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Latest From Cytochroma Inc.
With CEO leadership in the biopharma industry more short-cycled than ever, billionaire entrepreneur Phillip Frost ranks as a competitor for the long game – the last man standing in an endurance test spanning four decades of exposure to every iteration of a fast-changing business model. Frost’s strategy at Opko eschews the approach of most of his CEO peers to seek therapeutic dominance in a narrow band of core competencies.
Contract manufacturer Catalent Pharma is under the gun to prepare an action plan after FDA’s complete response letter on vitamin D drug Rayaldee (calcifediol).
Keeping Track: Submissions By Insys, Elusys, Opko and Bio Products; Immuno-Oncology User Fee Goals; A Genzyme 'Breakthrough'
The latest drug development news and highlights from our FDA Performance Tracker.
Opko Health will submit a new drug application (NDA) to the US FDA for Rayaldee (CTAP101) based on a second set of positive Phase III results in the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.