Drugs in the Pipeline
Lexicon announced top-line results from the Phase 3 study, TELESTAR, which evaluated oral telotristat etiprate in cancer patients with carcinoid syndrome that is not adequately controlled by the current standard of care.
The New Drug Application (NDA) for EDO-S101 (Mundipharma) has been accepted by the Food and Drug Administration (FDA) for the treatment of relapsed or refractory hematologic malignancies and solid tumors.
Synergy announced positive top-line results from the second Phase 3 trial of plecanatide 3mg and 6mg doses in adult patients with chronic idiopathic constipation (CIC).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to dactinomycin nanoparticle formulation (NanoSmart) for the treatment of Ewing's sarcoma.
The New Drug Application (NDA) for NT-0202 (amphetamine XR-ODT, Neos) has been resubmitted to the Food and Drug Administration (FDA) for the treatment of attention-deficit/hyperactivity disorder (ADHD).
The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Rayaldee (calcifediol modified-release capsules, Opko) for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
Sanofi announced that the Phase 3 trial of the fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide met its primary endpoint in patients with type 2 diabetes treated with metformin.
The Food and Drug Administration (FDA) has accepted CSL Behring's Biologics License Application (BLA) for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment of hemophilia A.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lenvatinib for use in patients with advanced or metastatic renal cell carcinoma (RCC) who were previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy.
The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for grazoprevir/elbasvir (Merck) for the treatment of adult patients infected with chronic hepatitis C virus (HCV) genotypes (GT) 1, 4, or 6.
Eli Lilly announced the continuation of the Phase 3 trial of evacetrapib in participants with high-risk atherosclerotic cardiovascular disease (ASCVD).
Adapt Pharma announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Narcan (naloxone) Nasal Spray for the treatment of opioid overdose.
Janssen Therapeutics announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) to update the label for once-daily, all-oral Olysio (simeprevir) in combination with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection with or without cirrhosis.
The FDA has granted Fast Track designation to OMS721 (Omeros) for the treatment of patients with atypical hemolytic uremic syndrome (aHUS).
The sNDA for Kyprolis (carfilzomib, Amgen) was submitted to the FDA for the treatment of patients with relapsed multiple myeloma, who has received at least one prior therapy.
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)
- High-Grade Prostate Cancer Linked to Low Testosterone
- Statin Use Fails To Prevent Progression to Lethal Prostate Cancer
- Erectile Function Worsens In Most Men After Prostate Biopsy
- Biomarkers Help Distinguish Prostate Cancer from Prostatitis
- Low Magnesium Linked to Worse Survival in Hemodialysis Patients