Novella Clinical

FDA announces new Orphan Drug Modernization Plan to eliminate orphan designations backlog

Monday, July 10, 2017

On June 29, 2017, the U.S. Food and Drug Administration (FDA) announced a recent initiative for the eradication of the agency’s orphan disease designation request backlog. This backlog includes around 200 orphan drug designation requests. In addition to eliminating this backlog, the FDA has in place a new strategic plan of action for the prevention of a future requests backlog via the implementation of a 90-day response system.

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Novella hires three new executives

Thursday, July 21, 2016

Three new team members have joined Novella Clinical. Fiona Markwood is Novella’s new executive vice president of Oncology Project Management; Anusha Bala, BSc, LLB, is Novella’s new global head of Regulatory Affairs; and Joy Yucaitis joins Novella as senior director of Oncology Strategy.

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Novella Clinical selected by Scioderm to manage rare disease study

Thursday, October 17, 2013

CRO Novella Clinical, a Quintiles company, has been selected by Scioderm, is a privately held, clinical-stage pharmaceutical company, to manage a phase IIb trial for the treatment of Epidermolysis Bullosa (EB), a rare genetic connective tissue condition. The trial will evaluate Scioderm’s investigational topical product, SD-101, for the treatment of skin blistering and erosions associated with this disease, including facilitation of healing of skin lesions and reduction of the incidence and/or severity of new lesions.

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