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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CenterWatch Data Library
CWWeekly

January 19

Roche takes $1B majority stake in Foundation Medicine to use genomic testing to personalize oncology treatments

BRANY launches software, iPad app to streamline protocol creation for investigator-initiated trials

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The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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