Drugs in the Pipeline

Evacetrapib Phase 3 Study to Continue in High-Risk ASCVD

Eli Lilly announced the continuation of the Phase 3 trial of evacetrapib in participants with high-risk atherosclerotic cardiovascular disease (ASCVD).

Intranasal Narcan NDA Submitted for Opioid Overdose

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.

Olysio sNDA Submitted for Labeling Update

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.

OMS721 Granted Fast Track Designation for Atypical Hemolytic Uremic Syndrome

The FDA has granted Fast Track designation to OMS721 (Omeros) for the treatment of patients with atypical hemolytic uremic syndrome (aHUS).

Kyprolis sNDA Submitted for Expanded Relapsed Multiple Myeloma Indication

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.

FDA Accepts Ready-to-Use Bivalirudin NDA for Filing

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).

Delayed-Start Method Shows Early Treatment With Solanezumab Beneficial

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.

Single Tablet HIV-1 Infection Regimen Non-Inferior to TDF-Based Regimens

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.

First Study Tests New Combo Tx for HCV/HIV Co-Infection

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.

Osmolex ER Awarded Orphan Drug Status for Levodopa-Induced Dyskinesia in Parkinson's Disease

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.

BMS-663068 Receives Breakthrough Therapy Designation for HIV-Infection

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.

Melphalan Designated Orphan Drug for Bile Duct Cancer

The Food and Drug Administration (FDA) has granted Orphan Drug designation to melphalan (Delcath Systems) for the treatment of cholangiocarcinoma.

Cometriq Demonstrates Efficacy in Renal Cell Carcinoma Study

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).

Study on Opdivo for Renal Cell Carcinoma Halted Early

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.

Sustol NDA Resubmitted for Chemotherapy-Induced Nausea and Vomiting

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.