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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Quest Diagnostics

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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CWWeekly

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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