Santarus

FDA approves Ruconest for hereditary angioedema attacks

Thursday, July 17, 2014 10:49 AM

The FDA has approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

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WIRB Copernicus Group

Salix Pharmaceuticals to acquire Santarus

Friday, November 8, 2013 12:11 PM

Salix Pharmaceuticals will acquire Santarus, a specialty biopharmaceutical company, in an all-cash transaction valued at approximately $2.6 billion. 

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CRF Health eCOA webinar series

Specialty CRO Agility Clinical is formed

Thursday, May 31, 2012 02:36 PM

David F. Hale, chairman and CEO of Hale BioPharma Ventures, has founded a new CRO, Agility Clinical, in Carlsbad, Calif.

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Adventrx establishes regulatory advisory board

Monday, April 9, 2012 03:47 PM

San Diego-based Adventrx Pharmaceuticals has established a regulatory advisory board, which will provide drug development and regulatory affairs guidance on the company’s interactions with the FDA.

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Santarus initiates phase IIIb study with Uceris in ulcerative colitis

Tuesday, February 14, 2012 07:40 AM

Santarus, a specialty pharmaceutical company, has begun patient enrollment in phase IIIb clinical study with the investigational drug Uceris (budesonide) tablets 9mg in combination with current oral aminosalicylate (5-ASA) therapy for patients with active ulcerative colitis.

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CWWeekly

July 28

WCG acquires Alliance Biosciences to expand its biosafety oversight capabilities, ensure compliance

Facilitated review meetings for protocol design catching on, decreasing amendments, complexity

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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The CenterWatch Monthly

June

CRO market poised for growth and consolidation
Sponsors expanding pipelines, shrinking infrastructure fuel strategic outsourcing

Strategies for success evolving in phase I space
Sites see increasing complexity, more patients, greater focus on efficacy

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