Theorem Clinical Research

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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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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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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October 20

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

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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The CenterWatch Monthly

September

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

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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