Indian Policy Shifts Could Force Firms To Abandon 'Second Brand' Strategies
Executive Summary
India’s new draft pharmaceutical policy proposes a raft of radical changes that have left industry jittery and could force a significant realignment in the operations of foreign and local firms. Second brand strategies and widespread licensing-out of manufacturing are no longer favored, and a 'one company – one drug – one brand name – one price' thrust are among the key changes proposed.
You may also be interested in...
Genfit Not Fully Exiting NASH, Despite Terminating RESOLVE-IT
A fuller look at interim Phase III data shows no path forward to accelerated approval in NASH, company says. Genfit turns focus to developing elafibranor for PBC, as well as a NASH diagnostic.
Intercept’s NASH Drug Delayed By April Advisory Committee
US FDA sets 22 April for advisory committee review of obeticholic acid in NASH, though whether the extended review was due to scheduling issues or any questions about Intercept's application itself remain unclear.
Intercept’s NASH Drug Delayed By April Advisory Committee, But Firm Is Ready For Launch
Intercept announced that the US FDA has set April 22 as date for an advisory committee review of OCA in NASH, meaning March 26 action date could be pushed back as much as three months.