Orexigen announced that it has resubmitted an NDA to the FDA for Contrave (naltrexone sustained release [SR]/bupropion SR), an investigational drug for weight loss and maintenance of weight loss.
The FDA has granted a 6-month Priority Review designation to Genzyme's New Drug Application (NDA) for Cerdelga (eliglustat), an investigational oral therapy for adults with Gaucher disease type 1.
AbbVie announced Phase 3 results for its investigational three direct-acting antiviral (3D) regimen plus ribavirin in patients with chronic, genotype 1 (GT1) hepatitis C virus (HCV) infection.
Seattle Genetics has announced updated results from a Phase 2 clinical trial of Adcetris (brentuximab vedotin) in diffuse large B-cell lymphoma (DLBCL) and other B-cell non-Hodgkin's lymphoma.
Baxter announced that it has submitted a Biologics License Application (BLA) to the FDA for OBI-1 in patients with acquired hemophilia A.
Daiichi Sankyo Company announced results from a prespecified subgroup analysis of 771 cancer patients enrolled in its Phase 3 Hokusai-VTW study evaluating the use of edoxaban.
Interim results announced from Gilead's Phase 2 study evaluating GS-9973 for the treatment of patients with relapsed or refractory hematologic malignancies.
Results have been announced from Study 101-09, Gilead's Phase 2 study evaluating idelalisib for the treatment of patients with indolent non-Hodgkin's lymphoma (iNHL) that is refractory (non-responsive) to rituximab and to alkylating-agent-containing chemotherapy.
Baxter has announced that it has submitted an application to the FDA for a pediatric indication of Rixubis (coagulation factor IX [recombinant]) for the treatment of hemophilia B.
Positive interim results announced for Emergent BioSolutions' Phase 2 study evaluating the combination of otlertuzumab (TRU-016) and bendamustine vs. bendamustine alone in patients with relapsed chronic lymphocytic leukemia (CLL) (Study 16201).
Shire announced top-line results from OPUS-2, a Phase 3 efficacy and safety study of 5.0% lifitegrast ophthalmic solution for dry eyes.
Eli Lilly and Company announced that the primary study objective from three studies of edivoxetine for superior efficacy was not met in depression after eight weeks of treatment.
Sanofi announced full results for EDITION II (basal insulin + oral therapy) and additional results from its EDITION Phase 3 program for EDITION III, EDITION IV, and EDITION JP I for the investigational new insulin U300 in patients with type 1 or type 2 diabetes.
The FDA has designated isavuconazole (Astellas Pharma) a Qualified Infectious Disease Product (QDIP) for the treatment of invasive aspergillosis.
The FDA has accepted the New Drug Application (NDA) for Zalviso (sufentanil sublingual microtablet system; AcelRx) for the management of moderate-to-severe acute pain in adult patients in the hospital setting.