Peyronie's Disease News and Research

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Of all penile diseases, Peyronie’s disease represents one with often devastating physical and psychological consequences on affected individuals. Also known as induratio penis plastica, this is an incurable, fibrotic (scarring) disease that results in penile curvature, erectile dysfunction and subsequent coital failure.

Auxilium seeks FDA approval for XIAFLEX sBLA to treat multiple Dupuytren's contracture cords concurrently

Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, today announced the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration requesting approval of XIAFLEX (collagenase clostridium histolyticum, or CCH) for the treatment of multiple Dupuytren's contracture cords concurrently.

20 Dec 2013

Auxilium doses first patient in CCH Phase 2b study for treatment frozen shoulder syndrome

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in the EU, today announced that its partner Auxilium Pharmaceuticals, Inc. has dosed the first patient in its Phase 2b study of collagenase clostridium histolyticum for the treatment of frozen shoulder syndrome (adhesive capsulitis).

16 Dec 2013

Auxilium Pharmaceuticals' XIAFLEX gets FDA approval for treatment of Peyronie's disease

Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration has approved XIAFLEX (collagenase clostridium histolyticum, or CCH), an in-office, biologic for the treatment of Peyronie's disease. XIAFLEX is the first and only FDA-approved treatment proven effective for PD in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy.

6 Dec 2013

FDA extends PDUFA goal date for Auxilium Pharmaceuticals' sBLA for XIAFLEX

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration has notified the Company that it is extending the Prescription Drug User Fee Act goal date for the Company's supplemental biologics license application for XIAFLEX (collagenase clostridium histolyticum) for the treatment of Peyronie's disease from September 6, 2013 to December 6, 2013.

28 Aug 2013

MHN, Auxilium Pharmaceuticals launch new health awareness program on Peyronie's disease

Men's Health Network and Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, have announced the launch of a new health awareness program called "Ask About the Curve" to provide information about Peyronie's disease and to help empower men to have meaningful discussions about their condition with their partner and their healthcare provider.

11 Jun 2013

Study suggests erectile dysfunction in young men may be more prevalent than previously thought

In a recent analysis of one outpatient clinic, one in four men seeking medical help for newly-developed erectile dysfunction (ED) was younger than 40 years, and nearly half of young men with the condition had severe ED.

7 Jun 2013

The Journal of Urology publishes results from BioSpecifics XIAFLEX trials on Peyronie's disease

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in Europe and Eurasia, today announced that The Journal of Urology has electronically published the uncorrected proof of the pivotal IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials on its website.

5 Feb 2013

Additional data from Auxilium XIAFLEX phase III studies on Peyronie's disease

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, announced that additional data will be presented from its IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the phase III studies that assessed XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, in-office, first-in-class biologic therapy for the potential treatment of Peyronie's disease (PD).

27 Aug 2012

Health Canada approves XIAFLEX for Dupuytren's contracture

Auxilium Pharmaceuticals, Inc. and Actelion Pharmaceuticals Canada Inc. announced today that Auxilium was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, first-in-class biologic for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada.

9 Jul 2012

Positive results from BioSpecifics’ XIAFLEX Phase III clinical program on Peyronie's disease

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in Europe and Eurasia, today announced positive top-line results from the IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) Phase III clinical program of XIAFLEX for the treatment of Peyronie's disease, which was conducted by BioSpecifics' partner Auxilium Pharmaceuticals, Inc.

5 Jun 2012

Positive results from Auxilium’s XIAFLEX phase III studies on Peyronie's disease

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced positive top-line results from its IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the phase III studies that assessed XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, in-office, first-in-class biologic therapy for the potential treatment of Peyronie's disease (PD).

4 Jun 2012

Actelion, Auxilium partner to develop and commercialize XIAFLEX

Auxilium Pharmaceuticals, Inc. and Actelion Pharmaceuticals Ltd. announced today that they have entered into a long-term partnership for the development, supply and commercialization of XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class biologic for the potential treatment of Dupuytren's contracture and Peyronie's disease.

23 Feb 2012

BioSpecifics reports $0.3M net income for third quarter 2011 vs. $0.5M net loss for third quarter 2010

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in Europe today announced its financial results for the third quarter ended September 30, 2011 and provided a corporate update. For the quarter, the Company reported net income of $0.3 million or $0.04 per share on a basic and on a fully diluted basis.

9 Nov 2011

Auxilium reports net revenues of $66.7 million for third quarter 2011

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced financial results and operational highlights for the quarter ended September 30, 2011.

31 Oct 2011

Auxilium second quarter net loss decreases to $5.1 million

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced financial results and operational highlights for the quarter ended June 30, 2011. For the second quarter of 2011, Auxilium reported net revenues of $65.9 million compared to net revenues of $50.5 million in the second quarter of 2010.

1 Aug 2011

Peyronie's Disease News and Research

Further Reading

Auxilium seeks FDA approval for XIAFLEX sBLA to treat multiple Dupuytren's contracture cords concurrently

Auxilium doses first patient in CCH Phase 2b study for treatment frozen shoulder syndrome

Auxilium Pharmaceuticals' XIAFLEX gets FDA approval for treatment of Peyronie's disease

FDA extends PDUFA goal date for Auxilium Pharmaceuticals' sBLA for XIAFLEX

MHN, Auxilium Pharmaceuticals launch new health awareness program on Peyronie's disease

Study suggests erectile dysfunction in young men may be more prevalent than previously thought

The Journal of Urology publishes results from BioSpecifics XIAFLEX trials on Peyronie's disease

Additional data from Auxilium XIAFLEX phase III studies on Peyronie's disease

Health Canada approves XIAFLEX for Dupuytren's contracture

Positive results from BioSpecifics’ XIAFLEX Phase III clinical program on Peyronie's disease

Positive results from Auxilium’s XIAFLEX phase III studies on Peyronie's disease

Actelion, Auxilium partner to develop and commercialize XIAFLEX

BioSpecifics reports $0.3M net income for third quarter 2011 vs. $0.5M net loss for third quarter 2010

Auxilium reports net revenues of $66.7 million for third quarter 2011

Auxilium second quarter net loss decreases to $5.1 million

Penile extenders represent an effective lengthening method for men

Auxilium to receive $30 million from Pfizer following XIAPEX sale in EU market

BioSpecifics 2010 net loss decreases to $1.5 million

Auxilium completes patient enrollment in XIAFLEX phase III trial against Peyronie's disease

BioSpecifics Technologies third quarter net loss increases to $0.5 million

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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