Drugs in the Pipeline

Positive Results for AMG 416 in Secondary Hyperparathyroidism Trial

Amgen announced results from its Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) receiving hemodialysis.

Combination Antibiotic Effective for Complicated Intra-Abdominal Infections

Actavis announced positive topline results from its Phase 3 studies, RECLAIM-1 and -2, evaluating the use of ceftazidime-avibactam for the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI).

Palbociclib NDA Submitted for Advanced Breast Cancer

Pfizer announced that it has submitted an NDA to the FDA for palbociclib in combination with letrozole for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for the advanced disease.

Investigational Meningococcal B Vaccine BLA Under Review

The FDA has accepted for review Pfizer's Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), a vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10-25 year olds.

Rifaximin Efficacious in Irritable Bowel Syndrome with Diarrhea Trial

Salix announced top-line results from its Phase 3 TARGET 3 clinical trial evaluating rifaximin 500mg in patients with irritable bowel syndrome with diarrhea (IBS-D), who respond to an initial treatment course with rifaximin 500mg.

Mocetinostat Designated Orphan Drug for Diffuse Large B-Cell Lymphoma

The FDA has granted Orphan Drug designation to mocetinostat (Mirati Therapeutics) for diffuse large B-cell lymphoma (DLBCL).

Lucentis sBLA Submitted for Diabetic Retinopathy

Genentech has submitted a supplemental Biologics License Application (sBLA) to the FDA for Lucentis (ranibizumab) injection for the treatment of diabetic retinopathy.

BLA Submitted for Investigational IV Anthrax Immune Globulin

Emergent BioSolutions announced that it has submitted a Biologics License Application (BLA) to the FDA for Anthrax Immune Globulin Intravenous (Human) [AIGIV] as an intravenous therapy for inhalation anthrax.

Pacritinib Designated Fast Track for Myelofibrosis

The FDA has granted Fast Track designation to pacritinib (CTI BioPharma) for the treatment of intermediate and high risk myelofibrosis.

Jakafi sNDA Accepted for Polycythemia Vera

The FDA has accepted for filing the supplemental New Drug Application (sNDA) for Jakafi (ruxolitinib) for the treatment of polycythemia vera in patients who have inadequate response to or intolerant of hydroxyurea.