Da Hee Han, PharmD, Author at MPR

Da Hee Han, PharmD

All articles by Da Hee Han, PharmD

Zulresso Approved as First Treatment for Postpartum Depression

The Food and Drug Administration (FDA) has approved Zulresso (brexanolone; Sage Therapeutics) injection for the treatment of postpartum depression in adult women, the first drug to be approved for this indication. Zulresso, an analogue of the endogenous human hormone allopregnanolone, is intended for continuous intravenous (IV) infusion over 2.5 days following a titration schedule. It…

ovarian cancer

Phase 3 JAVELIN Ovarian Cancer Study Halted

Merck and Pfizer announced the discontinuation of the phase 3 JAVELIN Ovarian PARP 100 study that was comparing the safety and efficacy of avelumab plus chemotherapy followed by avelumab plus talazoparib (Talzenna) vs an active comparator in treatment-naive patients with locally advanced or metastatic ovarian cancer (stage III or IV).

multiple myeloma

FDA Places Clinical Hold on Venetoclax Trials for Multiple Myeloma

The Food and Drug Administration (FDA) has placed a partial hold on all clinical trials evaluating venetoclax (Venclexta; AbbVie and Genentech) for the treatment of multiple myeloma. This was prompted after a review of data from the phase 3 BELLINI trial (M14-031) showed a higher proportion of deaths in the venetoclax treatment arm compared with…