Protocols

Intellipharmaceutics shares crushed as FDA experts snub pain drug; Moncef Slaoui joins Moderna board

→ After getting chastised by regulators in an internal FDA review of Toronto-based Intellipharmaceutics$IPCI new pain drug Rexista, a panel of outside experts joined in, voting to recommend a rejection of the therapy. Billed as a new version of oxy with new features which the biotech claimed would deter abuse, the panelists voted 22 to 1 against an OK. And all of them agreed that the company never offered the data that would be needed to gain an abuse-deterrent note on the label, if it were to be approved. The company’s shares cratered, dropping 45%.

→ Radnor, PA-based Complexa has raised a big $62 million round designed to fuel a pair of mid-stage trials for its lead therapy, CXA-10. The drug will be tested in focal segmental glomerulosclerosis (FSGS), an orphan disease affecting the kidney, and pulmonary arterial hypertension (PAH), a rare pulmonary disease. New Enterprise Associates and Pfizer Venture Investments led the round with help from Edmond de Rothschild Investment Partners, HBM Healthcare Investments and existing investors including JAFCO, which led the Company’s Series B financing in 2014.

→ Fremont, CA-based Quark Pharmaceuticals is reporting that their Phase II study for the siRNA drug QPI-1002 came through with positive data for reducing the rate of acute kidney injury following cardiac surgery. The study enrolled 341 subjects. “Quark is developing QPI-1002 in a variety of indications associated with ischemia-reperfusion renal injury,” stated Shai Erlich, CMO and president of Quark’s US operations. “We are excited about the QRK-209 study results which reinforce the positive effect of QPI-1002 as previously reported in a randomized, double-blind, placebo-controlled multicenter Phase 2 study (QRK-006b; NCT00802347) where QPI-1002 was shown to reduce the incidence and severity of delayed graft function (DGF) in patients undergoing renal transplantation.”

→ Moncef Slaoui, the former R&D and vaccines chief at GlaxoSmithKline, is joining the board at the mRNA company Moderna. Slaoui is an enthusiastic champion of pioneering drug R&D. And he says he’s looking “forward to working with the team to navigate this uncharted territory, and support the strategic planning already underway as Moderna works to deliver mRNA medicines and vaccines to address serious unmet medical needs in the U.S. and globally.”


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RAPS Regulatory Convergence 2017