

6 Nov 2009

Auxilium Pharmaceuticals reports increased net revenues of $42.1 million in third quarter 2009

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced financial results and operational highlights for the quarter ended September 30, 2009. For the third quarter of 2009, Auxilium reported net revenues of $42.1 million compared to net revenues of $32.6 million in the third quarter of 2008.

28 Oct 2009

FDA Advisory Committee recommends marketing approval for Auxilium's XIAFLEX to treat Dupuytren's contracture

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) recommended by a unanimous vote of 12 to 0 that XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, be granted marketing approval by the FDA for the treatment of Dupuytren's contracture.

17 Sep 2009

Phase III clinical trial results of XIAFLEX published in a journal

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products today announced results of the pivotal CORD I Phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class biologic for the nonsurgical treatment of Dupuytren's disease, was published in today's edition of the New England Journal of Medicine.

4 Sep 2009

CORD I phase III clinical trial results of XIAFLEX published

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that The New England Journal of Medicine (NEJM) has published in its September 3rd edition, the Company's pivotal CORD I Phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum) a novel, first-in-class, biologic for the nonsurgical treatment of Dupuytren's contracture.

3 Sep 2009

New method for treating hand disorder discovered

Researchers in the Department of Orthopaedics at Stony Brook University Medical Center have developed an injectable form of the enzyme, collagenase, that significantly improves outcomes of Dupuytren's contracture (or disease), a debilitating disorder caused by progressive accumulation of collagen that deforms fingers and limits motion. Reported in September 3, 2009, issue of The New England Journal of Medicine, the study involved treatment of 308 patients with Duputren's disease in 16 sites nationwide. The results indicate that the injections are safe and effective.

3 Sep 2009