Theorem Clinical Research

BioSante Pharmaceuticals

BioSante, ANI Pharmaceuticals ink merger

Friday, October 5, 2012 08:00 AM

Lincolnshire, Ill.-based BioSante Pharmaceuticals and ANI Pharmaceuticals, a fully integrated specialty branded and generic pharmaceutical company of Baudette, Minn., have entered into a definitive merger agreement through an all-stock transaction, with BioSante as the surviving company.

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FDA approves BioSante’s Bio-T-Gel

Wednesday, February 15, 2012 03:59 PM

The FDA has approved Bio-T-Gel for the treatment of male hypogonadism (low testosterone levels), according to BioSante Pharmaceuticals.

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BioSante completes study enrollment

Tuesday, March 1, 2011 08:40 AM

BioSante Pharmaceuticals has completed enrollment of subjects in the first of two pivotal phase III LibiGel (testosterone gel) safety and efficacy trials, being conducted under an FDA-approved special protocol assessment (SPA) agreement.

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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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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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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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