miércoles, 21 de noviembre de 2018

Global Blood's FDA filing plan for a sickle cell drug is riskier than you think - STAT

Global Blood's FDA filing plan for a sickle cell drug is riskier than you think - STAT

The Readout

Damian Garde



Beware the Black Friday news dump


There’s no better (or more popular) time to announce bad news than late on a Friday, and there’s no Friday quieter than the one that follows Thanksgiving. With that in mind, here are a few outstanding biotech questions that will get answers before the year is out, and, if those answers are negative, could cross the wires in Friday’s gloaming hours.

Neurocrine Biosciences hopes a drug called Ingrezza, approved to treat the movement disorder tardive dyskinesia, can help patients with Tourette’s syndrome. Results from a mid-stage study are expected any day now.

Marinus Pharmaceuticals is angling to compete with Sage Therapeutics in treating postpartum depression. Key data on its treatment, ganaxolone, have been repeatedly delayed, but management said last month that the results would be available “shortly.”

Global Blood Therapeutics believes its in-development treatment for sickle cell disease merits FDA approval despite mixed results in a late-stage study. It’s unknown whether the FDA is on board with that belief, and Global Blood has promised to relay the agency’s opinion before the year is out.

No hay comentarios: