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Expert research scientists in demand to support evaluation of new drug approvals for novel technologies, including retinal stem cell and gene therapies

The pace of new technology and novel medical treatments has reached a point at which regulators and assessors require additional expert evaluation in reviewing and assessing marketing authorizations. A recent Nature editorial has called for increased support from research scientists into translational medicine, specifically in regards to cutting edge and novel technologies now seeking marketing […]

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Topline data from GenSight’s Phase III REVERSE study provide an unusual and unexpected outcome

  GenSight Biologics S.A. (Euronext: SIGHT) has announced topline results from the company’s Phase III “REVERSE” clinical study of an experimental gene therapy, ”GS010”, designed for the treatment of Leber Hereditary Optic Neuropathy (LHON). According to the company, the study evaluated the safety and efficacy of a single intravitreal injection of GS010 (rAAV2/2-ND4) in 37 […]

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FDA approves first AI enabled software diagnostic to detect diabetic retinopathy without human graders

  The US FDA has announced the authorization of an AI (artificial intelligence) enabled software diagnostic for the screening of diabetic patients for retinopathy. The approved device, manufactured by US company IDx, uses specialized software to determine the status of a fundus image and adjudicate whether or not specialist ophthalmic consultancy is required. As the […]

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