FDA starts the priority review clock for Symbiomix; Cornerstone gets a green light on pivotal studies
→ The FDA accepted Symbiomix’s NDA for Solosec (secnidazole oral granules), an antibiotic designed to treat bacterial vaginosis, and stamped it with a priority review status that will cut the decision process down to six months. The PDUFA date is September 17.
→ Cranbury, NJ-based Cornerstone Pharmaceuticals got a regulatory green light to launch pivotal studies of their lead drug, CPI-613, in patients with acute myeloid leukemia (AML) and pancreatic cancer. Said Cornerstone COO Sanjeev Luther: “The FDA has provided valuable feedback to inform a design that will enhance the robustness of our trials. This would allow the Agency to assess them as registrational trials.”
→ The FDA handed Genentech Breakthrough Therapy Designation status to Rituxan (rituximab) for pemphigus vulgaris, a rare, serious and life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. This is Genentech’s 15th BTD.
→ A year after reorganizing its pipeline and slimming down the projects it’s working on, Ignyta says it has also reworked its licensing pact with Eli Lilly on taladegib, which remains a priority. After Lilly had expressed its dissatisfaction, the biotech says in an SEC filing that they agreed to toss a near-term $18 million milestone in favor of a $15 million set of timed payments. Lilly released Ignyta from any claims it had under the old deal and both have the right to do some sub licensing deals.
→ The UK’s Redx is slashing jobs as it refocuses on its lead R&D programs.