Intercept's NASH decision date is deferred; EMA investigates safety of LEO Pharma gel
→ The first drugmaker tipped to win approval for a NASH therapeutic is going to have to wait three months longer. The FDA is now expected to make its final decision on Intercept Pharmaceuticals‘ obeticholic acid by June 26. The delay was attributed to a major amendment — additional information was provided by the company in response to FDA requests — as well as to accommodate an advisory committee meeting, Intercept said in a filing on Friday. Last month, the FDA notified the company it tentatively intended to hold the adcomm on April 22 — so a delay to the March PDUFA was in any case expected.
→ This week, the EMA’s safety committee recommended suspending the marketing authorization of Danish drugmaker LEO Pharma‘s gel Picato. Patients should stop using the therapy — which is approved to treat the skin condition actinic keratosis — while the regulator investigates the topical treatment’s links to skin cancer, the agency said.
→ A Chinese fund has invested AUS$45 million to allow researchers from the University of Adelaide, University of South Australia, state hospitals and other institutions to focus on drug development and clinical diagnostics. An LuFan, executive director of D&R Pharmaceuticals, heads the fund and is backed by private investors based in Nanjing, China.