The FDA’s decision to decline the drug’s approval for a much larger cohort of patients with clinical depression, along with strict safety warnings for its use in PPD, is still a “strike against (Biogen’s) management”, Baird analyst Brian Skorney said.
Tag Archive for: postpartum depression
Having access to an oral medication will be a beneficial option for many of women coping with PPD and having extreme, and sometimes life-threatening, feelings, says the FDA.
Among updates from several pharma companies, Sanofi CEO Paul Hudson presented the company’s outlook for the new year, highlighting upcoming milestones and achievements that mark what he called the “new Sanofi.”
Sage Therapeutics and Biogen’s zuranolone met its primary and key secondary endpoints in the Phase III SKYLARK study of women with postpartum depression (PPD), the companies announced Monday.
Sage Therapeutics and partner Biogen shared news that their Phase III Skylark study has yielded promising results for women suffering from severe postpartum depression (PPD).
