Drugs in the Pipeline
The Food and Drug Administration (FDA) has accepted for review the amended Biologics License Application (BLA) for Coagadex (coagulation factor X, human) for hereditary X deficiency.
Novartis announced results from its Phase 3 EXPEDITION trial for indacaterol/glycopyrronium (QVA149) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to CRLX101 (Cerulean Pharma) for the treatment of ovarian cancer.
Boehringer Ingelheim announced new data analyses from the Phase 3 TONADO 1&2 studies of tiotropium/olodaterol delivered via Respimat inhaler for chronic obstructive pulmonary disease (COPD).
Regeneron and Sanofi announced results from their Phase 3 SARIL-RA-TARGET trial of sarilumab in patients with rheumatoid arthritis (RA).
Ampio Pharmaceuticals announced positive results from the OptimEyes Trial for Optina in patients with diabetic macular edema (DME).
Tris Pharma announced that the Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for Dyanavel XR (amphetamine) CII, an Extended-Release Oral Suspension.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to revusiran (Alnylam) for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR amyloidosis).
Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy designation for the investigational daclatasvir and sofosbuvir combination for use in hepatitis C (HCV) patients.
Astellas Pharma and Medivation announced data from the Phase 2 STRIVE trial comparing Xtandi (enzalutamide) and bicalutamide in non-metastatic (M0) and metastatic (M1) prostate cancer patients whose disease progressed despite treatment with a luteinizing hormone-releasing hormone (LHRH) analogue therapy of following surgical castration.
Astellas Pharma announced results from the Phase 3b BESIDE trial with solifenacin (SOLI) with mirabegron (MIRA) as an add-on therapy in incontinent overactive bladder (OAB) patients.
The Food and Drug Administration (FDA) has granted Fast Track designations to luspatercept (Celgene and Acceleron) for use in two separate indications: for the treatment of patients with transfusion dependent beta-thalassemia and for the treatment of patients with non-transfusion dependent beta-thalassemia.
AbbVie announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for Humira (adalimumab) as an investigational treatment for moderate-to-severe hidradenitis suppurativa (HS; Hurley Stage II and III disease).
Vertex announced that the Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 12 to 1 to recommend that the FDA approve Orkambi (lumacaftor/ivacaftor) for people with cystic fibrosis (CF) aged 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The Food and Drug Administration (FDA) has granted Fast Track status to evofosfamide (Merck KGaA) in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer.
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)