Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|January 30, 2014
DS Healthcare Group Moves Prescription Hair Loss Treatment Forward with Appointment of Aptiv Solutions as CRO
DS Healthcare Group, Inc announced it has appointed Aptiv Solutions as its CRO for its proprietary topical prescription treatment.
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DS Healthcare Group, Inc. (NASDAQ:DSKX), a leading developer of personal care products, today announced it has appointed Aptiv Solutions as its clinical research organization (CRO) for its proprietary topical prescription treatment. If approved the drug will be positioned as frontline therapy in the fight against hair loss, a condition that affects nearly half of the population.
Aptiv Solutions will prepare DS Healthcare's Investigational New Drug Application(IND), for its proprietary topical hair loss treatment, for submission to the United Stated Food and Drug Administration (FDA). An IND is a request for the FDA's authorization to administer an investigational drug to humans and is the first step towards designing and conducting clinical trials in the U.S. To date, only one other topical treatment for hair loss has been approved by the FDA. Aptiv Solutions will also conduct a Gap analysis to ensure that DS Healthcare's operations are in line with regulatory requirements for drug approval.
Aptiv Solutions is a leading global CRO with extensive global drug development and trial management expertise. Aptiv Solutions has conducted over 2,600 clinical trials and assisted in over 140 FDA and European Union drug and biologic approvals, as well as over 700 medical device approvals and clearances. DS Healthcare recently announced its intention to submit an IND to the FDA. The move follows the Company's patent application filing with the United StatesPatent and Trademark Office for its prescription hair loss treatment invention.
"Our intention is to move the development of our prescription-grade hair loss product at a swift pace. Aptiv Solutions has been central to the successfuldevelopment, clinical trials, and subsequent regulatory approval of numerous market leading products and we are pleased to have their support as our CRO," commented DS Healthcare President and CEO, Daniel Khesin.
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