Drugs in the Pipeline
Amgen announced pooled data from two Phase 3 trials evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis.
Merck has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for grazoprevir/elbasvir 100mg/50mg for the treatment of adults with chronic hepatitis C genotypes 1, 4, or 6 infection
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).
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