Drugs in the Pipeline
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.
The Food and Drug Administration (FDA) has granted orphan drug designation for Retrophin's sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS).
Debiopharm announced that the Food and Drug Administration (FDA) has granted Fast Track designation for Debio 1450, an antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
AbbVie announced positive results from one of two ongoing Phase 3 trials for elagolix in premenopausal women with endometriosis.
Soligenix announced that the FDA has granted a Fast Track designation for SGX301 (synthetic hypericin) for the first-line treatment of cutaneous T-cell lymphoma.