FDA experts back GSK's new malaria drug; Sangamo's newly minted CTO jumps to biotech upstart
→ GlaxoSmithKline has turned the final corner in the race to gain an FDA approval for tafenoquine, a new treatment for patients with P. vivax malaria. A panel of outside experts voted 13 to 0 to endorse the drug and recommend an approval. That comes on top of an internal review that also backed the application. “If approved, tafenoquine would be the first new medicine for this indication in more than 60 years,” says Pauline Williams, head of Global Health R&D at GSK.
→ Longtime Sangamo staffer Michael Holmes has left the gene-editing company to pursue a “ground-floor opportunity at a biotech startup,” opening up the senior vice president and chief technology officer role for his colleague Edward Rebar to fill. While Holmes had only been in the role for a few months, his involvement with Sangamo’s zinc finger tech — a platform that has drawn Pfizer in as a partner — stretches back to 2001, when he joined as a scientist straight out of graduate school. Rebar, who has had an even longer history with the company, has helped research and optimize the technology.
→ Now that Tonix Pharma $TNXP has gotten the greenlight to test its PTSD drug’s efficacy in treating agitation in Alzheimer’s disease, the FDA has handed them a fast track designation to speed things along. That’s a decent win for the New York-based biotech, which has focused much of its energy on the PhIII program in military-related post-traumatic stress disorder. In both indications, the drug — TNX-102 SL — will be given as a bedtime treatment. Thanks to the new status, Tonix will have enjoy more of the FDA’s attention and eligibility for priority review if they make it to the NDA stage.