Office of Neuroscience Director Billy Dunn touted FDA’s ability to withdraw approval for AMX0035 if subsequent data indicate a lack of substantial evidence of effectiveness. However, this provision appears to have been infrequently used and involves a potentially time-consuming hearing.

Most Indian pharma stocks, including large firms, yielded double digit negative returns over the last 12 months while the overall market (Bombay Stock Exchange Sensex) delivered positive returns, a new study by an investment banking and consulting services firm indicates. The prognosis for fiscal years 2023/24, though, is optimistic.

Lannett continued to talk up its prospects of launching numerous low-competition, high-value products in the coming years – as it disclosed another sizeable loss for its 2022/23 financial year.

Wockhardt’s US arm Morton Grove Pharmaceuticals, which is bound by a consent decree of permanent injunction, discontinues production to undertake an “orderly closure” and potential sale of its Illinois site. Indian parent firm taps contract manufacturers to service US market.