Drugs in the Pipeline
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.
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.
Alkermes announced positive results for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD).
Spectrum announced the submission of an NDA for Captisol-Enabled Melphalan (CE-Melphalan) HCl for injection (propylene glycol-free) for use as high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma, and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
NEPHROLOGY & UROLOGY NEWS
- Acute Kidney Injury (AKI)
- Chronic Kidney Disease (CKD)
- Contrast Nephropathy
- Cardiovascular Disease (CVD)
- Diabetic Nephropathy
- End-stage Renal Disease (ESRD)
- Lupus Nephritis
- Peritoneal Dialysis
- Secondary Hyperparathyroidism (SHPT)