Regeneron (REGN) and Sanofi’s (SNY) Praluent has been approved by the apanese Ministry of Health, Labor and Welfare for the treatment of uncontrolled low-density lipoprotein (LDL) cholesterol in certain adult patients with hypercholesterolemia at high cardiovascular risk.
Cempra (CEMP) announced that the FDA has accepted for review its New Drug Applications (NDAs) seeking approval of intravenous and oral capsule formulations of Solithera (solithromycin) for the treatment of community-acquired bacterial pneumonia (CABP). The FDA has designated it a Qualified Infectious Disease Product (QIDP) for Fast Track review.
Juniper Pharmaceuticals (JNP) announced that Merck KGaA has been granted approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) for OneCrinone 90 mg (progesterone) for the indication of luteal phase supplementation in assisted reproductive treatment. The market launch should commence later this year. Merck KGaA has global rights (ex-U.S.) to Crinone and OneCrinone.
Insys Therapeutics (INSY) announced that the FDA has approved its dronabinol oral solution, Syndros, for the treatment of anorexia-associated weight loss in patients with AIDS and the treatment of chemotherapy-induced nausea and vomiting (CINV) in patients who have not responded to conventional antiemetic treatments. It is the first dronabinol solution approved in the U.S.
Biogen (BIIB) and AbbVie’s (ABBV) ZINBRYTA (daclizumab) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) has been approved by the European Commission (EC). The EC approval of ZINBRYTA is supported by results from two studies, Phase 3 DECIDE and Phase 2b SELECT involving 2,400 subjects. ZINBRYTA is a once-monthly, self-administered, subcutaneous injection.
Five Prime Therapeutics (FPRX) announced that the FDA has granted its FPA144 an Orphan Drug for the treatment of gastric cancer, including cancer of the gastroesophageal junction, in patients with tumors that overexpress a protein called FGFR2b, an oncogene that is present in up to 35% of gastric cancer cases that is associated with aggressive disease.