Category: Approval

August 25, 2017 Off

FDA OK’s Novo Nordisk’s diabetes drug

By Dino Mustafić

The U.S. Food and Drug Administration (FDA) has approved a new indication for Novo Nordisk’s Victoza (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes and established CV disease.

August 24, 2017 Off

EC approves Novartis’s metastatic breast cancer drug

By Dino Mustafić

European Commission (EC) approved Novartis’s Kisqali (ribociclib) in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.

August 2, 2017 Off

FDA OK’s Gilead Sciences’s hepatitis C drug

By Dino Mustafić

The U.S. Food and Drug Administration (FDA) has approved updated labeling for Gilead Sciences’s Epclusa (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV.

July 26, 2017 Off

Midatech wraps up pre-clinical liver cancer programm, human studies in 2018

By Dino Mustafić

Midatech Pharma has prepared its candidate MTD119 (previously MTR104) for advanced liver cancer for the clinical testings, in a pre-clinical programme that included three subcutaneous or orthotopic liver cancer xenograft models treated with the active cytotoxic compound maytansine conjugated with Midatech’s gold nanoparticle (GNP) technology.