K-V Pharmaceutical (KV) announced that it filed a lawsuit against the FDA for its alleged failure to crack down on compounded versions of its premature birth drug Makena. Pharmacies have been using the active ingredient hydroxyprogesterone, to compound less expensive versions of Makena, even though the ingredient lacks formal FDA clearance. Makena is an injectable hormonal medicine that reduces the risk of pre-term birth in pregnant women who have a history of early deliveries. K-V shares fell sharply on the news.
A California District Court denies Sequenom (NASDAQ:SQNM) its petition for an injunction against Ariosa Diagnostics to stop it from offering or selling its Harmony Prenatal Test, until such time as a settlement of current litigation between the two companies should occur.
QIAGEN (NASDAQ:QGEN) reports that it’s won FDA approval to market its therascreen KRAS test to provide guidance on the use of Erbitux, as a treatment for patients suffering from metastatic colorectal cancer.
Want news like this in real-time so you can get an edge? Click here for Wall St. Cheat Sheet Pro.