Japan's MHLW to review 3 drugs, 2 devices for Sakigake list

Japan's Ministry of Health, Labor and Welfare (MHLW) will review another five candidates for its fast-track approval process known as Sakigake, all of which started as academic work and include two medical devices.

A MHLW spokesman said three of the products are regenerative medicine candidates that includes a gene therapy backed by Tokyo-based Daiichi Sankyo and developed at the University of Tokyo's Institute of Medical Science dubbed G47Δ to treat brain tumors and in Phase II trials.

As well, Osaka-based Nipro won a nod for a potential stem cell treatment for spinal cord injuries, STR01. Also in the regenerative medicine field was an unspecified candidate using autologous cardiac stem cells to treat heart disease in children.

Source: FiercePharma