Drugs in the Pipeline
The Food and Drug Administration has granted Fast Track status to Axovant Sciences for their investigational New Drug application for intepirdine for the treatment of dementia with Lewy bodies.
GW Pharmaceuticals announced positive data from the second randomized, double-blind, placebo-controlled Phase 3 trial of Epidiolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).
Janssen announced the submission of a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib; Janssen and Pharmacyclics) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy.
Janssen Biotech announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for the approval of sirukumab for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
The Food and Drug Administration (FDA) has granted Fast Track designation to Sanaria PfSPZ Vaccine, a preventative vaccine for malaria.
The FDA has granted Fast Track designation to Aerosurf (lucinactant for inhalation; Windtree Therapeutics) for the treatment of respiratory distress syndrome (RDS) in premature infants.
The FDA has accepted for review the New Drug Application (NDA) for Yuvvexy (17β-estradiol; TherapeuticsMD) for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.
Aerie Pharmaceuticals announced topline data from the Mercury 1 study, a Phase 3 trial evaluating the fixed-dose combination product, Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, to lower intraocular pressure (IOP) in patients with glaucoma.
The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to VT-1598 (Viamet) for the treatment of coccidioidomycosis, or Valley Fever.
GlaxoSmithKline (GSK) announced the publication of results from The Phase 3 study, ZOE-70, evaluating the investigational shingles vaccine, Shingrix, in patients aged 70 years and older. Detailed study findings were published in the New England Journal of Medicine (NEJM).
Genentech announced new study analyses from ORCHESTRA, the Phase 3 clinical development program for Ocrevus (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
The Food and Drug Administration (FDA) has granted NYX-2925 (Aptinyx) Fast Track designation for the potential treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN).
The FDA has granted Orphan Drug designation to Coversin (Akari Therapeutics) for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), an ultra-rare, life-threatening and debilitating hematological disorder.
The FDA has granted MGB-BP-3 (MGB Biopharma) Qualified Infectious Disease Product (QIDP) designation for the treatment of Clostridium difficile-associated diarrhea (CDAD).
Lexicon announced positive findings from the pivotal Tandem 1 study, a Phase 3 trial of sotagliflozin for the treatment of type 1 diabetes.
Renal and Urology News Articles
- Uric Acid Threshold That Predicts Kidney Stone Formation Identified
- Hypogonadism in Male HD Patients Linked to Poor ESA Response
- Teaching Low Phosphorus Cooking May Improve Hyperphosphatemia
- Elevated CRP Linked With CKD Risk in Rheumatoid Arthritis
- Study Identifies Predictors of HD Initiation After AVF Surgery
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)