I.V. Zulresso is the first US FDA-approved drug for postpartum depression (PPD) and Sage's first commercial product – with a list price of $34,000. It will help the company build a presence in PPD as it completes late-stage development for oral candidate SAGE-217.
The US FDA approved Sage Therapeutics Inc.'s Zulresso (brexanolone) on March 19 as the first agency-endorsed treatment for postpartum depression (PPD). It's also Sage's first approved product, helping the company establish a commercial organization as it completes Phase III development for the more broadly applicable postpartum and major depression candidate SAGE-217.
Zulresso's 60-hour I.V
Company surprises investors with Jørgensen's exit but insists its strategy will not change.
The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.
Recent moves in the industry include changes at the top at Akamis Bio, Innospera Pharma & Ispen, plus Astellas Korea appoints an ex-Novartis Korea executive.
