Protocols: Editas gets a gene editing collaborator; Regulus hustling up response to clinical hold; Sanofi drug OK’d
Gene editing pioneer Editas has signed on with the experts at the San Raffaele Telethon Institute for Gene Therapy (SR-TIGET) on a new alliance to research and develop genome edited hematopoietic stem cell and T cell therapies. They’ll focus on rare diseases, with a special spotlight on blood and bone marrow.
Bedeviled by a clinical hold, Regulus execs say they are now on track to answering the FDA’s questions so regulators can make up their minds before the end of this year. “We are working expeditiously to resolve the issues outlined in the letter and anticipate a decision from the FDA in the fourth quarter,” said Paul Grint, president and CEO of Regulus.
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