No Cialis committee?
Executive Summary
Lilly/ICOS's erectile dysfunction therapy Cialis is not scheduled for review at May advisory committee that will discuss Levitra's QT prolongation issues. Lilly says there has been no evidence of QT problems with Cialis, even in study patients dosed with up to 500 mg; the maximum dose being sought for approval is 20 mg. Like Levitra, Cialis is "approvable" at FDA and was recently approved in Europe. EMEA notes no cardiovascular effects were observed, but Lilly/ICOS "has committed to conduct a HERG channel assay with tadalafil as a post-authorization follow-up measure"...
You may also be interested in...
California Court’s Inaction On TiO2 Prop 65 First Amendment Case Breeds New Lawsuits
The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.
Kenvue Breaks Ground On New Headquarters, Appoints Chief Corporate Affairs Officer
Firm hosts groundbreaking for 290,000 square-foot global headquarters it’s having built in Summit, NJ, starting with 100,000 square-foot science and innovation and expected to open in 2025. It announced adding Russell Dyer as chief corporate affairs officer starting 13 March.
Xaira Launches With $1bn-Plus And End-To-End AI Strategy
ARCH and Foresite incubated the company and recruited Genentech R&D veteran Marc Tessier-Lavigne to keep data generation, machine learning research and drug development under one roof.