The FDA has granted sebelipase alfa Breakthrough Therapy designation for the treatment of early onset lysosomal acid lipase deficiency.
Genetech announced results from CLL11, a Phase 3 study of obinutuzumab (GA101), comparing the combination of either obinutuzumab or Rituxan and chlorambucil to chlorambucil alone in chronic lymphocytic leukemia (CLL).
The FDA has accepted Seattle Genetics' sBLA for filing of Adcetris for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma.
The FDA has accepted the Biologics License Application for Eloctate, a first in class recombinant factor VIII Fc fusion protein for hemophilia A treatment.
The FDA has granted Janssen R&D's NDA priority review for simeprevir in combination with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults.
The FDA has accepted for filing Actavis' NDA for a once-weekly progestin-only transdermal contraceptive patch to prevent pregnancy in women.
The FDA has accepted for review the Biologics License Application for ragweed pollen sublingual allergy immunotherapy tablet.
Phase 3 trial evaluating Vectibix vs. Erbitux for the treatment of chemo-refractory metastatic colorectal cancer meets its primary endpoint for overall survival.
Baxter's immunoglobulin study for the treatment of Alzheimer's has been discontinued after a Phase 3 study failed to meet co-primary endpoints.
Antibiotic candidate, ceftolozane/tazobactam, has been granted Fast Track Status for the treatment of hospital-acquired bacterial pneumonia/ acquired bacterial pneumonia and complicated urinary tract infections.