Theorem Clinical Research

Auxilium Pharmaceuticals

Xiaflex approved for concurrent treatment in Dupuytren's contracture patients

Friday, October 24, 2014 12:48 PM

Auxilium Pharmaceuticals has announced that the FDA has approved a supplemental Biologics Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH) for the treatment of up to two Dupuytren's contracture (DC) joints in the same hand during a single treatment visit.

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Endo to acquire Auxilium Pharmaceuticals for $2.6 billion

Friday, October 10, 2014 12:01 PM

Dublin, Ireland-based Endo International has agreed to acquire Chesterbrook, Pa.-based Auxilium Pharmaceuticals. Endo will acquire all outstanding common stock for $33.25 per share in a cash and stock transaction. The boards of directors of both companies have unanimously approved the transaction, valued at $2.6 billion, which includes the repayment and assumption of debt.   

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Zynerba Pharmaceuticals expands management team

Thursday, October 2, 2014 01:30 PM

Zynerba Pharmaceuticals, a specialty pharmaceutical company dedicated to the development of innovative transdermal cannabinoid treatments, has named three seasoned pharmaceutical executives to its management team. Donna Gutterman, PharmD, is a consultant who will be vice president, medical affairs; Carol O'Neill will be vice president, development; and Suzanne Hanlon will be general counsel and vice president, human resources.

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Endo International seeks to acquire Auxilium Pharmaceuticals for $2.2B

Wednesday, September 17, 2014 02:12 PM

Endo International, a Dublin-based global specialty healthcare company, has delivered an unsolicited proposal to acquire all of the outstanding shares of Chesterbrook, Pa.-based Auxilium Pharmaceuticals for a per share consideration of $28.10, in a cash and stock transaction valued at $2.2 billion.

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Vivus, Sanofi ink agreement

Friday, December 13, 2013 01:57 PM

Biopharmaceutical company Vivus has entered into a license and commercialization agreement with Sanofi to commercialize avanafil on an exclusive basis in Africa, the Middle East, Turkey and the Commonwealth of Independent States (CIS) including Russia. Sanofi will be responsible for obtaining regulatory approval in its territories. Sanofi intends to market avanafil under the trade name Spedra or Stendra.

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Vivus, Auxilium ink license agreement

Monday, October 14, 2013 02:18 PM

Vivus has signed an agreement providing Auxilium Pharmaceuticals the exclusive rights to market Stendra (avanafil) in the U.S. and Canada. The companies also signed a commercial supply agreement by which Vivus will be responsible for the manufacture and supply of Stendra to Auxilium. Stendra is an oral therapy approved by the FDA for the treatment of erectile dysfunction (ED).

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AcelRx appoints Adrian Adams to board

Tuesday, February 12, 2013 08:00 AM

AcelRx Pharmaceuticals, a specialty pharmaceutical company focused on acute and breakthrough pain, has appointed Adrian Adams, CEO and president of Auxilium Pharmaceuticals, to its board of directors as chairman of the board.  

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Auxilium touts top-line data from Xiaflex study in Dupuytren's contracture

Monday, July 30, 2012 11:34 AM

Auxilium Pharmaceuticals, a specialty biopharmaceutical company based in Malvern, Penn., issued positive top-line data from its phase IIIb trial evaluating Xiaflex for the treatment of adult Dupuytren's contracture patients with multiple palpable cords. 

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Auxilium and GSK to co-promote Testim in U.S.

Monday, May 21, 2012 12:35 PM

Auxilium Pharmaceuticals, a specialty biopharmaceutical company based in Malvern, Penn., and GlaxoSmithKline LLC, the U.S. subsidiary of GlaxoSmithKline plc, have entered into an agreement for the co-promotion of Auxilium’s Testim 1% (testosterone gel), which is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone.

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Auxilium and Actelion collaborate for Xiaflex

Monday, February 27, 2012 09:53 AM

Auxilium Pharmaceuticals, a specialty biopharmaceutical company, and Actelion Pharmaceuticals 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.

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

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Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

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Reality of costs and impact rain on Sunshine Act
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Benefits outweigh the complexities, challenges of finding right vendors

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