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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Quest Diagnostics

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Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials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