Results announced from nine new Phase 3 ODYSSEY trials of alirocumab (Sanofi and Regeneron) in patients with hypercholesterolemia.
The FDA has issued a Complete Response Letter (CRL) for AcelRx's NDA for Zalviso (sufentanil sublingual tablet system) for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
The FDA has designated Recombinant Human Nerve Growth Factor (rhNGF; Dompe) Orphan Drug status for the treatment of neurotrophic keratitis.
Puma Biotechnology announced results from its Phase 3 ExteNET trial of neratinib (PB272) for the extended adjuvant treatment of breast cancer.
The FDA grants Genentech's sBLA for Avastin (bevacizumab) plus chemotherapy Priority Review for the treatment of women with recurrent platinum-resistant ovarian cancer.
The FDA has designated Fast Track status to SAGE-547 (SAGE Therapeutics) for the treatment of adult patients with refractory status epilepticus who have not responded to standard regimens.
The FDA has granted Orphan Drug designation to RG-012 (Regulus), a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 for the treatment of Alport syndrome.
Positive Phase 3 results announced for AMG 416 (Amgen) for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD), receiving hemodialysis.
Regeneron announced results from its Phase 3 VIVID-DME trial of Eylea (afilbercept) injection for the treatment of diabetic macular edema (DME).
The FDA has designated isavuconazole (Astellas) as a Qualified Infectious Disease Product (QDIP) for the treatment of invasive candidiasis.