DIA Biosimilars 2013

Omthera Pharmaceuticals

AstraZeneca to acquire Omthera, NDA-ready novel dyslipidemia treatment

Wednesday, May 29, 2013 11:35 AM

Global biopharmaceutical company, AstraZeneca, has entered into a definitive agreement to acquire Omthera Pharmaceuticals, a specialty pharmaceutical company based in Princeton, N.J., focused on the development and commercialization of new therapies for abnormal levels of lipids in the blood, referred to as dyslipidemia.

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Cenduit: Now with Patient Reminders

Omthera names Lloyd VP regulatory affairs

Monday, August 1, 2011 12:32 PM

Omthera Pharmaceuticals reports that Ramona M. Lloyd has joined the company as vice president regulatory affairs, effective immediately.  In this newly created position, Dr. Lloyd will be responsible for the management of all regulatory activities, including regulatory strategy and interactions with the FDA.

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CRF Health – eCOA Forum

Omthera Pharmaceuticals begins phase III EVOLVE trial

Thursday, March 17, 2011 12:46 PM

Omthera Pharmaceuticals, a privately-held New Jersey-based specialty pharmaceuticals company, said the first patient has been dosed in its pivotal phase III EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs) trial for Epanova, the company's lead compound for the treatment of patients with very high triglycerides. Epanova is an Omega-3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).  The phase III trial was granted a Special Protocol Assessment (SPA) from the FDA.

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Omthera raises $34 million in venture funding

Tuesday, March 15, 2011 01:34 PM

With a phase III study of its lead drug now under way, Omthera Pharmaceuticals has raised $33.9 million in its second round of venture cash. New Enterprise Associates led the round, with former MedImmune chief David Mott now slated to join the biotech's board. Sofinnova Partners, which had set up the Series A, also participated in the new round.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

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New growth and decline in Asia clinical trials
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Harnessing Big Data to transform clinical trials
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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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