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).