Drugs in the Pipeline
The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) to Neutrolin Catheter Lock Solution for oncology, hemodialysis, and intensive care unit patients, where catheter-related blood stream infections and clotting can be life threatening.
The Alzheimer's Drug Discovery Foundation has awarded a $900,000 grant to AgeneBio to support the initiation of a Phase 3 clinical trial with AGB101 for the treatment of amnestic mild cognitive impairment (aMCI).
Amgen announced that it has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Kyprolis (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.
The Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for Praluent (alirocumab) for the treatment of hypercholesterolemia.
The Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate (Janssen R&D) to treat schizophrenia in adults.
The Food and Drug Administration (FDA) has granted Fast Track designation to deflazacort (Marathon Pharmaceuticals) for the treatment of patients with Duchenne Muscular Dystrophy (DMD).
The Food and Drug Administration (FDA) has granted Fast Track status to CPX-351 (cytarabine:daunorubicin; Celator Pharmaceuticals) for the treatment of elderly patients with secondary acute myeloid leukemia (AML).
Amgen announced new data from its PEAK and PRIME studies that support Vectibix (panitumumab), in combination with FOLFOX, as first-line therapy in patients with wild-type RAS metastatic colorectal cancer (mCRC)
Pernix announced that the sNDA for Treximet (sumatriptan/naproxen sodium) for use in adolescents aged 12-17 years for the acute treatment of migraine with or without aura has been accepted by the FDA.
A new oral vaccine to prevent HIV infection that does not contain the HIV virus is currently being tested in clinical trials at the University of Rochester Medical Center.