Pharmaceuticals, Biotechnology and Life Sciences
The U.S. Food and Drug Administration on Tuesday approved Gildad’s Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir.
Novatris has reported net income of $2.9 million for the second quarter of 2017 which is a slight decrease comparing the same period last year.
The U.S. Food and Drug Administration has approved Puma Biotechnology’s neratinib for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
Ablynx has announced that Hilde Windels will be nominated as an Independent Non-Executive Director at the Company`s forthcoming Special General Meeting of its shareholders to be held on 18 August 2017.
Novartis has confirmed positive 5 year efficacy and safety results for Cosentyx from a Phase III long-term extension study in patients with moderate-to-severe plaque psoriasis.
The U.S. Food and Drug Administration (FDA) has approved Janssen Biotech’s Tremfya (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the Mylan’s and Biocon’s proposed biosimilar trastuzumab.
European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for CTI BioPharma’s pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia.
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
Eli Lilly has entered into a settlement agreement with generic companies to resolve pending patent litigation in the U.S. District Court for the Eastern District of Virginia regarding the Cialis (tadalafil) unit dose patent.