Drugs in the Pipeline
Genentech announced positive results from the pivotal Phase 3 GALLIUM study.
Sarepta announced that the Food and Drug Administration (FDA) is continuing the pending New Drug Application (NDA) review for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).
Galapagos announced positive study data from the Phase 2 trial, FITZROY, evaluating filgotinib for the treatment of Crohn's Disease. Detailed results were presented at Digestive Disease Week 2016 in San Diego, CA.
Symbiomix announced positive results from the second pivotal Phase 3 trial of SYM-1219 (secnidazole) for the treatment of bacterial vaginosis (BV).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Biohaven's investigational agent BHV-4157 for the treatment of Spinocerebellar Ataxia (SCA).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to VT-1598 (Viamet) for the treatment of coccidioidomycosis or Valley Fever, a common lung infection in the southwestern US.
Janssen announced new data from the Phase 3 study, IM-UNITI, showing that a significantly greater proportion of adult patients with moderate to severe Crohn's disease receiving maintenance treatment of Stelara (ustekinumab) achieved clinical remission at one year. Study findings were presented for the first time at Digestive Disease Week 2016.
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for oxymetazoline HCl cream 1% (Allergan) for the treatment of persistent facial erythema associated with rosacea in adults.
Synergy announced additional clinical data from two Phase 3 trials, Study-00 and Study-03, evaluating the efficacy and safety of plecanatide for the treatment of chronic idiopathic constipation (CIC). Study findings were presented at Digestive Disease Week (DDW) in San Diego.
Tonix Pharmaceuticals announced topline results from the Phase 2 AtEase Study, evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of military-related Post-Traumatic Stress Disorder (PTSD).
Celator announced that the FDA has granted Breakthrough Therapy designation to Vyxeos (CPX-351) for the treatment of adults with therapy-related acute myelogenous leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
The FDA has granted Fast Track designation for the investigational drug, VM202 (VM BioPharma/ViroMed), for the potential treatment of Amyotrophic Lateral Sclerosis (ALS).
AstraZeneca announced that the FDA has granted Orphan Drug designation to selumetinib for the adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC).
AstraZeneca announced that two pivotal Phase 3 registrational trials for benralizumab achieved their primary endpoint, demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo.
The FDA has granted Orphan Drug designation to ALLN-177 (oxalate decarboxylase; Allena) for the treatment of pediatric hyperoxaluria.
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)