Drugs in the Pipeline
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.
The FDA has accepted for filing the New Drug Application (NDA) for ready-to-use (RTU) bivalirudin (Eagle) for the treatment of patients undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIa inhibitor; undergoing PCI with, or at risk of heparin-induced thrombocytopenia and thrombosis syndrome; or with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).
Eli Lilly and Company announced results from the Phase 3 study evaluating whether the treatment effect of solanezumab was preserved within a pre-specified amount in patients with mild Alzheimer's disease who received solanezumab earlier in the disease compared to patients who began treatment at a later point.
Gilead Sciences announced results from Study 109, a Phase 3 study evaluating once daily single tablet regimen (STR) of elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, and tenofovir alafenamide 10mg (E/C/F/TAF) in adults switching from tenofovir disoproxil fumarate (TDF) containing regimens.
Researchers from the University of California, San Diego School of Medicine reported a new combination therapy that effectively treated hepatitis C virus (HCV) in patients co-infected with HIV.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Osmolex ER (amantadine HCl extended release tablets; Osmotica) for the treatment of levodopa induced dyskinesia (LID) for patients with Parkinson's disease.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to BMS-663068 (Bristol-Myers Squibb), when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to melphalan (Delcath Systems) for the treatment of cholangiocarcinoma.
Exelixis announced positive top-line results from the primary analysis of METEOR, a Phase 3 trial comparing Cometriq (cabozantinib) to everolomus in patients with metastatic renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI).
Bristol Myers Squibb Company announced that CheckMate-025, a Phase 3 study investigating Opdivo (nivolumab) vs. everolimus in previously treated patients with advanced or metastatic renal cell carcinoma (RCC) was stopped early due to the primary endpoint being met.
Heron Therapeutics announced that it has resubmitted its New Drug Application (NDA) for Sustol (granisetron) injection, extended release to the Food and Drug Administration (FDA) for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy HEC) regimens.
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)